Canada has the
become the first country to announce it has authorized a
company to make for export a cheap, generic version of a
patented AIDS drug, the WTO said Friday.
The Canadian
decision is aimed at treating people with HIV in Rwanda,
where some 190,000, or 2.1% of the population, are living
with the condition, according to the United Nations.
''The triple
combination AIDS therapy drug, TriAvir, can now be made and
exported to Rwanda, which is unable to manufacture the
medicine itself,'' a World Trade Organization
statement said.
Canada's
notification that it would make use of the so-called
''compulsory license'' procedure completes action that began
July 17 when Rwanda informed the WTO that it would
invoke the provision in ordering the drugs from
Canada.
That was ''the
first notification from any government that it has
authorized a company to make a generic version of a patented
medicine for export under special WTO provisions
agreed in 2003,'' WTO said. Under WTO rules, countries
can issue compulsory licenses to disregard patent rights
only after negotiating terms with the patent owners.
Rwanda said
originally that it intended to import 260,000 packs of
TriAvir fixed-dose combination product of zidovudine,
lamivudine, and Nevirapine over two years. The drug is
being made in Canada by Apotex Inc., which is calling
it Apo-Triavir.
''Both
notifications were required for the medicine to be exported
to Rwanda,'' WTO said. The accord eases the way for
countries with public health problems to import
cheaper generics made under compulsory licensing
elsewhere when they are unable to manufacture the medicines
themselves.
Combivir, made by
Britain's GlaxoSmithKline PLC, contains lamivudine and
zidovudine. Nevirapine is a generic version of Viramune,
made by Boehringer Ingelheim GmbH of Germany.
Boehringer
Ingelheim issued a statement saying it ''not only does not
object to the grant of this authorization under Canada's
Access to Medicines Regime but does support the CIPO
(Canada's patent office) decision in this respect.''
Jack Kay,
president and chief operating officer of Apotex, said, ''We
are doing this on a not-for-profit basis and hope that
this lifesaving drug gets to the thousands of patients
in Africa dying every month. The Canadian Federal
Government must change the process to get quality
affordable medicines to those who have no access,'' he said.
Many AIDS
patients have developed resistance to older antiretrovirals
and now need more expensive second-line drugs. The
international aid group Oxfam says the patent-busting
procedure is almost never used because developing
countries face pressure from rich governments acting on
behalf of their drug companies.
Brazil and
Thailand have recently issued compulsory licenses to develop
cheap generic versions of American AIDS drugs for use
domestically, but they have yet to use the
notification procedure for exporting the drugs.
Industry groups criticized the countries, and the United
States later placed Thailand on its copyright watch
list. (AP)
