Lead Author: Martin Bernhardt
The 2030 Agenda for Sustainable Development recognizes the importance of “the role of the diverse private sector, ranging from microenterprise to cooperatives to multinational corporations” to achieve the Sustainable Development Goal (SDGs), and calls for a “revitalized global partnership” that includes the private sector.
Beyond extensive collaborations, addressing the issue of universal health coverage (3.8.) will require a holistic approach – one that acknowledges the challenge complexity (e.g., general poverty; health education; healthcare infrastructure; healthcare workers; distance to hospitals or treatment centers; and pricing factors including taxes, fees, markups, and many other elements in addition to intellectual property).
Sanofi has long been engaged in improving Access to Health and advocates that new mechanisms will not achieve our shared goals unless they are pragmatic and respond to the realities of the complex global health landscape, engaging a coalition of actors in both the public and private sector. The viability of the pharmaceutical industry depends on the existence of functional pathways that bring medicines to the people who need them. Affordability for the patients is an essential condition. Access to healthcare programs and differential pricing approaches contribute to creating better conditions. But low prices alone are not always the solution and can even have negative impacts on R&D and innovation, as seen in the field of antibiotics or in the vaccines market.
1. Lowering IPRs to Improve Access: A Major Policy Incoherence?
1.1. Structural Obstacles to Access to Medicines
One out of three people in the world do not have access to essential medicines3. In most cases, the reason for inadequate access to essential medicines lies with important factors such as poverty and inadequate national health infrastructures and financing systems4, rather than patents. Over 90% of all medicines on the WHO’s essential drugs list are off patent, and in the poorest parts of the world a significant proportion of new medicines have to date been neither registered nor covered by actively enforced Intellectual Property Rights (IPRs)5.
Patents are legal or constitutional national rights granted to a patent holder that allows the patent holder to determine who may not make, use or sell the patented invention. In exchange for the disclosure of innovations to the public, the government provides to a patent holder certain exclusive rights for the purpose of stimulating research and development of new products. The exclusivity lasts for 20 years from filing, which, for medicines, results in an effective term that often is many years shorter. During the patent term, anyone who may want to use the invention must seek the approval of the patent holder.
The international IP regime also foresees a number of exceptions and options that can be used to improve access to medicines, as clarified notably in the 2001 Doha Declaration on TRIPS and public health6. Key options include transition periods for least developed countries (LDCs). A recent example is the 6 November 2015 decision of the WTO's Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) to extend the waiver for LDCs allowing them not to enforce IPRs on pharmaceutical products to support access to medicines until at least 20337. Another important step was the decision by WTO members in 2003 to propose amending the TRIPS Agreement to make it easier for countries to import medicines produced under compulsory licensing if they are unable to manufacture the medicines themselves ("Paragraph 6 System"). In this regard, Pugatch et al8 showed, in their review and analysis of the existing body of knowledge on the role of IPRs in biopharmaceutical and biotechnological innovation, that there is growing evidence that the introduction of strengthened IP protection correlates positively with inward capital investment levels.
1.2. Access to Medicines Is Not Without Challenges in the Absence of IPRs
A policy incoherence would be to advocate for lowering IPRs to improve access while a myriad of examples demonstrates that access to medicines is first hindered by non IP-related issues.
Venezuela’s Article 15 of the 1955 industrial property law excludes, among other, medicines from patent protection (with the exception of process patents). Notwithstanding the fact that this disposition contravenes Article 27 of the TRIPS Agreement, it should be noted that this absence of IP protection did not facilitate patients’ access to medicines. In March 2015, Doctors for Health (Médicos por la Salud), a nationwide network of public hospitals medical residents, reported that 60% of routinely stocked medicines or medical supplies were entirely or partially unavailable in the hospitals, and that a majority of medicines included in the WHO’s Model List of Essential Medicines were not available in pharmacies9.
Price Gouging Scandals Impacting Some Off-Patents Drugs
Stories of staggering drug price increases in the US, mostly undertaken by newly-founded, opportunistic, small R&D-based “pharmaceutical” companies, have been put in the spotlight over the past months. However, as illustrated by the recent case of a 5,500% price increase on a drug approved by the FDA more than 60 years ago12, price gouging scandals impeding access to health are not about patented medicines.
Impact of Impaired Access to Controlled Medications
In many parts of the world, patients suffering from severe pain face immense challenges in obtaining analgesics, because the opioids that could provide such relief have been categorized as “controlled substances”. They are, therefore, subject to strong national and international controls and very often rendered inaccessible10. According to WHO11, 6 million people die annually from cancer without sufficient analgesia or even often without any treatment of their pain. In addition, nearly half of end-stage AIDS patients face severe pain, as well as many people suffering from acute severe pain from injuries (e.g., car accidents, war victims, etc.) or myocardial infarction.
These examples highlight the complex dynamics underlying access to medicines and the need for a holistic approach. Sanofi is striving towards meeting this challenge by implementing innovative programs that are designed to enable access to medicines by overcoming structural barriers, in collaboration with governments, multilaterals and other stakeholders.
2. Our Actions
2.1 Access to Healthcare
Access to a particular drug today, and access to new drugs tomorrow, can only be ensured through constructive and cooperative conversations between and actions by, all appropriate stakeholders. Sanofi is determined to work with healthcare professionals, tax payers, governments, patients’ representatives and non-profit organizations to help find economically, socially and environmentally sustainable solutions when access issues exist for medicines and vaccines. Sanofi also wants to remain an important contributor to the wellbeing of patients and to the economic development of the many countries in which it is present.
· Since 2003, Sanofi has adhered to the ten principles of the Global Compact. Sanofi’s CEO presents the Group’s yearly communication on progress (COP) to the UN Secretary General.
· Whenever it is both necessary and possible, Sanofi carries out actions in favor of access to healthcare, especially through differential pricing policies adapted to populations’ purchasing power, notably through the activities of its “Access to Medicines Department” and Sanofi Pasteur, its Vaccines Division. Sanofi has developed access to medicines programs for malaria, tuberculosis and neglected tropical diseases, as well as to innovative pilot programs in mental health, epilepsy, diabetes and oncology in resource-limited countries. These initiatives do not focus only on treatment, but also on prevention and diagnosis, for a comprehensive disease management that involves all healthcare stakeholders.
· Sanofi is committed to raising awareness of and encouraging debate about non-communicable diseases (NCD). Sanofi is one of the most committed pharmaceutical companies in the field. The Group is currently running many programs in different regions of the World and is working on new NCD management projects. The Group values scientific and economic development in emerging countries. For instance, the Group develops and manufactures “Allstar”, the first Indian-manufactured, re-usable insulin pen, manufactured by a global company.
· Sanofi also supports the development of new activities in the field of access to care, notably through its not-for-profit foundation. In 2014, Sanofi Espoir Foundation13 was involved in 42 development aid long-term programs, including 14 in the fight against maternal and infant mortality and 13 in the fight against childhood cancer in low and middle income counries, 35 main partners, 30 recipient countries. In addition to answer to humanitarian emergencies, 2.8 million people in 11 countries, of which 10 emerging countries, received free medicines and vaccines. Recognizing these achievements, the UN granted Sanofi Espoir Fondation a consultative status to the ECOSOC in July 201414.
2.2 R&D and Innovation
The protection of IP (patents, brands and proprietary information) is essential to innovation as it encourages exploration into the scientifically uncertain work of drug creation. Indeed, this scientific process is long costly and very risky with no certainty that the patent will lead to an approved drug, allowed on the market, and adopted by healthcare professionals. Significant revenue has to be generated to offset development costs. It is therefore a high-risk endeavor that involves many failures. Large amounts of time and money may be invested without market success.
With the clear objective of addressing unmet medical needs wherever they occur, the R&D based pharmaceutical industry has embraced innovative approaches to increase access to medicines where the return on investment on R&D for diseases may be too low to enable adequate allocation of resources. This may arise because the number of patients is small or the need is for medicines adapted to a particular population. Poverty is always an underlying factor. Many of these activities have potential for to be scaled up to benefit many more people if the scientific and financial risks that can help initiate and accelerate R&D are shared.
Product development partnerships (PDPs): Sanofi is increasingly collaborating in PDPs, which involve companies providing the technology that they have invested in for decades, as well as their development and distribution expertise, to the partnership. Participating companies do take IP into account, yet these measures do not pose a barrier to drug development in these contexts. Public sector partners help fund the development costs while also helping to ensure that the medicines and vaccines developed reach the people who need them by financing implementation programs. This has the double benefit of encouraging R&D and accelerating the product’s uptake in the developing world.
Here are some examples showing that he PDP approach is working:
· The Global Alliance for TB Drug Development (TB Alliance), established in 2000, brings together AstraZeneca, Bayer HealthCare, Lilly, GlaxoSmithKline, Novartis, Sanofi and other companies with 30 NGOs, governments, foundations from around the world to accelerate the discovery and development of cost-effective new medicines. Currently, the portfolio includes eleven drugs between phase I and IV of clinical trials15.
· WIPO Re:Search is a global consortium through which public and private sector organizations share their IP, compounds, expertise, facilities and know-how with qualified researchers working on new solutions for NTDs, malaria and tuberculosis. WIPO Re:Search members provide royalty-free licenses for research, development and manufacture anywhere in the world; make products available royalty-free to all Least Developed Countries (LDC); and consider in good faith access for all developing countries. Industry members include Alnylam Pharmaceuticals, Eisai, GSK, J&J, Merck, MSD, Novartis, Pfizer, Takeda and Sanofi16.
· Through its “Access to Medicines Department”, Sanofi has set up a public-private partnership (PPP) with the Drugs for Neglected Diseases Initiative (DNDi) to develop and manufacture the antimalarial ASAQ Winthrop®. Development of semi-synthetic artemisinin was made to complement production of vegetal origin and stabilize prices of malaria treatments at levels affordable to resource-poor countries but also sufficient to enable farmers to earn a living from vegetal artemisinin. Given the large need for safe and effective malaria medicines, Sanofi and DNDi did not seek a patent for this medicine, over 400 million treatments of which have been distributed since 2007, showing that it fulfills unmet needs. This demonstrates the Group’s flexibility under specific circumstances17. On April 2015 Sanofi received, at the White House, the prestigious “Patent for Humanity” award from the United States Patent and Trademark Office (USPTO). The “Patents for Humanity” program was launched as part of an Obama administration initiative promoting game-changing innovations to solve long-standing development challenges. Sanofi is being recognized for its patent on semi-synthetic artemisinin, a key component for the production of anti-malarial treatments recommended by the WHO18.
· Since 2009, Sanofi and DNDi have expanded their partnership to other neglected diseases and are, in particular, collaborating on the development of an oral treatment for Human African Trypanosomiasis (or sleeping sickness), the first of its kind, which may be a decisive tool for the disease elimination targeted for 2020 by the WHO.
· The 2012 London Declaration on Neglected Tropical Diseases: inspired by the WHO’s 2020 Roadmap on Neglected Tropical Diseases (NTDs), partners including pharmaceutical companies, donors, endemic countries and non-government organizations have contributed technical knowledge, drugs, research, funding and other resources to treat and prevent NTDs among the world’s poorest populations. Great progress has been made, and we believe that we can meet our goals by 202019.
· Since May 2011, Sanofi has made available its library of proprietary data on neglected tropical diseases to DNDi. It was the first innovative undertaking of this kind.
· The TB Drug Accelerator is a unique partnership that includes AstraZeneca, Bayer, Eli Lilly, Eisai, GlaxoSmithKline, MSD, AbbVie and Sanofi, and several academic and non-profit research institutions, together with the Bill and Melinda Gates Foundation. The consortium is sharing its clinical assays and expertise to speed the identification of most promising approaches to shorten and improve the quality of TB therapy20.
· Simultaneously, Sanofi continues to invest in malaria, tuberculosis and neglected tropical diseases R&D programs in order to respond to future biological resistance to existing medicines. This R&D is an integral part of the Group’s commitments.
2.3 Technology and knowledge transfer
In November 2010, WIPO’s Committee on Development and Intellectual Property (CDIP) developed a project which aims to foster developing countries’ access to knowledge and technologies. According to the TRIPS Agreement, the protection and enforcement of intellectual property should contribute to the promotion and diffusion of the transfer of technology (TOT).
However, TOT is not yet fully implemented, and thus creates high expectations on the part of developing and emerging countries. Technology transfer for the research-based pharmaceutical industry can take many forms other than developing manufacturing facilities, such as capacity building in terms of research, development, ethics, pharmacovigilance, and education.
· Sanofi has established more than 30 factories in emerging and developing countries. For example, the antimalarial ASAQ Winthrop® is manufactured in a factory in Casablanca, in Morocco, close to the region most affected by malaria. The site has been certified “Good Manufacturing Practices” (GMP) by WHO.
· Sanofi Pasteur has initiated major local manufacturing projects in Thailand, Argentina, Brazil, Mexico, China and India. Due to the vast human expertise required for such initiatives, Sanofi Pasteur is limited in the number of projects it can support. Local manufacturers must have GMP processes and stronger bio-security laws.
· Sanofi is also involved in knowledge transfer in many different ways: the company enables local professionals to participate in clinical trials in developing countries; it supports various training and information initiatives for health professionals and works with many different academic institutions throughout the world to foster a holistic management of disease including prevention, diagnosis and treatment.
Conclusion and Proposal
Although the access debate is often restricted to the price of medicines, many factors can impact the ability of patients to get appropriate access to health. Meanwhile, the main issue for pharmaceutical companies is: how to find the right balance between contributing to improve access to medicines and ensuring sufficient profits to recoup investment in R&D. The current intellectual property system, with its flexibility, is an effective tool to promote access by incentivizing innovation.
Access to medicines also requires access to appropriate diagnosis and to an affordable and accessible healthcare system. Sanofi has embraced a holistic approach, implementing innovative programs that are designed to enable access to medicines by overcoming structural barriers, in collaboration with governments, multilaterals and other stakeholders. Our efforts, guided by SDGs 1 (end poverty), SDG 3 (ensure health, promote well-being), and SDG 9 (foster innovation) have aimed to improve both the affordability and accessibility of medicines and vaccines by strengthening local economies and health infrastructure and employing innovative approaches to address patients’ ability to pay for medicines.
It is important the UN HLP supports and scales-up current mechanisms (such as PDPs) that have successfully enabled stakeholders to collectively improve access to medicines. This collaborative approach was rightly promoted by UN Secretary General Ban Ki-moon who declared, at UN private sector forum held on 27 September 2015, that “realizing the Sustainable Development Goals will improve the environment for doing business and building markets. Trillions of dollars in public and private funds are to be redirected towards the SDGs, creating huge opportunities for responsible companies to deliver solutions”.
References and Bibliography
1. World Health Organization. The World Medicines situation (2004). Chapter 7. http://apps.who.int/medicinedocs/fr/d/Js6160e/9.html#Js6160e.9 . Accessed on October 1st, 2014.
2. “Equitable Access to Essential Medicines: A Framework for Collective Action”, WHO Policy Perspectives on Medicines, No. 008, March 2004, http://apps.who.int/medicinedocs/en/d/Js4962e/1.1.html
3. A. Attaran. How do patents and economic policies affect access to essential medicines in developing countries ? (2004) Health Affairs. Volume 23, Number 3.
4. The WHO Model List of Essential Medicines is a guide for the development of national and institutional essential medicine lists. It was not designed as a global standard. However, for the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Most countries have national lists and some have provincial or state lists as well. National lists of essential medicines usually relate closely to national guidelines for clinical health care practice which are used for the training and supervision of health workers.
5. “Declaration on the TRIPS agreement and public health”, adopted on 14 November 2001, ttps://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
6. “WTO members agree to extend drug patent exemption for poorest members”, 6 November 2015, TRIPS, WHO, https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm
7. Extract from the WHO-WIPO-WTO trilateral study - the paragraph 6 System:
Special export licences for medicines, https://www.wto.org/english/tratop_e/trips_e/who-wipo-wto2013_par6_extract_e.pdf
8. Pugatch M.P. et al. (2012). Taking stock: How global biotechnology benefits from intellectual property rights. The Pugatch Consillium
9. The Washington Post, Venezuelans can’t get even the most basic lifesaving medical supplies, April 2015, https://www.washingtonpost.com/posteverything/wp/2015/04/29/venezuelans-cant-get-even-the-most-basic-lifesaving-medical-supplies/
10. WHO, Access to Analgesics and to Other Controlled Medications
11. WHO, Impact of Impaired Access to Controlled Medications
12. FDA - Daraprim
13. Fondation Sanofi Espoir, Annual Report 2014-2015
14. ECOSOC Decision 2014/222
15. TB Alliance (2015) TB Alliance Pipeline http://www.tballiance.org/downloads/Pipeline/TBA_Pipeline_Q3_2015.pdf
16. WIPO Re:Search, http://www.wipo.int/research/en/
17. DNDi, “Sanofi-Aventis et DNDi signent un accord de collaboration pour un nouveau médicament dans la maladie du sommeil, le fexinidazole,” http://www.dndi.org/2009/media-centre/press-releases/langues-press-releases/sanofi-aventis-et-dndi-signent-un-accord-de-collaboration-pour-un-nouveau-medicament-dans-la-maladie-du-sommeil-le-fexinidazole-09/
18. USPTO Announces Patents For Humanity Winners, http://www.uspto.gov/about-us/news-updates/uspto-announces-patents-humanity-winners
19. The London Declaration, http://unitingtocombatntds.org/resource/london-declaration
20. Nathan C. Cooperative development of antimicrobials: looking back to look ahead. Nature Reviews Microbiology. 2015 Oct 1;13(10):651-7.