WHO adds new fixed dose combinations to its list of quality products for AIDS treatment
Key component of 3 by 5 strategy
Geneva, 1 December 2003 - As the World Health Organization (WHO) and UNAIDS today launch their 3 by 5 strategy to treat three million people living with AIDS by 2005, there is already substantial progress in one key area. WHO is adding three new generic products for first-line AIDS treatment to its list of medicines meeting WHO standards of quality, safety and efficacy.
The products are fixed-dose triple therapy combinations containing lamivudine, stavudine and nevirapine. Their introduction in the list of quality medicines will increase choice and competition, thus contributing to make AIDS treatment progressively more affordable.
“The 3 by 5 strategy recommends simplified AIDS treatment regimens so that countries can quickly expand access to antiretroviral medicines," said Dr Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and Pharmaceuticals. “These new products will help the countries which are hardest-hit by the AIDS epidemic get easy-to-take AIDS medicines to the people who need them most urgently." Single-pill combinations of antiretrovirals are a major breakthrough for AIDS treatment in poor countries as they improve the reliability and security of supplies, which has so far been one of the major obstacles to access. From a therapeutic point of view, they reduce the number of pills, are easier to take and promote greater patient compliance. They also ensure that the right dosage of each substance is given to the patient.
As part of the 3 by 5 strategy, WHO and its partners have set up the AIDS Medicines and Diagnostics Service (AMDS), a new mechanism created to make sure that the supply of safe, effective and affordable medicines of good quality are more easily accessible.
The WHO Prequalification Project will work with the AMDS to assess the quality, safety and clinical efficacy of HIV medicines distributed in developing and transition countries. At present, the Prequalification list contains over 50 single-drug, two-drug, and three-drug combinations, including the three newly qualified products. In assessing products and their manufacturers, Prequalification provides a rigorous review process and ongoing quality monitoring. One of the benefits of this initiative is that it limits the entry of substandard and counterfeit medicines into the supply channels. In addition, the project helps build local regulatory and production capacity by involving local experts in the evaluations. Prequalification also respects intellectual property rights while reflecting the highest public health standards.
The project, which partners with UNICEF, UNAIDS, the UN Population Fund (UNFPA) and receives support from the World Bank, has been running for two years. It will keep adding products and suppliers to its list, as and when they are found to meet the set standards.
“We are involved in a dynamic process,” explains Jonathan Quick, Director of Essential Drugs and Medicines Policy at WHO. “We expect that the list will grow steadily as more companies take an interest in participating and countries expand their HIV/AIDS programmes.”