As UNAIDS highlights the fact that only 32,000 people in resource-limited countries are receiving antiretroviral therapy, a satellite meeting at the Fourteenth World AIDS Conference organised by Medecins sans Frontieres (MSF) and Health GAP Coalition heard that obstacles to drug supply need to be addressed at an international level, with leadership from institutions such as Unicef and the World Health Organisation (WHO).
Carmen Casas Perez of MSF told the meeting that it was realistic to assume that the price of triple therapy could be brought below $100 a year within the next months if the volumes of antiretrovirals ordered are increased, offering clear hope that affordability will improve. She reminded delegates that MSF had set the target of a drug combination for $250-300 at the Durban World AIDS Conference in 2000, and that goal had been achieved.
MSF is proposing an approach called Equitable Access, which would establish global guidelines designed to ensure that:
- Price reductions are offered equitably to countries with the same level of resources, and with agreed criteria shared by all companies (including generic manufacturers) over who qualifies for offers of price reductions.
- Producers of generic antiretrovirals are reviewed by the World Health Organisation in order to provide quality assurance to governments who are unable to do this for themselves.
- Technology transfer from current generic producers and brand-name producers of antiretrovirals is supported, to allow more countries to scale up local production of antiretrovirals.
- Centralised procurement becomes a reality, driving down the price of antiretrovirals more rapidly.
- Competition between generic and proprietary producers is preserved, and competition between generic producers is also encouraged. Competition at both levels has already served to drive down prices.
Inequitable price reductions
A survey published this week by MSF highlights the degree to which countries at the same economic level are being offered radically divergent prices for the same drugs. Whilst Guatemala is being offered nelfinavir at a cost of $8300 per year, Brazil has been able to negotiate the price down to $2336 per year, and other countries have been offered the drug at approximately $3100 per year, according to Carmen Casas Perez of MSF.
There are also big differences between the best prices obtainable for different triple combinations based on AZT/3TC. Whilst a generic combination of AZT/3TC and nevirapine is available at $316 from generic manufacturers, the most expensive AZT/3TC based combination is the one that includes abacavir, offered at $2409 by Glaxo SmithKline.
The MSF report Untangling the web of price reductions also highlights the differences between companies in eligibility criteria for reduced price drugs. For example, while abacavir is offered at $1387 a year to least developed countries by Glaxo Smith Kline, the price is negotiated on an individual basis with middle income countries. In contrast, Boehringer Ingelheim uses a much broader definition (the World Bank’s Low income and lower middle income category) to select which countries may benefit from free nevirapine for prevention of mother to child transmission.
Pre-qualification of generic producers
The World Health Organisation’s efforts to establish the bioequivalence of generic antiretrovirals were described by Hanne Bak Pederson of Unicef. The scheme, supported by WHO, Unicef, UNAIDS and MSF, seeks to assess the bioequivalence of any generic used in the treatment of HIV infection and opportunistic illnesses, with companies invited to submit samples and undergo inspection of the manufacturing facility. Certification is then given for the product produced at the inspected site.
However, one difficulty facing generic manufacturers of antiretrovirals is a lack of information about the purity standards of the Active Pharmacuetical Ingredients used to make antiretrovirals, an issue that will become increasingly critical if more players enter the APIs market, and if more countries begin manufacturing their own generic ARVS. WHO plans to establish quality specifications for APIs as part of the ongoing assessement process, which should see new products pre-certified on a regular basis. 160 products have been assessed so far, of which 47 have already been pre-qualified, with further announcements due on a quarterly basis.
Centralised procurement
Dr Koulla Shero from the Cameroon National AIDS Programme Coordinating Committee described how Cameroon decided to force all antiretrovirals coming into the country, including those sold through private pharmacy routes, to be supplied from a national procurement agency, which has been able to negotiate prices down by more than 50% since 2000. Regional procurement could save even more, since economies of scale would allow further price reductions, and would also make it economical for new producer countries to support regional drug supplies.
Competition
Dr Krisana Kraisantu of Thailand’s Government Pharmaceutical Organisation reported that competition between suppliers of Active Pharmaceutical Ingredients had helped drive down the price of a triple combination of d4T/3TC/nevirapine to $27 a month.