E-DRUG: WHO releases ARV quality data
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WHO has finally released the long expected quality data on generic and
original anti-retrovirals and other HIV-related medicines. In total 11 ARVs
have been put on the "white" list; 3 of them also from generic suppliers.
There is no "black" list.
Fears that WHO would bend to industry pressure, have not materialised. The
list is, however, a mixed bag.
If this list should be the basis for purchasing ARVs from Global Funds, one
would run into trouble: some popular ARVs are absent (e.g. efavirenz,
indinavir).
Interestingly the only "approved" nevirapine is from a generic company
(CIPLA India); the original manufacturer (Boehringer Ingelheim) is not
listed. Similarly, capsules of AZT (zidovudine) are only available from
Spain, and not from GSK. Reasons why some drugs are not listed are not
given.
One can only hope that the "missing" original and generic companies get
their products listed in the next update.
Finally, just to congratulate WHO that they have taken this bold step. It
is the first time that the organisation sticks its neck out, although with
plenty of legal disclaimers.
We will look forward to the update.
See press release below; the original is at:
http://www.who.int/inf/en/pr-2002-19.html
The list of suppliers can be found at:
http://www.who.int/medicines/organization/qsm/activities/pilotproc/supplier
s.doc
[older] ARV pricing info can be found at:
http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml
regards
Wilbert
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Dr Wilbert Bannenberg, E-drug moderator
Box 456, Irene 0062, South Africa
Mobile +27-82-5756249
Tel +27-12-6671752
Fax +27-12-6671762
Email: WilbertBannenberg@compuserve.com
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Press Release WHO/19
20 March 2002
Joint Press Release WHO/UNAIDS/UNICEF
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 programmes."
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 programmes 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/
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For further information, journalists can contact: Daniela Bagozzi,
Communications, Heath Technology and Pharmaceuticals, WHO, Geneva, tel.
(+41 22) 791 4544; mobile (+41) 79 475 5490, e-mail bagozzid@who.int.
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/
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