Lead Author: James Malar
Additional Author: Jennifer Ho
Intellectual Property regimes require review to ensure medicines are affordable and accessible for those who are most in need. For people living with (or having lived with) HIV, TB or malaria in developing countries of Asia and the Pacific, the promotion and protection of their right the health is an ongoing struggle. This submission calls for the need for a human rights and equity based approach to intellectual property and describes the Asia Pacific regional experience where essential drugs for HIV, TB and malaria, prevention, diagnostics, treatment and care are a luxury, rather than a right.
APCASO Submission: High-Level Panel on Access to Medicines
APCASO is a Bangkok-based civil society network of community-based (CBOs) and non-governmental organisations (NGOs) on HIV, health, and social development, and with focus on advocacy and community capacity development in Asia and the Pacific. APCASO has prioritised access to essential health services, including access to affordable medicines, in its 2015-2020 Strategic Plan and as the current host of the Global Fund Communities, Rights and Gender Platform for Asia Pacific, will be highlighting the need for great promotion and protection of human rights in the existing or any future international trade and international intellectual property regimes. APCASO hope that this submission to the High-Level Panel ensures that HIV and TB key populations and communities have a voice in the Panel’s deliberations.
Asia Pacific & HIV
Asia and the Pacific has made tremendous progress in tackling the HIV epidemic. The majority of people living with HIV across the region (90%) live in 12 countries; China, Cambodia, India, Indonesia, Malaysia, Myanmar, Nepal, Pakistan, Papua New Guinea, The Philippines, Thailand and Vietnam. India accounts for 2.1 million of those living with HIV. The number of new infections has dramatically reduced since 2001 by 26%, with 350,000 new infections in 2012, however, infections identified among key populations is continuing to rise (UNAIDS ‘AIDS in Asia and the Pacific’ (2013)).
In the region the epidemic is largely characterised by concentrated and growing epidemics in a variety of countries, particularly among key affected populations including men who have sex with men, people who use drugs, sex workers and transgender persons. These populations must be central to any HIV response if there is to be an end of AIDS. Equally, it is key populations who must play a lead role in the response to TB and ensure that no community is left behind.
Currently, there are a number of barriers that impede an effective HIV response. These are broadly categorised as legal and policy barriers (including the criminalisation of key populations but also access to medicines for prevention, treatment, diagnostics and care); and, stigma and discrimination of key populations and people living with the disease particularly at the hands of law enforcement and health service providers. While treatment coverage has steadily increased over the last five years, equating to 51%, a 46% rise since 2009, these barriers remain require a great deal of further thought.
Are medicines affordable in Asia Pacific?
In Asia and the Pacific there are a number of indicators that highlight the significant burden that the price of medicines places on households.
• There are high-level out-of-pocket health % payments (when compared to total health expenditure) in the region. For example, in Myanmar the out-of-pocket health payment accounts for 80.68%, in Lao PDR 61.7% and in Cambodia 60.1%. (Source “Health-financing reforms in Southeast Asia: challenges in achieving universal coverage. Lancet 2011 /Figure for Myanmar: WHO National Health Account database).
• Out of pocket payment is largely for medicines and the proportion spent is closely aligned to social economic status. Drug expenditures consume 70% if the out-of-pocket health expenditures of the poor, while only 53% of the rich, and this 70% are largely spent on heavily marketed non essential and mostly ineffective medications (Source: Alberto Romualdez, Jr. et al, 2010: 94).
• Universal health coverage (UHC) should include comprehensive coverage of essential medicines and should reduce the out-of-pocket health impoverishment that is currently faced by the poor, in Lao PDR for example. (Source World Bank 2010. Out-of-pocket spending and health service utilisation in Lao PDR).
• While UHC should reduce drug expenditure, in Thailand drug expenditure increased at a rate of 9% over 5 years prior to UHC and 34% over 5 years after UHC has been full implemented. (Source Thailand Health Report 2008-10)
• This is particularly troubling given non-communicable diseases are the dominant cause of deaths in ASEAN, for example accounting for 73% in Viet Nam and Malaysia and 71% in Indonesia. (Source: WHO (2014) “Non-communicable Disease Country Profile 2014”)
• Non-communicable diseases are also rapidly increasing in many countries across the region. In Indonesia there has been close to a 20% increase between 1995-2007 in terms of % deaths caused from non-communicable disease.
• In Thailand non-communicable disease burden has increased also. But so has the access to better NCD medicines that have been access through licencing. At the same time, drug expenditures have also increased. (Assessing the implications of Thailand’s government use licenses, issued in 2006-2008”). During the period in time Thailand has seen over 80,000 more people on treatment with a benefit of around $132.4 million USD (Yamabhai, I., et al (2011)).
• For HIV and ART Thailand has seen a 50% increase of people on treatment without increasing budget (Sorakij, B/ National Health Security Office of Thailand).
• However, TRIPS-plus market exclusivity (including data exclusivity and patent term compensation for patent /marketing approval delay) is forecast to result in a 10 year additional cost of USD 5.1 billion which will reduce accessibility of medicines, reduce financial stability and increase out of pocket expenses. (Akaleenohan, C., Wibulpolpratert, S et al (2009) Extension of market exclusivity and its impact on the accessibility to essential medicines in Thailand). Analysis of the effect of TRIPS-Plus propsal. Health Policy 174-182.
• In Vietnam 50.9%, in Myanmar 45.8% and in Thailand 44.1% of total health expenditure goes to pharmaceuticals. (OECD (2012): Health at a Glance: Asia Pacific 2012)
• Vietnam, Myanmar and Lao PDR each experience greater than 10% annual average growth rate in real per capita pharma expenditure. (OECD (2012): Health at a Glance: Asia Pacific 2012)
• Affordability is often a starting point for other areas of critical importance to UHC – such as accessibility, availability, acceptability.
• Multi-drug Resistant TB treatment unaffordable despite growing cases. In Myanmar for example, it is 50x more expensive to access MDR treatment compared to treatment for standard TB.
For many people in Asia Pacific, there is still much to be done in order for those people to have affordable medicines for prevention, diagnostics, treatment and care of HIV, TB and malaria. Medicines are increasing in cost and the most significant burden is falling on the individuals who can least afford to pay it. Compounded, or possibly contributing to, rising rates of non-commutable diseases emphasises why a human rights approach to intellectual property and affordable medicines must be pursued.
A Right to Health
Every person has the inalienable right to accessing affordable medicines. It is the responsibility governments and inventors to ensure financial barriers, stigma or legal barriers do not prevent access or discourage universal health coverage to medicines, particularly for key populations of these diseases. Awareness of how this right is realised is particularly important for members of society who are particularly marginalised or vulnerable, which in the cases of TB and HIV, are the Key Populations.
The Right to Health has a long history in international human rights law. Article 25 of the Universal Declaration of Human Rights declares that:
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing, medical care and necessary social services.
The right to health was further developed by Art 12 International Covenant on Economic, Social and Cultural Rights:
(12.1) The State Parties to the present Covenant recognise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
As was previously mentioned, the right to health and accessing medicines is a right of all people. However, particular care should be taken to ensure those who are most vulnerable can also realise this right. For TB and HIV, those who are most marginalised are the Key Populations,. Key Populations, as per the Global Fund Key Populations Action Plan 2014 -2017 (p. 5), defines any group that:
• Epidemiologically faces increased vulnerability and/or burden due to a combination of biological, socio-economic and structural factors;
• Access to relevant services is significantly lower for the group than for the rest of the population (and therefore requiring dedicated, strategic investments to increase coverage, equity and accessibility) for such a group; and,
• The group faces frequent human rights violations, systematic disenfranchisement, social and economic marginalisation and/or criminalisation – which increases vulnerability and risk and reduces access to essential services.
Health policies and/or programmes have the ability to either promote or violate human rights, including the right to health, depending on the way they are designed or implemented. All to often however, these key populations are left behind by other stakeholders, their rights are ignored or abused and their existence is further marginalised. While it is not access to affordable medicines alone that is preventing many key populations from realising their right to health, accessing affordable prevention, diagnostics, treatment and care is an important component of an effective response to TB and HIV.
TRIPS & Human Rights
Prior to the signing of GATT in 1994 and the establishment of the WTO the following year, countries had diverse intellectual property regimes. The rationale for TRIPS and a standardised intellectual property regime, is to encourage innovation of new useful products, and through the trade of those products, increase the wealth of WTO members. However, TRIPS can also potentially play a restrictive role in development, including through restricting access to affordable medicines.
Attempts have been made to remedy this detrimental impact of TRIPS. The WTO Declaration on TRIPS and public health makes a strong statement on the respect of fundamental human rights, stating that TRIPS:
can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
Articles 7-8 of TRIPS, are where the flexible nature of the agreement, and suggested opportunity for developing countries, is contained. This flexible aspect aims to provide flexibilities to developing countries and can be utilised to serve a variety of objectives, including, public health and nutrition, the promotion and curbing the monopolistic potential of patent rights, and the encouragement of technology transfer and dissemination of knowledge. However, whilst this segment of the TRIPS appears to be of great benefit, flexibilities have been little used and/or only minimally effective – resulting in higher prices and reduces access to key medicines.
There are certainly examples that can convey improved access to medicines through the TRIPS regime, ARVs in Thailand for example. However, in Asia Pacific this example is the minority of cases. There has been minimal usage of licencing, parralell importing and the flexibilities generally, and the stronger TRIPS-Plus arrangements are likely to further hinder access to medicines.
The Global Commission on HIV and the Law Working Paper ‘Access to Medicines: The Role of Intellectual Property Law and Policy’ by Said and Kapczynski identify several key factors that have inhibited the effectiveness of flexibilities: A lack of supportive legal framework, resource constraints and limited coordination and continued unilateral pressure. That being the case, the existing TRIPS system is inadequate, or support services facilitating implementation of the system require reform at the very least.
The HIV and the Law Working Paper also makes a number of key recommendations that APCASO wishes to reiterate. For developed countries, there is a need for an indefinite moratorium on increased IP standards such as TRIPS-Plus. There is a need to credibly commit to not using unilateral threats to enhance IP protections, and all least developed countries should be exempt from compliance.
For developing countries, there is a critical need to adopt robust TRIPS flexibilities into national law as a matter of urgency: Compulsory licencing, parallel importing, retain remedial flexibility, promulgate and potential use of unfair competition laws. Developing countries must take full advantage of the transitional periods and be assisted to implement these changes. Finally, there is need to build capacity in this area. Developing countries (and members of Key Affected Populations in those countries) need to be empowered to understand and engage in patent law at national and international level.
Equity Pricing & Human Rights
In addition to those recommendations highlighted in the previous section, pricing more generally requires further consideration. The high host of many lie-saving drugs not only keeps patients from getting treatment, but also discourages health ministries from improving the quality of patient care through the use of newer or better medicines. (MSF ‘Pills and Pocketbooks’ 2001). Having a more equitable approach to pricing, could see increased access to medications for people living with HIV, TB and malaria but also motivate governments to include such medicines within any universal health care system within the country.
‘Equity pricing’ is something that should be incorporated into the TRIPS regime. That is, the price of the drug is:
fair, equitable and affordable, even for a poor population and/or health system that serves them. Equity pricing is based on the principle that the poor should pay less for, and have access to, essential medicines.
As Medicines Sans Frontieres have elaborated previously, a number of strategies can assist in achieving this:
1. Encourging generic competition – through pro-public health interpretation of TRIPS and active efforts to use compulsory licencing;
2. Differential pricing of drugs – this tiered approach works well in theory, however, there is an unfortunate reliance on the will of companies and the requirement for a strict separation of markets;
3. Adopting TRIPS safeguards into national legislation
4. Creating high volume/ high demand through global regional procurement – possibly through bulk production and pre-qualifying producers; and
5. Encouraging local production through voluntary licencing and technology transfer – largely through voluntary licencing and technology transfer.
To complement this approach, M D Nair (TRIPS and Access to Affordable Drugs: 307) has also suggested more rational R&D models, better drug delivery systems, discovery of new indications for marketed drugs, improved production of marketing logistics which could all contribute to reducing the costs of drugs.
APCASO wants to thank to High-Level Panel for consideration of HIV, TB and malaria community and key populations perspectives within deliberations. For many, medicines in prevention, diagnostics, treatment and care have helped them to remain well and realise a high quality of life. However, for many in Asia Pacific, more work is required. More affordable and accessible medicines, and an intellectual property rights regime that facilitates this it one critical step in ending AIDS, TB and Malaria that can help many in the region realise their right to health. While many submissions may offer greater insight and expertise, we hope to have leant our voice to those submissions requesting greater realisation of rights and equity in international intellectual property regimes design and implementation.