E-drug: New Law Blocks Import of HIV/Aids Generics Into Nairobi
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[Copied from Ip-health. KM]
New Law Blocks Import of HIV/Aids Generics Into Nairobi
The East African (Nairobi)
NEWS
July 1, 2002, Posted to the web July 2, 2002
By Dagi Kimani
Desperate and dying, Kenya's 2.4 million HIV-infected people are unlikely to
get cheap generic anti-retrovirals any time soon, thanks to an amendment
introduced into the country's patent law by the government barely one month
after it came into effect.
The amendment, published under the Statute Law (Miscellaneous Amendments)
Act, 2002, in the Kenya Gazette Supplement dated June 7, makes it virtually
impossible for any Kenyan to import generic Aids drugs, reversing a key
provision of the Industrial Property Act (IPA).
The only option still left open is importation under an emergency government
order, as is the case in Zimbabwe, but this has never been issued in Kenya
despite President Daniel arap Moi's 1999 declaration of HIV/Aids as a
national disaster.
The new amendment says that importation of generic versions of patented
drugs, including key anti-retrovirals, can now only be done by the "owner of
the patent or with his express consent," which means that anybody who wants
to import a generic will have to get permission from the international
pharmaceutical company that holds the patent - a near- impossible
proposition.
In contrast, the unamended IPA provision allowed for a mechanism known as
parallel importation, which would have enabled the importation of generics
for the treatment of any disease without reference to the patent holder.
Among the Aids drugs on the Kenyan market for which cheaper generics would
have been available before the amendment of the Act are AZT, Abacavir and
3TC (patents held by GlaxoSmithKline), and Nevirapine (Boeringer Engelheim).
Intriguingly, the Ministry of Health and the Kenya Industrial Property
Office (KIPO) deny knowledge of the amendment, which was drafted and tabled
by the Attorney-General's office and passed in parliament in the absence of
the chairman of the Parliamentary Committee on Health, Dr Newton Kulundu.
According to the Kenya Coalition on Access to Essential Medicines, a lobby
group bringing together several local and international NGOs in Nairobi, the
contentious amendment is especially troubling because it was introduced just
a month after IPA came into effect.
Only on March 28 this year did the Minister for Trade and Industry, Mr
Nicholas Biwott, publish a gazette notice giving the commencement date, May
1, 2002, of the patent law, which had been passed by parliament in June
2001.
"We are shocked that an amendment to an Act, which we were involved in, was
drafted and passed without consultation with any of the stakeholders in
civil society," Ms Lisa Kimbo, co-ordinator of the coalition, told The
EastAfrican last week. "It seems that some of the important gains that IPA
have now been taken away." Ms Kimbo said the coalition had engaged a lawyer
to advise it on the implications of the amendment with a view to petitioning
parliament to revoke it.
The speed with which the latest amendment was drafted and tabled before
parliament, critics say, is also intriguing. Last December, Kenya's
Assistant Minister for Trade and Industry, Albert Ekirapa, explained to an
enraged Parliament that his ministry had not given the commencement date for
the IPA because the Attorney-General's office had not drafted subsidiary
regulations to govern its implementation six months after it had been
passed. The same office however, took less than a month to have the
contentious amendment passed.
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