E-DRUG: ARV parallel export from Africa to Europe
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The Netherlands Drug Inspectorate have discovered that 3642 of packs of
Combivir and 2424 packs of Epivir (Glaxo) have been reimported in the
Netherlands from francophone West Africa, where the ARVs were sold by GSK
at discounted prices under the Accelerating Access Initiative. The ARVs
(meant for African patients) were reimported into Europe by a Dutch trader,
and brought into circulation in the Netherlands through two wholesalers.
Many of these drugs have already been consumed. Similar ARVs appear also to
have reached Germany and possibly the UK. Up to 1/3 of the ARVs supplied to
Senegal, Ivory Coast, Congo, Togo and Guinee-Bissao may have been rerouted
in 28 shipments via Brussels, Paris and Antwerp since July 2001, earning
the traders millions of USD. The implicated batches have meanwhile been
recalled by the Dutch Drug Inspectorate, although no quality defects have
been found. The trader and wholesalers involved will apparently be
prosecuted, although it is yet unclear under which law.
The AIDS Foundation of the Netherlands has accused the traders of criminal
practices and pointed out that several African AIDS patients may have died
as they did not get access to their ARVs.
This "parallel export" trade is obviously a shame, as the drugs were meant
for African patients, while the European patients paid the "normal" high
price. The traders made a lot of money, and no patients benefited. What can
we do to prevent this?
The original products sold by pharmaceutical companies are registered in
Europe, so are allowed to be marketed. Parallel import from outside the
European Union is a breach of Patent legislation, but not Medicines
legislation. If the traders changed or tampered with packaging, that would
be considered as manufacturing, for which they probably did not have a
license. There might be other charges that the Dutch Inspectorate may
consider. Someone in Africa may have broken a bilateral agreement between
GSK and the countries/importers. However, these contracts are not public.
The parallel export of "A-drugs" that are being sold at discounted prices
in Africa back to the "high price" markets in Europe is probably legal on
its own merits under WTO rules, which aim to promote free trade. However,
the risk of polluting the profitable European and USA markets is high for
drug companies, and insurers and AIDS patients in Europe could also
question why they are asked to pay 5-10x more than African patients.
The drug companies could market a special dosage form for low-priced
markets, like for example Pfizer does for its donated fluconazole (which is
a tablet, whereas the sold product is a capsule). But this would require
new registration procedures and special batches. As these drugs are
different from the "high-priced" versions, they could not enter the
profitable European markets, as they would not be registered.
The best development alternative would be that drug companies allow generic
manufacturers in developing countries to produce ARVs under a voluntary
license. The locally manufactured "B-generics" would then also be different
from the "A-product" and not be able to penetrate European markets. This
would also allow developing countries to build the additional manufacturing
capacity needed to supply ARVs to the 3 million Africans that WHO wants on
ARVs in 2005. One South African generic manufacturer (Aspen Pharmacare) has
already received voluntary licenses for at least 5 ARVs from 3 different
companies.
Anyway, the re-routing of "cheap" ARVs is to be deplored, and developing
countries need to strengthen their drug supply systems. This is even more
pressing as the Global Fund is soon to disburse its millions for AIDS, TB
and malaria drugs.
What do E-druggers think should be done about this problem? The debate is
open.
regards
Wilbert Bannenberg
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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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