[e-drug] MSF presentation on counterfeit drugs at the WHA

[Beverley Snell <bev@burnet.edu.au>]

To: e-drug@usa.healthnet.org
From: ethoen@compuserve.com
Subject: MSF presentation on counterfeit drugs at the WHA

E-drug: MSF presentation on counterfeit drugs at the WHA
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Presentation by Margriet de Boer of MEDECINS SANS FRONTIERES at the
technical briefing on drug quality and counterfeits at the World Health
Assembly, Geneva, 17 May 2000.

What can be considered a counterfeit drug? This should be defined clearly;

Workshop WHO/IFPMA 1992: a drug which is deliberately and fraudulently
mislabelled with respect to identity and/or source. Counterfeiting 
can apply to both branded and generic products and counterfeit 
products may include products with the correct ingredients, wrong 
ingredients, without active ingredients, with insufficient quantity 
of active ingredient or with fake packaging.

Will using manufacturers of brand name drugs instead of generic ones give
more guarantee on avoiding counterfeits and low quality drugs? No,
because....

? Producing counterfeits is deliberate fraud. The frequency of counterfeits
on the market is mainly due to a lack of pharmaceutical legislation, but is
independent of a supposed difference in quality of generic and brand name
products. MSF has field experience in counterfeit drugs and has reported
those cases as well.

? A lack of legislation does also create drug quality problems on the
market, however as well for generics as for brand name products. 
There are many known cases of multinationals that have manufacturing 
plants of
doubtful standard in developing countries to produce brand name drugs for
the local market. This is however completely legal when quality assurance
regulations of the local government are less strict then in the West. It
means however that the same brand name drug bought in a developing 
country and in a developed country can differ greatly in quality. 
Quality defects of brand name drugs which are produced in developing 
countries are thus common.

? A lack of legislation in developed countries can also have the consequence
of poor quality drugs on the market of developing countries. This is the
case when developed countries do not have the same quality 
requirements for drugs produced for export as for drug for the home 
market.

? The quality of drugs produced by generic manufacturers varies greatly.
However, there are numerous high quality generic manufactures in 
developing countries like India, Brazil , Thailand and China that are 
a very reliable source for low priced drugs. They are used by well 
known high quality drug wholesalers like the International Dispensary 
Association (IDA) or supplier agencies like Unicef, Copenhagen. 
Generic manufacturers are the preferred source for drugs used by 
NGO's in the field because branded products are not affordable. 
However, it is important to use a professional wholesaler like IDA 
with a strict quality control system that includes laboratory testing 
and regular inspections of the generic factories. This is because in 
countries with less strict regulations, there are also low quality 
generic manufacturers present, which offer extremely low priced drugs 
by cutting down on quality.

? The lack of quality requirements in international drug tenders of donors
like the World Bank tend to introduce substandard or even fake drugs on the
market of developing countries, as price is the only criterium used.

Conclusion
MSF sees the expansion of generic production and the encouragement of
manufacturing generic drugs in developing countries as key points to 
improve access to drugs for all. This should go hand in hand with the 
development of a strong national pharmaceutical legislation and 
regulation as part of a
National Drug Policy recommended by WHO. Correct implementation of 
the WHO Certification Scheme is also an important part of securing 
drug quality. A minimum quality standard can then be assured. This 
minimum quality standard should be well defined; it is of extreme 
importance that the standard setting by  the International Conference 
on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) does not aim at the highest 
quality standard possible, as this might negatively affect the 
possibility of manufacturing drugs in developing countries.
Technology transfer and improving the manufacturing capacity in 
developing countries are a more positive approach, that must be taken.

_________________________________________
Ellen F.M. 't Hoen LL.M.
Drug Policy Consultant
PO Box 15605
1001 NC Amsterdam
The Netherlands
e-mail: ethoen@compuserve.com
tel: + 31 20 6201743
fax: + 31 20 6201581
Mobile: + 31 6 55735472
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