Text: U.N. Health Agencies Unveil List of Screened HIV Medicines

20 March 2002

Text: U.N. Health Agencies Unveil List of Screened HIV Medicines

Goal to provide better access to drugs for poor countries

The World Health Organization (WHO), in partnership with other U.N. health agencies, has announced the results of its evaluation of HIV-related medicines and medical products manufactured in 13 countries on five continents. This screening process is intended to provide better guidance and support for health-care providing agencies and governments in need of quality guidance and assurance as they attempt to provide medicine and care for HIV/AIDS patients.

"This U.N. initiative marks an important step in increasing the number of qualified suppliers of HIV medicines and improving the procurement of these drugs for people living with HIV/AIDS in developing countries," said Dr. Peter Piot, executive director of the Joint United Nations Program on HIV/AIDS (UNAIDS) in a March 20 press release from the U.N. health agencies.

The list includes 40 products from eight branded and generic manufacturers so far. Thirteen more suppliers and 100 products are currently under review in what will be an ongoing process to insure that drugs and other products meet international standards for quality and purity.

Working with national drug regulating authorities, WHO has evaluated products manufactured in Argentina, Canada, Denmark, Estonia, Finland, France, Hungary, India, Mexico, Philippines, Sweden, Switzerland and Zimbabwe.

Further information on the quality review process and international standards for the evaluation of drugs is available at http://www.who.int/medicines/

Following is the joint release from WHO, UNAIDS and UNICEF:

(begin text)

WORLD HEALTH ORGANIZATION (WHO)
JOINT UNITED NATIONS PROGRAM ON HIV/AIDS (UNAIDS)
UNITED NATIONS CHILDREN'S FUND (UNICEF)

Joint Press Release

March 20, 2002

INITIATIVE TO PROMOTE ACCESS TO QUALITY HIV MEDICINES RELEASES FIRST BATCH OF RESULTS TODAY

A new effort to assess the quality of HIV medicines could make treatment services more accessible to poor countries. The World Health Organization (WHO) has evaluated several HIV-related medicines and today publishes the first list of products which were found to meet WHO recommended standards. This initial phase of the project includes forty products from eight branded and generic manufacturers. Managed by WHO, the initiative counts on the expertise of UNICEF and the UNAIDS Secretariat, and is supported by the UN Population Fund (UNFPA) and the World Bank.

"The project demonstrates the vital contributions research-based and generic companies can make to innovation, quality, and access to life-saving medicines," says Gro Harlem Brundtland, Director-General of WHO. "We want to see an expansion in people's access to quality health care, particularly in relation to those diseases, like HIV/AIDS, that keep them poor and prevent the economic development of their communities."

The Access to Quality HIV/AIDS Drugs and Diagnostics project is part of a UN-wide strategy to improve access to HIV treatment. The strategy is meant to promote rational use of drugs; affordable prices for medicines and diagnostics; sustainable financing; and reliable health and supply systems.

"This process will assist countries, as well as UNICEF and other agencies, in the procurement of quality products for HIV treatment," says Carol Bellamy, Executive Director of UNICEF.

"This UN initiative marks an important step in increasing the number of qualified suppliers of HIV medicines and improving the procurement of these drugs for people living with HIV/AIDS in developing countries," says Dr Peter Piot, UNAIDS Executive Director. "We hope this project will help HIV-positive people gain greater access to affordable HIV medicines of good quality."

The list released today includes eleven anti-retrovirals (ARVs) and five products for opportunistic infections. The ARVs on the list allow for several triple therapy combinations.

The pilot project evaluates pharmaceutical products according to WHO recommended standards of quality and for compliance with Good Manufacturing Practices. It is just the beginning of an ongoing process that will keep adding products and suppliers to its list, as and when they are found to meet the set standards. The list is now available on the web sites of WHO and the other collaborating agencies. So far, eight companies have been evaluated but another 13 suppliers and 100 products are currently under review.

"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 programs."

Appropriate diagnostic support is essential to monitoring the progression of AIDS, the success of medical treatment and the extent of viral resistance to medication. Through its department of Blood Safety and Clinical Technology, WHO is also evaluating HIV test kits and technologies to monitor HIV drug treatment.

In addition, guidelines on minimum requirements for laboratory monitoring of HIV drug treatment are being developed. WHO is also developing training and quality assessment programs for health care workers to ensure correct use of diagnostic tests.

HIV/AIDS has become the leading cause of mortality in Africa; out of the 40 million people living with AIDS in the world, 28 million are in Africa. In Asia and the Pacific, AIDS is rapidly spreading. An estimated 7.1 million people are now living with HIV/AIDS in the region.

The first list of products and suppliers assessed by the Access to Quality HIV/AIDS Drugs and Diagnostics project is available on WHO web site: http://www.who.int/medicines/

All WHO Press Releases, Fact Sheets and Features as well as other information on this subject can be obtained on Internet on the WHO home page http://www.who.int/

(end text)