Saturday, July 27, 2013
The World Trade Organization (WTO) last month extended the deadline for enforcement of patents and copyrights, mainly held by multinational companies, in the world’s least developed countries (LDCs) by a further eight years which elapse in 2021. The extension did not however include cheaper generic HIV drugs or pharmaceutical products in general whose deadline expires in 2016. Human rights organizations warn that the lives of half a million Ugandans enrolled on HIV treatment will hang in the balance if generic drugs are outlawed based on international trade law or the Trade Related Aspects of Intellectual Property Rights (TRIPS). According to Denis Kibira, medicines advisor for the non-governmental organisation HEPS-Uganda, over 90% of all HIV drugs in Uganda are generics manufactured in India. Generic drugs are identical copies of brand drugs manufactured by originator pharmaceutical companies, most of which are based in Western Europe and the US. HIV treatment was previously a preserve for patients in the west on account of the high prices of antiretroviral drugs (ARVs) and international patents which did not permit manufacture of ARVs at cheaper prices. HIV treatment became a possibility for millions in Sub Saharan Africa principally because of the introduction of generic ARVs in 2001. HIV drugs must be affordable Joshua Wamboga from The AIDS Support Organization, where over 100,000 people are enrolled on HIV treatment, said: "The ability to access cheap medicines on the market will be curtailed and the fight against HIV in Uganda may be lost if expansive trade laws are adopted without improving the incomes of Ugandans." According to the Ugandan Ministry of Health, there are over 500,000 antiretroviral users in the country. PEPFAR, the leading funder of HIV treatment in Uganda, indicated in its 2012 country operational plan that it depends on Indian generic drugs for 96% of those treated under its implementing partners. Generics drugs were a major factor in scaling up access to the over seven million who are currently on treatment in Africa according to a UNAIDS report of May 2013. Medicins San Frontiers reported this month the price of first line and second line antiretrovirals has fallen due to competition among generic drug manufacturers, further making antiretrovirals affordable by poor countries. The much more expensive second-line and third-line drugs, which are prescribed when a patient develops drug resistance to the first-line drugs are however, still patent protected. Putting lives at risk Outlawing generic antiretrovirals would jeopardize the lives of those already on treatment and be a crippling impediment to further scaling up access for those who become eligible for treatment. The demand for antiretrovirals in Uganda is set to increase given the increase in national prevalence of HIV from 6.4% in 2005 to 7.3% in 2012, according the Ugandan health ministry. The new World Health Organization HIV treatment guidelines issued on 30 June, recommend antiretroviral therapy now be initiated earlier before people’s CD4 counts get too low. So the demand for generic HIV pharmaceuticals is set to increase even further based on these recommendations. Professor Brook Baker of the US-based organisation Health GAP, in a joint statement with Uganda’s Centre for Health, Human Rights and Development (CEHURD), calls for least developed countries to start early in their quest for an unconditional extension to the grace period given by the World Trade Organization for manufacture and sale of generic antiretrovirals, which elapses in 2016. Uganda’s pharmaceutical industry Moses Mulumba, director at CEHURD, said: “Uganda has major technological and infrastructural deficiencies for its indigenous pharmaceutical industry to be able to develop its own original antiretrovirals. This would require millions of dollars in investment and highly qualified researchers.” He advised that Uganda could overcome these challenges through technology transfer arrangements with countries such as Brazil, China and India. Quality Chemicals is currently the only Ugandan pharmaceutical company manufacturing generic HIV drugs in a joint venture with Cipla of India.