Bridges Weekly Trade News Digest • Volume 8 • Number 12 • 31st March 2004
Botswana Conference Sparks Debate On Generics
A meeting on generic HIV/AIDS drugs was held in Gaborone, Botswana, from 29-30 March. Prior to the meeting, civil society organisations sent a letter to the US representative, highlighting concerns that the US was blocking the use of sorely needed inexpensive generic versions of HIV/AIDS drugs in poor countries, seeking instead to secure the market for US patented drugs.
Entitled "Fixed-Dose Combination Products: Scientific and Technical Issues Related to Safety, Quality and Effectiveness," the Gaborone conference focused on how to evaluate the relatively inexpensive generic fixed-dose combinations (FDCs) of antiretrovirals. The generic drugs, regarded as the key to scaling up HIV/AIDS treatment in poor countries, meet WHO standards. They have not, however, been approved by the US Food and Drug Administration (FDA). The conference was organised by the Joint UN Programme on HIV/AIDS, the WHO, the Southern African Development Community and the US Department of Health and Human Services.
NGOs express concern over restricting access to affordable drugs
AIDS activists and non-governmental organisations (NGOs) expressed concern over the US agenda at the meeting. A letter endorsed by 381 organisations was sent to US Global AIDS Coordinator Randall Tobias condemning the Bush administration’s "efforts to undermine FDC generics". Jacqueline Patterson, HIV/AIDS programme manager for Interchurch Medical Assistance highlighted the importance of generic FDCs, noting that "due to lower prices of FDCs, we can treat up to four times more people than we would be able to treat with non-FDC/branded drugs". The US has pledged to spend US$15 billion to help fight HIV/AIDS over the next five years. This money will, at least initially, be spent on patented drugs approved by the US FDA.
Human Rights Watch, in a press release, said that while generics meet stringent WHO standards, "the US, under pressure from pharmaceutical companies selling the brand-name equivalents, claims instead that ‘There are no uniform principles, guidelines or international standards addressing the development’ of generic drugs - an assertion that calls into question the WHO’s widely accepted review process".
William Haddad, representing generics manufacturers, said that the US wanted to add a new level of approval, "so that US brand name companies can sell their products, and generic companies cannot use US money [to produce drugs for developing countries]". The civil society letter stated that the Gaborone meeting "needlessly casts doubt upon the clinically proven quality of generic AIDS medicines, and disregards the WHO’s internationally recognised Drug Prequalification Program. The meeting is intended to justify the use of expensive, more complex branded treatment regimens, and will be used by the US as the minimum basis to justify its efforts to use bilateral assistance programs to lock generics out of developing countries".
Mark Dybul, head of the US President’s Programme for AIDS Relief, defended his county’s cautious stance on FDCs, focusing on the issue of drug resistance. If improper HIV/AIDS drug combinations are widely used, this raises the risk of the virus developing drug resistance. Dybul said that "we know from a decade of clinical experience that if you do not maximally suppress the virus, you significantly increase the risk of resistance. That is why we use three drug combinations, not one or two".
Following a deal cut at the WTO on 30 August last year on the conditions under which countries without pharmaceutical manufacturing capacity can import generic versions of drugs still under patent (see BRIDGES Weekly, 4 September 2003), access to generic drugs is expected to become more widespread. Some developed countries are currently in the process of drafting legislation to operationalise the deal.
For further information on the meeting, including the NGO letter, visit http://www.cptech.org/ip/health/aids/fdc/
ICTSD reporting; "U.S. May Cut Access To Generic AIDS Drugs In Poor Nations," UNWIRE, 26 March 2004; "AFRICA: Generics challenge brand-name anti-AIDS," IRIN, 30 March 2004.