E-DRUG: Parallel import and counterfeits?
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[copied from DRUGINFO with thanks; WB]
Hi all
As the debate on access to medicines goes into a post-Durban
phase there have been increasing references in the press to the
risks of parallel importation. The key risk is obviously that of
importing medicines that do NOT comply with the quality standards
of the equivalents offered on the local market. However, this risk is
not unique to parallel traded goods - if the regulatory body's random
checking process is not efficient and effective, even goods made in
the country and marketed here may prove to be sub-standard.
Checking parallel imports does however place additional strain on
that system, for example by increasing the distance between the
inspectorate and the manufacturing plant. Greater reliance has to
be placed on the good offices of the regulatory body in the country
of origin of such goods, or on international mechanisms (such as
WHO certification schemes). I'm not convinced, however, that such
considerations make parallel trade (or importing from external
holders of compulsory licenses or manufacturers of products not
patented in SA) too dangerous to even contemplate. The spinoff
may in fact be improved post-marketing surveillance of ALL
products on the SA market - something that is probably already
needed.
The same concerns (and ultimate reasoning) seem to have
informed recent US political choices on parallel trade of medicines.
Market segmentation by US firms has been as obvious as any -
downward pressure on prices has always been felt to a greater
extent in Canada, for example, than in the US. Many US citizens
therefore wish to re-import US made drugs which are put on the
Canadian and other markets at reduced prices.
Below is a quick note from Jamie Love (CPT Washington) on the
recent vote to lift the ban on such practices, and the cautionary
measures being undertaken to assure quality.
regards
Andy
------- Forwarded message follows -------
Date sent: Thu, 20 Jul 2000 10:59:32 -0400
http://www.nytimes.com/library/politics/072000senate-spend.html
July 20, 2000
Bill Would Lift Ban on Import of U.S. Drugs
By STEVEN A. HOLMES and ROBERT PEAR
WASHINGTON, July 19 -- The Senate today overwhelming voted to
permit pharmacies and wholesale distributors of prescription drugs to
import and sell American-made medicine that originally had been exported
to foreign countries.
But in voting 74 to 21 to overturn the ban on such imports, the
lawmakers also unanimously adopted an amendment requiring the Food and
Drug Administration to certify that the action would pose no risk to
public health and safety and would significantly reduce costs to
consumers.
[snip]