Sunday, August 18, 2013

Why continued access to affordable HIV drugs hangs on a bill in the Ugandan parliament

Today Wednesday 21st August 2013, a bill critical to the lives of half a million Ugandans enrolled on HIV treatment comes up for debate in the plenary of the Ugandan parliament. Not many Ugandans have heard about the Industrial properties bill (2009) but here is why we should pay attention. Uganda’s national HIV prevalence rates have shot up from 6.4% in 2005 to 7.3% in 2012 with a clearly worrying upward trajectory. Uganda continues to register steady increases in annual HIV infection rates since 2010. Annual infection rates have risen from 100,000 in 2010 to 150,000 in 2011 according to statistics from the AIDS Information centre (AIC). Now, here is why the industrial properties bill (2009) can make or break not just the lives of Ugandans currently enrolled on HIV treatment but the Ugandan economy as a whole given that a 2008 UNDP study showed that continued access to HIV treatment offsets the negative economic growth rate of HIV by 5.3%. According to the 2013 Ministerial policy statement signed by Dr Ruhakana Rugunda, the Health Minister, there are 520,000 Ugandans currently enrolled on HIV treatment- and counting. Over 90% of these half a million Ugandans depend on Indian generic antiretroviral drugs (ARVs) for treatment- according to Denis Kibira, a Pharmacist and Medicines Advisor at HEPS-Uganda. The trouble is that the Indian generic ARVs, and yes, even those manufactured by Quality Chemicals at Luzira, are not brand drugs. Put another way, the generics consumed by Ugandan ARV users were not developed by Indian pharmaceutical companies. Indian companies copied the formulas for manufacturing these drugs by companies mostly from Western Europe and North America (without their authority). Almost all these Indian ARVs were originally developed after painstaking research and development by a pharmaceutical giant after investing literally millions of dollars of their own R&D funds to develop these drugs and have taken though rigorous animal and human trials and getting them approved from agencies such as the Food and Drug Administration (FDA) in the US. These pharmaceutical giants are then granted patents or exclusive right of use and distribution of say 30 years under international trade law relating to intellectual property rights. These patents imply that the ARVs are NOT to be copied by another manufacturer, in Uganda’s case, an Indian one. Of course this would not be a problem if Ugandans could afford to buy these drugs from Pfizer or Norvatis. The trouble is that these drugs are often priced at prices tailored to western markets yet a quarter of Ugandans live below the poverty line and Indian generics, which go about a tenth of the price of brand drugs is all they can afford. Even the US’s PEPFAR program in Uganda depends on generic ARVs for 96% of those treated under its numerous implementing partners-according to PEPFAR’s 2012 country operational plan. 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 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 expires on 1st January 2016 unless the Ugandan parliament sits today and calls for amendments to the Industrial properties bill (2009) to include ‘flexibilities’ that allow Uganda to lawfully extend this deadline or suspend international pharmaceutical patents with regard to some specific public health emergencies or import these drugs from India. These ‘flexibilities’ were agreed upon by the World Trade Organization (WTO) in 2005 and all the Ugandan parliament needs to do is include them in the industrial properties bill (2009). Short of this, come 2016, generic HIV drugs will become illegal under Uganda law and western pharmaceutical giants would successfully enforce patents for HIV drugs in Ugandan courts. According to CSOs involved in access to medicines issues in a joint statement issued on Monday 19th August 2013, the current bill does not include these ‘flexibilities’. ’’ Every Ugandan who has ever taken a tablet or a syrup to treat an ailment should pay attention to the Industrial properties bill’’says Primah Kwagala of Center for Health, Human Rights and Development’’

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