WHO Leadership Failing to Improve Generic Medicines Prequalification System

Geneva, May 17, 2005 – Doctors Without Borders/Médecins Sans Frontières (MSF) said today that lack of commitment from the leadership of the World Health Organization (WHO) is crippling the effort to improve access to affordable versions of needed drugs.

"As health professionals running HIV/AIDS, TB, and malaria programs in developing countries, we are dismayed that WHO leadership has not done more to empower its in-house potential specifically designed to expand access to affordable medicines," said Dr. Rowan Gillies, president of MSF's International Council, at a press briefing in Geneva.

Established in 2001, the WHO prequalification project provides a reliable international reference to countries in procuring essential medicines. With more than half of the medicines prequalified so far being generic versions, the project has dramatically improved access to affordable quality medicines, particularly AIDS drugs. "If the WHO Director-General does not increase the capacity of this vital program, the project risks becoming a barrier to, rather than a tool for, expanding access to medicines," Dr Gillies said.

The need for a WHO prequalification system is widely recognized by caregivers and developing country governments. The 2004 World Health Assembly asked the WHO Director-General to "take measures to improve access of developing countries to pharmaceutical and diagnostic products to diagnose, treat and manage HIV/AIDS, including by strengthening WHO's prequalification project" (WHA resolution 57.14).

But 12 months later, with only 3.5 permanent staff supported by a limited number of external evaluators, the project remains considerably understaffed and under-resourced. In addition, there has been no increase in the project's financial resources since 2004.

MSF's diagnosis is that the WHO prequalification project today suffers from the same lack of support from WHO leadership it did a year ago. The Global Fund's recent decision to only fund medicines approved either by WHO or by a stringent drug regulatory authority has brought the urgent need to expand the project into even sharper focus. Continuing to assist countries in the procurement of quality medicines for AIDS, malaria and tuberculosis is becoming a mission impossible for the project's current staff. For example, of the 31 tuberculosis drugs listed on the WHO Essential Medicines List, 26 do not have even a single source prequalified, including all second-line TB drugs.

"This is restricting patients' access to essential medicines in many of the places we work in, particularly in countries that have limited capacity to assess the quality of medicines themselves," said Dr. Gillies.

"WHO must also take action to ensure the affordability and availability of new generation essential medicines to all those who need them," said Ellen 't Hoen, director of policy advocacy and research with the MSF Campaign for Access to Essential Medicines. "This is especially important in a world where all but Least Developed Countries are granting patents on medicines – international mechanisms are needed to mitigate the impact of prices of new drugs shooting up."