Pauline Londeix, ACCESS (English Translation)

Lead Author: Pauline Londeix
Organization: ACCESS
Country: France

Abstract

INITIAL FINDING

Current treatments for the hepatitis C virus (HCV) would result in the eradication of HCV. Although the pandemic is now on the upswing, political will could reverse it. In early 2014, Médecins du Monde [Doctors of the World] published a report analyzing the pharmaceutical industry’s traditional strategies and comparing them to specific HCV epidemiological data. Whether they involved “standardized” pricing in high-income countries (HIC), “differentiated” pricing in middle-income countries (MIC), or voluntary licensing in low-income countries (LIC), this report demonstrated that access to these new medicines is being compromised.

RESULTS

Two years after this publication, it is clear that the pharmaceutical firms’ commercial strategies block access. These profit-based strategies are not compatible with the goals of universal access. What is more, these commercial strategies are to the detriment of respect for basic human rights, insofar as countries, including those with strong political wills, are unable to guarantee universal access to medicines because of their costs. In terms of public health, this is an aberration, to the extent that it is sometimes expected that patients must progress to a more advanced stage of fibrosis to obtain access to DAA.

CONCLUSION/ RECOMMENDATIONS/ IMPLEMENTATION

Recourse to flexibility in TRIPS [trade-related intellectual property] agreements is often found to be effective in terms of access. But this must be encouraged and supported by international institutions despite political pressures. These institutions must ensure that a generics industry and strong and independent sources of raw materials are capable of supplying countries that are excluded from voluntary licenses. Furthermore, at the same time, research and development systems and the negotiation of medicine prices must be completely re-thought and re-organized in order to conform solely to public health challenges, with no profit logic whatsoever.

Submission

The WHO [World Health Organization] estimates that 150 million people around the world are infected with chronic hepatitis C virus (HCV). The HCV epidemic is concentrated in middle-income countries (MIC), which account for 72% of affected persons, followed by 15% in high-income countries (HIC) and 13% in low-income countries (LIC) [i1]. 2014 marked a major turning point in the history of the HCV pandemic. New “direct-acting antiviral” (DAA) [1] treatments, which arrived on the market in early 2014, present a number of advantages over their predecessors (Peginterferon and Ribavirine).

The arrival of DAAs is the culmination of immense hope for millions of people who carry HCV, as their use may result in excellent treatment success rates. The most important molecule is sofosbuvir, which is marketed by Gilead, and is considered the “backbone” of the new cures. Declastavir, sold by Bristol-Meyers Squibb, is a priori the best option in combination with sofosbuvir.

“We are witnessing a revolution in the treatment of hepatitis C virus, with powerful molecules capable of healing the infection. There is no question that these treatments, which can save millions of lives, are not universally available at an affordable price,” declared Nobel Medicine Winner Prof. Françoise Barré-Sinoussi, on the occasion of the publication of the Médecins du Monde report “New Hepatitis C Treatments: Strategies for Universal Access.” [2]

This study heralded the arrival of the new treatments but showed concern at the issue of access. The study sought to determine whether universal access to these new treatments would be a reality in HIC, MIC and LIC. To this end, the report examined marketing strategies implemented by the brand pharmaceutical industry in all the various World Bank country categories with regard to access to HIV/AIDS treatments, and tried to estimate the number of persons affected, applying epidemiological data specific to HCV.

“Although they resulted in improved quality of life for individuals infected by HCV and an increased number of healings, the price of these new molecules put them out of reach of most people who needed them.” Médecins du Monde found that if these marketing strategies involving standard pricing, differentiated pricing and recourse to voluntary licensing were applied to the new HCV medicines, access to the medicines by the largest number of people would be impossible, particularly in countries (the majority) that lack national programs or a sufficient budget to combat hepatitis.

To guarantee a better impact in terms of public health, better consistency in the global HCV response and compliance with the basic human right of access to health, Médecins du Monde recommends learning from the lessons of the struggle against HIV/AIDS. “Although none of these strategies

favor access, what are our other options? In the case of HIV/AIDS, recourse to flexibility in TRIPS agreements has yielded very good results in terms of access and reduced prices of medicines.”

ACCESS TO HCV TREATMENT IN MIDDLE-INCOME COUNTRIES

The MdM [Médecins du Monde] study thus studied the pharmaceutical industry’s various commercial strategies around the world, as a function of the categories established by the World Bank. The five countries where the largest number of persons infected by HCV are concentrated are China, India, Egypt, Indonesia and Pakistan. According to the World Bank’s criteria, these countries are “middle-income countries” (MIC) [3] [4]. In MIC, the pharmaceutical industry holding active ingredients traditionally applies a “differentiated pricing” policy, which consists of proposing specific prices for each country, most often as part of opaque bilateral negotiations. A country’s negotiating abilities differ depending on its size, the likelihood it will resort to generics if its domestic laws so permit, its industry and the political will of the current government.

The Médecins du Monde study took the case of the cost of sofosbuvir in Egypt [i2] and Indonesia [i3]. In Egypt, the administration of sofosbuvir (alone) at the minimum price of 2,000 USD (price mentioned by Gilead at the time) to this entire population represented five times the country’s total public healthcare spending in 2011. In April 2014, the Egyptian patents office rejected Gilead’s patent application for sofosbuvir due to a “lack of innovation,” which afforded an opening to competition by generics on Egyptian territory. In order not to lose ground in the Egyptian market, Gilead finally included Egypt in its voluntary licensing program (VL) [5]. Competition by generics led to a low starting price of 800 USD for 12 weeks of treatment [6]. In reality, this price drop resulted from Gilead’s alignment on the price, as it was expecting to propose the Egyptian laboratory in the process of placing a generic on the market.

Médecins du Monde further emphasized that in Indonesia, over 9.9437 billion USD “would be necessary, i.e., slightly over the total annual healthcare budget, to supply sofosbuvir (alone) at a minimum price of 2,000 USD to 50% of the 9 million individuals living with chronic HCV.” Even if Gilead’s price in Indonesia was not yet confirmed, this projection had the advantage of applying a kind of order to the inconsistency and lack of reality of the policies implemented by the pharmaceutical industry in their treatment access programs, and the firms’ lack of interest in the impact of their programs on public health and healthcare systems.

A study was carried out by the organization I-MAK, which estimated the over-pricing due to lack of recourse to generics in several MIC [7]. These figures tell an eloquent story, and clearly demonstrate the consequences to healthcare systems of the lack of competition by generics.

These prices also prove that pharmaceutical firms do not seek to guarantee access to all their medicines, but are essentially aimed at also generating the greatest possible profit as quickly as possible. It might appear legitimate for richer countries to pay more than poorer countries for a given medicine. Unfortunately, in most of these countries, the constitution or the healthcare system do not guarantee free access to the essential medicines listed by the WHO.

Moreover, studies [8] have shown that the category of countries with the greatest amount of inequality, including in access to healthcare, and where most of the poor are concentrated around the world, are MIC.

Thus, even with a strong political will, most governments cannot buy new DAA at these prices, to be administered to all those who need them. That would mean dedicating a country’s entire public spending for a year or more to purchasing sofosbuvir. This would represent a major inconsistency in terms of public health. Even a strong political will and country commitments, as in Thailand and Georgia, have not resulted in a guarantee of universal access to date.

ACCESS TO HCV TREATMENT IN HIGH-INCOME COUNTRIES

In the United States, Gilead set the price for sofosbuvir at 1,000 USD per capsule, i.e., 84,000 USD for 12 weeks, which does not include the cost of other necessary molecules, diagnosis and biological monitoring. In this country, where the health insurance system is very complex and reimbursement systems vary, one portion of the individuals who need treatment must pay a share of this amount out of pocket [9] [10], as the various insurance systems have not truly tried to negotiate the best prices with firms. In the United States, sofosbuvir alone administered for 12 weeks costs 1.5 times more than annual average household income [i4]. The pharmaceutical lobby’s influence on politics and domestic economics prevents any transparency in the process surrounding medicine prices. However, recent studies have shown that generics, which represent some 80% of the medicines administered, “helped Americans save 193 billion USD in 2011” [11.]

In France, where the health insurance system allows patients to avoid these costs, Gilead initially requested over 61,216 USD from the Health Ministry for sofosbuvir. In 2014, individuals affected by fibrosis stages F2 to F4 and those suffering from complications represented 55% of the 232,196 persons affected by chronic hepatitis in France, i.e., 127,700 persons for whom treatment should be initiated [12]. The cost of sofosbuvir to the health insurance regime would therefore be 9.92 billion USD, which for comparison purposes, represents four times what France has paid to the Global Fund Against AIDS, Tuberculosis and Malaria (GFATM) since 2001 [I5].

In France, Gilead set its price at 49,000 USD for 12 weeks through the healthcare authorities. The French Health Ministry then took a heavy line to the laboratory, accusing it of pricing that “threatened the equilibrium of the French health insurance system” [13]. Negotiations lasted several months until the Minister announced to the National Assembly in November 2014 that it had come to an agreement with Gilead at 44,800 USD, congratulating herself “on these negotiations, which guaranteed access to high-quality and innovative healthcare, at the best cost for Social Security and patients” [i6 and i7]. The Minister then buried the possibility of issuing an official license for sofosbuvir: “Resorting at the outset to official licensing would undoubtedly lead us to a difficult forced relationship with the laboratory,” she declared. [15] According to estimates from a study yet to be published (Londeix P., ACCESS, 2016), the combination of sofosbuvir and daclatasvir would cost 74,300 USD per person. For 55% of individuals affected by chronic HCV, and given the need for immediate treatment, it would be necessary to spend 9.492 billion USD, i.e., more than the Paris public hospital system budget [i8] and [16].

In yielding to Gilead’s demands, the French Health Ministry weakened the basic health insurance principles decreed in 1945 just after the Second World War, including fairness and non-discrimination in access to care [17]. This choice was thus made despite good sense and the possibility of the French government’s resorting to flexibility in the TRIPS, issuing an official license, importing or producing a generic.

In the United Kingdom, the National Health Service (NHS) decided not to provide reimbursement for sofosbuvir [18] due to its price. In Germany, the healthcare authorities have recommended that doctors only prescribe sofosbuvir in the absence of any other alternative treatment. In Spain, given the consumer price of sofosbuvir, the government decided that only a very small number of individuals, i.e., fewer than 2% of those needing treatment, will have access to the treatments [19].

Two years after placing DAAs on the market in Western Europe and the United States, the MdM report accurately foresaw that the “standardized” pricing of Gilead and BMS would restrict access to DAA or considerably burden the healthcare systems, to the detriment of the combat against other diseases or the financing of other programs, which is an aberration in terms of public health, consistency in the policies carried out, and access to the basic human right of non-discrimination in access to care.

ACCESS TO HCV TREATMENT IN LOW-INCOME COUNTRIES

The signing of voluntary licenses (VL) is the strategy most often employed by the pharmaceutical industry in low-income countries (LIC). VLs address the firms’ industrial interests, allowing them to continue controlling markets. Unlike mandatory licenses, VLs are not based on flexibility in TRIPS. In the case of access to new HCV treatments, are VL effective? This question, which was raised by MdM in its report, found the start of a response over a two-year process. In 2014, Gilead approved a VL for sofosbuvir to Indian firms that produce generics. The first VL covered 60 countries. Later, this geographic territory was extended [20]. In

November 2015, BMS announced a VL agreement for daclasavir with the Medicines Patent Pool (MPP) [21].

VL on new HCV treatments have confirmed MdM’s hypothesis [i9]. In September 2014, HepCoalition.org performed new calculations, taking into consideration the new countries included in the geographic territory of the Gilead VL. 73 million individuals were potentially excluded from access to sofosbuvir [22]. A number of MIC, including China and Brazil, were excluded from this license.

Since 2014, have persons infected by HCV in countries included in these VL had access to the medicines? The minimum price for 12 weeks of sofosbuvir in generic form sold through the Gilead VL by an Indian generics producer currently remains exorbitant for LIC (800/900 USD/ person/ 12 weeks). A country such as the Democratic Republic of Congo, where millions of people are living with HCV, is characterized by a lack of basic healthcare structure, and has only very few chances of offering sofosbuvir to its population in the future at anywhere near 900 USD per person. In conclusion, in the absence of GFATM that allow for financing of the purchase of HCV treatments, it is quite likely that a number of people in LIC will suffer a lack of access to sofosbuvir. The contribution of these VLs is therefore only theoretical.

Moreover, by “waiving” its intellectual property rights in certain countries, Gilead and BMS have given a tainted gift to the PMA [sic; abbrev. not expanded in source] covered by the VL, insofar as the PMA have a period of time to apply the TRIPS and are not required to award patents, territorial law [sic]. In other words, in certain countries, Gilead, BMS and the MPP receive royalties for a medicine on which there is no intellectual property right.

Finally, in Egypt and Morocco, the patents offices of these two countries rejected Gilead’s patent application for sofosbuvir. In Egypt, a local laboratory began production of a generic. In Morocco, firms have stated their interest in doing so. To block development of the generic production of sofosbuvir outside India and its VL, Gilead decided to include these two countries in its VL.

Thus, it clearly appears that VLs allow the brand industry to control the production of generics, by keeping its thumb on the market for raw materials and by preventing generics producers who have signed a sub-licensing agreement from supplying countries excluded from the license, i.e., most MIC and HIC.

CONCLUSION

Unlike the situation facing HIV or HBV [hepatitis B virus], new treatments afford the hope of eradicating HCV. Although the pandemic is currently on an upswing, international and national political will would allow for a reversal of this trend, and attainment of the goal of eradication.

However, the commercial strategies of the pharmaceutical companies holding patents block access to the medicines. These policies, based on profit interests,

are not compatible with meeting the public health objectives of international organizations. What is more, these commercial strategies violate respect for basic human rights, insofar as even countries with high political will are unable to guarantee universal access to these medicines because of their costs. In terms of public health, this is an aberration, to the extent that it is expected that patients must have progressed to a more advanced stage of liver disease to obtain access to DAAs, as in the case in France.

Recourse to flexibility in the TRIPS has been shown to be effective when possible. But this must be encouraged and supported. Political pressures for countries to not use this flexibility are high. Moreover, a number of developing countries are currently negotiating bilateral trade agreements with the United States or the European Commission. These agreements tend to further strengthen the pharmaceutical industry’s monopolies. These agreements are incompatible with the goals of universal access to medicines.

Finally, the brand pharmaceutical industry has found a new opportunity to extend these monopolies. It is based on control of all global production of raw materials and quasi-total control of the generics industry around the world. Thus, without access to active ingredients for pharmaceutical products, i.e., the raw materials, production is not possible, even in the absence of intellectual property rights. In the case of HIV/AIDS, a generics industry that is independent and capable of producing very high volumes has resulted in the supply of antiretroviruses to millions of people around the world. This will also be necessary in the case of HCV.

RECOMMENDATIONS AND IMPLEMENTATION

Various strategies must be implemented simultaneously to remedy the current blockage, obtain global consistency and guarantee the best impact in terms of public health.

On the one hand we need a complete recasting of the research and development system, the negotiation of medicine prices, innovation prices, access to clinical data and the production of medicines.

Thus, in order to pragmatically and immediately address the problems of access, we recommend:

- Suspending the support of UN agencies for voluntary licenses that violate the principles of universal access to treatment and the principle of equitable access to care and thus of basic human rights

- Unfailing political and technical support by United Nations agencies to allow the largest number of countries to have recourse to flexibility in TRIPS

- Setting of a maximum price for new medicines for each country, with no possibility of appeal by the pharmaceutical firms

- Decree of laws to prevent anti-competitive practices with regard to access to medicines

- A moratorium on bilateral trade agreements that strengthen intellectual property rights

Bibliography and References

 [i1] illustration 1: Table showing the distribution of persons living with HCV. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [1] “Pipeline Report,” Treatment Action Group, Hepatitis C – new direct-acting anti-virals and the best possible combinations.

 [2] Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [3] World Bank, country classification

 [4] in Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i2] illustration 2: Egypt sofosbuvir cost estimate – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i3] illustration 3: Indonesia sofosbuvir cost estimate – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [5] Hepcoalition.org, “Gilead license for the HCV medicines sofosbuvir and ledipasvir: a fools’ market! http://www.hepcoalition.org/agir/outils-de-plaidoyer/article/licence-de-gilead-sur-les?lang=en

 [7] I-MAK-, see I-MAK study, September 2014

 [i4] illustration 4: United States: Average annual household income vs. 12 weeks of sofosbuvir treatment.- Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [12] in Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i5] illustration 5: Contribution of France to the 2001-2014 GFATM vs. cost of sofosbuvir for 55% of individuals living with chronic HCV in France – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [13] Le Monde, September 2014, Government attacks the exorbitant cost of an innovative hepatitis C medicine http://www.lemonde.fr/financement-de-la-sante/article/2014/09/29/le-gouvernement-s-attaque-au-cout-exorbitant-d-un-medicament-innovant-contre-l-hepatite-c_4496563_1655421.html#kY03cIWGoyGtVFru.99

 [i6 and i7] illustrations 6 and 7: French Health Ministry press release concerning the conclusion of negotiations on the price of sofosbuvir with Gilead Laboratories (November 2014)

 [15] “The minister added that measures exist, such as official licensing, established in 1992 and applied when a laboratory requests a very high price, but that it “had never been implemented” and she assumed that fee negotiations had failed. However, “negotiations are under way. (…) Resorting to official licensing at the outset would undoubtedly lead us into a difficult forced relationship with the laboratory,” added Mrs. Tourains. Le Figaro, “Hepatitis C: ‘an emergency solution’ for Touraine” http://www.lefigaro.fr/flash-actu/2014/10/08/97001-20141008FILWWW00387-hepatite-c-une-solution-d-urgence-pour-touraine.php

 [i8] Cost of sofosbuvir for 100% of persons infected by chronic HCV in France, for 55% of them, vs. annual Paris public hospital system budget, 2014. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [16] Data updated based on actual prices for Sovaldi and Daklinza in France – London P., Access, not yet published, 2016

 [17] The principles of fair and non-discriminatory health insurance in access to care http://www.ameli.fr/l-assurance-maladie/connaitre-l-assurance-maladie/missions-et-organisation/la-securite-sociale/histoire-de-l-8217-assurance-maladie.php

 [19] Spain/ See article: http://www.davidhammerstein.com/article-high-priced-hepatitis-c-treatments-spark-massive-public-outcry-and-political-debate-in-spain-125376732.html

 [20] see [5]

 [21] “Medicines Patent Pool signs licensing agreement with Bristol-Myers Squibb to facilitate access to daclatasvir, a hepatitis C medicine”

 [i9] Illustration 9: Estimate of number of persons excluded from the Gilead VL with 60 countries. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [22] see [5] and [20]

 [i1] illustration 1: Table showing the distribution of persons living with HCV. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i2] illustration 2: Egypt sofosbuvir cost estimate – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

[i3] illustration 3: Indonesia sofosbuvir cost estimate – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [4] in Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i5] illustration 5: Contribution of France to the 2001-2014 GFATM vs. cost of sofosbuvir for 55% of individuals living with chronic HCV in France – Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

[i6 and i7] illustrations 6 and 7: French Health Ministry press release concerning the conclusion of negotiations on the price of sofosbuvir with Gilead Laboratories (November 2014)

 [i8] Cost of sofosbuvir for 100% of persons infected by chronic HCV in France, for 55% of them, vs. annual Paris public hospital system budget, 2014. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

 [i9] Illustration 9: Estimate of number of persons excluded from the Gilead VL with 60 countries. Source: Londeix P., with Forette C., Médecins du Monde, March 2014; “New hepatitis C treatments: strategies for universal access”

Pauline Londeix (Original Language)

Lead Author: Pauline Londeix
Organization: ACCESS
Country: France

Click here to read the submission from Pauline Londeix

Safiatou Simpore Diaz, Yolse (English Translation)

Lead Author: Safiatou Simpore Diaz
Organization: Yolse
Country: Switzerland

Abstract

Conversion of the patent department of the national intellectual property offices of least developed countries (LDC) into an innovation, technology and science office (ex. Sub-Saharan Africa).

Since LDCs have been released from their obligation to protect pharmaceutical patents and clinical trial data, we propose converting the patent department of the national intellectual property offices of LDCs into innovation, technology and science offices.  Their objective is to ensure national coherence to correct the incoherence at the global level.  They will be responsible for coordinating the following activities:
- The effective implementation of the transition period for LDCs.
- Leveraging flexibilities to promote access to essential medicines.
- Coordinating the different national stakeholders.
- Establishing a strategy for attracting foreign investors.
- Coordinating the national capacity building activities.
- Promoting the adoption of a Research and Development treaty (R&D).

Submission

Contribution of the NGO Yolse to the work of the United Nations Secretary-General’s High-Level Panel Group on Access to Medicines
February 28, 2015

1. Access to medical products, a right to health?
Today, access to essential medicines, to diagnoses and to vaccines is both a moral and a legal requirement. The world has technical and scientific means at its disposal allowing access to medicines to save human live; these means are widely available in developed countries. Conversely, these means are inaccessible in least developed countries, which have a greater need for them.
Access to medicines is the realization of a fundamental right to health recognized in various international and regional instruments and evoked in several international studies. The realization of this right is a responsibility incumbent first and foremost on the States, which are primarily responsible for fulfilling the obligations in this field. Pursuant to article 12 of the International Covenant on Economic, Social and Cultural Rights of 1966 (ICESCR), the States are legally obligated to take necessary steps to prevent and treat their citizens’ illnesses. In fact, since the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) took effect in 1994, analyses have shown that apart from the precariousness of the healthcare systems, the TRIPS patent system prevents least developed countries (LDC) from benefiting from patented medicines and therefore from protecting the public health of their population. The media coverage given to access to HIV-AIDS drugs in South Africa in 1998 revealed to the world the conflict between the protection of pharmaceutical patent rights and the protection of the States’ right to health.

2. The right to health versus pharmaceutical patent rights

The conflict between the two rights has been ongoing since TRIPS took effect in 1994.
In fact, the high prices of certain essential medicines are due to the patent system, which grants it’s holder a monopoly. Nevertheless, an essential medicine must be available and affordable for all populations whatever their origin. However, the exclusive pharmaceutical patent protections system of the TRIPS Agreement prevents other players from producing the same medicine of sufficient quality and in sufficient quantity at an affordable price.
Thus, the World Trade Organization (WTO) recognized the effects of pharmaceutical patents on the price of medicines in the Doha Declaration on the TRIPS Agreement and Public Health of

2001. While recognizing “the right of the Members of the WTO to protect public health and, in particular, to promote access to medicines for all,” the Doha Declaration set forth a certain number of flexibilities allowing Least Developed Countries (LDC) to facilitate access to affordable medicines. The most important flexibility is the extension of the transition period specific to pharmaceutical products.  On November 6, 2015, the TRIPS Council extended this period until January 1, 2033.
Through the extension of the transition period, LDCs, particularly of Sub-Saharan Africa, have the possibility of fulfilling their obligations vis-à-vis their population in accordance with the regional and international agreements on the right to health while at the same time complying with their commitment relating to TRIPS.

3. Implementation of the transition period in Francophone Africa, a question of right to life, to health and to access to scientific development

The NGO Yolse in collaboration with the African Union, the United Nations Development Program (UNDP), UNAIDS, the Ambassador of Senegal, the South Centre and TWN organized a workshop on November 23, 2015 to raise the awareness of the representatives of the OAPI [African Intellectual Property Organization] member States concerning the importance of integrating the flexibility of the transition period in the Bangui Agreement. The Workshop was a success because, thanks to the awareness raising work of the NGO Yolse and its partners, the OAPI member States included the decision of the TRIPS Council of November 6, 2015 exempting LDCs from the obligation to grant or enforce patents on pharmaceutical products and to protect the data resulting from clinical trials in relation with pharmaceutical products until January 1, 2033 in the Bangui Agreement revised in Bamako on December 14, 2015.
The population of Sub-Saharan Africa is the population whose access to essential medicines is the weakest.  According to the World Health Organization, at least one-third of the world’s population does not have access to essential medicines.  This percentage exceeds 50% in the poorest regions of Africa and Asia.
This lack of access to essential medicines in Africa underscores the importance of implementing the TRIPS flexibilities granted to LDCs, particularly the one relating to the exclusion of the patentability of pharmaceutical products and the one concerning clinical trial data.

Since the adoption of the Doha Declaration on Public Health and the TRIPS Agreement in 2001, the LDCs of Sub-Saharan Africa have not been able to exploit the flexibilities made available to them to improve access to medicines. Certain countries have even introduced protective provisions for pharmaceutical patents in their laws that are more restrictive than the TRIPS   Agreement itself.  Through the revised Bangui Agreement of 1999. It is clear that under these circumstances, the States are unable to fulfill their duty to treat and prevent the illnesses of their population pursuant to art.12 ICESCR. However, experience has shown that the absence of a pharmaceutical patents has allowed the development of the pharmaceutical industry of a certain number of developed and developing countries.

For almost 111 years, i.e., from the Paris Convention of 1883 to the effective date of the TRIPS Agreement in 1994, developed countries were able to strengthen their pharmaceutical industries.  It was only after these industries had achieved a sufficient level of development that these countries established – even re-established – the protection of their pharmaceutical manufacturing. By way of example we can cite countries like Germany, France, Japan or Switzerland, which once again protected their pharmaceutical products during the 1960s to the 1970s.  To be fair, it would be desirable for LDCs to have a lengthy period like the developed countries so that they can create infrastructures and benefit from the necessary skills in the fields of research, development and pharmaceutical innovation.

It has often been mentioned that patents are key elements for pharmaceutical innovation and that without them, there would be no more research or development of new medicines.  However, the

current patent system has not fostered research and development in the case of neglected diseases that essentially affect developing countries.  In fact, the production of medicines to fight these diseases has only slight economic appeal for the major pharmaceutical companies. This is why it is necessary to encourage the adoption of the research and development treaty.

4. Proposals for helping to realize the right of the populations of LDCs to life and to health.

Our contribution is the following:

The conversion of the patent department of the national intellectual property offices of least developed countries (LDC) into an innovation, technology and science office (ex.:  Sub-Saharan Africa).

Since LDCs have been released from their obligation to protect pharmaceutical patents and clinical trial data following the extension of the transition period by decision of November 6, 2015, we propose converting the patents departments of the national intellectual property offices of LDCs into an office of innovation, technology and science. Their objective is to ensure national coherence to correct the incoherence at the global level.  They will be in charge of coordinating the following activities:
- The effective implementation of the transition period for LDCs.
- Leveraging flexibilities to foster access to essential medicines.
- Coordinating the different national stakeholders.
- Establishing a strategy for attracting foreign investors.
- Coordinating the national capacity building activities.
- Promoting the adoption of a research and development treaty (R&D).

IMPACT ON POLICY COHERENCE:

The problem of intellectual property and access to medicines, to vaccines and to diagnostic tools is linked to several factors necessitating a coherent national, regional and global approach.  We think that a coherent national policy will have more influence at the global level and therefore on the effectiveness of the entire system. Our proposal deals with national and global coherence.

Frequently in certain LDCs, political instability and constantly changing contacts prevent project monitoring. Additionally, the lack of communication between the different sectors concerned often results in a loss of crucial information. Thanks to coordination work and knowledge of the country’s national realities, the national office of innovation, technology and science that we are proposing would deal with the effective implementation of the flexibilities of the TRIPS Agreement and the special extension of the transition period for LDCs set forth in the Doha Declaration on Public Health and the TRIPS Agreement and the flexibilities of the TRIPS Agreement. Furthermore, it would be responsible for implementing all of the alternative solutions favorable to public health.   Finally, it would ensure that any intellectual property or trade rule that conflicts with access to medicines is revised.


IMPACT ON PUBLIC HEALTH:

At present, we can cite by way of illustration, the Global Fund, the (President's Emergency Plan for AIDS Relief) PEPFAR and other donations that guarantee access to 1st line AIDS drugs.  On the other hand, the case of 2nd and 3rd-line anti-retrovirals (ARV) has not been settled. There are also treatments like those for cancer and hepatitis C that are inaccessible to the populations of LDCs.  For example, the current price of sofosbuvir is 41,000 euros in France and 74,000 euros in the United States for a complete twelve-week treatment. Only competition between generics manufacturers could make these medicines accessible in LDCs.  Today, there are no international funds or donations for these diseases.  Furthermore, these are not sustainable solutions.  Therefore, our proposal would effectively lower the price of and accelerate access to medical products. The budget of LDCs dedicated to purchasing will be the same, but the quantity of medicines available would increase appreciably and they would be available in national pharmacies.  There will also be a general impact on health because the office’s work to promote innovation and research at the national level will make it possible in the long-term to produce medicines locally. If these types of offices exist everywhere in the LDCs of Sub-Saharan Africa, they will be provide human and scientific resources in support of the African Union’s manufacturing plan.


ADVANCING HUMAN RIGHTS:

The coordinated work of the national office would inevitably encourage the progressive and sustainable realization over time of human rights in LDCs. It would thus ensure that the national efforts are dedicated to the achievement of progressive access to pharmaceutical products.  In accomplishing its tasks, the office should strive at both the regional and international levels to prevent all initiatives to strengthen pharmaceutical patent rights relating to LDCs because these rights prevent the States from being able to prevent and treat the diseases from which their populations suffer in accordance with art.12 ICESCR. However, the national office is required to defend the necessity of introducing a treaty governed by international law relating to research and development that disassociates the cost of research and development from the cost of medicines making it possible to undertake research to find medicines intended for neglected diseases. Finally, the office would favor the right of all peoples to acquire knowledge in the medical sciences in order to build a local pharmaceutical production industry, which is essential for achieving the objectives of the right to health. In general, “the right to science is considered a means of advancing toward the realization of other human rights and of responding to the common needs of all mankind. “ In the same way, it has been recognized that the progress of science and of technology and the transfer of science and technology are of major importance for accelerating the economic and social development of developing countries.  This is the condition under which LDCs will be able to achieve the objectives of sustainable development, the right to live and to health.


IMPLEMENTATION:

The conversion of the offices will not require other financial costs because they would operate with the existing budget. The national authorities will potentially be able to strengthen this conversion to expand research and development at the national level in view of local production. What would change would be their objectives, their strategies and the composition of the members. The existing staff would remain in place, but they would be retrained to make their work more relevant with respect to public health needs. The goal is to concentrate the mobilization of national resources, to implement the flexibilities of the TRIPS Agreement and the Doha Declaration on Public Health and TRIPS in order to improve access to pharmaceutical products. This also involves coordinating the national capacity building activities concerning intellectual property and public health, the transfer of technology as well as the creation of capacities in the research and science sectors and a solid pharmaceutical technology. The office is a project targeting the achievement of sustainable development objectives. Therefore, it is presented as a structure that should withstand political instability and the lack of coordination between the different national and international stakeholders. To this end, stakeholders with regard to health, education, scientific research, intellectual property right, industry, trade and foreign affairs should be set up.
A group of experts in promoting access to pharmaceutical products and in pharmaceutical innovation would then provide support for the office.  The office would also work with universities, NGOs and development organizations such as, for example, UNDP, UNCTAD, etc.

In concrete terms, a pilot project could be set up quickly in Burkina Faso. Then, this experience could be extended to other LDCs.

Bibliography and References

Bibliography
1 The Universal Declaration of Human Rights of 1948 (article 25), the International Covenant on Economic, Social and Cultural Rights of 1966 (article 12(1)), the International Convention on the Elimination of All Forms of Racial Discrimination of 1965 article 5 (e) (iv), the Convention on the Elimination of all Forms of Discrimination against Women of 1979 articles 11.1 (f) and 12 and the Convention on the Rights of the Child of 1989 article 24, the WHO Constitution.
2 The European Social Charter of 1961 revised (Art. 11), the African Charter on Human and Peoples’ Rights of 1981 (art. 16) and the Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights of 1988 (art 10). And the Vienna Declaration and program of action of 1993.
3 The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), 2006 report, p.22., Consultative Expert Working Group, 2012 report, p.9. (CEWG).
4 Centrale Sanitaire Suisse Romande (CSSR), Propriété intellectuelle et accès aux medicaments: l’impact de l’Accord sur les Aspects de Droits de Propriété Intellectuelle qui touchent au Commerce (ADPIC) sur l’accès aux medicaments essentials, [Intellectual Property and access to medicines: the impact on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the access to essential medicines], Geneva, Switzerland, 2006, p.40.
5 Elangi Botoy Ituku, Propriété intellectuelle et droits de l'homme, L'impact des brevets pharmaceutiques sur le droit à la santé dans le contexte du VIH/SIDA en Afrique [Intellectual property and human rights.  The impact of pharmaceutical patents on the right to health in the context of HIV/AIDS in Africa], Schulthess Verlag, Genevan Collection, Zurich, 2007, p.3., http://www.section27.org.za/wp-content/uploads/2010/10/TACvMSDstatementOfComplaint.pdf.
6 Doha Declaration, §3 in fine.
7 This decisions implements the second and third sentences of section 7 of the Doha Declaration on the TRIPS Agreement and Public Health. Least developed countries will not be required to protect patents for pharmaceutical products or data resulting from clinical trials until January 1, 2016.  Now until 2033.  The LDCs have the right to request a subsequent extension beyond January 1, 2033 (66§1 TRIPS).
8 TRIPS Council decision of November 6, 2015.
9 WHO Medicines Strategy: Framework for action in Essential Medicines and Medicines Policy 2000–2003, p.38.
http://apps.who.int/medicinedocs/pdf/s2282f/s2282f.pdf.
10 Bangui Agreement revised, 1999. http://oapi.int/index.php/oapi/cadre-juridique/accord-de-bangui?lang=fr-FR.
11 https://www.erudit.org/revue/cd/2005/v46/n3/043861ar.pdf. Richard Gerster, Patents and Development, Lessons learnt from the economic history of Switzerland, 2002, p.2.
12 Council on Health Research for Development (COHRED) and New Partnership for Africa’s Development (NEPAD, Strengthening pharmaceutical innovation in Africa.  Developing national pharmaceutical innovation strategies:  choices for the decision-makers and the countries, 2010. P.31.
13 Several regional and international organizations and NGOs have expressed the interest for LDCs in taking advantage of the leeway provided by the TRIPS Agreement and by the Doha Declaration on Public Health and the TRIPS Agreement.  The African Union expressed [it?] in Ibid. p.10 and in the Roadmap on Shared Responsibility and Global Solidarity for AIDs, Tuberculosis and Malaria Response in Africa. Through the joint publication of the United Nations program, ONUSIDA, Implementation of TRIPS and Access to Medicines for HIV after January 2016: Strategies and Options for Least Developed Countries, Technical Brief 2011., ONUSIDA, Using TRIPS flexibilities to improve access to HIV treatment, Policy Brief, 2011., ONUSIDA, TRIPS transition period extensions for least-developed countries, issue Brief, 2013). The WHO, in its “Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.” Resolutions WHA61.21.
14 Ibid., p.5.
15http://www.lemonde.fr/planete/article/2015/02/10/conflit-autour-d-un-traitement-contre-l-hepatite-c_4573300_3244.html. Consulted on 2/27/2016.
15 ONUSIDA, Using TRIPS flexibilities to improve access to HIV treatment, Policy Brief, 2011, p.5.
16 Pharmaceutical Manufacturing Plan for Africa; http://apps.who.int/medicinedocs/en/d/Js20186en/., http://au.int/en/sites/default/files/newsevents/workingdocuments/14462-wd-pmpa_strategic_framework_1.pdf.
17 WHO, Constitution, preamble, p.1. http://www.who.int/governance/eb/who_constitution_fr.pdf.
18 https://documents-dds-ny.un.org/doc/UNDOC/GEN/G12/134/92/PDF/G1213492.pdf?OpenElement, p.3.
Declaration on the use Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind. Proclaimed by the United Nations General Assembly on November 10, 1975 [resolution 3384 (XXX)]. http://www.ohchr.org/FR/ProfessionalInterest/Pages/ScientificAndTechnologicalProgress.aspx

Safiatou Simpore Diaz, Yolse (Original Language)

Lead Author: Safiatou Simpore Diaz
Organization: Yolse
Country: Switzerland

Abstract

La transformation du département des brevets des bureaux nationaux de propriété intellectuelle des pays les moins avancés (PMA) en bureau de l’innovation, de l’accès à la technologie et à la science (ex: Afrique Subsaharienne).

Les PMA ayant été libérés de leur obligation de protéger les brevets pharmaceutiques et les données des essais cliniques suite à l’extension de la période transitoire sur décision du 6 novembre 2015, nous proposons de transformer le département des brevets des offices nationaux de propriété intellectuelle des PMA en bureau de l’innovation, de l’accès à la technologie et à la science. Leur but est d'assurer la cohérence nationale pour corriger l'incohérence au niveau globale. Ils seront chargés de coordonner les activités suivantes:
- De la mise en œuvre effective de la période transitoire pour les PMA.
- D’utiliser le levier des flexibilités pour favoriser l’accès aux médicaments essentiels.
- De coordonner les différents acteurs nationaux.
- De mettre en place une stratégie pour attirer des investisseurs étrangers.
- De coordonner les activités de renforcement de capacité nationale.
- De promouvoir l’adoption d’un traité de recherche et développement (R&D).

Submission

Contribution de l’ONG Yolse au travail du Groupe d’Experts de Haut Niveau du Secrétaire général des Nations Unies sur l’Accès aux Médicaments
28 février 2015

1. L’accès aux produits médicaux, un droit à la santé ?
Aujourd’hui, l’accès aux produits médicaux essentiels, aux diagnostics et aux vaccins est un impératif à la fois moral et juridique. Le monde dispose des moyens techniques et scientifiques permettant l’accès aux médicaments pour sauver des vies humaines, ceux-ci étant largement disponibles dans les pays développés. En revanche, ces moyens sont inaccessibles dans les pays les moins avancés qui en ont le plus grand besoin.
L’accès aux médicaments est la réalisation d’un droit fondamental à la santé reconnu dans divers instruments internationaux , régionaux et rappelé dans plusieurs études internationales . La concrétisation de ce droit est une responsabilité qui incombe au premier chef aux Etats, débiteurs principaux des obligations dans ce domaine. En vertu de l'article 12 du le Pacte international relatif aux droits économiques, sociaux et culturels de 1966 (PIDESC), les Etats sont dans l'obligation légale de prendre des mesures nécessaires pour prévenir et soigner les maladies de leurs populations. En effet, depuis l’entrée en vigueur de l’Accord sur les aspects de droit de propriété intellectuelle qui touchent au commerce (ADPIC) en 1994, les analyses ont montré qu’en dehors de la précarité des systèmes de santé, le régime des brevets de l’ADPIC empêche les pays les moins avancés (PMA) de bénéficier des médicaments sous brevets et ainsi de protéger la santé publique de leur population . La médiatisation de l’accès aux médicaments contre le VIH-SIDA en Afrique du Sud dans les années 98 a révélé au monde le conflit entre la protection des droits des brevets pharmaceutiques et celle du droit à la santé pour les Etats .

2. Le droit à la santé versus le droit des brevets pharmaceutiques

Le conflit entre les deux droits est permanent pour les pays en développement depuis l’entrée en vigueur de l’ADPIC en 1994.
En effet, les prix élevés de certains médicaments essentiels de base sont dus au système de brevets qui accorde un monopole à son détenteur. Pourtant, un médicament essentiel de base doit être disponible et abordable pour toutes les populations quelle que soit leur origine. Or le système exclusif de protection des brevets pharmaceutiques de l’Accord ADPIC empêche d’autres acteurs de produire le même médicament en qualité et en quantité suffisante et à un prix abordable.
Ainsi, l’Organisation Mondiale du Commerce (OMC) a reconnu les effets des brevets pharmaceutiques sur les prix des médicaments dans la Déclaration de Doha sur l'Accord sur les ADPIC et la santé publique de 2001 . Tout en reconnaissant « le droit des Membres de l'OMC de protéger la santé publique et, en particulier, de promouvoir l'accès de tous aux médicaments », la Déclaration de Doha a énoncé un certain nombre de flexibilités susceptibles de permettre aux Pays les moins avancés (PMA) de faciliter l’accès à des médicaments abordables. La flexibilité la plus importante est la prolongation de la période de transition spécifique aux produits pharmaceutiques . Le 6 novembre 2015 le Conseil des ADPIC a prolongé cette période transitoire jusqu’au 1er janvier 2033 .
Les PMA, notamment d’Afrique subsaharienne, ont à travers l’extension de la période transitoire la possibilité de remplir leurs obligations vis-à-vis de leur population conformément aux conventions régionales et internationales sur le droit à la santé tout en respectant leur engagement relatif à l’ADPIC.

3. Mis en œuvre de la période transitoire en Afrique francophone, une question de droit à la vie, à la santé et à l'accès au développement scientifique

L’ONG Yolse en collaboration avec l’Union Africaine, le Programme des Nations Unies pour le Développement (PNUD), l’ONUSIDA, l’Ambassadeur du Sénégal, le South Centre et le TWN ont organisé un atelier le 23 novembre 2015 en vue de sensibiliser les représentants des Etats membres de l’OAPI de l’importance d’intégrer la flexibilité de la période transitoire dans l’Accord de Bangui. L’Atelier a eu un succès car grâce au travail de sensibilisation de l’ONG Yolse et ses partenaires, les Etats membres de l’OAPI ont intégré dans l’Accord de Bangui révisé à Bamako le 14 décembre 2015, la décision du Conseil des ADPIC du 6 novembre 2015 exemptant les PMA de l’obligation d'accorder ou de faire respecter les brevets sur les produits pharmaceutiques et de protéger les données résultant d’essais cliniques en rapport avec les produits pharmaceutiques jusqu'au 1er Janvier 2033.
La population d’Afrique subsaharienne est celle dont l’accès aux médicaments essentiels de base est le plus faible. Selon l’Organisation Mondiale de la Santé, au moins un tiers de la population du monde n’a pas d’accès aux médicaments essentiels. Ce pourcentage dépasse les 50% dans les régions les plus pauvres d’Afrique et d’Asie .
Ce manque d’accès aux médicaments essentiels en Afrique souligne l’importance de mettre en œuvre les flexibilités ADPIC accordées aux PMA, notamment celle relative à l’exclusion de la brevetabilité des produits pharmaceutiques et celle concernant les données des essais cliniques.

Depuis l’adoption de la Déclaration de Doha sur la santé publique et l’Accord ADPIC en 2001, les PMA d’Afrique subsaharienne n’ont pas su exploiter les souplesses mises à leur disposition pour améliorer l’accès aux médicaments. Certains pays ont même introduit dans leur législation des dispositions de protection des brevets pharmaceutiques plus restrictives que l’ADPIC lui-même. Par l’Accord de Bangui révisé de 1999 . Il est évident que dans ces conditions, les Etats sont dans l’incapacité de remplir leur devoir de soigner et de prévenir les maladies de leur population au titre de l’art.12 PIDESC. Or, l’expérience a montré que l’absence de brevet pharmaceutique a permis le développement de l’industrie pharmaceutique d’un certain nombre de pays développés et en développement.

Depuis près de 111 ans, soit depuis la Convention de Paris de 1883 jusqu’à l’entrée en vigueur de l’Accord ADPIC en 1994, les pays développés ont pu renforcer leurs industries pharmaceutiques. Ce n’est que lorsque celles-ci ont atteint un niveau de développement suffisant que ces pays ont instauré -voire réinstauré- la protection de leurs productions pharmaceutiqus. On peut citer à titre d’exemple les pays comme l’Allemagne, la France, le Japon ou la Suisse qui ont protégé à nouveau leurs produits pharmaceutiques dans les années 60 à 70 . Afin d’être équitable, il serait souhaitable que les PMA disposent d’un large délai à l’instar des pays développés afin qu’ils puissent créer des infrastructures et bénéficier des compétences nécessaires dans les domaines de la recherche, du développement et de l’innovation pharmaceutique.

Il a souvent été mentionné que les brevets sont des éléments-clés pour l’innovation pharmaceutique et que sans eux, il n’y aurait plus ni recherche, ni développement de nouveaux médicaments. Or le système de brevet actuel n’a pas favorisé la recherche et le développement dans le cas des maladies négligées qui touchent essentiellement les pays en développement. En effet, la production de médicaments pour combattre ces maladies n’a que peu d’attrait économique pour les grandes firmes pharmaceutiques. C’est pour cette raison qu’il faut encourager l’adoption du traité en recherche et développement .

4. Les propositions pour contribuer à concrétiser le droit des populations des PMA à la vie et à la santé.

Notre contribution est la suivante :

La transformation du département des brevets des bureaux nationaux de propriété intellectuelle des pays les moins avancés (PMA) en bureau de l’innovation, de l’accès à la technologie et à la science (ex: Afrique Subsaharienne) .

Les PMA ayant été libérés de leur obligation de protéger les brevets pharmaceutiques et les données des essais cliniques suite à l’extension de la période transitoire sur décision du 6 novembre 2015, nous proposons de transformer le département des brevets des offices nationaux de propriété intellectuelle des PMA en bureau de l’innovation, de l’accès à la technologie et à la science. Leur but est d'assurer la cohérence nationale pour corriger l'incohérence au niveau globale. Ils seront chargés de coordonner les activités suivantes:
- De la mise en œuvre effective de la période transitoire pour les PMA.
- D’utiliser le levier des flexibilités pour favoriser l’accès aux médicaments essentiels.
- De coordonner les différents acteurs nationaux.
- De mettre en place une stratégie pour attirer des investisseurs étrangers.
- De coordonner les activités de renforcement de capacité nationale.
- De promouvoir l’adoption d’un traité de recherche et développement (R&D).

IMPACT SUR LA COHÉRENCE DES POLITIQUES :

La problématique de la propriété intellectuelle et de l’accès aux médicaments, aux vaccins et aux outils de diagnostic est liée à plusieurs facteurs nécessitant une approche cohérente à la fois nationale, régionales et globale. Nous pensons qu’une politique nationale cohérente aura plus d’influence au niveau mondial, par conséquent sur l’efficacité de l’ensemble du système. Notre proposition traite de la cohérence nationale et globale.

Il est fréquent que dans certains PMA l’instabilité politique et le changement permanent d’interlocuteurs empêchent le suivi des projets. De plus, le manque de communication entre les différents secteurs concernés entraine souvent une perte d’informations cruciales. Grâce au travail de coordination et la connaissance des réalités nationales du pays, le bureau national de l’innovation, de l’accès à la technologie et à la science que nous proposons s’occuperait de la mise en œuvre effective des flexibilités de l’Accord ADPIC et l’extension spéciale de la période transitoire pour les PMA énoncés dans la Déclaration de Doha sur la santé publique et l’Accord ADPIC et les flexibilités de l’Accord ADPIC. En outre, il se chargerait de mettre en œuvre toutes les solutions alternatives favorables à la santé publique. Enfin, il s’assurerait que toute règle de propriété intellectuelle ou de commerce contraire à l’accès aux médicaments soit revisée.


IMPACT SUR LA SANTÉ PUBLIQUE:

Actuellement, nous pouvons citer à titre illustratif le Fond Mondial, le (President's Emergency Plan for AIDS Relief) PEPFAR et d’autres dons qui garantissent l’accès à la 1ère ligne des médicaments contre le sida. En revanche, le cas de la 2ème, la 3ème ligne d’anti-rétroviraux (ARV) ne sont pas réglés . Il existe aussi des traitements comme ceux contre le cancer et l’hépatite C qui sont inaccessibles aux populations des PMA. Par exemple, le prix actuel du sofosbuvir est de 41 000 euros en France et 74 000 euros aux Etats-Unis pour un traitement complet de douze semaines . Seule une concurrence entre les fabricants de génériques pourra rendre ces médicaments accessibles dans les PMA. Aujourd’hui il n’existe aucun fond international ou don pour ces maladies. De plus ce ne sont pas des solutions durables. Par conséquent, notre proposition aurait pour effet de faire baisser les prix et d’accélérer l’accès aux produits médicaux . Le budget des PMA dédié à l’achat sera le même mais la quantité de médicaments disponible serait sensiblement augmentée et disponible dans les pharmacies nationales. Il y aura aussi un impact général sur la santé car le travail de promotion à l’innovation et la recherche au niveau national du bureau permettra à long terme de produire localement des médicaments. Si de tels bureaux existent partout dans les PMA d’Afrique subsaharienne, ils seront un soutien en ressource humaine et scientifique pour le plan de fabrication de l’Union Africaine .


FAIRE PROGRESSER LES DROITS DE L’HOMME:

Le travail coordonné du bureau national favoriserait inéluctablement la réalisation progressive et durable dans le temps des droits de l’homme dans les PMA. Il s’assurerait ainsi que les efforts nationaux sont dédiés à l’accomplissement de l’accès progressif aux produits pharmaceutiques. Dans l’accomplissement de ses tâches, le bureau devrait s’atteler aussi bien au niveau régional qu’international à empêcher toutes initiatives de renforcement des droits de brevets pharmaceutiques relatifs aux PMA car ceux-ci empêchent les Etats de pouvoir prévenir et soigner les maladies dont souffrent leurs populations conformément à l’art.12. PIDESC. Toutefois, le bureau national est amené à défendre la nécessité d’introduire un traité de droit international de relatif à la recherche et développement dissociant le coût de la recherche et développement de celui des médicaments permettant d’entreprendre des recherches pour trouver des médicaments destinés aux maladies négligées. Enfin, le bureau favoriserait le droit de tous les peuples d’acquérir les connaissances en sciences médicales afin de construire une industrie locale de production pharmaceutique, essentielle pour atteindre les objectifs du droit à la santé. En général, « le droit à la science est considéré comme un moyen de progresser vers la réalisation des autres droits de l’homme et de répondre aux besoins communs à l’humanité tout entière» . De même il a été reconnu que le progrès de la science, de la technique et le transfert de la science et de la technique est d'une grande importance pour accélérer le développement économique et social des pays en développement . C’est à cette condition que les PMA pourront réaliser les objectifs du développement durable, le droit à la vie et à la santé.


MISE EN OEUVRE:

La transformation des bureaux ne nécessite pas d’autres frais financiers car ils fonctionneraient avec le budget existant. Les autorités nationales pourront éventuellement la renforcer pour accroitre la recherche et le développement au niveau national en vu de la production locale. Ce qui changera seraient leurs objectifs, leurs stratégies et la composition des membres. Le personnel existant restera en place mais il sera recyclé pour rendre son travail plus pertinent par rapport aux besoins de santé publique. Le but est de concentrer la mobilisation des ressources nationales, pour mettre en œuvre les flexibilités de l’Accord ADPIC et la Déclaration de Doha sur la santé publique et l’ADPIC afin d’améliorer l’accès aux produits pharmaceutiques. Il s’agit aussi de coordonner les activités de renforcement des capacités nationales en propriété intellectuelle et en santé publique, le transfert de technologie ainsi que la création des capacités dans les secteurs de la recherche, de la science et une technologie pharmaceutique solide. Le bureau est un projet visant à la réalisadtion des objectifs du développement durable. Donc il se présente comme une structure qui devrait résister à l’instabilité politique et le manque de coordination entre les différents acteurs nationaux et internationaux. A cette fin, il devrait être constitué des acteurs de la santé, de l’éducation, de la recherche scientifique, du droit de la propriété intellectuelle, de l’industrie, du commerce et des affaires étrangères.
Un groupe d’experts de promotion de l’accès aux produits pharmaceutiques et à l’innovation pharmaceutique viendrait par la suite en appui au bureau. Le bureau collaborerait également avec les universités, les ONG et les organisations du développement comme par exemple le PNUD, la CNUCED, etc.

De manière concrète, un projet pilote pourrait rapidement être mis en place au Burkina Faso. Ensuite, cette expérience pourrait être étendue à d’autres PMA.

References and Bibliography

Bibliographie
1 La Déclaration universelle des droits de l’homme de 1948 (article 25), le Pacte international relatif aux droits économiques, sociaux et culturels de 1966 (article 12(1)), la Convention internationale sur l'élimination de toutes les formes de discrimination raciale de 1965 article 5 (e) (iv), la Convention sur l'élimination de toutes les formes de Discrimination à l'égard des femmes de 1979 les articles 11.1 (f) et 12 et la Convention sur les Droits de l'enfant de 1989 article 24, la Constitution de l’OMS.
2 La Charte sociale européenne de 1961 révisée (Art. 11), la Charte africaine des droits de
Les homme et des peuples de 1981 (art. 16) et le Protocole additionnel à la Convention américaine des droits de l'homme, des droits économiques, sociaux et culturels de 1988 (art 10). De même que la Déclaration de Vienne et le programme d’action de 1993.
3 La Commission sur les Droits de Propriété intellectuelle, l'Innovation et la Santé publique (CIPIH), rapport de 2006, p.22., Consultative Expert Working Group, rapport de 2012, p.9. (CEWG).
4 Centrale Sanitaire Suisse Romande (CSSR), Propriété intellectuelle et accès aux médicaments : l'impact de l'Accord sur les Aspects de Droits de Propriété Intellectuelle qui touchent au Commerce (ADPIC) sur l'accès aux médicaments essentiels, Genève, Suisse, 2006, p.40.
5 Elangi Botoy Ituku, Propriété intellectuelle et droits de l'homme, L'impact des brevets pharmaceutiques sur le droit à la santé dans le contexte du VIH/SIDA en Afrique, Schulthess Verlag, Collection Genevoise, Zürich, 2007, p.3., http://www.section27.org.za/wp-content/uploads/2010/10/TACvMSDstatementOfComplaint.pdf.
6 Déclaration de Doha, §3 in fine.
7 Cette décision met en œuvre les deuxième et troisième phrases du paragraphe 7 de la Déclaration de Doha sur l'Accord sur les ADPIC et la santé publique. Les pays les moins avancés ne seront pas tenus de protéger les brevets pour les produits pharmaceutiques ni les données résultant d'essais jusqu'au 1er janvier 2016. Désormais jusqu’en 2033. Les PMA ont le droit de demander une prorogation subséquente au-delà du 1er janvier 2033 (66§1 ADPIC).
8 Décision du Conseil des ADPIC du 6 novembre 2015.
9 Stratégie pharmaceutique de l’OMS : cadre d’action pour les médicaments essentiels et politiques pharmaceutiques 2000–2003, p.38.
http://apps.who.int/medicinedocs/pdf/s2282f/s2282f.pdf.
10 Accord de Bangui revise 1999. http://oapi.int/index.php/oapi/cadre-juridique/accord-de-bangui?lang=fr-FR.
11 https://www.erudit.org/revue/cd/2005/v46/n3/043861ar.pdf. Richard Gerster, Patents and Development, Lessons learnt from the economic history of Switzerland, 2002, p.2.
12 Conseil de la recherche en santé pour le développement (COHRED) et Nouveau Partenariat pour le développement de, l'Afrique (NEPAD), Renforcer l'innovation pharmaceutique en Afrique, Élaborer des stratégies nationales d'innovation pharmaceutique : des choix pour les décideurs et les pays, 2010. P.31.
13 Plusieurs organisations régionales, internationales et ONG ont exprimé l’intérêt pour les PMA de tirer parti des marges de manœuvre prévues par l’Accord ADPIC et par la Déclaration de Doha sur la santé publique et l’ADPIC. L’Union Africaine a exprimé dans Ibid., p.10., et dans sa Feuille de route sur la responsabilité partagée et la solidarité mondiale pour le riposte au sida, à la tuberculose et au paludisme en Afrique. À travers la publication conjointe du programme des Nations Unies, ONUSIDA, Implementation of TRIPS and Access to Medicines for HIV after January 2016: Strategies and Options for Least Developed Countries, Technical Brief 2011., ONUSIDA, Using TRIPS flexibilities to improve access to HIV treatment, Policy Brief, 2011., ONUSIDA, TRIPS transition period extensions for least-developed countries, issue Brief, 2013). L’OMS, dans sa « Stratégie mondiale et Plan d’action pour la santé publique, l’innovation et la propriété intellectuelle », Résolutions WHA61.21.
14 Ibid., p.5.
15http://www.lemonde.fr/planete/article/2015/02/10/conflit-autour-d-un-traitement-contre-l-hepatite-c_4573300_3244.html. Consulté le 27.02.2016.
15 ONUSIDA, Using TRIPS flexibilities to improve access to HIV treatment, Policy Brief, 2011, p.5.
16 Pharmaceutical Manufacturing Plan for Africa : http://apps.who.int/medicinedocs/en/d/Js20186en/., http://au.int/en/sites/default/files/newsevents/workingdocuments/14462-wd-pmpa_strategic_framework_1.pdf.
17 OMS, Constitution, préambule, p.1. http://www.who.int/governance/eb/who_constitution_fr.pdf.
18 https://documents-dds-ny.un.org/doc/UNDOC/GEN/G12/134/92/PDF/G1213492.pdf?OpenElement, p.3.
Déclaration sur l'utilisation du progrès de la science et de la technique dans l'intérêt de la paix et au profit de l'humanité. Proclamée par l'Assemblée générale de l'Organisation des Nations Unies le 10 novembre 1975 [résolution 3384 (XXX)]. http://www.ohchr.org/FR/ProfessionalInterest/Pages/ScientificAndTechnologicalProgress.aspx

Jerome Reichman, DUKE UNIVERSITY SCHOOL OF LAW

Lead Author: Jerome Reichman
Additional Authors: Tracy Lewis and Anthony So
Organization: Duke University School of Law
Country: USA

Click here to read the submission from Jerome Reichman.

JASON CROSS, Foundation for Commercializing Innovation

Lead Author: Jason Cross
Organization: Foundation for Commercializing Innovation
Country: USA

Click hear to read the submission from the Foundation for Commercializing Innovation

German Holguin, OSC LatinoAmerica (English Translation)

Author: Germán Holguín
Organizations: Misión Salud; LAC-Global Alliance for Access to Medicines (Regional Organization); Ifarma Foundation; Colombian Commission of Legal Experts; Latin American Bishops’ Council (CELAM – Regional Organization); Committee on Oversight and Healthcare Cooperation (CVSC – Colombia); Brazilian Interdisciplinary AIDS Association – ABIA (Brazil); Gestos – Positive Sorology, Communication and Gender; National Network of Individuals Living with HIV/AIDS – São Luis/Maranhão Nucleus; IDDA Group of Rio de Janeiro;  Rio+ Youth Network (Brazil); Positive Effect Group Foundation (FGEP – Argentina); Latin American Network for Access to Medicines (RedLAM – Regional Organization); Argentine Network of Positive Individuals (Redar Positiva – Argentina); International Action for Health (Regional Organization)

Abstract

The lack of medicines is not a natural, inevitable and irreversible phenomenon, like an earthquake, but rather the result of strategies designed and executed by certain multinational pharmaceutical companies, with the support of their governments, to take over the pharmaceutical markets and impose high monopoly prices on them.

This situation occurs because there is no political clarity as to the right to health’s priority over commercial interests, and due to ignorance of the fact that models to promote innovation, such as intellectual property, are only valid if they benefit the population as a whole.

We identify three specific causes of this problem:

    i.      The current incentive model for medical technology R&D;

   ii.      High prices of medicines, particularly pioneer medicines; and

  iii.      Blocked access to generic medicines.

Since countries have the obligation both to take measures to gradually enforce the right to health, and to respect, protect and comply with this right, specifically guaranteeing access to the necessary medicines, we propose:

   1.      Abolishing pharmaceutical patents on medicines necessary for health and life.

   2.      Full use of public health safeguards applied in international regulations to counteract harmful effects on patients.

   3.      Promoting the legal classification of blocking of generic medicines as a Crime Against Humanity subject to prosecution in domestic and international courts.

Successful implementation of these proposals necessarily requires putting into effect a reform of the current model of healthcare innovation R&D.

The solution for the current lack of alignment between public health, innovation and trade starts with complete willingness by the players involved to prioritize the right to health over commercial interests.

Submission

As announced in the High-Level Panel’s invitation to accept contributions, there is a “lack of alignment between the rights of inventors, international human rights law, trade regulation and public health if it impedes innovation in healthcare technology and access thereto.”

In our opinion, this lack of alignment has its origin in:

    i.      The incentive model for medical technology R&D;

   ii.      High prices of medicines, particularly pioneer medicines; and

  iii.      Blocked access to generic medicines.

First cause: Incentive model for medical technology R&D.

With respect to medium- and low-income countries, addressing the diseases to which they are subject, including forgotten tropical diseases, requires significant efforts both to prevent them, through healthcare policies that systematically use cost-effective tools, such as mosquito nets, water purification, etc., and to develop and improve healthcare technologies appropriate for prevention, timely diagnosis and treatment of patients.

As diagnosed by the Consultative Expert Working Group (CEWG) established by the World Health Assembly (WHA) in its Resolution WHA63.28, the reason for the lack of healthcare R&D to address these diseases is the current system of incentives for this activity, which is based on inventors’ expectations of patenting their inventions and charging high monopoly prices for their products, allowing them to recoup their investment and frequently earn exaggerated profits.

As is obvious, this system of incentives causes resources intended for medical research to be concentrated in the development of business medicines, ignoring actual healthcare needs. In the words of a Bayer™ senior executive,

“We do not develop medicines for Indians. We do it for Western patients who can pay for them."

To reverse this situation, the CEWG recommends creating an alternative incentives system, severing the link between patients and high prices, for example, a public international fund, financed by a small percentage of the GDP of all countries, which would award significant economic premiums to inventors of technology intended for diseases prevalent in medium- and low-income countries. Innovations financed this way would be considered “public goods,” i.e., free of intellectual property obstacles.

Although it might seem impossible, the truth is that the failure of the patent-based R&D model is also clear in high-income countries, where high medicine prices due to patents are placing in check the financial sustainability of their healthcare systems. This is the case, for example, with cancer medicines, medicines for treating hepatitis C and biotechnology medicines, the unaffordable prices of which we cite further below.

It is clear that implementation of this initiative by the CEWG needs to be reestablished to include these clear phenomena in high-income countries and will require negotiation of a Global Agreement on Healthcare R&D. This has not been possible due to a lack of will in some leading countries. It is necessary to reverse this situation in a manner parallel to implementation of the proposals we raise here for addressing the other two causes.

Second cause: High medicine prices, especially for pioneer medicines.

The reason for their existence is primarily pharmaceutical patents which, by granting monopoly privileges, afford the opportunity to set product prices higher than those which would obtain in a competitive market, in order to recoup expenses incurred in the R&D process and obtain a reasonable profit.

The downside is that those who claim this privilege do not always exercise it responsibility, with a structure of production costs plus a rational profit margin, but rather apply completely speculative criteria. This practice results in scandalous prices, unaffordable both for the healthcare systems without risking their financial stability, and for individuals who must pay for their medicines out of pocket, which is frequently the case in medium- and low-income countries.

In cancer, for example, “among the 12 treatments approved in 2012 by the FDA, 11 cost some 100,000 US dollars per year,” making them unaffordable.

Sofosbuvir, used to treat chronic hepatitis C, currently has a price of USD$ 1,000 per day in the US, while its production cost is between USD$ 58 and USD$ 136. The private sector’s investment cost in R&D for this product has been estimated at USD$ 300 million, while sales were USD$ 10.3 billion in only one year (2014).

The situation is even more alarming in the case of biotechnologies used for treating acute diseases such as cancer, rheumatoid arthritis and diabetes, among others, the average prices of which range from 50,000 to 250,000 dollars/patient/year. There is also the additional factor that, according to a study by the University of Utrecht, the production cost/ sales price ratio is an average of only 2.3%.

Given the out-of-control increase in prices and healthcare spending, many countries have been forced to implement strategies to control this expense and improve affordability levels. The strategy that has proven to be the most effective is the stimulation of generic competition.

Third cause: Blocked access to generic medicines.

This is the set of intellectual property standards and practices by large pharmaceutical multinationals and their governments designed to block the supply of affordably priced generic medicines, to only those that can access

both the population and the healthcare systems without sacrificing the provision of other essential services.

Ironically, the reason for the existence of this blocking lies in the two essential attributes of generic medicines: good quality, as attested to by studies carried out in several countries, and affordable prices. Regarding the latter, in the international scenario, generics cost an average of one half to one third the cost of pioneer medicines, and in some cases almost 50 times less.

These qualities have opened the doors of the pharmaceutical markets to generics, with the consequent benefits in terms of public health, while at the same time unleashing the pharmaceutical multinationals’ strategies to block them. The following quote from a senior executive of a pharmaceutical multinational summarizes this attitude:

“We are not in the business of saving lives, but rather of making money. Saving lives is not our business.”

According to this principle, certain companies that manufacture pioneer medicines resort to every mechanism available to them, both legal and illegal, to retain and strengthen their monopoly, without regard to the consequent impacts on public health and the wellbeing of the people.

Among the most effective legal mechanisms are pharmaceutical patents, which offer their holders a nominal monopoly of 20 years and an effective monopoly of 10 to 15 years. During this period, generic versions may not enter the market, with the consequent effects on access and public healthcare.

We need to keep in mind that pharmaceutical patents have not always existed, as many believe, but rather were only invented a short time ago by the large pharmaceutical multinationals to protect their commercial interests. In England, Germany, Switzerland, Italy and Spain, for example, they were only established between 1949 and 1986; and in medium- and low-income countries in 1994, through the TRIPS [Trade-Related Aspects of Intellectual Property Rights] Agreement.

Countries should never have committed to granting them and should take the necessary steps to abolish them, as medicines are a public social good and not merchandise, and therefore are not subject to patent protection. Assuming the commitment to grant them is a serious violation of the right to health and life.

Contrasting with this reality are the recently concluded negotiations of the Trans-Pacific Partnership (TPP), which is in the process of being approved by the legislative bodies of the 12 signatory countries. Its provisions concerning intellectual property represent a threat to access to medicines that save lives.

Regarding the illegal mechanisms used to block generics, the three most common are:

    i.      Campaigns to discredit generics

   ii.      The payment of economic stimuli to physicians to prescribe certain pioneer products of identical quality as generics, but which are much more costly; and

  iii.      Agreements between manufacturers to delay the entry of generics into the market.

Conclusion

The problem of these three causes is that their effects are not limited to the field of economics, but rather they endanger the health and life of individuals. Because they depend on human intentions, they are an ethically censurable and legally condemnable event. Therefore, taking measures to end them is an imperative of social justice.

International regulation views the right of access to medicines as one of the basic elements for progressively achieving full exercise of the right to health. Countries have the obligation both to take measures to gradually achieve this right, and to respect it, protect it and comply with it, by specifically guaranteeing access to the necessary medicines.

PROPOSALS

   1.      Abolition of pharmaceutical patents on medicines necessary for health and life.

Keeping in mind the intense harm that pharmaceutical patents have caused to global public health since they were invented, in terms of the concentration of pharmaceutical innovation on “business medicines,” the setting of high monopoly prices

and the blocking of access to existing treatments, the time appears ripe to abolish them, at least for necessary medicines.

It is clear that this measure involves entering into a global agreement, the goal of which is to modify the TRIPS Agreement which, as explained above, globalized the commitment to award pharmaceutical patents. It is also necessary to modify regional, bilateral and multilateral commercial treaties in which this is being contemplated.

We are aware that abolition is an extreme measure, although not so much as was its establishment, but we also know that without it, it will not be possible to stop the blocking of affordable generic medicines. As long as there are mechanisms that favor monopolies and giant gains, the beneficiaries will persecute generic competition by all available means because they are not willing to lose their privileges.

Along this line of thinking, the document by the UNDP Global Commission on HIV and the Law, “Risks, Rights and Health,” which is part of the reason for convening this High Level Panel by the United Nations General Secretary, established the need to design “a new intellectual property regime for pharmaceutical products,” and states that until this is achieved, “WTO member states must urgently suspend TRIPS as it relates to essential pharmaceutical products for low- and medium-income countries.” That is to say, among other measures, suspend pharmaceutical patents in those countries.

The Special Rapporteur for Health for the United Nations, the WHO, DWB and other important international human rights organization say much the same thing: that is, there are clear indications of an international climate appropriate for the abolition of pharmaceutical patents.

As wisely noted by DNDi Director Dr. Bernard Pécoul:

“Patents are not divine rights. They are tools created to benefit society as a whole, and are not for a handful of pharmaceutical companies to line their pockets.”

It may be said that abolishing pharmaceutical patents is inconvenient because the high prices deriving from them are necessary for large pharmaceuticals to be able to recover the immense resources invested in R&D for products capable of curing diseases and saving lives. This is part of what we might call the myths of the pharmaceutical world. This truth is that:

    i.      The cost of developing a molecule is not 1.3 billion dollars, as the industry claims, but rather much less: 43.3 million, according to a London School of Economics study.

   ii.      This cost is not assumed by the pharmaceuticals but largely by governments: 85% in the case of the five most widely sold medicines in the US in recent years.

  iii.      Starting in the 1980s, when pharmaceutical patents first appeared, only 14 to 16% of new approved medicines were considered innovative. The rest were “me too” medicines, i.e., trivial modifications of known molecules, with therapeutic virtues similar to those of products already marketed but more costly. That is, rather than incentivizing innovation, patents are suppressing it.

  iv.      The treatment of diseases prevalent in the world requires a system to encourage innovation unrelated to patents, as mentioned above.

The initiative to design and put into place the process of abolishing pharmaceutical patents falls to the governments of every country, as part of their obligation to respect, protect and comply with the basic right to health. The support of international agencies charged with promoting and respecting this right is key for this process to occur and conclude successfully.

   2.      Full use of public health safeguards contained in international regulation to counteract the harmful effects of patents

Until abolition of pharmaceutical patents is achieved, governments have the task, resulting from the obligation to protect the right to health, to take the necessary measures to mitigate the harmful effects of patents by applying the legal instruments at their disposal, including the following:

    i.      Strict need to satisfy the established requirements for meriting the privilege of patent: novelty, inventive level and industrial application.

   ii.      Rejection of new intellectual property barriers or strengthening of existing ones through commercial treaties.

  iii.      Monitoring of abusive prices of medicines that most heavily affect the healthcare system and implementation of measures to control them.

  iv.      Full exercise of the right to use public health safeguards deriving from international regulation to counteract the harmful effects of pharmaceutical patents, especially mandatory licenses.

Regarding the last one, several reports from the United Nations’ Special Rapporteur for Health have recommended this measure, given the ability of mandatory licenses to favor competition, break monopoly prices and protect the right of access to necessary medicines.

Unfortunately, only a very few countries have dared to exercise this right, due to pressures from certain pharmaceutical multinationals and their governments.

Consequently, it is necessary to make a great effort on the part of the organizations charged with defending the right to health, to control these pressures and encourage countries to use the aforementioned instruments to the maximum extent.

   3.      Promoting the classification of blocking generic medicines, as a Crime Against Humanity subject to prosecution by domestic and international courts

Given the social effects of the blocking of generic medicines and the fact that it is not a matter of fate, but rather the result of policies and strategies conceived and executed by man, we have established the working hypothesis that this is a crime against humanity subject to prosecution by domestic and international courts.

In support of our position, there is evidence that the conduct that leads to this blocking results in disease, suffering and disability, and is responsible for the deaths of millions of human beings each year. Thus, in our view, it is first necessary that it satisfy the four essential requirements of crimes against humanity, and second, that it be framed as being among the criminal acts that are subject to such classification under the Statute of Rome.

What we propose in formulating this hypothesis is that the matter be submitted to the highest level of international debate, which would contribute to publicizing the

drama it is causing, open the doors to its inclusion on the policy agendas of international agencies responsible for protecting the right to health and life, and most assuredly unleash both a process of searching for and finding solutions, such as a change in commercial conduct and policies of major players in the international pharmaceutical industry.

To the extent that these three proposals are implemented along with a binding Global R&D agreement, a model will be achieved to promote innovation and the consistent development of healthcare, in which the human right to health is prioritized against profit interests; in which access to technology will not be blocked by intellectual property rights that permit medicine prices to be set based on speculative criteria; and in which there will be no opportunity to engage in practices that illegally block access by the lower-income population to affordable medicines.

The goal is to resolve policy inconsistencies by achieving a new world order in which the right to health is the basis for healthcare policy in every corner of the planet, against intellectual property rights, trade and the race for money.

As Pope Francis said in his Apostolic Exhortation Evangelii Gaudium, “As long as the problems of the poor are not radically resolved by rejecting the absolute autonomy of markets and financial speculation and by attacking the structural causes of inequality, no solution will be found for the world's problems or, for that matter, to any problems. Inequality is the root of social evil.”

OSC LatinoAmerica (Original Language)

Author: Germán Holguín
Organizations: Misión Salud; Alianza LAC-­‐Global por el Acceso a Medicamentos (Organización Regional); Fundación Ifarma; Comisión Colombiana de Juristas; Consejo Episcopal Latinoamericano (CELAM‐Organización Regional); Comité de Veeduría y Cooperación en Salud (CVCS –Colombia); Associação Brasileira Interdisciplinar de Aids –ABIA; Gestos - Soropositividade, Comunicação e Gênero; Rede Nacional de Pessoas Vivendo com HIV/AIDS -­‐Núcleo SãoLuis/Maranhão; Grupo Pela VIDDA do Rio de Janeiro; Rede Jovem Rio+; Fundación Grupo Efecto Positivo (FGEP-­‐ Argentina); Red Latinoamericana por el Acceso a Medicamentos (RedLAM - Organización Regional); Red Argentina de Personas Positivas (Redar Positiva-­‐Argentina); Acción Internacional para la Salud (Organización Regional)
 

Click here for the submission from OSC LatinoAmerica

Sergey Golovin, ITPCRU (English Translation)

Lead Author: Sergey Golovin
Additional Authors: Aleksey Mikhailov, Andrey Skvortsov, Georgy Giakonia, Gregory Vergus, Ksenia Babikhina, Natalia Egorova, S Natalia Khilko, Tatyana Khan,  Julia Dragunova
Organization: ITPCru
Country: Russia

Abstract

This presentation examines arguments supporting the statement that patent monopolies have extremely negative impact on affordability of medications even given the existence of the flexible provisions of the Agreement of Trade Related Aspects of Intellectual Property Rights (TRIPS) in national statutory regulations. The analysis of the market for anti-retrovial therapy for treating HIV (hereinafter – the ART) and the direct-acting antiviral medications (DAA) for treating hepatitis C (hereinafter (HCV) in the Russian Federation (RF) is used as an example.

Submission

The drug manufacturers’ monopoly status on the market that is due to exclusive ownership of Intellectual Property rights continues to directly impact the availability of vital therapy to patients and to a large extent contributes to the spread of epidemics on the global scale. Even if there are legislative mechanisms in any given country that allow balancing the interests of patent-holders and interests of public healthcare (the so-called flexible provisions of Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS), in real life their use is made difficult by a number of significant barriers. Among various problems, the lack of clearly defined procedures and criteria for using the TRIPS mechanisms should be noted, as well as numerous related regulations that prevent their use.
This presentation examines arguments supporting the statement that patent monopolies have extremely negative impact on afffordability of medications even given the existence of the flexible provisions of the Agreement of Trade Related Aspects of Intellectual Property Rights (TRIPS) in national statutory regulations. The analysis of the market for anti-retrovial therapy for treating HIV (hereinafter – the ART) and the direct-acting antiviral medications (DAA) for treating hepatitis C (hereinafter (HCV) in the Russian Federation (RF) is used as an example.
The HIV infection epidemic continues to grow in the Russian Federation and many experts, including those representing official institutions, describe the epidemiological situation as critical. According to the information of the AIDS Federal Center, over 900 thousand patients are currently registered with HIV infection diagnosis in the RF, and the annual growth of new HIV cases is approximately 10% [1].
Official figures show that approximately 200 thousand patients [3] receive ART; that said, according to independent estimates, this number may be lower in real life (around 160 thousand according to the data for 2015 of the Treatment Preparedness Coalition, to be published in March 2016). It must be noted that both official and unofficial estimates agree that the number of those who need ART exceeds the number of those who receive it by several times. In October 2015 the Minister of Health of the RF Veronika Skvortsova stated that the number of those who receive ART is only 23% of the total number of those who need it [2]. Taking into account the new HIV infection treatment protocols adopted by the World Health Organization (hereinafter – the WHO), according to which therapy should be prescribed when the number of CD4 cells is 500 or lower (this threshold used to be 350 cells), the need for medications may be even greater.
Besides the obvious negative implications to the health of those who live with HIV, this problem directly contributes to further growth of the epidemic. As the results of the HPTN052 study [4] show, the decrease of the viral load to an unmeasurable level as a result of having ART reduces the risk of viral transmission by 96%. It follows that extensive coverage by treatment programs should promote the halting of the epidemic, while a shortage of treatment, on the contrary, will significantly increase the risk of further expansion of the HIV infection.
Starting in 2010, regular shortages of anti-retrovial medications have been recorded in the RF, and recently more and more situations occur when, in the context of limited resources, AIDS Centers in a number of constituent territories of the RF do not prescribe therapy to new patients due to lack of funds for medications [5]. In the course of unofficial discussions with representatives of AIDS centers, public organizations receive information that the reason for this problem is the excessively high prices for a number of clinically significant medications, for which there are no counterparts on the market.
The HIV infection treatment program funded by the national budget began in Russia at the end of 2010’s. For the last five years the International Treatment Preparedness Coalition in partnership with other organizations has been independently monitoring procurement and provision of ART medications and HCV medications in Russia and a number of other countries in the Eastern Europe and Central Asia (EECA) region. According to the available information, the prices of medications, for which there are no counterparts on the market due to patenting, remain persistently high for a number of years, while prices for medications for which counterparts have been registered, go down tens of times [6]. Among expensive patented medications without counterparts, the protease inhibitors lopinavir/ritonavir (which is included in the preferred program for continued anti-retrovial therapy under the WHO protocols, patent EA011924B1, expires in 2024), atazanavir (patent RU2186070C2, expires in December, 2018), as well as the combination of nucleoside/nucleotide inhibitors for reverse transcriptase tenofovir/emtricitabine should be noted. This combination is part of the preferred program for early anti-retrovial therapy under the WHO protocols. Because of the registration policy of the company holding the patent, tenofovir/emtricitabine was not available on the RF market until 2012. The existence of the patent (EA015145B1, expires in 2024, there are also other patents) did not allow generics manufacturers to register on the RF market. As a result, the weighted average cost of this medication is approximately USD 3,700 per patient per year [6], which exceeds many times the minimum world price according to information of Doctors Without Borders [7]. The number of patients who receive this medication is less than 1% [6].
It is important to note that the medication tenofovir/emtricitabine/efavirenz in one pill is not registered on the RF market. That is why not a single patient in Russia receives the preferred program for early anti-retrovial therapy under the latest version of the WHO protocols (tenofovir, emtricibine or lamivudine and efavirenz as a combined medication with a fixed dosage, to be taken as one pill once a day) funded by the federal budget. We believe that in this case there is a flagrant violation of human rights to high quality, affordable healthcare services. The combined medication tenofovir/emtricitabine/efavirenz is patent-protected (patent EA015145B1, expires in 2024) and its generic counterparts are not registered in Russia.
Recently, the problem of limited access to medications due to patent barriers has also been actively discussed in the context of hepatitis C virus. According to approximate estimates, up to 5 million people with HCV [8] live in Russia. Therapy is provided to a limited number of patients as part of various federal and regional programs. According to market analysis, the number of people who receive therapy based on direct-acting antiviral medications (DAA ), which is the current world standard for treating HCV, is around one thousand patients (analysis information of the Treatment Preparedness Coalition, to be published in March 2016). The average cost of DAA therapy is around USD 10,000 [8], which is significantly higher than average income per person. That said, the medication sofosbuvir, which is found in most preferred programs for treating HCV according to recommendations of AASLD and EASL, is still not registered in Russia. Due to existence of patents, which patient organizations are currently trying to oppose, manufacturers of generics cannot register sofosbuvir in the RF at this time.
According to the World Bank classification, the Russian Federation is a country with a high level of income and it is to a large extent for this reason that it is systematically excluded from volunteer programs for improved accessibility practiced by pharmaceutical companies and other organizations, including the Medicines Patent Pool. Thus, Russia was not included in any licensing agreements entered into by the Medicines Patent Pool with manufacturers of medications for treatment of HIV infection and hepatitis C virus. Nor is Russia a part of geographical coverage of the agreement entered into by Gilead with a number of Indian companies for the right to manufacture and deliver medications for treatment of hepatitis C virus sofosbuvir, ledipasvir, and velpatasvir [9]. These facts, in conjunction with a large number of medication patents in the RF, mean that one of the few options to provide most access to medications is the use of the TRIPS regulatory mechanisms that allow removing patent barriers, which limit people’s right to healthcare.
The current legislation of the RF contains a number of similar mechanisms, including provisions for issuing compulsory licenses in cases of threat to national security and for opposing already granted patents (post-grant opposition) or patent applications (pre-grant opposition). However, until now, the opportunities for opposing patents have been used to a very limited extent, and the option for compulsory licensing of medications has never been used. Furthermore, key attempts to implement these mechanisms in the area of socially significant diseases (HIV, hepatitis C virus) were made by patient organizations. A recommendation of the option to issue compulsory licenses (hereinafter – CL) for medications to treat HIV infections was made by public organizations back in 2012. Subsequently, this recommendation was included in several reports on monitoring procurement and delivery of ART medications and anti-hepatitis medications in Russia, and in late 2015 nineteen public organizations sent a letter to the Government of the RF requesting considering  the option of issuing CLs due to deteriorating epidemiological situation and policies of pharmaceutical companies. This letter was supported by a number of interested parties and is still under review by the Government. In the answer to the letter, the Ministry of Health of the RF cited positive global experience of compulsory licensing, however it noted certain risks: a possibility of reduced co-operation by foreign manufacturers, as well as cessation of supply to the RF market of original medications for which CL mechanisms would be used [11]. Review of the option to issue CLs in Russia has been taking place for half a year now, despite the fact that provisions of the Civil Code of the RF (Article 1360 and Article 1362) allow using a simplified administrative procedure (a Government decree) in cases of national security threat (HIV infection is included in the list of national security threats under the 2012 National Security Strategy [12]).
For the purpose of removing patent barriers that prevent access to therapy for treatment of HCV, in May 2015 the Treatment Preparedness Coalition and Humanitarian Action Fund have submitted to the Patent Dispute Chamber an application to oppose a patent for the sofosbuvir prodrug – patent No. 2478104 “Nucleosite phosphoramidates as anti-viral agents” in the name of Gilead Pharmasset LLC. Due to the specifics of procedure for reviewing applications to oppose patents, no decision has yet been made on this issue. The Treatment Preparedness Coalition has sent a letter to the Intellectual Property Ombudsman with the Human Rights Commissioner, in which it has expressed concern regarding the specifics of the existing procedure for submitting applications to oppose granted patents. Among others, it refers to the absence of regulations with a clearly defined review timeframe, which makes the opposing procedure practically endless. This situation deliberately favors patent holders, actually limiting the right to protection against unfounded claims for violations of exclusive rights to an object whose patentability is doubtful.
The letter also says that according to the information in the 2014 statistical reports of Rospatent [Russian Federal Agency for Intellectual Property, Patents and Trademarks] the Patent Dispute Chamber reviewed 162 oppositions to patents for inventions and utility models. As a result of their review, 69 patents, including designs, were held invalid (in full or in part). This gives reason to believe that the decision to grant a patent may be subjective and the quality of examination – low. Under these circumstances, the probability is high that secondary and evergreen patents will significantly delay the entry to the market of cheaper generic medications (see the case of the Eurasian patent for abacavir); that is, will limit the access of patients to treatment and will adversely affect the healthcare budget.
Based on the results of the letter, a number of recommendations were formulated for optimizing patent legislation in the RF, namely:
1. To create Regulations with a clearly defined timeframe for reviewing and adopting decisions on opposition to granting patents for inventions, utility models, and designs;
2. To match the timeframe for reviewing and adopting decisions on opposition with the timeframe for judicial settlement of disputes at general jurisdiction courts and commercial courts;
3. For the purpose of improving the quality of decisions, to insure access by the Rospatent examiners to full-scale search systems of non-patent literature and foreign scientific publications databases;
4. To amend the Regulations in the part of mandatory inclusion in the patent application of clear proof of achieving technical results as compared to all previously known or obtained substances (for inventions on medications). The results of examination must be published in open sources within 6 months of adopting a decision or earlier;
5. To create a separate judicial authority, independent of Rospatent and Intellectual Property Courts (IPC) to review patent validity disputes pursuant to the Administrative Procedure Code, as follows from the very intention of the administrative procedure reform or to submit the cases of patent opposition to the jurisdiction of IPC in the first instance;
6. To define liability, including financial liability, for each party to the process of review and decision on the opposition: for Rospatent for granting invalid patents; for the Patent Dispute Chamber for delaying opposition review; for the patent holder in case of patent opposition; for the party filing opposition in cases the patent is deemed valid;
7. To remove liability for patent violation from the area of criminal liability, at least for cases related to public healthcare.
These actions, initiated by the patient community, aim to improve the availability of vital therapy in the RF, which, as has been demonstrated above, remains limited. Limited access to medications violates the right to healthcare and leads to deteriorating epidemiological situation and dire consequences to public health. We believe that the High Level Group for Access to Medications should especially stress in its resolution recommendations for use of mechanisms that allow balancing the interests related to protection of intellectual property with public healthcare interests and the right to health as provided for by international legislation. We believe that these mechanisms should be specified in the national legislation as clearly as possible with the criteria regulating the opportunities for their use, including at the initiative of third parties, such as patient organizations. Currently, the options for using flexible provisions of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) by countries with low and medium levels of income are emphasized; however, the authors believe that active discussion on the subject should be held in countries with high level of income, such as Russia, as well. The High Level Group should recommend developing clear guidelines for countries in this area. First and foremost, we are talking about recommendations for modification of patent legislation as regards the criteria of patentability, integration of opportunities for using the compulsory licensing mechanism, and submission of opposition to the patents (before and after they are granted) to the national legislation. What is especially important is that the High Level Group should give special recommendations for optimal versions of compliance practices. The experience of the RF and other countries in the EECA region, where the compulsory licensing mechanism exists in theory but has never been used (Belarus, Moldova, etc. [13]), shows that the benefit of the hypothetical use of the flexible provisions of TRIPS is cancelled out by the difficulty of their application in real life.

Bibliography and References

1. Fact Sheet. HIV infection in the Russian Federation as of December 31, 2014. Federal Research Guidance Center for AIDS Prevention and Control. Document available online at: http://hivrussia.metodlab.ru/files/spravkaHIV2014.pdf (as of 02.26. 2016).
2. Skvortsova: “At least 21 billion rubles are needed to cover the needs of the HIV infected.” Information portal vesti.ru. http://www.vesti.ru/doc.html?id=2671134 (as of 26.02.2016)
3. UN calls on Russia to copy AIDS medicines. Izvestia. 10.15. 2015. http://izvestia.ru/news/593134

4. HPTN052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. http://www.hptn.org/research_studies/hptn052.asp
5. “Immunodeficiency meets medication deficit. HIV infected may have to do without medicine due to inflated prices.” Kommersant. http://www.kommersant.ru/doc/2707768
6. ART medications purchases in 2014: decentralization timeline. Results of ART medication procurement and provision monitoring in the RF. Treatment Preparedness Coalition. St. Petersburg, 2015.
7. Untangling the Web of Antiretroviral Price Reductions. MSF. 17th edition – July 2014. http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions-17th-edition-%E2%80%93-july-2014
8. “Hepatitis C treatment in Russia: the old, the new, the unaffordable. Analysis of government procurement of medications for treatment of hepatitis C in the Russian Federation in 2014.” Treatment Preparedness Coalition. St. Petersburg, 2015. http://itpcru.org/wp-content/uploads/2015/08/Analiz_goszakupok_gepatit_2014_FINAL_28.071.pdf
9. Hepatitis C Generic Licensing Fact Sheet. Available at: http://gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615.pdf
10. International Treatment Preparedness Coalition of Eastern Europe and Central Asia – ITPCru. “Blackbox. Russian HIV policy and its economic effectiveness.” St. Petersburg, 2012. Available at: http://itpcru.org/wp-content/uploads/2014/11/Chernyi_yashchik.pdf
11. Russian Federation Presidential Decree No. 537 of May 12, 2009. Available at: http://www.rg.ru/2009/05/19/strategia-dok.html
12. Health Ministry of the Russian Federation. Letter No. 25-1/3084740-8050. Available at: http://itpcru.org/2015/11/03/obrashhenie-k-ministru-zdravoohraneniya-po-itogam-pravitelstvennoj-komissii/
13. Implementation of flexible provisions of TRIPS for the purpose of expanding access to medications in Belarus, Georgia, Moldova, and Ukraine. Analytical Report. International Bureau of Education. Eastern European and Central Asian PLHIV Association. 2013

Sergey Golovin (Original Language)

Lead Author: Sergey Golovin
Additional Authors: Aleksey Mikhailov, Andrey Skvortsov, Georgy Giakonia, Gregory Vergus, Ksenia Babikhina, Natalia Egorova, S Natalia Khilko, Tatyana Khan,  Julia Dragunova
Organization: ITPCru
Country: Russia

Abstract

В настоящем докладе рассматриваются доводы, подкрепляющие утверждение о крайне негативном влиянии патентных монополий на доступность препаратов даже в условиях наличия в национальном законодательстве норм, содержащих гибкие положения ТРИПС. В качестве примера использован анализ рынка антиретровирусной терапии для лечения ВИЧ (далее – АРВ-терапия) и противовирусных препаратов прямого действия (ПППД) для лечения гепатита С (далее – ВГС) в Российской Федерации (РФ).

Submission

Монопольное положение производителей лекарственных средств на рынке, обусловленное эксклюзивными правами на интеллектуальную собственность, продолжает напрямую влиять на доступность жизненно важной терапии для пациентов и в немалой степени способствует разрастанию эпидемий в глобальном масштабе. Даже при наличии в законодательстве той или иной страны механизмов, которые позволяют балансировать интересы патентообладателей и интересы общественного здоровья (так называемые гибкие положения Соглашения о торговых аспектах прав на интеллектуальную собственность, ТРИПС), в реальности их использование затруднено рядом серьезных барьеров. Среди проблем следует отметить отсутствие четко прописанных процедур и критериев для использования механизмов ТРИПС, а также многочисленные сопутствующие нормы, мешающие их применению.
В настоящем докладе рассматриваются доводы, подкрепляющие утверждение о крайне негативном влиянии патентных монополий на доступность препаратов даже в условиях наличия в национальном законодательстве норм, содержащих гибкие положения ТРИПС. В качестве примера использован анализ рынка антиретровирусной терапии для лечения ВИЧ (далее – АРВ-терапия) и противовирусных препаратов прямого действия (ПППД) для лечения гепатита С (далее – ВГС) в Российской Федерации (РФ).
Эпидемия ВИЧ-инфекции в Российской Федерации продолжает расти, и многие эксперты, в том числе представляющие официальные учреждения, характеризуют эпидемиологическую ситуацию как критическую. По данным Федерального центра СПИД, в настоящее время в РФ зарегистрировано более 900 тысяч человек с диагнозом ВИЧ-инфекция, а ежегодный прирост новых случаев ВИЧ-инфекции составляет примерно 10% [1].
По официальным данным, в стране около 200 тысяч человек [3] получают АРВ-терапию, при этом согласно независимым оценкам это число в реальности может быть ниже (около 160 тысяч – данные «Коалиции по готовности к лечению» за 2015 год, публикация планируется в марте 2016 года). Важно отметить, что официальные и неофициальные оценки сходятся на том, что число нуждающихся в АРВ-терапии в несколько раз превышает число людей, получающих ее. В октябре 2015 года министр здравоохранения РФ Вероника Скворцова заявила, что число получающих АРВ-терапию составляет всего 23% от общего количества нуждающихся [2]. С учетом принятия Всемирной организацией здравоохранения (далее – ВОЗ) новых протоколов лечения ВИЧ-инфекции, в соответствии с которыми терапию следует назначать при количестве CD4-клеток 500 и ниже (ранее данный порог составлял 350), потребность в препаратах может быть еще больше.
Помимо очевидных негативных последствий для здоровья людей, живущих с ВИЧ, данная проблема напрямую способствует дальнейшему распространению эпидемии. Как показали результаты исследования HPTN052 [4], снижение вирусной нагрузки до неопределяемого уровня вследствие приема АРВ-терапии уменьшает риск передачи вируса на 96%. Следовательно, масштабный охват программами лечения должен способствовать остановке эпидемии, а дефицит лечения, напротив, значительно повышает риск дальнейшего распространения ВИЧ-инфекции.
Начиная с 2010 года, в РФ регулярно фиксируются перебои с предоставлением антиретровирусных препаратов, а в последнее время все чаще возникают ситуации, когда в условиях ограниченных ресурсов в ряде субъектов РФ центры СПИД не назначают терапию новым пациентам по причине отсутствия средств на закупку препаратов [5]. В ходе неофициальных бесед с представителями центров СПИД общественные организации получают информацию о том, что причиной данной проблемы являются чрезмерно высокие цены на ряд клинически значимых препаратов, для которых отсутствуют аналоги на рынке.
Программа лечения ВИЧ-инфекции за средства национального бюджета началась в России в конце 2010-х годов. В течение последних пяти лет «Коалиция по готовности к лечению» в партнерстве с другими организациями осуществляет независимый мониторинг закупок и предоставления АРВ-препаратов и препаратов для лечения ВГС в России и в ряде других стран региона Восточная Европа и Центральная Азия (ВЕЦА). Согласно имеющимся данным, цены на препараты, не имеющие аналогов на рынке по причине наличия патента, остаются стабильно высокими на протяжении нескольких лет, в то время как цены на препараты, для которых зарегистрированы аналоги, снижаются в десятки раз [6]. В ряду дорогостоящих препаратов без аналогов, находящихся под патентом, следует выделить ингибиторы протеазы лопинавир/ритонавир (входит в состав предпочтительной схемы для продолжения антиретровирусной терапии в соответствии с протоколами ВОЗ, патент EA011924B1, истекает в 2024 году), атазанавир (патент RU2186070C2, истекает в декабре 2018 года), а также комбинацию нуклеозидных/нуклеотидных ингибиторов обратной транскриптазы тенофовир/эмтрицитабин. Данная комбинация входит в состав предпочтительной схемы для начала антиретровирусной терапии в соответствии с протоколами ВОЗ. В связи с регистрационной политикой компании, владеющей патентом, препарат тенофовир/эмтрицитабин не был доступен на рынке РФ до 2012 года. Наличие патента (EA015145B1, истекает в 2024 году, существуют также другие патенты) не позволяло регистрироваться на рынке РФ производителям дженериков. В результате в 2014 году средневзвешенная стоимость данного препарата составила около 3 700 долларов США на пациента в год [6], что во много раз превышает минимальную цену в мире по данным организации «Врачи без границ» [7]. Количество пациентов, получающих данный препарат, составило менее 1% [6].
Важно отметить, что на рынке РФ не зарегистрирован препарат тенофовир/эмтрицитабин/эфавиренз в одной таблетке. По этой причине ни один пациент в России не получает предпочтительную схему для начала антиретровирусной терапии в соответствии с последней редакцией протоколов ВОЗ (тенофовир, эмтрицитабин или ламивудин и эфавиренз в виде комбинированного препарата с фиксированной дозировкой, режим приема одна таблетка один раз в день) за средства федерального бюджета. На наш взгляд, в этом случае имеет место вопиющий факт нарушения прав людей на качественные и доступные услуги в сфере здравоохранения. Комбинированный препарат тенофовир/эмтрицитабин/эфавиренз находится под патентной защитой (EA015145B1, истекает в 2024 году), дженерики препарата в России не зарегистрированы.
В последнее время проблема ограниченного доступа к лекарственным средствам по причине патентных барьеров также интенсивно обсуждается в контексте эпидемии вирусного гепатита С. В России по приблизительным оценкам до 5 миллионов человек живут с ВГС [8]. Терапия предоставляется ограниченному числу пациентов в рамках различных федеральных и региональных программ. Согласно анализу рынка, число людей, получающих терапию на основе противовирусных препаратов прямого действия (ПППД) – текущий стандарт лечения ВГС в мире, – составляет около тысячи человек (данные анализа «Коалиции по готовности к лечению», публикация планируется в марте 2016 года). Средняя стоимость терапии ПППД составляет около 10 000 долларов США [8], что значительно превышает средний доход на душу населения. При этом в РФ до сих пор не зарегистрирован препарат софосбувир, входящий в состав большинства предпочтительных схем для лечения ВГС в соответствии с рекомендациями Американской (AASLD) и Европейской ассоциации по изучению болезней печени (EASL). В связи с наличием патентов, которые в настоящее время пытаются оспорить пациентские организации, производители дженериков пока не могут зарегистрировать софосбувир в РФ.
Согласно классификации Всемирного банка Российская Федерация является страной с высоким уровнем дохода, и во многом по этой причине систематически исключается из добровольных программ повышения доступа, практикуемых фармацевтическими компаниями и другими организациями, в том числе Патентным пулом лекарственных средств (Medicines Patent Pool, Патентный пул). Так, Россия не была включена ни в одно из лицензионных соглашений, заключенных Патентным пулом с производителями препаратов для лечения ВИЧ-инфекции и вирусного гепатита С. Также Россия не входит в географическое покрытие соглашения, заключенного компанией «Гилеад» с рядом индийских компаний на право производить и поставлять препараты для лечения вирусного гепатита С софосбувир, ледипасвир и велпатасвир [9]. Данные факты в сочетании с наличием в РФ большого количества патентов на лекарственные средства означают, что одной из немногих возможностей быстро предоставить максимально широкий доступ к лекарственным средствам является использование законодательных механизмов ТРИПС, позволяющих устранить патентные барьеры, которые ограничивают право людей на здоровье.
В действующем законодательстве РФ прописан ряд подобных механизмов, в том числе положения о выдаче принудительных лицензий в случае возникновения угрозы национальной безопасности и об оспаривании уже выданных патентов (post-grant opposition) или заявок на выдачу патентов (pre-grant opposition). Однако до настоящего времени возможности в сфере возражений против патентов использовались в крайне ограниченном объеме, а возможности принудительного лицензирования в отношении лекарственных средств не применялись ни разу. Более того, основные попытки по реализации данных механизмов в сфере социально значимых заболеваний (ВИЧ, вирусный гепатит С) предпринимались именно пациентскими организациями. Рекомендация относительно возможностей выдачи принудительных лицензий (далее – ПЛ) на препараты для лечения ВИЧ-инфекции была сформулирована общественными организациями еще в 2012 году. В дальнейшем эта рекомендация была включена в несколько отчетов по результатам мониторинга закупок и предоставления АРВ-препаратов и противогепатитных препаратов в РФ, а в конце 2015 года 19 общественных организаций отправили в Правительство РФ письмо с требованием рассмотреть возможность выдачи ПЛ в связи с ухудшающейся эпидемиологической ситуацией и политикой фармацевтических компаний. Данное обращение было поддержано рядом заинтересованных сторон и до сих пор рассматривается Правительством. В ответе на письмо Министерство здравоохранения РФ сослалось на положительный опыт принудительного лицензирования в мире, однако обозначило определенные риски: вероятное снижение степени сотрудничества со стороны зарубежных производителей, а также прекращение поставок на рынок РФ оригинальных лекарственных средств, в отношении которых будет применен механизм ПЛ [11]. Рассмотрение возможности выдачи ПЛ в РФ ведется уже около года, несмотря на то, что положения Гражданского Кодекса РФ (ст.1360 и ст.1362) позволяют применить упрощенный административный порядок (постановление Правительства) в случае угрозы национальной безопасности (ВИЧ-инфекция входит в перечень угроз национальной безопасности в соответствии со Стратегией обеспечения национальной безопасности от 2010 года [12]).
С целью устранения патентных барьеров, препятствующих доступу к терапии для лечения ВГС, в мае 2015 года «Коалиция по готовности к лечению» и фонд «Гуманитарное действие» подали в Палату по патентным спорам заявку на оспаривание патента на пролекарственную форму софосбувира – патент №2478104 «Нуклеозидфосфорамидаты в качестве противовирусных агентов» на имя компании «Гилеад Фармассет ЛЛС». В связи с особенностями процедуры рассмотрения заявок на оспаривание патента решение по данному вопросу до сих пор не вынесено. «Коалиция по готовности к лечению» отправила письмо на адрес омбудсмена в сфере интеллектуальной собственности при уполномоченном по защите прав человека, в котором выразила беспокойство по поводу специфики существующего порядка подачи возражения против выданных патентов. Среди прочего, речь идет об отсутствии регламента с четко прописанными сроками рассмотрения, что делает процедуру возражения практически бесконечной. Данная ситуация заведомо дает преимущества патентообладателям, фактически ограничивая право на защиту от необоснованных претензий по нарушению исключительных прав на объект, патентоспособность которого вызывает сомнения.
Также в письме говорится о том, что по данным статистических отчетов Роспатента за 2014 г., палатой по патентным спорам было рассмотрено 162 возражения против выдачи патентов на изобретения и полезные модели. В результате их рассмотрения 69 патентов, включая промышленные образцы, были признаны недействительными (полностью или частично). Это дает основания предполагать, что решение о выдаче патента может быть субъективным, а качество экспертизы – невысоким. В таких условиях высока вероятность, что вторичные и вечнозеленые патенты существенно задержат выход на рынок более дешевых воспроизведенных препаратов (см. дело о евразийском патенте на абакавир), т.е. ограничат доступ к лечению пациентов и нанесут ущерб бюджету на здравоохранение.
По итогам письма был сформулирован ряд рекомендаций по оптимизации патентного законодательства в РФ, а именно:
1. Создать регламент и прописать в нем сроки рассмотрения и принятия решений по возражениям против выдачи патентов на изобретения, полезные модели и промышленные образцы;
2. Привести сроки рассмотрения и принятия решений по возражениям в соответствие со сроками судебного рассмотрения споров в судах общей юрисдикции и арбитражных судах;
3. В целях повышения качества принятия решений обеспечить доступ экспертизы Роспатента к полноценным системам поиска непатентной литературы и базам данных иностранных научных изданий;
4. Дополнить Регламент в части обязательного приведения в материалах заявки четких доказательств достижения технического результата по сравнению со всеми ранее известными и полученными веществами (для изобретений, относящихся к лекарственным средствам). Результаты работы экспертизы должны быть опубликованы в открытых источниках в течение 6 месяцев после принятия решения или ранее.
5. Создать отдельную, независимую от Роспатента и Судов по интеллектуальным правам (СИП) судебную инстанцию для рассмотрения споров о действительности патента в соответствии с кодексом административного судопроизводства, как это следует из самого замысла реформы административного судопроизводства, либо передать дела об оспаривании патента в компетенцию СИПа по первой инстанции.
6. Определить ответственность, в том числе финансовую, для каждой стороны участвующей в процессе рассмотрения и принятия решений по возражениям: Роспатента за неправомерно выданный патент; ППС за затягивание сроков рассмотрения возражения; патентовладельца, в случае оспаривания патента; стороны, подавшей возражение, в случае признания патента действительным
7. Вывести ответственность за нарушение патента из зоны уголовной ответственности по крайней мере для процессов, связанных с общественным здравоохранением.
Данные действия, инициированные пациентским сообществом, нацелены на то, чтобы улучшить ситуацию с доступом к жизненно важной терапии в РФ, который, как было продемонстрировано выше, продолжает оставаться ограниченным. Ограниченный доступ к препаратам ущемляет право людей на здоровье и ведет к ухудшению эпидемиологической ситуации и катастрофическим последствиям для общественного здоровья. На наш взгляд, Группа высокого уровня по доступу к лекарственным средствам в своей резолюции должна сделать особый упор на рекомендациях в отношении использования механизмов, которые позволяют балансировать интересы, связанные с защитой интеллектуальной собственностью, с интересами общественного здравоохранения и правом на здоровье, закрепленном в международном законодательстве. На наш взгляд, данные механизмы должны быть максимально четко прописаны в законодательстве стран с критериями, регулирующими возможность их использования, в том числе по инициативе третьих сторон, таких как пациентские организации. В настоящее время делается упор на возможности использования гибких положений Соглашения о торговых аспектах прав на интеллектуальную собственность (ТРИПС) странами с низким и средним уровнем дохода, однако, на взгляд авторов доклада, необходимо вести активную дискуссию на эту тему и в странах с высоким уровнем дохода, таких как Россия. Группе высокого уровня следует дать рекомендацию относительно разработки четких рекомендаций для стран в этой сфере. В первую очередь речь идет о рекомендациях по модификации патентного законодательства в отношении критериев патентоспособности, интеграции возможностей для применения механизма принудительного лицензирования и подачи возражений против патентов (до и после выдачи) в национальные законодательства стран. Что особенно важно, Группа высокого уровня должна дать особые рекомендации касательно оптимальных вариантов правоприменительной практики. Опыт РФ и других стран региона ВЕЦА, где механизм принудительного лицензирования существует в теории, но ни разу не применялся (Беларусь, Молдова и т.д. [13]) показывает, что польза от гипотетической возможности по использованию гибких положений ТРИПС нивелируется сложностями, связанными с их применением в реальных условиях.

1. Справка. ВИЧ-инфекция в Российской Федерации на 31 декабря 2014 года. Федеральный научно-методический центр по профилактике и борьбе со СПИДом. Документ доступен онлайн по ссылке: http://hivrussia.metodlab.ru/files/spravkaHIV2014.pdf (на 26.02.2016).
2. Скворцова: для покрытия нужд ВИЧ-инфицированных нужен минимум 21 млрд рублей. Информационный портал vesti.ru. http://www.vesti.ru/doc.html?id=2671134 (на 26.02.2016)
3. ООН призвала Россию к копированию лекарств от СПИДа. Газета «Известия». 15.10.2015. http://izvestia.ru/news/593134
4. HPTN052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples. http://www.hptn.org/research_studies/hptn052.asp
5. Иммунодефицит столкнулся с дефицитом лекарств. ВИЧ-инфицированные могут остаться без препаратов из-за завышенных цен. Газета «Коммерсантъ». http://www.kommersant.ru/doc/2707768
6. Закупки АРВ-препаратов в 2014 году: хроника децентрализации. Результаты мониторинга закупок и предоставления АРВ-препаратов в РФ. «Коалиция по готовности к лечению». Санкт-Петербург, 2015.
7. Untangling the Web of Antiretroviral Price Reductions. MSF. 17th edition – July 2014. http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions-17th-edition-%E2%80%93-july-2014
8. «Лечение гепатита С в России: старое, новое, недоступное. Анализ государственных закупок препаратов для лечения гепатита С в Российской Федерации в 2014 году». «Коалиция по готовности к лечению». Санкт-Петербург, 2015. http://itpcru.org/wp-content/uploads/2015/08/Analiz_goszakupok_gepatit_2014_FINAL_28.071.pdf
9. Hepatitis C Generic Licensing Fact Sheet. Available at: http://gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615.pdf
10. Международная коалиция по готовности к лечению в Восточной Европе и Центральной Азии – ITPCru. «Черный ящик». Российская политика по ВИЧ и ее экономическая эффективность. Санкт-Петербург, 2012. Доступно по ссылке: http://itpcru.org/wp-content/uploads/2014/11/Chernyi_yashchik.pdf
11. Указ Президента Российской Федерации от 12 мая 2009 года №537. Доступно по ссылке: http://www.rg.ru/2009/05/19/strategia-dok.html
12. Министерство здравоохранения Российской Федерации. Письмо №25-1/3084740-8050. Доступно по ссылке: http://itpcru.org/2015/11/03/obrashhenie-k-ministru-zdravoohraneniya-po-itogam-pravitelstvennoj-komissii/
13. Имплементация гибких положений ТРИПС с целью расширения доступа к лекарственным средствам в Беларуси, Грузии, Молдове и Украине. Аналитический отчет. МБО «Восточноевропейское и Центральноазиатское Объединение ЛЖВ». 2013

Olivier Okakessema Nyamana, WORKING GROUP ON HUMAN RIGHTS AND HIV IN DR CONGO (English Translation)

Lead Author: Olivier Okakessema Nyamana
Organization: Groupe de travail sur les droits humains et le VIH en RD Congo; Horizon Justice et santé ASBL (ex Avocats au Ruban Rouge ASBL)
Country: Democratic Republic of the Congo

Abstract

The author describes three local situations that illustrate the issue of innovation and access to medicines in the Democratic Republic of the Congo (DR Congo).

First, he addresses the contrast of a pharmaceutical firm in a country where industrialization is hardly a hallmark, one that has had the opportunity to produce antiretroviral (ARV) drugs and contribute to satisfying local, even regional demand, but whose momentum was halted by international mechanisms for certifying a medication already in use elsewhere, for which the firm had only obtained a license; and also by other requirements, particularly to compete in international invitations to tender against major companies that operate on a different level entirely. This obstruction was perceived locally as a protectionism for the interests of companies from countries that donate and lend ARV drugs, and the author calls for adapting the criteria for marketing medications in the future using a proactive approach of empowerment for developing countries.

Second, he describes the usefulness of traditional medicine, which remains the last resort for medications for the Congolese population in times of crisis and conflict when the mainstream or modern medical system has become dysfunctional, by way of defending the efficacy of this type of widely used treatment, which, after all, forms the basis of modern pharmacopeia, but has been slow to achieve legitimacy.

Finally, he denounces the abuses of a few promoters of dietary supplements and other scam artists, who victimize the consumers of their deceptive compounds, delaying them from arranging access to care that is relevant to their case. Subsequently, he underlines the need for addressing these setbacks.

Submission

Promoting innovation and access to medicines in DR Congo

Introduction

We wish to present our contribution without pretensions; however, in order to achieve even this modest task, we feel it indispensable to be concrete in the stigmatization of these issues, specifically to consult the available literature, as well as interviews with several key informants, to support or disprove our perception of the issue of innovation in the medical field and of access to pharmaceutical products, so that we may submit to the Committee the most objective information possible that could have even the slightest relevance. We have also consulted a number of available documents to form a more educated opinion, but at this stage we have not been able to obtain all the data we sought, particularly in terms of statistics, given the waiting times for responses to our requests for them. Nevertheless, we have also gathered information available in articles and reports on the internet.

Availability of medicines, Pharmakina Bukavu case: a missed rare opportunity to promote local production of ARV drugs to satisfy local demand

With an estimated population of 70 million inhabitants, the Democratic Republic of the Congo (DRC) constitutes a potentially interesting market for pharmaceutical firms, despite the weak purchasing power of the majority of the population. Since 2002, the country has employed a National Essential Medicine Supply Program (NEMSP), which currently contributes to implementing the national pharmaceutical policy adopted in 2008. In addition, the DRC has twenty or so pharmaceutical production laboratories, most notably those with Indian origins, which hold the upper hand in the sector, but these only cover 15 to 20 percent of the national consumption; the rest is imported. In its introduction, the pharmaceutical policy manual criticizes the insufficiency of local medicine production. However, if industry representatives are to be believed, the issue does not lie at the level some patent law or other that would hinder their room for maneuver in producing generic medications to satisfy demand, the fabric of the pharmaceutical industry being too underdeveloped to autonomously and optimally profit from the flexibilities provided for in the TRIPS Agreement or even in the Doha Agreement, unless there is also a lack of interest in doing so. As an exception, the legislation on industrial property of 7 January 1982 already provided that drug patents be accorded for fifteen years, as opposed to twenty in other cases, before entering the public domain, as an ethical consideration seeking to limit profit in a such a socially vital sector. Above all else, the problem is availability and accessibility, both geographic and economic, of these medications, but it is also quality control. In particular, it should be considered that the DRC is a vast tropical country with a population dispersed over an immense territory, with serious accessibility and communication problems and in the grip of widespread poverty. Multiple governmental challenges must also be addressed, not least of which are production control, supply and distribution of medications.

Given this situation, we feel it pertinent to describe the emblematic and contradictory case of Pharmakina Bukavu. This pharmaceutical company, which is Congolese by law but was first owned by German shareholders before passing into Swiss hands, was founded in 1942 and is based in the eastern part of the country. Its core business is production of quinquina, the active ingredient in which is used to make quinine. In 2005, it inaugurated with great pomp an antiretroviral production site dubbed “Afrivir” after a license allegedly obtained gratis from an Asian industrial philanthropist whom we were unable to identify. But unfortunately, it was not long before disenchantment set in, because commercial success was not to be; the orders expected for this populated country, where the estimated rate of HIV-positivity reaches 4 percent, never came.

Inquiries into the source of the growing problem revealed that the partners who supplied the country with ARV drugs required a pre-qualification according to WHO criteria, as well as submission of a response to an international invitation to tender. The firm’s management quickly realized what prohibitive financial conditions and tedious processes this would require, and let go of their illusions. For local right to health activists, this episode revealed the limited sovereignty of a feeble State faced with inescapable external partners who fill in the gaps in its governmental powers. It is no coincidence that certain countries known to be more organized, such as Rwanda, have still been able to procure ARV drugs for their populations. In fact, the Congolese government has been deplored for its lack of political will to assist and support a national pharmaceutical flagship in the aforementioned pre-qualification process.

Today, Pharmakina has closed the book on ARV drug production; nevertheless, we believe that there is a lesson to be learned from it, for it is unacceptable that at a time when the waiting list for ARV drugs is long, a wait that is sometimes fatal, the stakeholders in this matter failed to take a proactive approach to supporting local production. True, an invitation to tender means competition, but we share the point of view that not all basic needs should be subject to the law of the market, especially when lives are at stake. Indeed, the right to life is the first of all human rights; it is sacred and has no price, and consequently the commodities essential to maintaining it cannot be reduced to a purely mercenary value.

Thus, we recommend that within WHO and in other relevant instances, the rules for pre-qualification be relaxed and integrate accommodations for supporting promotion of the local industry in order to promote the well-being of the population in question. We admit that in a time of economic crises, financial considerations cannot be put aside; furthermore, we recognize that we do not possess all the objective information needed for an educated appraisal of the situation described above. However, we firmly believe that the step we are proposing is worthwhile, because it is a question of policy coherence, so far as there is agreement that the interest of the beneficiaries should be the ultimate criterion that supplants all others. The policy should always be to serve the people, and not fall into sterile bureaucracy.

Life is the first of all rights within the realm of civil and social rights; that is, the first generation human rights, as they are known in various instruments of human rights. Article 16 of the Congolese constitution, in the manner of other texts such as the Universal Declaration of Human Rights or other regional charters with similar dispositions, declares that “the human person is sacred. The State is obliged to respect it and to protect it. All people have the right to life, to bodily integrity, and the free development of human personality in respect of the law, of public order, of the rights of others and of morality…” Life has no price, life is sacred, and therefore the commodities essential to maintaining it cannot be reduced to a purely mercenary value.

Framework for traditional medicine: demonstration by contradiction of its necessity with regard to recent crises in DR Congo

As one author points out, traditional medicine has regained attention and interest in urban African settings over recent decades. It is well known that Africans resort en masse [to this] form of medicine. Based on this reality, WHO’s strategy since 2002 has ordered the governments of member states “to integrate relevant aspects of traditional medicine within national health care systems by framing national traditional medicine policies and implementing programmes; and to promote rational use of traditional medicine.” In response to this recommendation, other national texts, such as the national pharmaceutical policy, offer the same idea in the form of several proposals for crisis applications, but even so, the implementation process seems particularly laborious. Statistics would shed even more light on the need to validate traditional medicine; for example, according to the Ministry of Health, in 1998 in the DRC, there were approximately 4.4 doctors for every 100,000 inhabitants, one of the lowest numbers in the world, which coincides with the country’s poverty. Also in 1998, there were about 58 nurses for every 100,000 inhabitants in the DRC. In contrast, in the province of South Kivu for example, according to one author, in the same year there were 200 doctors, or one doctor for every 13,250 inhabitants; and 648 traditional medicine practitioners, or one traditional medicine practitioner for every 4,100 inhabitants.

This wide availability of traditional medicine practitioners merits being capitalized upon. The recent experience of the DRC, a country that barely emerged from many crises and conflicts that disorganized and paralyzed its modern, Western-model health system, was a blunt reminder of the validity, the urgency even, of such an action. On this subject, the researcher Balagizi Karhagomba writes, “The war situations Kivu has endured have enabled local communities to take an approach of action-research based on sharing knowledge of medicinal plants, of reinforcing local capacity to promote local indigenous knowledge in order to satisfy medical supply needs. And currently, a harmony exists in the collaboration between traditional and modern medicine. Therefore, it makes sense for health care providers to document and promote local knowledge via participative experimentation aiming to promote traditional pharmacopeia and gear it toward the market.” But conflict is not the only reason for resorting to this form of medicine. More platonically, economic motives often come into play in a situation of collapse. Of all the actions recommended by different sources in the field in favor of traditional medicine practitioners, we believe there is good reason to give priority to the following:

- Creating of a codex of traditional medicine

- Forming an incentive that would benefit traditional medicine practitioners who agree to record and register their methods

- Training and endowment of material resources to enable those who wish to present their products in more conventional galenic formulations.

- Educating the population on phytotherapy and training service providers in phytotherapy by attaching them to health care zones, the community-based unit of the primary health care system in the DRC, which is destined above all for primary health care in the spirit of the Alma Ata Declaration.

When dealing with traditional medicine practitioners, it is common to hear them justify their refusal to register with fear of seeing their methods “stolen” by someone who would get rich off of their work, or more simply with the fear of being held back. Thus, it is important to find reassuring response to these concerns. Furthermore, industrial packaging of traditional pharmacopeia could prove to be profitable, as demonstrated particularly by the local success of the products Manadiar and Meyamicine from the pharmacist TONDELE, Manalaria from the pharmacist MBAMU, and the Herbopharma products from another herbalist.

In 2013, a census was taken of traditional medicine practitioners in the city of Kinshasa, which identified close to 2,500 of them, along with their work sites. This list is certainly not exhaustive, and spiritualists of all kinds must also be counted. But this at least constitutes a first step in the right direction.

The population’s confidence in this medicine, which is perceived as pushing past the limits of modern medicine, is accorded largely in terms of recovery results. It has even been shown that in urban areas, it can be almost as expensive, if not more, than modern medicine, proof that it has attained increasing credibility in the public opinion. There is also holistic medicine, in which providers combine roles that in modern medicine are divided between the many specializations of the medical profession. Thus, it is important to organize traditional medicine and not treat it with contempt, because in times of crisis it is traditional medicine that will prevail, since it is closer to nature.

Abuse of public trust in medications: The issue of false pharmaceutical advertising, dietary supplements, fraud and charlatanism and their negative impact on public health

They can be registered as dietary supplements at the Ministry of Health, but in the field, they develop via parallel circuits for distributing products that are presented as genuine, even quasi miraculous remedies, capable, for example of sparing a patient from surgical operation. It is often acknowledged that those in need of health care start with modern establishments before resorting to traditional medicine practitioners. But in the case of these exotic medicines, more and more people are using them as a first resort, and sadly, they most often end up in conventional hospitals after having bled out financially without getting the cure they counted on. Unfortunately for this very lucrative business, they sometimes have the support on the highest State level at their disposal, as demonstrated by the defiance of a Chinese remedy business, which the Minister of Health KABANGE NUMBI visited in person in 2013, only to be met with unexpected and stunning resistance. Their marketing practices are admittedly very attractive, with unprecedented, quasi aggressive methods that border on solicitation. Take for example the offers of so-called electromagnetic scanners, capable of providing comprehensive information on the body’s condition for a modest sum, ten times less than the conventional scanners at university clinics, whose three-hundred-dollar price tag is prohibitive for the little people, leaving aside the long waiting list. Citizens are not left out, because certain impostors would offer to perform all medical investigations solely on the basis of saliva—a nod, no doubt to those who have fears of needles and other punctures.

Similarly, the Congolese media landscape was at one time saturated with false advertisements for gurus who claimed to be able to cure practically anything, disregarding the legislation on this matter, specifically ordinance no. 70 / 158 of 30 April 1970, which prohibits all advertisements or publicity related to healing arts in the DRC, and which in the meantime seems to have fallen into oblivion.

These apothecaries of all kinds, whom we are denouncing here, have had ample time to get rich, especially in the wake of the HIV/AIDS pandemic, by profiting from loopholes in the system, and have often built up goldmines for themselves by shamelessly exploiting the distress of others. Without a doubt, the passivity and lethargy of the public authorities has formed the bed for grave violations of human rights, for here it is difficult to put a number on the casualties.

There is reason, therefore, for the public authorities and their partners to invest in dispelling confusion in the minds of an often illiterate and credulous population. Furthermore, it should also be clearly stated that dietary supplements are not medications, and their circuits of distribution must be supervised. The population is in fact often inundated with inappropriate offers, and left to themselves, they no longer know what treatment to seek!

There is a glimmer of hope that stamping pharmaceutical products and the process of making holograms are on track to help authenticate medications for final consumers, giving them access to quality products by reinforcing the control and identification system.

Conclusion

It is generally acknowledged that economic and social rights are still in the process of being achieved, but because the right to heath is directly linked to the first of all rights, the right to human life, it is essential that all decision makers consider that the secondary must follow the principal, and must therefore give it particular attention, for a healthy body and a health mind are the fundamental prerequisites of all sustained progress.

Olivier OKAKESSEMA NYAMANA
Kinshasa / DR Congo
Tel: +24 381 452 6922

Bibliography and References

Demographic and Health Surveys (DHS-DRC) 2013-2014


http://www.radiookapi.net/actualite/2010/05/07/arv-la-pharmakina-se-plaint-de-ne-pas-recevoir-des-commandes
http://osibouake.org/?RDC-Pharmakina-a-Bukavu-fabrique
http://www.lecongolais.cd/le-csac-interdit-la-publicite-des-produits-des-tradipraticiens-dans-les-medias/
http://www.kongo.l-h-l.org/?Fran%E7ais:M%E9decine_naturelle

Persons interviewed:
Mr. Clément WUTEJI, Head of Quality and Insurance division, Pharmacy management, medications and medicinal plants at the Ministry of Health

Director in charge of supplies, medications and equipment at the Ministry of Health

Director in charge of traditional medicine at the Ministry of Health

Olivier Okakessema Nyamana (Original Language)

Lead Author: Olivier Okakessema Nyamana
Organization: Groupe de travail sur les droits humains et le VIH en RD Congo; Horizon Justice et santé ASBL (ex Avocats au Ruban Rouge ASBL)
Country: République démocratique du Congo

Abstract

L’auteur recense trois situations locales pour illustrer la problématique de l’innovation et de l’accès aux médicaments dans en RD Congo.
D’abord il relève le contraste d’une firme pharmaceutique dans un pays dont l’industrialisation est loin d’être la marque de fabrique, laquelle a eu l’opportunité de produire des ARV en vue de concourir à satisfaire la consommation locale, voire régionale, mais dont l’élan a été brisé net par les mécanismes internationaux de certification d’un médicament pourtant déjà utilisé ailleurs et dont elle n’a obtenu que la licence, et aussi par d’autres exigences notamment de concourir à des appels d’offre internationaux face à des majors dont il ne partageait pas la même cour. Cet échec a été perçu localement comme un protectionnisme des intérêts de firmes de pays donateurs et bailleurs des ARV, d’où il en appelle à l’adaptation de critères de mise sur marché de médicaments à l’avenir dans une démarche volontariste d’autonomisation de pays en développement.

Il rapporte ensuite l’utilité de la médecine traditionnelle demeurée l’ultime recours en médicaments pour la population congolaise dans un contexte de crise et de conflit où le sytème médical classique ou moderne était devenu inopérationnel, ceci en guise de plaidoyer pour l’effectivité des appuis maintes fois évoqués à ce domaine, lequel constitue après tout l’essence de la pharmacopée moderne, mais dont la concrétisation tarde.
Afin, il dénonce les abus dont sont victimes les consommateurs des amalgames insidieuses orchestrés par quelques promoteurs de suppléments alimentaires et autres charlatans, ce qui les empêche de faire le tri pour un accéder à une prise en charge pertinente de leur cas. D’où il souligne la nécessité de mieux recadrer ces dérives.

Submission

Promouvoir l’innovation et l’accès aux médicaments en RD Congo
Introduction
Notre contribution s’est voulue sans prétention, cependant dans le cadre de la réalisation de cet œuvre même modeste il nous est apparu indispensable d’être concret dans la stigmatisation de problèmes et de recourir notamment à de la documentation disponible ainsi qu’à l’interview de quelques informateurs clés pour étayer ou infirmer notre perception de la problématique de l’innovation dans le domaine médicale et de l’accès aux produits pharmaceutiques afin de soumettre au haut comité une information tant soit peu relevante et la plus objective possible. Nous avons aussi compulsé un certain nombre de documents disponibles pour former une opinion plus éclairée, mais nous n’avons pas pu à ce stade obtenir toutes les données souhaitées, notamment en termes de statistiques, compte tenu du delà de traitement de nos requêtes dans ce sens. Toutefois nous avons aussi recueillies les informations disponibles sur internet à partir des articles ou mémoires disponibles virtuellement.
Disponibilité de médicaments , cas de la Pharmakina Bukavu : une rare opportunité manquée de promouvoir une production locale des ARV en vue de satisfaire la demande locale
Avec une population estimée à plus de 70 millions d’habitants, la RDC constitue potentiellement un marché intéressant pour les firmes pharmaceutiques, ceci en dépit du faible pouvoir d’achat caractérisant la majorité de sa population. Depuis 2002 le pays est doté d’un programme national d’approvisionnement en médicaments essentiels (PNAM), lequel concourt désormais à la mise en œuvre de la politique pharmaceutique nationale adoptée en 2008. La RDC compte par ailleurs une vingtaine de laboratoires de production pharmaceutique, notamment ceux d’origine indienne qui tiennent le haut de pavé du secteur, lesquels ne couvrent qu’entre 15 et 20 % de la consommation nationale, le supplément étant importé. Dans son introduction le manuel de la politique pharmaceutique épingle l’insuffisance de la production locale de médicaments. Cependant à en croire nos interlocuteurs le problème ne se situe pas au niveau de quelconques droits de brevet qui entraveraient leurs marge de manœuvre de production de médicaments génériques pour pouvoir satisfaire la demande, le tissus industriel pharmaceutique n’étant pas assez étoffé pour pouvoir de façon autonome tirer un profit optimal de flexibilités prévues dans les ADPIC ou encore par l’accord de DOHA, à moins qu’il n s’agisse aussi d’un manque d’intérêt pour ce faire. Déjà à titre exceptionnel déjà la législation sur la propriété industrielle du 7 janvier 1982 prévoyait que les brevets pour les médicaments sont accordés pour quinze ans au lieu de vingt ans dans les autres cas avant de tomber dans le domaine public, comme dans une considération éthique visant à limiter le profit dans un secteur aussi socialement vital. Le problème est avant tout celui de la disponibilité et de l’accessibilité géographique et économique desdits médicaments, mais aussi celui de leur contrôle de qualité. En effet, il faut notamment considérer que la RDC est un pays vaste tropical dont la population est dispersée sur l’immense territoire avec de problèmes sérieux d’enclavement et de communication et sous l’emprise d’une pauvreté généralisée. Plusieurs défis de gouvernance sont aussi à relever, le contrôle de la production, de l’approvisionnement et de la distribution de médicaments n’étant pas le moindre.
Sur fonds du décor ci-dessus, il nous apparaît pertinent de décrire le cas emblématique et contrastant de la Pharmakina Bukavu. Cette compagnie pharmaceutique de droit congolais, mais d’origine allemande quant à son actionnariat avant de passer entre de mains suisses, dont la fondation remonte en 1942 est basé à l’Est du pays et a pour cœur de métier la production de la quinquina dont la substance active sert à la fabrication de la quinine. En 2005 elle a inauguré en pompe un site de production des antirétroviraux baptisés « Afrivir » suite à une licence qui aurait été obtenue gracieusement d’une industrielle asiatique philanthrope que nous n’avons pu identifier . Mais hélas le désenchantement ne tarda pas à prendre place puisque le succès commercial ne fut pas au rendez-vous, les commandes attendues pour ce pays peuplé où le taux de séropositivité estimé atteignait les 4% ne vinrent pas.
En venant s’enquérir à la source creusant le problème, il est apparu que les partenaires qui approvisionnent le pays en ARV exigeaient notamment une pré-qualification suivant les critères de l’OMS ainsi que la soumission d’un tender à un appel d’offre international. Les dirigeants de la firme durent vite se rendre compte de conditions financières rédhibitoires et de démarches fastidieuses que cela exigeait et laissèrent tomber leurs illusions. Pour les activistes locaux du droit à la santé cet épisode a été révélateur de la souveraineté limitée d’un Etat défaillant face à de partenaires extérieurs incontournables qui comblent les lacunes de ses attributions régaliennes. Il se rapporte en effet que certains pays réputés plus organisés comme le Rwanda s’en sont pourtant procurés pour leur population. En effet, il a été déploré l’absence de la volonté politique de l’Etat congolais d’accompagner et appuyer un fleuron pharmaceutique nationale dans le processus sus évoqué de la pré-qualification.
A ce jour la Pharmakina a tourné cette page de la production des ARV, néanmoins nous croyons que la leçon doit être capitalisée car il est inadmissible qu’au moment où une longue file d’attente subsistait pour être placé sous les ARV, attente parfois mortelle, une démarche volontariste n’ait pas été engagée par les parties prenantes de cette affaire pour soutenir la production locale. Qui dit appel d’offre dit concurrence, mais nous partageons le point de vue selon lequel l’on ne peut soumettre tous les besoins primaires à la loi du marché, surtout quand c’est la vie le qui est en jeu. En effet, la vie est le premier de droits, elle est sacrée et n’a pas de prix, par conséquent les denrées essentielles à son maintien ne sauraient être assorties d’une valeur purement vénale.
Ainsi, nous préconisons qu’au niveau de l’OMS et des autres instances relevantes les règles de la pré-qualification soient assouplies et intègrent de variables de soutien promotion de l’industrie locale dans le but de promouvoir le bien être de la population considérée. Nous admettons qu’à l’heure de crises économiques l’on ne peut faire fi de considérations financières, nous reconnaissons en outre ne pas posséder tous les éléments objectifs pour une appréciation éclairée de la situation illustrée ci-dessus mais nous croyons fermement que la démarche proposée en vaut la chandelle pace que c’est une question de cohérence de politique, pour autant que l’on s’accorde que le l’intérêt de bénéficiaires doit être le critère ultime, lequel doit supplanter les autres. La politique doit demeurer au service de l’homme et ne pas verser dans un formalisme stérile.
La vie est le premier de droits, relavant de droits civiques et sociaux, soit les droits dits de première génération, dans les différents instruments de droit de l’homme . L’article 16 de la constitution congolaise, à l’instar d’autres textes comme la déclaration universelle de droits de l’homme ou autres chartes régionales en leurs dispositions similaires, proclame en effet que « la personne humaine est sacrée. L’Etat a l’obligation de la respecter et de la protéger. Toute personne a droit à la vie, à l’intégrité physique ainsi qu’au libre développement de sa personnalité dans le respect de la loi, de l’ordre public, du droit d’autrui et des bonnes mœurs… ». Elle n’a pas de prix elle est sacrée et donc les denrées essentielles à son maintien ne sauraient être assorties d’une valeur purement vénale.
Encadrement de la médecine traditionnelle : démonstration par l’absurde de sa nécessité au regard de crises récentes en RD Congo
Comme le rappelle un auteur la médecine traditionnelle a connu un regain d’attention et d’intérêt les décennies récentes dans les milieux urbains africains. Il est en effet de notoriété que les africains recourent massivement tte forme de médecine. Fort de cette réalité, la stratégie de l’OMS depuis 2002 a commandée aux gouvernements des Etats membres de : « intégrer les aspects pertinent de la médecine traditionnelle dans les systèmes nationaux de santé en formulant des politiques nationales en matière de médecine traditionnelle et en mettant en œuvre des programmes ; et promouvoir l’usage rationnel de la médecine traditionnelle ». En écho à cette recommandation d’autres textes nationaux, comme la politique pharmaceutique nationale, déclinent la même idée en plusieurs propositions de mise en œuvre crise mais dont l’implémentation semble toutefois particulièrement laborieuse. Le recours aux statistiques serait encore plus édifiant sur la nécessité de valoriser la médecine traditionnelle lorsqu’il en ressort par exemple que selon le Ministère de la santé en 1998 en RDC, on comptait environ 4,4 médecins pour 100 000 habitants, ce qui figure parmi les chiffres les plus bas au monde quoique conforme à la pauvreté du pays. On comptait également, en 1998, environ 58 infirmiers pour 100 000 habitants en RDC. En revanche pour la province du Sud Kivu par exemple, d’après un auteur, l’on compte à la même époque 200 médecins, soit 1 médecin pour 13.250 habitants alors alors qu’on compte 648 tradi-praticiens, soit 1 tradi-praticien pour 4100 habitants.
Cette disponibilité de tradi-praticiens mériterait d’être capitalisée. L’expérience récente de la RDC, pays qui sort à peine de moult crises et conflits ayant désorganisé et paralyse le système de santé moderne au modèle importé de l’occident vient de le rappeler crûment le bien-fondé, voire l’urgence d’une telle démarche. le chercheur Balagizi Karhagomba écrit à ce propos « Les situations de guerre que le Kivu a traversée ont permis aux communautés locales de mener une démarche de recherche-action basée sur le partage des connaissances sur les plantes médicinales, de renforcer les capacités locales pour la promotion du savoir local autochtone en vue de satisfaire les besoins d’approvisionnement en médicaments. Et, actuellement, il existe une harmonie dans la collaboration entre la médecine traditionnelle et moderne. Il convient donc aux acteurs de santé de documenter et promouvoir le savoir local par une expérimentation participative en vue de promouvoir la pharmacopée traditionnelle et l’orienter vers le marché ». mais les conflits ne constituent pas les seuls ressorts du recours à cette forme de médecine. Il y a aussi plus platoniquement les motifs économiques dans une conjoncture en effondrement. Parmi les actions préconisées par les différents intervenants du domaine en faveur de tradipraticiens, nous pensons qu’il y a lieu de privilégier notamment selon nous :
- La constitution d’un codex de la médecine traditionnelle ;
- Un appui incitatif au bénéfice de tradi-praticiens qui acceptent de s’enregistrer avec leurs procédés ;
- La formation ainsi que la dotation en moyens matériels afin de permettre à ceux qui le souhaitent de présenter leurs produits en forme galénique plus conventionnels.
- L’éducation de la population à la phytothérapie et d’en former les prestataires en les attachant aux zones de santé, unité de base à vocation communautaire du système de santé primaire en RDC, lequel est voué avant tout aux soins de santé primaire dans l’esprit d’ALMA ATA.
Lorsque l’on côtoie les tradi-praticiens, il est récurrent de les entendre justifier le refus d’enregistrement par la crainte de voir leurs procédés « volés » par de quidam qui s’enrichissent sur leur dos, ou encore simplement par celle de se voir étouffé. Il importera donc de trouver une réponse rassurante à ces apprehensions. Par ailleurs le conditionnement industriel de la pharmacopée traditionnelle pourrait s’avérer payant comme le prouve notamment le succès local des produits Manadiar et Meyamicine du pharmacien TONDELE, Manalaria du pharmacien MBAMU encore les produits Herbopharma d’une autre herboriste.
En 2013 un récensement de tradipraticiens de la ville de Kinshasa a été réalisée et a permis d’identifier près de 2500 d’entre eux avec leurs sites de travail. Cette liste n’est sans doute pas exhaustive, outre qu’il faut aussi compter avec les spiritualistes de tout genre. Mais ça constitue enfin un premier pas dans la bonne direction.
La population accorde largement sa confiance à cette médecine perçue comme repoussant les limites de la médecine moderne en termes de résultat de guérison. il s’avère même qu’en milieu urbain elle revient parfois aussi chère, si pas plus, que la médecine moderne, preuve qu’elle a acquiert de plus en plus de lettres de noblesses dans l’opinion. On parle aussi de médecine holistique tant les prestataires cumulent les rôles dévolues en médecine moderne à plusieurs corps de métier médical. Il importe donc de l’encadrer et de ne donc pas la traiter avec mépris parc qu’en cas de cataclysme elle est celle qui persistera, parce que plus proche de la nature.
Abus de la foi publique en matière de médicaments : La problématique de publicités pharmaceutiques mensongères, supplément alimentaire, falsification et de charlatanisme et leur impact négatif sur la santé de la population
Ils se font enregistrer comme supplément alimentaires au Ministère de la santé mais sur terrain ils développent en pratique de circuits parallèles de distribution de produits présentés alors comme de véritables remèdes, parfois quasi miraculeux, capables par exemple d’épargner au patient une opération chirurgicale. Habituellement l’on admet que les malades commencent par les établissements modernes avant d’atterrir chez les tradi-praticens. Mais dans le cas de ces médecines exotiques, de plus en plus de gens y recourent en première intention pour le plus souvent, hélas, s’échouer dans les hôpitaux conventionnels après avoir été saignés financièrement sans la guérison escomptée. Malheureusement pour ce business très lucratif ils disposent parfois des appuis au plus haut appareil de l’Etat comme le démontre la résistance d’une maison chinoise où était descendu le Ministre de la santé KABANGE NUMBI en personne en 2013 pour se heurter à une résistance inattendue et stupéfiante. Il faut avouer que leurs procèdes de marketing sont très alléchants avec de méthodes quasi agressives et inédites frisant le racolage. Prenons par exemple les offres de scanner dits électromagnétiques susceptibles de renseigner intégralement sur l’état du corps pour une modique somme, dix fois moindre que le scanner classique des cliniques universitaires dont le coût de trois cents dollars est rédhibitoire pour le petit peuple, sans compter la longue liste d’attente. Les nationaux ne sont pas en reste puisque certains imposteurs proposaient d’accomplir toutes les investigations médicales uniquement sur base de la salive, sans doute un avis aux minettes qui craignent la piqûre et autres ponctions !
Dans le même genre, le paysage médiatique congolais a été à un moment saturé de publicités mensongères de gourous qui prétendaient pratiquement tout guérir, ce au mepris de la législation en la matière, notamment l’ordonnance n° 70 / 158 du 30 avril 1970 prohibant toute réclame ou publicité relative à l’art de guérir en RDC, laquelle était dans l’entretemps passée aux oubliettes.
Ces apothicaires de tout poil que nous fustigeons ici ont eu largement le temps de s’engraisser, notamment consécutivement à l’apparition de la pandémie du VIH et SIDA, en profitant de failles du système et ont souvent constitué de pactoles consistant en exploitant de façon éhontée la détresse d’autrui. La passivité et la léthargie de pouvoirs publics a constitué sans doute le lit de violations graves de droits humains car l’hécatombe est ici difficile à chiffrer.
Il y a lieu donc que les pouvoirs publics et leurs partenaires s’investissent pour lever la confusion dans l’esprit de la population souvent analphabète et crédule. Ainsi il doit notamment être clairement mentionné que les suppléments alimentaires ne constituent pas de médicaments et leur circuit de distribution doit être surveillé. La population est en effet souvent submergée par des offres inappropriées et livrée à elle-même, ne sachant plus à quel traitement se vouer !
Une lueur d’espoir ce que l’estampillage de produits pharmaceutique et le procédé d’hologramme est sur le rail afin d’authentifier les médicaments et faire régresser la consommation de produits falsifiés. Il faut en effet faciliter le tri de médicaments aux consommateurs finaux pour un accès aux produits de qualité en renforçant le système de contrôle et leur identification.
En conclusion
Il est généralement admis que les droits économiques et sociaux sont de réalisation progressive, mais puisque le droit à la santé est étroitement lié à la vie laquelle occupe la primauté de droits, il importe que tous les décideurs considèrent que l’accessoire doit suivre le sort du principal et doivent donc lui attacher une attention particulière car un corps sain dans un esprit sain sont le préalable élémentaire de tout progrès soutenu.
Olivier OKAKESSEMA NYAMANA
Kinshasa / RD Congo
Tél : +243814526922

Bibliography and References

RISQUES, DROIT & SANTÉ JUILLET, Global commission on HIV and the law, 2012

REVALORISATION DE LA MEDECINE TRADITIONNELLE
POUR APPUYER LE DEVELOPPEMENT : Recherche et expérience au Sud-Kivu,
République Démocratique du Congo, par Chifundera Kusamba, CRSN/Lwiro in Santé et médecine, 1999
L’IMPACT DE LA MEDECINE NATURELLE DANS UNE REGION DE GUERRE,
CAS DU KIVU, EST DE LA REPUBLIQUE DEMOCRATIQUE DU CONGO
par Innocent Balagizi Karhagomba, Attaché de Recherche au Centre de Recherche en Sciences Naturelles, CRSN, Lwiro in Santé et médecine,1999
INTERACTIONS ENTRE LA MEDECINE TRADITIONNELE
ET LA MEDECINE MODERNE AU SUD-KIVU
Hilaire RUDAHABA BATUMIKE, ISDR/Bukavu.2014
CARTOGRAPHIE DES SYSTEMES D’APPROVISIONNEMENT ET DE DISTRIBUTION DES MEDICAMENTS ET AUTRES PRODUITS DE SANTE EN RDC OMS Janvier 2010,

Politique pharmaceutique nationale, Ministère de la santé, décembre 2008

Enquête Démographique et de Santé (EDS-RDC) 2013-2014


http://www.radiookapi.net/actualite/2010/05/07/arv-la-pharmakina-se-plaint-de-ne-pas-recevoir-des-commandes
http://osibouake.org/?RDC-Pharmakina-a-Bukavu-fabrique
http://www.lecongolais.cd/le-csac-interdit-la-publicite-des-produits-des-tradipraticiens-dans-les-medias/
http://www.kongo.l-h-l.org/?Fran%E7ais:M%E9decine_naturelle

personnes resources interogées :
Mr Clément WUTEJI, chef de division assurance et qualité, direction de lapharmacie, médicaments et plantes médicinales au Ministère de la santé
Mr le Directeur chargé de l'approvissionnement, medicaments et équipement au Ministère de la santé
Madame le Directeur en charge de la médecine traditionnelle, au Ministère de la santé

Gaelle Krikorian, Interdisciplinary Research Institute on Social Issues (English Translation)

Lead Author: Gaelle Krikorian
Organization: IRIS, Interdisciplinary Research Institute on Social Issues
Country: France

Abstract

In France, as in other countries, the arrival of Direct-Action Antivirals (DAAs) for the treatment of Hepatitis C has opened up debate regarding a heretofore unknown reality. First of all, it brought out the inability of the healthcare system to support the price levels demanded by the pharmaceutical industry, and in particular the economic inability of the State to follow medical recommendations. It underlines the excessive and unacceptable nature of the prices imposed by the industry. Lastly, it publicly points out for the first time the imperilment of the principle of universal access to care and treatment in the country. In order to resolve this crisis, broader and more systemic thought is required than simply taking random measures targeting specific medications. Returning to reasonable and acceptable price levels requires an in-depth reform of the economics of medication and the role of the various actors involved. This reform should involve at least four lines of action: evaluation of medications and the treatment delivered; relationships between industry and representatives of public institutions; the framework and rules for negotiation and the determination of prices; financing of medical research and the operation of the patent system. Although I would like to make a few comments on points 1 to 3, I will focus in this document on point 4.

Submission

Excessive prices for health products in France: revise the economics of medications and medical research.

Emergence of the problem in France

In France, as in other countries, the arrival of Direct-Action Antivirals (DAAs) for the treatment of Hepatitis C has opened up debate regarding a heretofore unknown reality.  Negotiating the price of Sovaldi® sold by Gilead in November 2014 resulted in € 41,000 for 3 months. But this situation is not an isolated case and hearkens back to a more systemic problem that undoubtedly explains the movement that it has created in various European countries. In ten years, new drug prices for treating serious diseases have experienced an unexpected increase. While at the start of the 2000s in France, the price of triple-drug therapies for AIDScost approximately € 8,000 per patient per year, the combinations of drugs for treating Hepatitis C cost up to € 70,000 for a 12-week course of treatment. For cancer, treatments that exceed € 100,000 per patient, per year, are multiplying, as is attested to by the arrival of products such as Kadcyla®, Perjeta® or Yervoy®.  In a ten-year period, the price of cancer drugs has nearly doubled, increasing from an average cost to the Government of € 3,700 to € 7,400 per month–a trend that can only worsen with the development of so-called “targeted” medicine, which promotes “niche” drugs (Nau 2013).
This abrupt change has raised questions in many countries (France, the U.S., Brazil, Greece, India, the UK, etc.). In France, in its 2016 report, the National Health Insurance Fund for Salaried Employees (CNAMTS) noted that, “[the] arrival of new treatments for Hepatitis C has caused a shock wave throughout all health systems. For the first time, the question of access to drug innovations is being asked, not for developing or emerging countries but for the most wealthy countries” (2015). At the United Nations, Secretary General Ban Ki-moon recently called it a “new agreement” regarding drugs (UN 2015).
In France, disagreements regarding the price of Sovaldi® have broken out in the context of the State’s financial inability to follow medical recommendations envision broad access to the drug by people who are carriers of Hepatitis C. The criteria for patient selection specified in the Decree dated November 18, 2014 have been deemed more restrictive than those recommended in the first expert interdisciplinary report on the treatment of persons infected with the Hepatitis B or Hepatitis C virus, published in May (Dhumeaux, 2014). The High Authority for Health (HAS) therefore recommended using sofosbuvir alone for patients in the severe stages of the disease, if they have developed cirrhosis (Stage F4) or reach the advanced hepatic fibrosis stage (Stage F3, “Severe” Stage F2), as well as patients co-infected withHIV.
This type of policy places a doubly untenable mandate on the shoulders of physicians, with regard to the ethical principles of their profession, on the one hand, and the imperatives of “financial responsibility” that are required of them, on the other. Some of them also believe that the price of the new Hepatitis C treatments impose “a logic of quotas, even rationing”. For its part, civil society has reacted vehemently, claiming access to products based on medical criteria, criticizing the prices that are deemed to be “unfair” and “excessive”, but also the negotiation procedure carried out by the Health Products Financial Committee (CEPS) which set the prices.

The situation encountered with DAAs brings to light more widespread major problems. On the one hand, French society is confronted with the expansion of the cases of medications that are useful for patients, the purchase of which is not sustainable for the health system. This makes the system as a whole more fragile and encourages Governments to restrict themselves to budgetary reasoning that feeds a headlong rush from a financial point of view. In the name of “access for all”, representatives of Gilead have, furthermore, announced in various meetings their intention to propose the ability for the States to pay on credit over several years for the three-month treatment for patients suffering from Hepatitis C, which they cannot pay in one installment due to the price. In order to maintain their annual budget and without needing to significantly alter the prices, since governments prefer a very short-term view, they could thus incur significant debts for their Governments vis-à-vis multinational pharmaceutical companies. In addition, the principle of universal access that is expensive for the countries is called into question. In spite of pockets of poverty, lawlessness or arbitrary decisions, universal social rights such as the right to health and drugs is deemed to be the rule in France. However situations arise in which drug price pressure translates into the weakening of this right and risks the development of measures for rationing among the general population. Various participants (physicians, patients, charities) condemn, for example, any restrictions or limitations on populations who have access or even deferred access due to financial and budgetary pressure exerted by prices and introduced through medical recommendations or instructions to prescribers.

The response publicized to date by the French Government regarding the price of Hepatitis C treatments has had no effect on the structural nature of the problem. In October 2014, the Minister of Health, Marisol Touraine, proposed, in the context of the Draft Social Security Financing Law (PLFSS), a mechanism intended to restrain expenses for the purchase of Sovaldi® from Gilead. Beyond a ceiling of the sale of 450 million Euros in 2014, and of 700 million Euros in 2015, and although the growth rate of revenues exceeds 10%, the various pharmaceutical companies selling Hepatitis C treatments must make an increasing contribution, the total amount of which is reliant on the gap between the income from sales and the amount of the allocation for the financing of these medications established by law. The contribution of each company is determined in proportion to their revenue, up to a ceiling representing 15% of that amount.

This mechanism was inspired by a so-called “K rate” mechanism adopted in France some 15 years ago in order to protect health care insurance from the risk of increases that were too massive or too fast in drug expenses. It provides for pharmaceutical companies to make a contribution to the health insurance entities when their total pre-tax revenue earned in France, for covered specialty medications, grows faster than a rate of increase specified by the Social Security Financing Act (LFSS). In the case before us, this provision has not had a great impact, in particular because the companies may be exempted from paying their contribution if they sign an agreement with the Health Products Financial Committee (CEPS). They thus offset the contractual payments, which does nothing to lower prices.

In addition, because this is a mechanism for regulating drug expenses after the fact, it does not provide for either the effect of financial pressure exerted on hospital budgets or the effects that the posted price of the medication may have on certain prescribers, seeking to limit expenses for certain populations, and it encourages the setting of drug prices at unacceptable levels.

Solutions for the future

Dealing with the issue of abusive prices requires broader and more systemic reflection than simply taking random actions targeting specific drugs. Returning to reasonable, acceptable price levels requires an in-depth reform of the economics of drugs and the roles of the various players involved. This reform should involve at least four lines of action: evaluation of medications and the treatment delivered; relationships between industry and representatives of public institutions; the framework and rules for negotiation and the determination of prices; financing of medical research and the operation of the patent system. Although I would like to make a few comments on points 1 to 3, I will focus in this document on point 4.

1. Evaluation of medications and the treatment delivered:
One of the resounding needs is to limit the prices of drugs that are still the most numerous, that do not provide anything new to patients (“me-too’s”). A report prepared at government request in 2015 envisions strengthening the use of medical-financial assessments, known as “efficiency reports,” conducted by the Financial and Public Health Evaluation Committee (CEESP) of the High Authority for Health (HAS). Although these reports have a certain role to play, one of the risks to be avoided is, nevertheless, that the medical-financial evaluation would not even out prices that are an invariable data point, when in contrast, the prices must be called into question. We have seen, for example, this type of logic being implemented with regard to DAAs: at a fixed price the effectiveness is assessed in terms of public health, which leads to establishing a cost-effectiveness balance that curtails access.

At the national as well as the European level, industry has led a strong offensive to accelerate and reduce procedures for access to drug contracts (through initiatives such as the Adaptive Pathway). Although it may be beneficial, even essential, to diseases at a therapeutic impasse to have early access to new products, it may not be a matter of revising requirements in terms of control of products, their efficacy and their toxicity downward. In France, this logic is flagrantly apparent in the new framework agreement between CEPS and the LEEM that was recently signed.

The evaluation of drugs also brings up the issue of pharmaco-monitoring of drugs that is in great need of strengthening. The endless progression of scandals pleads for the publication of data resulting from the biomedical clinical research studies by the competent authority when the authorization for commercial distribution is granted.

2. Fighting conflicts of interest between public institutions and industry:
For several years, scandals involving the industry have abounded (astronomical prices, conflicts of interest, collusion, dissimulated side effects, etc.).  The measures taken to date by the public authorities are insufficient to change the deal. This primarily involves the public Health Transparency database, which brings together stated data regarding all the monetary and in-kind benefits (contributions of equipment, transport, lodging, etc.) of a value greater than or equal to 10 Euros granted by a company to a professional. However data is only kept for 5 years, and the law does not require “the publication of benefits received in exchange for services rendered in the context of a contract”, which extensively limits its interest.

3. The framework and rules for negotiation and the determination of prices:
The crisis surrounding the price Sovaldi® has brought about a number of significant claims intended to counter the opacity of the work conducted by the CEPS:
- The transparency of face prices, actual prices, mechanisms for delivery and listing fees put into force.
- The transparency of the conventions signed between pharmaceutical firms and the CEPS.
- The transparency vis-à-vis procedures, stages and price determination criteria.
- The expansion of the parties included in price negotiations or having access to information regarding the contents of negotiations, and in particular the addition of representatives of patients and users of the health system.

4. Financing of medical research and the operation of the patent system:

Limit of the system focused on granting exclusive rights:
Drugs are protected by patents, each offering 20-year protection by the WTO but which is nevertheless frequently extended (specifically via Supplementary Protection Certificates). During this entire period, the patent holder enjoys a monopoly on the market covered by the patent. This makes price negotiations difficult, since there is only a single, possible source for the drug, and there is no competitive effect to push prices down.

According to the historical justification of the patent system, the exclusivity granted on the market must allow innovation to be encouraged, ensuring the reimbursement of investments in the research and the release of profits. However the current model that is systematically based on the granting of monopolies and other exclusive rights to industrial concerns shows its limits in an increasingly flagrant manner:
- the development of real medical innovations in a very limited number.
- a profusion of drugs that are similar to each other ("me too") because the companies direct their procurement of patents and/or their research and/or development based on the prospects for a financial return.
- for the same reasons, a shortage of research and treatments for diseases that affect few people or poor populations.
- increasing difficulties in access for patients or difficulties with sustainability for the health systems because prices of products for serious diseases are increasingly high.

Rebalancing the patent system:
A patent must not be granted unless it describes a real invention, and not something that is already known by at least some of the experts in the field in question: this is the basis for the social contract on which the patent system is based. This is the reason that there are patentable criteria that should be carefully applied by the patent offices (national or European), in order to not create an unjustified monopolistic situation. A challenge through the European Patent Office (EPO) of a Gilead patent on Sovaldi® filed by the humanitarian NGO Médecins du Monde (MDM) notes these abuses. A “good product”, that represents major progress for diseases (and that will, in this regard, be commercially distributed, sold at a price that is of interest to the company and reimbursed by the health system) is not necessarily an invention from the point of view of science, and in this regard, it does not necessarily merit a patent and a monopoly.

In addition, the fact of granting or assigning monopoly rights to private companies when the innovation in question is the fruit of work to a large extent financed by public funds poses the problem of a lack of return on investments for the public (all the more so since the price limits access by certain populations). 

When the drugs are covered by patents, and if the State deems it necessary, there are legal tools to break the monopoly. French law, in accordance with international rules (established by the WTO), allows that State granting the patents to lift the protection, in particular in the case of “abnormally high prices”, while having recourse to an automatic license. However, and in spite of the flagrant abuses by the industry, the government has so far refused to use this tool.

Diversifying the mechanisms supporting research and creating transparency:
There are various means of supporting and encouraging research and development in the medical field via mechanisms that do not necessarily lead to establishing monopolies and the fact of making funding contingent of drug sales:
- the public funding of research (grants, subsidies, research institutes, etc.).
- balanced public-private partnerships that do not translate into systematic privatization of the developed knowledge.
- the creation of conditional funding targeting specific health needs that reward the development of inventions without leading to the granting of exclusive rights to technologies or knowledge that is developed.

Several interesting mechanisms have been proposed in France in the context of the debates regarding the 2015 Health Act, in order to balance the relationship between public interest and private interest:
- The tracking of direct or indirect public support and funding for medical research (funding, public-private partnerships, availability of researchers, hospitals, tax credits, etc.), in order for it to be possible to identify the various public contributions to research that will allow the development of a new medication brought to market.
- The implementation of a procedure to support the use of a mandatory license through the European Commission in order to allow the Member States to use this indispensable tool to bring the operation of the patent system and negotiations with industry back into balance.
- The creation at the national or European level of “innovation prices” that fund innovation without granting a monopoly: the establishment of ad hoc funds intended to offset the development of medical innovations or stages of research necessary to develop innovations, the fruits of which will remain in the public domain.
- The obligation assumed by pharmaceutical firms wanting to bring a product to market to forward to the CEPS and make public the following:

• the actual amounts spent on R&D and in particular the amounts allocated to funding the clinical trials referenced during the registration of the product, indicating the number of trials and patients included in these trials;
• the tax credits, grants and other public funding granted to industrial concerns, in relation to these research and development activities;
• possible purchases of patents related to health products, the cost of acquisitions or speculation activities related to the acquisition of patents;
• the production costs of health products, as well as the costs of commercial sale and promotion incurred by the companies;
• the annual revenue earned in France, attributable to a commercially distributed specialty drug.

Bibliography and References

Gaëlle Krikorian is a sociologist and member of the , Interdisciplinary Research Institute on Social Issues (IRIS). She wrote her thesis in sociology at the Ecole des hautes études en sciences sociales in Paris, titled “La propriété ou la vie ? Économies morales, actions collectives et politiques du médicament dans la négociation d'accords de libre-échange. Maroc, Thaïlande, États-Unis” [Ownership or life? Moral economies, collective and political action regarding drugs in the negotiation of free-exchange agreements. Morocco, Thailand and the United States”]. This work involves the production of rules of law and policies for intellectual property in the context of globalization that have an impact on access to drugs. Her work primarily involves the place of legal and technical expertise in social and political controversies related to health and conflict analysis that oppose various types of social agents (representatives of States, activists and industrial concerns, etc.) in the field of ethical issues.

Among her recent publications are:
• Krikorian G. (2014), Un activisme savant. De la lutte contre le sida aux mobilisations contre les accords de libre-échange. La vie des idées. Dossier La fin du sida ? 20 November 2014. http://www.laviedesidees.fr/Un-activisme-savant.html
• Krikorian G. (2014). Le programme de préqualification de l’OMS au coeur d’un conflit sur la propriété intellectuelle. Commentary. Sciences Sociales et Santé, Vol. 32, No. 1, March 2014, 101-107.
• Krikorian, G. (2013). Conditions d’usage des licences obligatoires : l’action du gouvernement thaïlandais, in Accès aux antirétroviraux dans les pays du Sud. Propriété intellectuelle et politiques publiques, edited by Cristina Possas and Bernard Larouzé, ANRS, p. 51-67.
• Krikorian G. (2011), Intellectual Property and Access to Medicines: paradoxes in Moroccan policy, in Intellectual Property, Pharmaceuticals and Public Health. Access to Drugs in Developing Countries, Kenneth C. Shadlen, Samira Guennif, Alenka Guzmn, N. Lalitha (Eds.), Edward Elgar Publishing, p. 56-76.
• Krikorian G. (2011), Accès à la santé ou renforcement des droits de propriété intellectuelle : enjeux des normes internationales, in Libres Savoirs, les biens communs de la connaissance, C&F éditions, p. 105-115.
• Krikorian G. (2010). Décision de l’OMC du 30 août 2003 et l’étude de cas du Rwanda. In G. Velasquez & C. M. Correa, Innovation pharmaceutique et santé publique (L’Harmattan, Paris), p. 89-101.
• Krikorian G. (2010). Dispositions ADPIC-plus introduites dans le cadre des négociations internationales. In G. Velasquez & C. M. Correa (Ed.), Innovation pharmaceutique et santé publique (L’Harmattan, Paris), p. 131-143.
• Krikorian G. & Kapczynski, A. (2010), Access to Knowledge in the Age of Intellectual Property. (Zone Books Eds., New York), 652 p.

Gaelle Krikorian (Original Language)

Lead Author: Gaelle Krikorian
Organization: IRIS, Interdisciplinary Research Institute on Social Issue
Country: France

Abstract

En France, comme dans d'autres pays, l'arrivée des médicaments antiviraux à action directe (ADD) contre l'hépatite C a ouvert un débat sur une réalité jusque-là ignorée. Tout d'abord, il pointe l'incapacité du système de santé à supporter les niveaux de prix demandés par l'industrie pharmaceutique, et notamment l'impossibilité économique pour l'État à suivre les recommandations médicales. Il souligne le caractère excessif et inacceptable des prix imposés par l'industrie. Enfin, il signale pour la première fois de façon publique la mise en péril du principe d'universalité de l'accès aux soins et aux traitements dans le pays. Sortir de cette crise impose une réflexion plus large et plus systémique que la prise de mesures ponctuelles visant des médicaments particuliers. Revenir à des niveaux de prix raisonnables et acceptables nécessite une réforme profonde de l'économie du médicament et du rôle des différents acteurs impliqués. Cette réforme devrait porter sur au moins quatre axes : l'évaluation des médicaments et du service thérapeutique rendu ; les relations entre industrie et représentants des institutions publiques ; le cadre et les règles de la négociation et de la fixation des prix ; le financement de recherche médicale et le fonctionnement du système des brevets. Si je souhaite faire quelques remarques sur les points de 1 à 3, je me concentrerai cependant dans ce document sur le point 4.

Submission

Prix excessifs des produits de santé en France : revoir l'économie du médicament et de la recherche médicale

Emergence du problème en France

En France, comme dans d'autres pays, l'arrivée des médicaments antiviraux à action directe (ADD) contre l'hépatite C a ouvert un débat sur une réalité jusque-là ignorée. La négociation du prix du Sovaldi® vendu par Gilead s'est conclue en novembre 2014 à 41 000 euros pour 3 mois. Mais cette situation n'est pas un cas isolé et renvoie à un problème plus systémique, ce qui explique sans doute les mobilisations qu'elle suscite dans différents pays européens. En dix ans, le prix des médicaments nouveaux contre des pathologies graves a connu une augmentation inédite. Alors qu'au début des années 2000 en France, le prix des trithérapies contre le sida était d'environ 8 000 € par patient et par an, les combinaisons de médicaments contre l'hépatite C coûtent jusque 70 000 € pour une cure de 12 semaines. Dans le domaine du cancer, les traitements qui dépassent 100 000 € par patient et par an se multiplient, comme en atteste l'arrivée de produits comme Kadcyla®, Perjeta® ou Yervoy®. En une décennie, le prix des anticancéreux a quasiment doublé, passant d’un coût moyen pour l'État de 3 700 à 7400 € par mois – une tendance qui ne peut que s’aggraver avec le développement d'une médecine dite « ciblée » qui favorise les médicaments de « niche » (Nau 2013).
Cette évolution brutale suscite de fortes interrogations dans de nombreux pays (France, États-Unis, Brésil, Grèce, Inde, Royaume-Uni, etc.). En France, dans son rapport pour 2016, la Caisse nationale de l'assurance maladie des travailleurs salariés (Cnamts) constate que : « [l]’arrivée des nouveaux traitements de l’hépatite C a provoqué une onde de choc dans tous les systèmes de santé. Pour la première fois, la question de l’accès à l’innovation médicamenteuse s’est posée non pas pour des pays en développement ou émergents, mais pour les pays les plus riches » (2015). Aux Nations Unies, le Secrétaire général Ban Ki-moon en a appelé récemment à un « nouveau pacte » sur les médicaments (UN 2015).
En France, des controverses sur le prix du Sovaldi® ont éclaté dans le contexte d'une impossibilité économique pour l'État à suivre les recommandations médicales prévoyant un accès large au médicament des personnes porteuses de l'hépatite C. Les critères de sélection des patients définis dans l’arrêté du 18 novembre 2014 se sont avérés plus restrictifs que ceux recommandés dans le premier rapport d’experts interdisciplinaires sur la Prise en charge des personnes infectées par le virus de l’hépatite B ou de l’hépatite C publié en mai (Dhumeaux, 2014). La Haute autorité de santé (HAS) a, ainsi, recommandé d'utiliser le sofosbuvir uniquement pour les patients aux stades sévères de la maladie, ayant développé une cirrhose (stade F4) ou atteint le stade de fibrose hépatique avancé (stade F3, stade F2 « sévère »), ainsi que les personnes co-infectées par le VIH.
Ce type de politiques place les médecins dans une double injonction intenable, eu égard aux principes d'éthique de leur profession, d'une part et aux impératifs de "responsabilisation financière" qu'on leur pose, d'autre part. Une partie d'entre eux estime d'ailleurs que le prix des nouveaux traitements contre l'hépatite C impose « une logique de quota, voire de rationnement ». De son côté, la société civile a réagit vivement, revendiquant un accès aux produits suivant les critères médicaux, critiquant des prix jugées "injustes" et "excessifs" mais aussi la procédure de négociation du Comité Economique des Produits Santé (CEPS) par laquelle ils ont été fixés.
La situation rencontrer avec les ADD met en lumière deux problèmes majeurs plus généraux. D'une part, la société française est confrontée à une multiplication de cas de médicaments utiles aux patients dont l'achat n'est pas soutenable pour le système de santé. Ils fragilisent le système général et encourage les Etats à s'enfermer dans des logiques budgétaires qui alimentent une fuite en avant d'un point de vue financier. Au nom de "l'accès pour tous", des représentants de Gilead ont, d'ailleurs, fait part dans différentes réunions de leur intention de proposer aux Etats la possibilité de payer à crédit sur plusieurs années le traitement de trois mois des patients atteints d'hépatite C qui ne peut être payé en une fois du fait de son prix. Pour maintenir leur budget annuel et sans avoir besoin de toucher significativement aux prix, des gouvernants privilégiant une vue à très court terme pourraient ainsi endetter leur Etats auprès de multinationales pharmaceutiques. D'autre part, le principe d'universalité de l'accès cher au pays est mis en question. En dépit de poches de misère, de non-droit ou d'arbitraire, l'universalité de droits sociaux comme le droit à la santé et aux médicaments est tenue pour être la règle en France. Pourtant, émergent des situations où la pression du prix des médicaments se traduit par une fragilisation de ce droit et le risque du développement de mesures de rationnement au sein de la population générale. Différents acteurs (médecins, patients, associations) dénoncent, par exemple, des restrictions ou limitations des populations qui ont accès ou encore un différé de l'accès dus à la pression économique et budgétaire exercée par les prix et introduits au travers de recommandations médicales ou de consignes aux prescripteurs.
La réponse apportée jusqu'à présent par l'Etat français aux prix des traitements contre l'hépatite C est sans effet sur le caractère structurel du problème. En octobre 2014, la Ministre de la Santé, Marisol Touraine, proposait, dans le cadre du projet de loi de financement de la sécurité sociale (PLFSS), un dispositif destiné à contenir les dépenses induites par l'achat du Sovaldi® de Gilead. Au-delà d'un plafond de vente de produits de 450 millions d'euros en 2014, et de 700 millions d'euros en 2015, et si le taux de croissance des chiffres d'affaires est supérieur à 10 %, les différents laboratoires commercialisant les traitements contre l'hépatite C doivent payer une contribution progressive dont le montant total dépend de l'écart entre le produit des ventes et le montant de l'enveloppe dédiée au financement de ces médicaments fixé par la loi. La contribution de chaque entreprise est déterminée au prorata de son chiffre d'affaires, dans la limite d'un plafond représentant 15 % de celui-ci.
Ce dispositif s'inspire d'un mécanisme dit de « taux K » adopté en France il y a plus de 15 ans afin de prémunir l'assurance maladie d'un risque d'augmentation trop massive ou trop rapide des dépenses de médicament. Il prévoit que les laboratoires pharmaceutiques reversent à l'assurance maladie une contribution lorsque leur chiffre d'affaires global hors taxes réalisé en France, au titre des spécialités remboursables, a crû plus vite qu'un taux de progression défini par la loi de financement de la sécurité sociale (LFSS). Dans les faits, cette disposition n'a pas eu grand impact, notamment parce que les entreprises peuvent être exonérées du paiement de leur contribution si elles contractent une convention avec le comité économique des produits de santé (CEPS). Elles s'acquittent alors en contrepartie de remises conventionnelles, ce qui n'empêche pas les prix de rester très élevés.
Par ailleurs, parce qu'il s'agit d'un mécanisme de régulation des dépenses de médicaments a posteriori, il ne prévient ni l'effet de pression financière qui s'exerce sur les budgets des hôpitaux, ni les effets que le prix affiché du médicament peut avoir sur certain-e-s prescripteurs-trices cherchant à limiter les dépenses à l'égard de certaines populations, et encourage la fixation de prix de médicament à des niveaux inacceptables.

Solutions pour le futur

Traiter la question des prix abusifs impose une réflexion plus large et plus systémique que la prise de mesures ponctuelles visant des médicaments particuliers. Revenir à des niveaux de prix raisonnables et acceptables nécessite une réforme profonde de l'économie du médicament et du rôle des différents acteurs impliqués. Cette réforme devrait porter sur au moins quatre axes : l'évaluation des médicaments et du service thérapeutique rendu ; les relations entre industrie et représentants des institutions publiques ; le cadre et les règles de la négociation et de la fixation des prix ; le financement de recherche médicale et le fonctionnement du système des brevets. Si je souhaite faire quelques remarques sur les points de 1 à 3, je me concentrerai cependant dans ce document sur le point 4.

1. L'évaluation des médicaments et du service thérapeutique rendu :
L'une des besoins criants est de limiter les prix de médicaments toujours plus nombreux qui n'apportent rien de nouveaux aux patients ("me-too"). Un rapport réalisé à la demande du gouvernement en 2015 envisage le renforcement de l’usage des évaluations médico-économiques, appelées « rapports d'efficience », effectuées par la Commission d’Evaluation Economique et de Santé Publique (CEESP) de la Haute Autorité de Santé (HAS). Si ces rapports ont un rôle certain à jouer, l'un des risques à éviter est, cependant, que l'évaluation médico-économique n'induise un effet de naturalisation du prix qui se trouve pris comme une donnée invariable – quand au contraire, il devrait être remis en question. On a vu, par exemple, ce type de raisonnements être fait à propos des ADD : à prix fixe on évalue l'efficacité en terme de santé publique, ce qui amène à établir un équilibre de coût-efficacité qui rogne sur l'accès.
Au niveau national comme européen, l'industrie conduit une forte offensive pour accélérer et réduire les procédures d'accès aux marchés des médicaments (au travers d'initiatives comme l'Adaptive Pathway). S'il peut être bénéfique, voire essentiel, aux malades en impasse thérapeutique d'avoir accès tôt à de nouveaux produits, il ne peut être question de revoir à la baisse les exigences en matière de contrôle des produits, de leur efficacité et de leur toxicité. En France, cette logique est flagrante dans le nouvel accord cadre entre le CEPS et le LEEM signé récemment.
L'évaluation des médicaments soulève également la question de la pharmacovigilance des médicaments qui a grand besoin d'être renforcée. La succession sans fin de scandales plaide pour la publication des données issues des études cliniques des recherches biomédicales par l'autorité compétente lorsque l'autorisation de mise sur le marché est accordée.

2. Lutte contre les conflits d'intérêt entre institutions publiques et industrie :
Depuis plusieurs années, les scandales impliquant l'industrie se multiplient (prix astronomiques, conflits d'intérêt, collusions, effets secondaires dissimulés, etc.). Les mesures prises jusqu'à présent par les pouvoirs publics sont insuffisantes pour changer la donne. Il s'agit essentiellement de la Base de données publiques Transparence Santé qui rassemble des données déclaratives sur tous les avantages en espèces ou en nature (don de matériel, transport, hébergement, etc.) d’une valeur supérieure ou égale à 10 euros accordés par une entreprise à un-e professionnel-le. Cependant, les données ne sont conservées que 5 années, et la loi ne rend pas obligatoire "la publication des avantages reçus en échange de services rendus dans le cadre d'un contrat", ce qui limite grandement son intérêt.

3. Le cadre et les règles de la négociation et de la fixation des prix :
La crise autour du prix du Sovaldi® a fait émerger un certain nombre de revendications importantes visant à contrée l'opacité du travail conduit par le CEPS :
- La transparence des prix faciaux, des prix réels, des dispositifs de remise et de marge arrière mis en œuvre.
- La transparence des conventions signées entre firmes pharmaceutiques et CEPS.
- La transparence vis-à-vis des procédures, étapes, critères de définition des prix.
- L'élargissement des parties incluses lors de la négociation des prix ou ayant accès aux informations sur le contenu de la négociation et notamment l'ajout de représentant-e-s des malades et des usager-ère-s du système sanitaire.

4. Financement de la recherche médicale et fonctionnement du système des brevets :

Limite du système centré sur l'octroi de droits exclusifs :
Les médicaments sont protégés par des brevets, offrant chacun une protection fixée à 20 ans par l'OMC, mais qui est cependant fréquemment allongée (notamment via les certificats complémentaires de protection). Durant toute cette période le détenteur du brevet jouit d'un monopole sur le marché couvert par le brevet. Ceci rend la négociation du prix difficile puisqu'il n'existe qu'une seule source possible pour le médicament et aucun effet de concurrence pour faire baisser les prix.
Selon la justification historique du système des brevets, l'exclusivité accordée sur le marché doit permettre d'encourager l'innovation en assurant le remboursement des investissements dans la recherche et le dégagement de profits. Cependant, le modèle actuel qui s'appuie systématiquement sur l'octroi de monopoles et autres droits exclusifs aux industriels montre de façon de plus en plus criante ses limites :
- la mise au point de réelles innovations médicales en nombre très limité.
- une profusion de médicaments similaires les uns aux autres ("me too") parce que les firmes orientent leur achat de brevets et/ou leur recherche et/ou développement en fonction des perspectives de retour financier.
- pour les mêmes raisons, une pénurie de recherches et de traitements pour des maladies qui touchent peu de personnes ou des populations pauvres.
- des difficultés croissantes d'accessibilité pour les patient-e-s ou de soutenabilité pour les systèmes de santé parce que les prix des produits pour des pathologies graves sont de plus en plus élevés.

Rééquilibrer le système des brevets :
Un brevet ne doit être accordé que lorsqu'il décrit une invention réelle, et non quelque chose qui est déjà connu d'au moins une partie des experts du champ concerné : c'est la base du contrat social sur lequel repose le système des brevets. C'est la raison pour laquelle existent des critères de brevetabilité qui devraient être appliqués scrupuleusement par les offices des brevets (nationaux ou européen) afin de ne pas créer de situation de monopole injustifiées. L'opposition auprès de l'Office européen des brevets (OEB) d'un brevet de Gilead sur le Sovaldi® engagée par l'ONG humanitaire Médecins du Monde (MDM) pointe ces abus. Un "bon produit", qui représente un progrès majeur pour les malades (et sera à ce titre commercialisé, vendu à un prix intéressant pour la firme et remboursé par le système sanitaire) ne constitue pas nécessairement une invention du point de vue de la science, et à ce titre ne mérite pas forcément de brevet et de monopole.
Par ailleurs, le fait de donner ou céder des droits de monopole à des entreprises privées lorsque l'innovation concernée est le fruit de travaux en grande partie financés par l'argent public pose le problème d'une absence de retour pour le public des investissements publics (ce d'autant plus lorsque le prix limite l'accès à certaines populations).
Lorsque des médicaments sont couverts par des brevets, et si l'Etat le juge nécessaire, il existe des outils juridiques pour lever la situation de monopole. La loi française, en conformité avec les règles internationales (fixées par l'OMC) permet à l'Etat qui octroie les brevets d'en lever la protection notamment dans le cas de "prix anormalement élevés" en ayant recours à une licence d'office. Pourtant, et en dépit des abus flagrants de l'industrie, le gouvernement s'est pour le moment refusé à utiliser cet outil.

Diversifier les dispositifs de soutien de la recherche et faire la transparence :
Il existe différentes façons de soutenir et encourager la recherche et le développement dans le domaine médical via des mécanismes qui ne conduisent pas nécessairement à l'instauration de monopoles et le fait de faire dépendre le financement des ventes de médicaments :
- le financement de la recherche par le public (bourses, subventions, instituts de recherche, etc.).
- des partenariats public-privé équilibrés qui ne se traduisent pas par une privatisation systématique des connaissances développées.
- la création de financements conditionnés et ciblant des besoins sanitaires précis qui sanctionnent la mise au point d'inventions sans conduire à l'octroi de droits exclusifs sur les technologies ou les savoirs développés.

Plusieurs propositions intéressantes ont été introduites en France dans le contexte ses débats sur la loi de santé en 2015 afin de rééquilibrer la relation entre intérêt général et intérêt privé :
- La traçabilité des financements et soutiens publics directs ou indirects à la recherche médicale (financements, partenariats public-privé, mise à disposition de chercheurs, d'hôpitaux, crédit d'impôts, etc.) afin qu'il soit possible d'identifier les différents apports publics à la recherche qui auront permis de mettre au point un nouveau médicament mis sur le marché.
- La mise en place d'une procédure de soutien à l'usage de licence obligatoire auprès de la Commission européenne afin de permettre aux Etats membres d'utiliser cet outil indispensable pour rééquilibrer le fonctionnement du système de brevets et les négociations avec l'industrie.
- la création au niveau national ou européen de « prix à l'innovation » qui financent l'innovation sans octroi de monopole : la mise en place de fonds ad hoc destinés à récompenser la mise au point d'innovations médicales ou d'étapes de la recherche nécessaires à la mise au point d'innovations, et dont les fruits resteront dans le domaine public.
- L'obligation faite aux firmes pharmaceutiques souhaitant mettre sur le marché un produit de transmettre au CEPS et rendre public :
• les montants effectifs consacrés à la R&D et notamment les montants affectés au financement d'essais cliniques cités lors de l'enregistrement du produit, en indiquant le nombre d'essais et de patients inclus dans ces essais,
• les crédits d'impôt, les bourses et autres financements publics dont les industriels ont bénéficié en lien avec ces activités de recherche et de développement,
• les éventuels achats de brevets liés au produit de santé, le coût d'opérations d'acquisition ou de spéculation liées à l'acquisition de brevets,
• les coûts de production du produit de santé, ainsi que les coûts de commercialisation et de promotion engagés par les entreprises.
• le chiffre d'affaire annuel réalisé en France attribuable à une spécialité commercialisée.

Bibliography and References

Gaëlle Krikorian est sociologue et membre de l’Institut de recherche interdisciplinaire sur les enjeux sociaux (IRIS). Elle a réalisée une thèse de sociologie à l’Ecole des hautes études en sciences sociales à Paris intitulée « La propriété ou la vie ? Économies morales, actions collectives et politiques du médicament dans la négociation d'accords de libre-échange. Maroc, Thaïlande, États-Unis ». Celle-ci porte sur la production dans le contexte de la globalisation de règles de droits et de politiques de propriété intellectuelle qui ont un impact sur l’accès aux médicaments. Ses travaux s'intéressent notamment à la place de l’expertise légale et technique dans les controverses sociales et politiques sur la santé et l'analyse des conflits qui opposent différents types d’agents sociaux (représentants des Etats, militants, industriels, etc.) sur le terrain de la morale.
Among her recent publications are:
• Krikorian G. (2014), Un activisme savant. De la lutte contre le sida aux mobilisations contre les accords de libre-échange. La vie des idées. Dossier La fin du sida ? 20 novembre 2014. http://www.laviedesidees.fr/Un-activisme-savant.html
• Krikorian G. (2014). Le programme de préqualification de l’OMS au coeur d’un conflit sur la propriété intellectuelle. Commentaire. Sciences Sociales et Santé, Vol. 32, n° 1, mars 2014, 101-107.
• Krikorian, G. (2013). Conditions d’usage des licences obligatoires : l’action du gouvernement thaïlandais, in Accès aux antirétroviraux dans les pays du Sud. Propriété intellectuelle et politiques publiques, édité par Cristina Possas et Bernard Larouzé, ANRS, p. 51-67.
• Krikorian G. (2011), Intellectual Property and Access to Medicines: paradoxes in Moroccan policy, in Intellectual Property, Pharmaceuticals and Public Health. Access to Drugs in Developing Countries, Kenneth C. Shadlen, Samira Guennif, Alenka Guzmn, N. Lalitha (eds), Edward Elgar Publishing, p. 56-76.
• Krikorian G. (2011), Accès à la santé ou renforcement des droits de propriété intellectuelle : enjeux des normes internationales, in Libres Savoirs, les biens communs de la connaissance, C&F éditions, p. 105-115.
• Krikorian G. (2010). Décision de l’OMC du 30 août 2003 et l’étude de cas du Rwanda. In G. Velasquez & C. M. Correa, Innovation pharmaceutique et santé publique (L’Harmattan, Paris), p. 89-101.
• Krikorian G. (2010). Dispositions ADPIC-plus introduites dans le cadre des négociations internationales. In G. Velasquez & C. M. Correa (éd.), Innovation pharmaceutique et santé publique (L’Harmattan, Paris), p. 131-143.
• Krikorian G. & Kapczynski, A. (2010), Access to Knowledge in the Age of Intellectual Property. (Zone Books Eds., New York), 652 p.

Felix Lobo, UNIVERSIDAD CARLOS III DE MADRID_C (English Translation)

Lead Author: Felix Lobo
Organization: Universidad Carlos III de Madrid
Country: Spain

Abstract

 PROPOSAL FOR EXPANDING THE GENERIC MEDICINAL PRODUCT MARKETS, AFFORDABLE PRICES AND ACCESS TO THE MEDICINAL PRODUCTS FOR THE DISADVANTAGED, THROUGH APPROPRIATE NATIONAL AND INTERNATIONAL REGULATION, ADDED TO THE OTHER TWO PROPOSALS MADE BY F LOBO:

PROPOSAL 3. JOINT USE OF THE INTERNATIONAL NONPROPRIETARY NAMES (INN) AND TRADEMARKS BY PHYSICIANS WRITING PRESCRIPTIONS

Submission

Despite the fact that the international nonproprietary names appear on the label, physicians can continue to prescribe by brand name. but the physicians should use the nonproprietary names to achieve all of its social benefits. It would also be a good idea for them to be used by pharmacists, including beyond the procedures for substitution of a brand name by a generic product. It would also be good for the patients to have some familiarity with the nonproprietary names, especially with chronic illnesses.

Errors are still being made in prescriptions and doses due to confusion between a brand name written or pronounced similarly. The transparency of the market for generic products and the price competition depend to a great extent on the knowledge the physicians and patients have about the equivalence between competing medications, coming from various suppliers. The obligatory substitution of brand names with generics could overcome the lack of knowledge about the equivalence of the generics or the lack of the desire to prescribe them instead of more expensive brand names, but it is not always possible to develop this and it is not legal in every country.

To expand the use of nonproprietary names, the solution we propose is to have all prescriptions be written using them, even when there is not a possible substitution of a brand name by a generic. However, we do not recommend replacing all brand names by nonproprietary names. The brand names provide incentive for pharmaceutical companies to invest in research and development beyond the patents, since they are a mechanism that lets them internalize the profits earned from the sale of their products. They also give consumers, understood as the physicians, pharmacists and patients, the chance to choose their preferred medicines and manufacturers.

It is true that the function of brand names as a consistent guarantee of quality is redundant to the extent that the regulatory agencies develop the appropriate quality controls. But the redundancy is certain only with individual products. Brand names are useful so that consumers can recognize and reward the overall reputation of a  company, such as being a leader in research efforts. So this total prohibition of trademarks for medications would entail costs and could not be recommended.

The recommendation is therefore that the prescription contain a dual identification of the medication, using the nonproprietary name and the manufacture name or the brand name. This will decrease the number of errors and promote transparency and price competition. During the life of the patent writing the nonproprietary name would increase knowledge and awareness of the possible supplies coming from other companies when the patent expires.

The dual prescription is also a fair solution for pharmaceutical companies since it combines the property right incorporated in the trademarks with the public interest in reducing confusion and promoting competition.

It would be good to minimize the additional effort that a dual prescription requires of physicians. In any event, in a world where in many countries medicines are prescribed with the help of computers and this trend will increase in the future this extra effort would not be very much. It would be a matter of reprogramming the electronic prescription systems to include the nonproprietary name on each prescription.

The rollout of the INN system had been a success but needs to be completed. The dual use of nonproprietary names and trademarks, a fair solution, would facilitate the universal use of the INNs by health professionals. This solution would bring benefits to the patients and improve the efficiency of the health systems.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. [Current medicinal product price policies in Europe: a general overview], Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervention de precios of the medicamentos en España. Panorama de la regulation y los estudios empíricos [Medicinal product price intervention in Spain: overview of regulation and empirical studies], Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription medicinal product markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Medicinal product Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, June 2013.
ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505.

Felix Lobo_C (Original Language)

Lead Author: Felix Lobo
Organization: Universidad Carlos III de Madrid
Country: Spain

Abstract

PARA EXPANDIR LOS MERCADOS DE MEDICAMENTOS GENÉRICOS, LOS PRECIOS ASEQUIBLES Y EL ACCESO A LOS MEDICAMENTOS POR LAS POBLACIONES MENOS FAVORECIDAS MEDIANTE UNA REGULACIÓN INTERNACIONAL Y NACIONAL ADECUADA FORMULAMOS UNA PROPUESTA QUE SE AÑADE A LAS OTRAS DOS PRESENTADAS POR F LOBO:

PROPUESTA 3. UTILIZACIÓN CONJUNTA DE LAS DENOMINACIONES COMUNES INTERNACIONALES (DCI) Y LAS MARCAS COMERCIALES POR LOS MÉDICOS AL PRESCRIBIR SU RECETAS.

Submission

A pesar de que las denominaciones comunes internacionales aparezcan en el etiquetado, los médicos pueden seguir prescribiendo por marca. Pero las denominaciones comunes deben ser utilizadas por los médicos para alcanzar todos sus beneficios sociales . También sería conveniente que fueran utilizadas por los farmacéuticos, incluso más allá de los procedimientos de sustitución de una marca por un genérico. También sería buena cierta familiaridad de los pacientes con las denominaciones comunes, especialmente en el caso de enfermedades crónicas.

Siguen produciéndose errores en las recetas y en la dosificación debido a confusiones entre marcas que se escriben o se pronuncian de manera parecida. La transparencia de los mercados de genéricos y la competencia en precios dependen en buena medida del conocimiento que los médicos y los pacientes tengan sobre la equivalencia entre medicamentos competidores procedentes de diversas empresas oferentes. La sustitución obligatoria de marcas por genéricos puede superar la falta de conocimiento acerca de la equivalencia de los genéricos o la falta de voluntad de prescribirlos en lugar de marcas más caras, pero no siempre es posible desarrollarla y no es legal en todos los países.

Para expandir la utilización de los nombres comunes la solución que proponemos es que todas las recetas se escriban con ellos, incluso aunque no exista posibilidad de sustitución de marcas por genéricos. Sin embargo no recomendamos reemplazar totalmente las marcas por las denominaciones comunes. Las marcas proporcionan incentivos a las compañías farmacéuticas para invertir en investigación y desarrollo más allá de las patentes, ya que son un mecanismo que les permite internalizar las rentas ganadas con las ventas de sus productos. También dan a los consumidores, entendiendo por tales los propios médicos, farmacéuticos y pacientes, la oportunidad de seleccionar los medicamentos y los fabricantes que prefieran.

Es verdad que la función de las marcas como garantía consistente de calidad es redundante en la medida en que las agencias reguladoras desarrollan los controles de calidad adecuados. Pero la redundancia es cierta sólo cuando se habla de productos individuales. Las marcas son útiles para que los consumidores reconozcan y recompensen la reputación general de una empresa, por ejemplo como líder en esfuerzos de investigación. Por eso la prohibición total de las marcas comerciales para los medicamentos tendría costes y no sería recomendable.

La recomendación por tanto es que la recetas contengan una identificación dual del medicamento: por la denominación común y por el nombre del fabricante o su marca. Con la prescripción dual disminuirían los errores y se promovería la transparencia y la competencia en precios. Durante la vida de la patente escribir la denominación común además de la marca en la receta incrementaría el conocimiento y la conciencia acerca de las posibilidades de ofertas procedentes de distintas empresas cuando la patente caduca.

Para las empresas farmacéuticas la prescripción dual también constituiría una solución equilibrada ya que compagina el derecho de propiedad incorporado a las marcas comerciales con los intereses públicos de reducir la confusión y promover la competencia.

Convendría minimizar el esfuerzo adicional que la prescripción dual requiere a los médicos. De todas maneras en un mundo en el que en muchos países la prescripción de medicamentos se realiza con el auxilio de computadoras y la tendencia se va a incrementar en el futuro, dicho esfuerzo adicional no sería muy grande. Bastaría con reprogramar los sistemas electrónicos de prescripción para incluir el nombre genérico en cada receta.

El despliegue del sistema de las DCI es una historia de éxito pero requiere ser completada. El uso dual de nombres genéricos y marcas comerciales, una solución equilibrada, facilitaría el uso universal de las DCI por los profesionales de la salud. Esta solución aportaría ventajas a los pacientes y mejoraría la eficiencia de los sistemas sanitarios.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervención de precios de los medicamentos en España. Panorama de la regulación y los estudios empíricos, Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription drug markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Drug Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, Junio 2013. ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505.

Felix Lobo, UNIVERSIDAD CARLOS III DE MADRID_B (English Translation)

Lead Author: Felix Lobo
Organizations: Universidad Carlos III de Madrid
Country: Spain

Abstract

SECOND PROPOSAL FOR EXPANDING THE GENERIC MEDICINAL PRODUCT MARKETS, AFFORDABLE PRICES AND ACCESS TO THE MEDICINAL PRODUCTS FOR THE DISADVANTAGED, THROUGH APPROPRIATE NATIONAL AND INTERNATIONAL REGULATION.

PROPOSAL 2. ATTRIBUTE ONE SINGLE INN TO BIOLOGICAL MEDICINAL PRODUCTS, WITH NO ADDITIONAL PORTIONS OR QUALIFIERS, AND IDENTIFY THE MANUFACTURER AND THE MANUFACTURING PROCESS THROUGH THE NAME OR A BRAND NAME

Submission

1. INTRODUCTION
Establishing the equivalence between innovative biological medicinal products with expired patents and products with the same active ingredient launched on the market to compete with lower prices has some specific problems:
• It deals with proteins, large and complex molecules, different from chemically synthesized medicinal products.
• Its production methods are complex, more subject to variations than chemically synthesized medicinal products.
• They could be immunogenic
• Many are applied parenterally

Products with the same composition manufactured and sold once the original patent expires  have come to be known as biosimilar products.

The biological medicinal products and their biosimilar products currently are at the core of the majority of medicinal product innovation and they are of great economic importance.

European Union regulations on this matter have advanced. Their main points are:

 
• Directive 2003/63/EC establishes the concept of “biologically similar medicinal product”, “biosimilar medicinal product”: “Biological medicinal product that has been developed as the equivalent to another biological medicinal product already sold (called "reference medicinal product").
• The active ingredient is essentially the same
• There may be small differences due to the complexity of the structure and the production method.
• When a biosimilar medicinal product is authorized it is because these differences have no significant impact on safety or efficacy.

But the most important mandate to ensure the equivalence is established by Directive 2004/27/EC, which amends Art. 10 of Directive 2001/83/EC:
“When a biological medicinal product that I similar to a reference biological product does not meet the conditions for defining generic medicinal products, due in particular to differences in raw materials or differences in the manufacturing process for the biological medicinal product and the reference biological product, the results from the appropriate preclinical or clinical trials concerning these conditions shall be provided.”

Currently it is a matter of the highest importance to ensure, as European legislation does, that the biosimilar products are equivalent to the originals, and, therefore, interchangeable without the intervention of the physician, through substitution by the pharmacist or directly through the health system when selecting them. If the response is positive, the field for price competition is much larger than if it is negative. It is a technical issue. The funders and the companies selling biosimilar products are well-disposed to the positive responses while the companies owning reference biological products and well-disposed to negative ones. If the biosimilar products can be considered equivalent to the innovators they could follow the path of the chemically-synthesized genetics and, once the patent expires, there will be more markets for biosimilar products dominated by price competition and affordable price levels.


2. BIOLOGICAL PRODUCTS AND INNs

The WHO group of INN experts, when choosing the names for the recombinant proteins, do not address substances with well-defined structures, but products with a highly complex composition or even mixtures of those products.

There is a clear conflict of interest:

• The innovative biological product companies have an interest in having an INN attributed exclusively to their product. If an INN is attributed exclusively to a reference biological medicinal product and subsequent biosimilarproducts are designated with a different INN, the innovating company owning the former would have a potential monopoly that would extend beyond expiration of the patent. The nomenclature would be the strongest way to differentiate between a reference product and successive biosimilar products and among the latters, drastically reducing the options for the competition in terms of price.

• The companies marketing biosimilar products have a mutual interest in having the INN be the same as that for the reference product.

• The consumers do as well if they are therapeutically equivalent

The current situation can be summarized as follows:
• Currently 40% of INN applications refer to biological substances.
• INNs for biosimilar products follow the general principles.
• But some companies have already established a special system to characterize the biosimilar products (United States, Japan, Australia). For example, non-glycosylated protein biosimilar products have the same INN, while the glycosylated proteinshave a different name from the reference product), (one Greek letter added).

These special systems could undermine the integrity of the INN system, which could be a negative from the public health perspective and decrease the economic advantages of the price competition that could occur with the biosimilar products.

Various proposals are being used to handle these problems. Some tend to introduce additional items or "biological qualifiers."
• A characteristic element or unique special code added to the common name (Biological Qualifier, to indicate that it is a biosimilar product and which one it is
• A sequence of letters following the start of the INN?
• The code would be attributed to the substance but not the product, despite the fact that the product is what is being authorized and sold.

The European Medicines Agency has considered this code necessary, since in the European Union they trust that biosimilar products have a good level of equivalence with the reference products. (MEGERLIN… HA 2013).


3. A PROPOSED SOLUTION FOR THE PROBLEM OF INNs FOR BIOLOGICAL PRODUCTS

It is of the greatest importance to ,maintain the integrity of the INN system. This requires preserving its universality, such that the nonproprietary names are truly global or international s has happened to date. On the other hand, from the economic point of view it is necessary to prevent having international names with qualifier s be appropriated by a specific manufacturer or owner. This would give a permanent, universal advantage on the market, with the most effective differentiation. This advantage would result in less price competition and higher price levels in all of the countries for biological products.

Our proposal has two facets, one negative and the other positive:

• There will be no biological variants or qualifiers in the INN system. There will be only one for each substance.

• To address the problem of possible variations derived from the different manufacturing procedures, the notational legislations should make it obligatory that on transactions involving these products, and above all on prescriptions from the doctors, there must be the INN plus the manufacturer name or one of its trademarks. This will solve the problem without undermining the INN system and with no detriment to price competition.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervención de precios de los medicamentos en España. Panorama de la regulación y los estudios empíricos, Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription drug markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Drug Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, Junio 2013. ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505.

Felix Lobo_B (Original Language)

Lead Author: Felix Lobo
Organizations: Universidad Carlos III de Madrid
Country: Spain

Abstract

PARA EXPANDIR LOS MERCADOS DE MEDICAMENTOS GENÉRICOS, LOS PRECIOS ASEQUIBLES Y EL ACCESO A LOS MEDICAMENTOS POR LAS POBLACIONES MENOS FAVORECIDAS MEDIANTE UNA REGULACIÓN INTERNACIONAL Y NACIONAL ADECUADA FORMULO UNA SEGUNDA PROPUESTA. PROPUESTA 2. ATRIBUIR UNA SOLA DCI A LOS MEDICAMENTOS BIOLÓGICOS, SIN PARTÍCULAS O CALIFICATIVOS ADICIONALES E IDENTIFICAR AL FABRICANTE Y AL PROCESO DE FABRICACIÓN POR EL NOMBRE O POR UNA MARCA

Submission

EXPANDIR LOS MERCADOS DE MEDICAMENTOS GENÉRICOS, LOS PRECIOS ASEQUIBLES Y EL ACCESO A LOS MEDICAMENTOS POR LAS POBLACIONES MENOS FAVORECIDAS MEDIANTE UNA REGULACIÓN INTERNACIONAL Y NACIONAL ADECUADA.
PROPUESTA 2. ATRIBUIR UNA SOLA DCI A LOS MEDICAMENTOS BIOLÓGICOS, SIN PARTÍCULAS O CALIFICATIVOS ADICIONALES E IDENTIFICAR AL FABRICANTE Y AL PROCESO DE FABRICACIÓN POR EL NOMBRE O POR UNA MARCA

1. INTRODUCCIÓN
Establecer la equivalencia entre los medicamentos biológicos innovadores con patente caducada y los productos con el mismo principio activo que se lanzan al mercado para competir con precios más bajos enfrenta algunos problemas peculiares:
• Se trata de proteínas, moléculas grandes y complejas, distintas de los fármacos de síntesis química.
• Sus métodos de producción son complejos, más susceptibles a variaciones que los de síntesis química.
• Pueden ser inmunogénicos
• Muchos se aplican por vía parenteral

Se han venido a designar como biosimilares los productos de la misma composición que se fabrican y comercializan una vez que ha caducado la patente del innovador.

Los medicamentos biológicos y sus biosimilares concentran en la actualidad una gran parte de la innovación en medicamentos y tienen una gran importancia económica.

La regulación de la Unión EUROPEA ha sido avanzada en este campo. Sus puntos principales son:
• La Directiva 2003/63/CE establece el concepto de “medicamento biológico similar”, “medicamento biosimilar”: “Medicamento biológico que ha sido desarrollado como equivalente a otro medicamento biológico ya comercializado (denominado “medicamento de referencia”).
• El principio activo es esencialmente el mismo
• Pueden existir pequeñas diferencias debido a la complejidad de su estructura y al método de producción.
• Cuando se autoriza un medicamento biosimilar es porque estas diferencias no tienen un impacto significativo en la seguridad y eficacia.

Pero el mandato más importante para garantizar la equivalencia está establecido por la Directiva 2004/27/CE que modifica el Art. 10 de la Directiva 2001/83/CE:
“Cuando un medicamento biológico que sea similar a un producto biológico de referencia no cumpla las condiciones de la definición de medicamentos genéricos, debido en particular a diferencias relacionadas con las materias primas o diferencias en el proceso de fabricación del medicamento biológico y del medicamento biológico de referencia, deberán aportarse los resultados de los ensayos preclínicos o clínicos adecuados relativos a dichas condiciones.”

Hoy en día efectivamente es una cuestión de la máxima trascendencia garantizar, como hace la legislación europea, que los biosimilares sean equivalentes a los originales y, por tanto, intercambiables sin intervención del médico, mediante la sustitución por el farmacéutico o directamente por los sistemas de salud al seleccionarlos. Si la respuesta es afirmativa el campo para la competencia en precios es mucho mayor que si es negativa. En principio es una cuestión técnica. Los financiadores y las empresas que venden biosimilares son proclives a la respuesta afirmativa mientras que las empresas propietarias de biológicos de referencia a la negativa. Si los biosimilares se pueden considerar equivalentes a los innovadores podrían seguir la senda de los genéricos de síntesis química y repetirse, caducada la patente, la aparición de mercados de biosimilares dominados por la competencia en precios y los niveles de precios asequibles.


2. LOS PRODUCTOS BIOLÓGICOS Y LAS DCI
El Grupo de Expertos en DCI de la OMS, cuando selecciona los nombres para las proteínas recombinantes, no lo hace frente a sustancias con estructuras bien definidas, sino a productos de una composición altamente compleja o incluso con mezclas de tales productos.

Estamos en presencia de un claro conflicto de intereses:

• Las empresas innovadoras de productos biológicos tienen interés en que se atribuya una DCI exclusivamente a su producto. Si una DCI se atribuye a un biológico de referencia en exclusiva y los biosimilares seguidores se designan con una DCI distinta, la empresa innovadora propietaria del primero disfrutaría de un potencial poder de monopolio que se prolongaría más allá de la caducidad de la patente. La nomenclatura sería la vía más contundente para diferenciar entre producto de referencia y biosimilares sucesivos y a éstos entre sí, reduciéndose drásticamente las posibilidades de la competencia en precios.

• Recíprocamente las empresas comercializadoras de biosimilares tienen interés en que su DCI sea la misma que la del producto de referencia.

• Los consumidores también si son terapéuticamente equivalentes

La situación actual puede resumirse así:
• Actualmente el 40% de las solicitudes de DCI se refieren a sustancias biológicas.
• Las DCI para biosimilares siguen los principios generales.
• Pero algunos países ya tienen establecido un sistema especial de caracterización para los biosimilares (Estados Unidos, Japón, Australia). Por ejemplo, los biosimilares proteínas no glicosiladas tienen la misma DCI, mientras que las proteínas glicosiladas tienen un nombre diferente del producto de referencia, (una letra griega añadida).

Estos sistemas especiales pueden suponer un menoscabo de la integridad del sistema de DCI que podría ser negativo desde el punto de vista de la salud pública y disminuir las ventajas económicas de la competencia en precios que podrían desarrollarse con los biosimilares.

Se están manejando diversas propuestas para resolver estos problemas. Unas se inclinan por introducir partículas adicionales o “calificativos biológicos”
• Un elemento caracterizador o código especial único añadido al nombre común (Biological qualifier, BQ), para indicar que se trata de un biosimilar y de cuál.
• ¿Una secuencia de letras que siguieran los principios de las DCI?
• El código se atribuiría a la sustancia pero no al producto, a pesar de que es el producto el que se autoriza y comercializa.

La Agencia Europea de Medicamentos ha considerado este código innecesario, ya que en la Unión Europea se confía en que los biosimilares tienen un buen nivel de equivalencia con los productos de referencia. (MEGERLIN… HA 2013).


3. UNA PROPUESTA DE SOLUCIÓN AL PROBLEMA DE LAS DCI PARA BIOLÓGICOS

Es de la máxima importancia mantener la integridad del sistema de las DCI. Por una parte, ello exige que conserven su universalidad, de tal manera que las denominaciones comunes sean realmente globales o mundiales como se había conseguido hasta ahora. Por otro lado, desde el punto de vista económico hay que impedir que a través de las denominaciones internacionales con calificativos la denominación acabe siendo apropiada por un fabricante o titular concreto. Ello le daría una ventaja permanente y universal en el mercado, con un elemento diferenciador de la máxima eficacia. Esta ventaja redundaría en una menor competencia en precios y niveles de precios más altos en todos los países para los productos biológicos

Nuestra propuesta tiene dos aspectos, uno negativo y otro positivo:

• No se introducirían variantes o calificativos biológicos en el sistema de las DCI. Se mantendría una sola para cada sustancia.

• Para afrontar el problema de las posibles variaciones derivadas de los distintos procedimientos de fabricación debería hacerse obligatorio en las legislaciones nacionales que en las transacciones referidas a estos productos y sobre todo en las recetas prescritas por los médicos figurara la DCI más el nombre del fabricante o una marca comercial de éste. Así se resolvería el problema sin menoscabo del sistema de las DCI y sin perjuicio para la competencia en precios.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervención de precios de los medicamentos en España. Panorama de la regulación y los estudios empíricos, Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription drug markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Drug Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, Junio 2013. ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505.

Felix Lobo, UNIVERSIDAD CARLOS III DE MADRID_A (English Translation)

Lead Author: Felix Lobo
Organization: Universidad Carlos III de Madrid
Country: Spain

Abstract

1. INTRODUCTION
The expansion of generic medicinal products to the entire world over the past 35 years is generally acknowledged as one of the phenomena that have contributed most to getting affordable prices and facilitating access to medicinal products in the developed and developing countries, including the disadvantaged. Generic medicinal products make it possible to provide great savings to individual patients, private health insurers and public health systems.

The policy that has fostered this development of generic medicinal products is based on appropriate national and international regulation, for international nonproprietary names (INN) as well as for the bioequivalence requirements allowing for interchangeability of brand names with generics and generics with other generics. This two-tier regulation allows for market transparency and price competition, resulting in affordable price levels. Added to this are the regulations fostering quick market access once the patents expire, eliminating the need to submit redundant clinical studies.

It is therefore of the highest importance to have appropriate national and international  legislation and medicinal product policies so the generic medicinal products can continue to develop throughout the world..

There are currently some problems that could limit expansion of generic medicinal products, We are referring to two in particular:

• New legal texts in some countries that create confusion between generics and brand names, reflected in a hybrid legal construction called "randed generics ."

• The measures being adopted in the World Health Organization International Nonproprietary names systemsto designate the new biological medicinal products that couldjeopardize the integrity of this system and be an obstacle to market transparency while making price competition more difficult between innovative biological products and their biosimilar products that appear once the patent expires.


2. THE WHO INN SYSTEM AND ITS SOCIAL BENEFITS
In 1950 the WHO committee of experts for unification of pharmacopoeias decided to create a common international nomenclature for medicinal products. In 1953 they introduced  the WHO International Nonproprietary Names (INN). These are generic names, in nontechnical language. Later the majority of national legislations adopted the INN.

Transparent generic medicinal product markets with price competition are based on national and international regulations arising from the INN and they have four cornerstones:

1. Common international nomenclature created by WHO, called INN.
2. Obligation of the manufacturers to use the generic name on labels and advertising.
3. Substitution by the pharmacist, or direct selection by the health system, of the less expensive generic for the more expensive brand name.
4. Incentives including the obligation for physicians to prescribe by generic name (Prescription by active ingredient)/

The INN (WHO International Nonproprietary Names) bring major social benefits:

Public health improvements:
• They facilitate mutual understanding between scientists and health professionals.
• They facilitate the work of the public health regulatory authorities.
• They improve patient safety and decrease medical errors.

From an economic point of view, the INN are public assets, which allow for transparency of the generic  markets and price competition, leading to affordable price levels, much lower than those for the brand name product originally patented.

And other economic benefits:
• Network externalities: the more they are used the greater the benefits for all
• They reduce transaction costs (Kindleberger, 1986).
• They promote trade
• They do not impede innovation.


3. IT IS ONLY NECESSARY TO RECOGNIZE AS GENERIC MEDICINAL PRODUCTS THOSE THAT IN ADDITION TO BEING EQUIVALENT ARE SOLD UNDER THE INTERNATIONAL COMMON NAME.

In order to be able to talk about generics that allow for market transparency and price competition and in order for all of these public health and economic benefits to come to fruition, it is necessary to have competition in the necessary conditions  but neither of these is sufficient:

• Equivalence between the generic medicinal product and the innovative medicinal product having lost its patent
• For the generic medicinal product to be sold under the international nonproprietary name. This has to appear in the medicinal product name prominently, on the packaging, in the leaflet, in the data sheet, on all labeling and in advertising.

Unfortunately, quite frequently there is confusion caused by the belief that all medicinal products are generic. This is not true. All generics must be equivalents but not all equivalent medicinal products are generic. In particular, sometimes some medicinal products are considered as generic that are equivalent but not sold under the International Nonproprietary Name but under a trademark. Sometimes these are called “branded generics,” even in economic studies and even in World Health Organization documents.

Clearly, these  “branded generics” do not produce the above public health benefits. Also, they do not compete mainly on price, but by differentiating the product, allowed by using the brand name, according to the market structure and the behavior of the traditional branded medicinal product company market. Although they are equivalent to the originals, they are not generic and do not generate the public health and economic benefits that come with price competition. The traditional example of this type of products is "copies," which come from countries with weak patents allowing for sale of the innovative medicinal products by competitors even before the patent expires. In many cases, the legislation does not require demonstration of bioequivalence.

Allowing access by the “branded generics” – which provide no public health benefit or price competition - the legal system of the generics, such as easy market access, or preference in purchases from the public health systemor in government intervention on prices, is not appropriate. It Is necessary to retain the clarity of regulation so the generics markets continue to be beneficialfrom the point of view of public health while maintainingtransparency and functionality under full price competition

4. THE 2004 STANDARD ON GENERICS FROM THE EUROPEAN UNION INTRODUCED THIS CONFUSION BETWEEN GENERICS AND BRAND NAMES

Before 2004, European legislation did not contain a “definition” of generic medicinal product as such. It regulated the "essentially equivalent" medicinal products and the permissible names of the medicinal products, to include the combinations of INN plus the manufacturer name and INN plus the brand name. This correct regulation allowed for development of generics meeting the two conditions indicated above: bioequivalence and name that includes the INN.

But in 2004 Directive 2004/27/EC changed and introduced confusion between generics and brand names, allowing  "branded generics" to appear and to use the generics legal system”:

It defines the generic medicinal products exclusively by the first condition but not the aforementioned bioequivalence.
Does not establish any requirement for naming generics.
Allows for “branded generics

The legislation from the member countries provided no improvement but simply transposed and incorporated this standard.

5. ACTIONS TO CLARIFY THE CONCEPT OF GENERICS AND FOSTER THEIR FUTURE DEVELOPMENT

The World Health Organization should promote discussions, studies and resolutions that definitively clarify the legal concept of generic medicinal product and its regulation nationally and internationally.

To do so, it should require simultaneous application of both of the aforementioned conditions:

• Equivalence between the generic medicinal product and the innovative medicinal product having lost its patent
• For the generic medicinal product to be sold under the international nonproprietary name.

This will reinforce market transparency, price competition, affordable price levels and improved access to the medicinal products in all countries, including the disadvantaged.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. [Current medicinal product price policies in Europe: a general overview], Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervention de precios of the medicamentos en España. Panorama de la regulation y los estudios empíricos [Medicinal product price intervention in Spain: overview of regulation and empirical studies], Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription medicinal product markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Medicinal product Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, June 2013.
ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505. http://jhppl.dukejournals.org/content/38/3/573.abstract.html

Felix Lobo _A (Original Language)

Lead Author: Felix Lobo
Organization: Universidad Carlos III de Madrid
Country: Spain

Abstract

FORMULO PROPUESTAS PARA EXPANDIR LOS MERCADOS DE MEDICAMENTOS GENÉRICOS, LOS PRECIOS ASEQUIBLES Y EL ACCESO A LOS MEDICAMENTOS POR LAS POBLACIONES MENOS FAVORECIDAS, MEDIANTE UNA REGULACIÓN INTERNACIONAL Y NACIONAL ADECUADA DE
1. LOS PROPIOS MEDICAMENTOS GENÉRICOS
2. LAS DENOMINACIONES COMUNES INTERNACIONALES APLICADAS A BIOLÓGICOS
3. LA PRESCRIPCIÓN POR LOS MÉDICOS QUE UNA LA DENOMINACIÓN COMÚN Y LA MARCA

Submission

EXPANDIR LOS MERCADOS DE MEDICAMENTOS GENÉRICOS, LOS PRECIOS ASEQUIBLES Y EL ACCESO A LOS MEDICAMENTOS POR LAS POBLACIONES MENOS FAVORECIDAS MEDIANTE UNA REGULACIÓN INTERNACIONAL Y NACIONAL ADECUADA. PROPUESTA 1: DEFINIR LEGALMENTE LOS PROPIOS MEDICAMENTOS GENÉRICOS INCLUYENDO EQUIVALENCIA Y DENOMINACIÓN POR DCI

1. INTRODUCCIÓN
La expansión de los medicamentos genéricos por todo el mundo en los últimos 35 años se reconoce generalmente que ha sido uno de los fenómenos que más han contribuido a conseguir precios asequibles y facilitar el acceso a los medicamentos en los países desarrollados y en vías de desarrollo, incluso de las poblaciones menos favorecidas. Los medicamentos genéricos permite grandes ahorros a los pacientes individuales, a las aseguradoras privadas de servicios médicos y a los sistemas públicos de salud.

La política que ha favorecido este desarrollo de los medicamentos genéricos se basa en una regulación internacional y nacional adecuada, tanto de las denominaciones comunes internacionales (DCI) como de las exigencias de bioequivalencia que permiten la intercambiabilidad de las marcas por los genéricos y de los genéricos entre sí. Esta regulación bifronte permite la transparencia en los mercados y la competencia de precios dando como resultado niveles de precios asequibles. A esto se añaden las regulaciones que favorecen su rápido acceso al mercado una vez que caducan las patentes, eximiendo de presentar estudios clínicos que serían redundantes.

Por tanto, es de la máxima importancia mantener una política de medicamentos y una legislación internacional y nacional apropiadas para que los medicamentos genéricos se sigan desarrollando en todo el mundo.

En la actualidad han surgido algunos problemas que pueden limitar la expansión de los medicamentos genéricos. En concreto nos referimos a dos:

• Nuevas disposiciones legales en algunos países que crean confusiones entre genéricos y marcas, concretadas en una construcción legal híbrida llamada genéricos con marca (“branded generics”, en inglés) .

• Las medidas que se están adoptando en el seno del sistema de denominaciones comunes internacionales de la Organización Mundial de la Salud para designar a los nuevos medicamentos biológicos que pueden poner en riesgo la integridad de este sistema y obstaculizar la transparencia en los mercados y dificultar la competencia en precios entre biológicos innovadores y sus biosimilares, que aparecen una vez caducada la patente.


2. EL SISTEMA DE LAS DCI DE LA OMS Y SUS BENEFICIOS SOCIALES
En 1950 el Comité de expertos para la unificación de farmacopeas de la OMS decide crear una nomenclatura internacional común para los medicamentos. En 1953 se instauran efectivamente las Denominaciones Comunes Internacionales (DCI) de la OMS (International Nonpropietary Names – INN - en inglés). En lenguaje no técnico son las denominaciones genéricas. Con posterioridad la mayoría de las legislaciones nacionales adoptan las DCI/INN.

Los mercados de medicamentos genéricos transparentes y con competencia en precios se basan en regulaciones internacionales y nacionales en cuyo origen están las DCI y tienen cuatro pilares:

1. Nomenclatura común internacional creada por la OMS, las DCI/INN.
2. Obligación de los fabricantes de utilizar el nombre genérico en etiquetado y publicidad.
3. Sustitución por el farmacéutico, o directamente selección por el sistema de salud del genérico más barato frente a la marca más cara.
4. Incentivos he incluso obligación para los médicos de prescribir por nombre genérico (Prescripción por principio activo)


Las DCI (nombres genéricos oficiales de la OMS) aportan grandes beneficios sociales:

Mejoras en la salud pública:
• Facilitan el entendimiento mutuo entre científicos y profesionales sanitarios.
• Facilitan el trabajo de las autoridades reguladoras de salud pública.
• Mejoran la seguridad del paciente y disminuyen los errores médicos.

Desde el punto de vista económico las DCI son bienes públicos que permiten la transparencia de los mercados de genéricos y la competencia en precios, que conduce a niveles de precios asequibles, muy inferiores a los del producto de marca original inicialmente patentado.


También generan otros beneficios económicos:
• Externalidades de red: cuanto más se usan mayores son los beneficios para todos
• Reducen los costes de transacción (Kindleberger, 1986).
• Promueven el comercio.
• No dificultan la innovación.


3. SÓLO SE DEBEN RECONOCER COMO MEDICAMENTOS GENÉRICOS A LOS QUE ADEMÁS DE SER EQUIVALENTES SE COMERCIALICEN BAJO DENOMINACIÓN COMÚN INTERNACIONAL.

Para que podamos hablar de genéricos que permiten la transparencia de los mercados y la competencia en precios y para que se realicen todos estos beneficios de salud pública y económicos es necesaria la concurrencia de dos condiciones necesarias, pero ninguna de las dos suficientes:

• La equivalencia entre el medicamento genérico y los medicamentos innovadores que han perdido la patente
• Que el medicamento genérico se comercialice bajo denominación común internacional. Esta ha de figurar en el nombre del medicamento de forma prominente, en el envase, en el prospecto, en la ficha técnica, en todo el etiquetado y en la publicidad.

Desgraciadamente es muy frecuente que se produzca la confusión de considerar que todos los medicamentos equivalentes son genéricos. Esto no es así. Todos los genéricos deben ser equivalentes, pero no todos los medicamentos equivalentes son genéricos. En especial se consideran a veces como medicamentos genéricos algunos que son equivalentes pero que no se comercializan bajo Denominación Común Internacional sino con marca comercial. A veces se les llama “genéricos con marca” (“branded generics”), incluso en sólidos estudios económicos y en los propios documentos de la Organización Mundial de la Salud.

Éstos “genéricos con marca” es obvio que no producen los beneficios de salud pública antes enumerados. Además, no compiten principalmente en precios, sino que lo hacen mediante la diferenciación del producto que les permite la marca comercial, de acuerdo con la estructura del mercado y la conducta de las empresas tradicional de los medicamentos bajo marca. Aunque sean equivalentes a los originales no son genéricos y no generan los beneficios de salud pública y económicos propios de la competencia en precios. El ejemplo tradicional de este tipo de productos son las “copias”, que surgían en los países con patentes débiles que permitían que se comercializaran competidores de los medicamentos innovadores incluso antes de que caducara la patente. En muchas ocasiones la legislación no obligaba a demostrar la bioequivalencia.

Atribuir a los “genéricos con marca” – que no aportan beneficios de salud pública ni de competencia en precios- el régimen legal de los genéricos, por ejemplo la facilidad de acceso al mercado, o la preferencia en las compras de los sistemas públicos de salud o en la intervención por los gobiernos de los precios, no es apropiado. Es necesario mantener la claridad de la regulación para que los mercados de genéricos sigan siendo ventajosos desde el punto de vista de la salud pública y manteniendo su transparencia y funcionamiento en condiciones de plena competencia de precios.


4. LA NORMATIVA DE 2004 DE LOS GENÉRICOS POR LA UNIÓN EUROPEA HA INTRODUCIDO ESTA CONFUSIÓN ENTRE GENÉRICOS Y MARCAS

Antes de 2004 la legislación europea no contenía una “definición” de medicamento genérico como tal. Regulaba los medicamentos “esencialmente equivalentes” y las denominaciones permitidas de los medicamentos incluían las combinaciones de DCI; DCI más nombre de fabricante y DCI más marca comercial. Esta correcta regulación permitió que se desarrollaran los genéricos cumpliendo las dos condiciones antes dichas: bioequivalencia y nombre que incluyera la DCI.

Pero en 2004 la Directiva 2004/27/CE cambió e introdujo confusión entre genéricos y marcas, permitiendo que aparecieran y siguieran el régimen legal de los genéricos los llamados “ genéricos con marca”:

Define los medicamentos genéricos exclusivamente por la primera condición necesaria pero no suficiente antes mencionada: equivalencia.
No establece ninguna exigencia para la denominación de los genéricos.
Permite los “genéricos con marca”.

Las legislaciones de los países miembros no han tenido más remedio que trasponer e incorporar esta normativa.

5. ACCIONES PARA ACLARAR EL CONCEPTO DE GENÉRICOS Y FAVORECER SU DESARROLLO FUTURO

La Organización Mundial de la Salud debería promover discusiones, estudios y acuerdos que permitieran aclarar definitivamente el concepto legal de medicamento genérico y su regulación a nivel internacional y nacional.

Para ello debe exigirse la concurrencia simultánea de las dos condiciones necesarias antes mencionadas:

• La equivalencia entre el medicamento genérico y los medicamentos innovadores que han perdido la patente.

• Que el medicamento genérico se comercialice bajo denominación común internacional.

Con ello se conseguiría reforzar la transparencia de los mercados, la competencia en precios, niveles de precios asequibles y mejorar el acceso a los medicamentos en todos los países incluidas las poblaciones menos favorecidas.

Bibliography and References

LOBO, F.: Políticas actuales de precios de medicamentos en Europa: panorama general. Springer Healthcare, Madrid 2015. 181 p. ISBN 978-84-940-3469-5

LOBO, F.: La intervención de precios de los medicamentos en España. Panorama de la regulación y los estudios empíricos, Springer Healthcare, Madrid 2013. 159 p. ISBN 978-84-940-3468-8.

FELDMAN, R. y LOBO, F.: “Competition in prescription drug markets: the roles of trademarks, advertising, and generic names”, The European Journal of Health Economics, 14(4): 667-675, August 2013. ISSN 1618-7598; e-ISSN 1618-7601. DOI 10.1007/s10198-012-0414-7.

LOBO, F. y FELDMAN, R.: ”Generic Drug Names and Social Welfare”, Journal of Health Politics, Policy and Law, 38(3): 573-597, Junio 2013.
ISSN: 0361-6878; e-ISSN: 1527-1927. DOI 10.1215/03616878-2079505. http://jhppl.dukejournals.org/content/38/3/573.abstract.html