Interrogating access to generic HIV drugs: Political Economy analysis matters

Uganda is one of the countries most affected by the global HIV/AIDS pandemic. According to a recent UN report, Uganda is only one of eleven countries where HIV prevalence rates are actually going up. In 2012, a national survey revealed that national HIV prevalence rates had increased from 6.4% in 2005 to 7.3% in 2011 pointing to an increase of the population in need of HIV treatment. Annual new HIV infections more than double those who are being enrolled on treatment. WHO enrollment eligibility criteria has been revised three times in past few years requiring that HIV treatment be initiated earlier than initially recommended further compounding the unmet need (WHO, 2013). Currently, more than half a million Ugandans are enrolled on HIV treatment in a population of 1.2 million who are HIV positive. According to PEPFAR-Uganda, over 97% of Ugandans currently enrolled on HIV treatment depend on Indian generic antiretroviral drugs (ARVs) for treatment. Generic drugs are identical, albeit un-authorized, copies of drugs originally developed by innovator pharmaceutical companies most of which are based in western Europe and North America. Because of the excessively high cost of research involved in developing new drugs, often in hundreds of millions of dollars, these pharmaceutical innovators are granted patents or exclusive right of use and distribution of typically 20 years under international trade law relating to intellectual property rights. PATENT BARRIERS These patents imply that the HIV drugs originally developed by western pharmaceutical innovators are not to be copied by another manufacturer, in Uganda’s case, an Indian one. Brand drugs are often quoted in prices tailored to western markets, yet a quarter of Ugandans live below the poverty line and Indian generics, which go for about a tenth of the price of brand drugs, is all they can afford. Because of these patent and international trade law barriers to access to essential medicines, poor countries met in Doha, Qatar in 2001 and made the Doha declaration which provided relief for poor countries to overcome these patent barriers by domesticating its provisions in their laws allowing poor countries to disregard these pharmaceutical patents on account of public health emergencies such as HIV/AIDS. The grace period for manufacturing generic pharmaceuticals however expires on January 1, 2016.The prospect is that generic HIV drugs may become illegal under Uganda law and western pharmaceutical giants would successfully enforce patents for HIV drugs in Ugandan courts. Low-income countries have however not taken advantage of the Doha declaration which provides for ‘flexibilities’ ,consented to by the World Trade Organization(WTO) in 2005, to circumvent patent barriers to access to HIV drugs. Continued access to generic HIV drugs is therefore a major determinant of long-term HIV program sustainability as are any efforts aimed at treatment scale-up including by western donor countries. Therefore, it’s imperative that analytical frameworks unearth the impediments to continued access to generic HIV drugs which low-income countries will need for generations to come owing to their development status. Doing this will require understanding the complex relationships that impinge on access to generic drugs from within Uganda but also from an external perspective. These analyses would also be relevant to the nascent Ugandan pharmaceutical industry such as the Quality Chemicals which began production of generic HIV and malaria drugs about six years ago. The global pharmaceutical industry has been seen to use international trade law and national laws in Uganda such as the Uganda industrial properties act and anti-counterfeit bill to protect their intellectual property rights beyond the recommended minimum international IP regime agreed between industry and global health lobbies. ACCESS TO HIV TREATMENT AN MDG. Universal access to antiretroviral therapy (ART) is Millennium Development Goal (MDG) six (b). The WHO, UNDP and UNAIDS in March 2011, issued a joint statement over their concern on the unsecured long-term sustainability of access to affordable HIV treatment. In Uganda, universal access to HIV treatment is a goal in the National Development Plan (NDP) 2010/2011-2014. The Uganda National Strategic Plan (NSP) sets universal access to HIV care and treatment as a goal, specifically, ensuring that 80% have coverage by 2015. WHY POLITICAL ECONOMY? As an analysis tool, this framework explains how population health and outcomes are shaped by economic and political determinants in a complex interaction from a national and international perspective. Unequal distribution of resources gives rise to the contest for pharmaceutical resources by low-income ARV users seeking life-saving treatment on the one hand and the capitalist industrial class and owners of means of production represented here by ‘big pharma’, on the other. On another level, the dichotomy can be extended to the competition for power and the struggle for scarce resources between low-income and high-income countries. From a human rights–based perspective, the fundamental right to life and health and intellectual property rights constitute competing rights. This classic contest of dichotomies finds a conceptual home within a political economy analytical framework. Understanding the complex relationships that impact on access to HIV in Uganda including the power play by multinationals to secure their commercial interests through using national and trans-national legal regimes is well suited to the rigour of political economy analysis. Pharmaceutical companies are known to lobby their home governments to adopt an IPRs enforcement agenda in low -income countries including at multilateral institutions that set international policy and legal frameworks. In 2012, the US Department of Trade scheduled an intellectual property rights enforcement conference in Cape Town, South Africa which was later called off after civil society protests. ‘Big pharma’‘s sphere of influence extends to African governments and legislatures which are often prevailed upon not to act in the public interest of their own people. An in-depth assessment of the interests and influence of innovator pharmaceutical companies and how their power is exercised is critical to efforts to secure long term access to HIV treatment in the developing world. A stakeholder analysis would inform any measures aimed at securing long-term access to generic drugs including attempts at finding a balance between pharmaceutical industry interests and public health interests in Uganda. Political economy therefore offers a set of methodological tools and contextual analysis particularly suited to understanding the complexities of access to generic HIV drugs in Uganda and the appropriate policy responses and remedial measures needed to secure HIV treatment in the long-term.