E-DRUG: MSF letter to WHA delegates on prequalification
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[The 57th WHO Assembly starts today in Geneva. See www.who.int/wha
Prequalification is probably going to become the hottest drug-related topic
this year. See below the open letter of MSF to WHA delegates.
WB]
Dear E-druggers
On May 10, in preparation of the 57th World Health Assembly, MSF have sent
a letter to country delegations to present our concerns related to the WHO
prequalification project.
To contact MSF during the WHA, you can call Ellen 't Hoen at 33 6 2237 5871
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Geneva, May 10th 2004
Re: 57th World Health Assembly
M�decins Sans Fronti�res (MSF) would like to share with you some of our
concerns regarding the WHO prequalification project, an issue that is
relevant for agenda items 12.1. (HIV/AIDS) and 12.12 (Quality and safety of
medicines) of the 57th World Health Assembly.
Achieving the goal of access to essential medicines for all requires
globally accepted mechanisms for ensuring that these medicines ? generic
and originator products ? are of quality.
What is the WHO prequalification project?
It is one of WHO's key functions to improve access to quality and
affordable medicines. The WHO prequalification pilot project was set up in
2001 by the United Nations (WHO, UNICEF, UNFPA and UNAIDS, supported by the
World Bank) to fulfill this mandate.
The specific tasks of the prequalification project include:
a) to assess the quality of essential drugs, produced by generic and
brand name companies, through the evaluation of product dossiers submitted
by companies, and
b) to assess manufacturing sites to comply with Good Manufacturing
Practices.
These evaluations are performed by international teams consisting of drug
regulatory experts from 20 countries.
The prequalification project publishes and regularly updates a list of the
drugs and manufacturing sites it has validated.
What are the achievements to date?
Three years after being set up, the WHO prequalification project has
dramatically improved access to quality essential medicines, particularly
AIDS drugs. More than 90 products ? 50 of them generics ? have been
prequalified to date. The project has also contributed to improving
standards of generic producers and helped enhance countries' capacity to
produce quality medicines.
Why is the WHO prequalification project so important?
The final responsibility for drug evaluation and approval is in the hands
of national drug regulatory authorities, but the existence of a reliable,
international reference facilitates the task of national drug authorities
and procurers. The WHO evaluations inform countries' drug approval
processes thus reducing the burden of product evaluations and facilitating
fast track registration of essential medicines. This is particularly
important for countries that lack regulatory capacity and resources for
assessing drugs.
Not only governments but also other providers of medical care such as MSF
and other NGOs need assurance of the quality of the drugs they use. The
example of antiretroviral medicines illustrates the vital role
prequalification plays in improving access to affordable medicines: today,
MSF is providing ARV treatment for over 13,000 people living HIV/AIDS in
more than 20 countries. Our ability to increase the number of patients on
treatment has largely depended on the majority of our programmes being able
to make use of WHO prequalified fixed-dose combinations of ARVs ? that is,
pills containing two or three AIDS drugs in one tablet.
Is the WHO prequalification project equipped to face the growing challenges
of AIDS, TB and malaria?
WHO's prequalification work must be adequately supported. If this is not
the case, much-needed essential medicines will not be assessed in a prompt
manner. This will have the undesirable effect of limiting the sources of
medicines rather than expanding them ? in particular when funding agencies
require that drugs are WHO prequalified. It could also lead to a
discrepancy between internationally recommended treatment guidelines and
the availability of these particular treatments. This has already been the
case with artemisinin-based malaria treatment. The prequalification project
should therefore become more proactive so that treatments that are
recommended and needed are assessed as soon as possible.
MSF urges the WHA to reinforce the WHO prequalification pilot project by
ensuring that it is a fully-fledged permanent function of the WHO Essential
Drugs and Medicines Policy Programme (EDM). In order to face current health
challenges, the WHO prequalification project needs to be strengthened and
expanded. We call upon the WHA to ensure that additional technical,
financial and human resources are made available.
Please do not hesitate to contact me or the relevant MSF representative in
your country for more details on any of the above.
Sincerely
Ellen 't Hoen
Interim Director
Campaign for Access to Essential Medicines
M�decins Sans Fronti�res
ellen.t.hoen@paris.msf.org
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