E-drug: Pharmaceutical exports (cont'd)
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In reply to Laura Akgulian's message:
Although not exactly in reply to your inquiry I would like to inform you
about a French publication by ReMeD, PIMED and Wemos (two French
NGOs and a Dutch NGO) called 'Les changes de medicaments entre
pays europeens et pays en developpement: efficacite des systemes de
regulation, problemes et perspectives' (1996). An english summary
was published under the name 'All we need is transparency: The trade
in medicinal drugs between Europe and Developing countries'.
This study about which is reported in the publication examines the
efficacy of drug export legislation in 17 European countries (European
Union, Norway and Switzerland). It also considers the regulatory
aspects controlling the pharmaceutical markets in 17 developing
countries (particularly Francophone countries). The report identifies
some of the strengths and weaknesses found in the legislation
involving both imports and exports. It underlines the need to introduce
new measures to control better the quality of drugs shipped from
Europe. Major loopholes in European legislation (until 1995) are for a
vast amount of European countries:
- no monitoring of quality, safety and efficacy of products not having
a license in the exporting country
- no restriction on exporting if license is refused
- no export restrictions on drugs withdrawn from the market
- package inserts not required and no obligations regarding the
labelling language
Since the study was conducted in 1995 in various European countries
legislation has changed although I don't expect major changes positive
for developing countries. At the moment it is considered to do a
follow-up to this study and publish the full results in English as well.
Anyone interested to participate is welcome to contact Wemos.
Regards,
Mark Raijmakers
Coordinator Programme on Pharmaceuticals
Wemos Foundation
P.O. Box 1693
1000 BR Amsterdam
The Netherlands
tel: +31-20-4.688.388
fax: +31-20-4.686.008
e-mail: wemos@wemos.nl
http://www.wemos.nl
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