[Ip-health] Kenya CL delay

[sean.flynn@cptech.org]

Licence Delays Kenya's Free ARVs Treatment Roll-Out
The EAST AFRICAN February 2-8, 2004
By Dagi Kimani Special Correspondent

A delay by Kenya's Ministry of Trade to issue a licence to a local drug
company is holding the production of life-saving AIDS medicines some of
which have already been ordered by the Ministry of Health.

Failure by the ministry to issue what is known as a compulsory licence to
Cosmos Ltd, a Kenyan generic drugs maker, means that the company cannot
commence production of generic ARVs at its Nairobi facility to, among
others, satisfy an order placed by the Ministry of Health last November.

Both the Minister of Trade and Industry Mukhisa Kituyi and his permanent
secretary Alex Keter were last week unavailable for comment.

The ministry's delay to issue the license, coupled with problems with other
components of the AIDS drugs tender, have contributed to a three-month delay
in the commencement of the government's treatment initiative.

The order by the health ministry for the ARVs was made through the
procurement firm Crown Agents as part of a $1 million AIDS medicine tender
to kickstart Kenya's first public hospital-based HIV/AIDS treatment
initiative.

Through the initiative, which was expected to commence last November, the
government hopes to treat 3,000 HIV-positive people in public hospitals at
the subsidised cost of Ksh 1,500 ($20) per month.  Cosmos won a component of
the tender to supply the drugs lamivudine, stavudine and nevirapine in
15-days and one-month patient packs.

Last week, Dr Prakash Patel, the managing director of Cosmos, said that the
compulsory licence was the only hindrance to the company's production of the
drugs, as well as other brands of generic ARVs.

"It is important that we get the compulsory licence to shorten the supply
chain for ARVs from the manufacturer to the user by building local
capacity," Dr Patel said.  "We are not sure why the delay has occurred, but
we look forward to the Ministry of Trade giving us the licence soon."

If given the compulsory license, Cosmos will become the first generic drug
maker in sub-Saharan Africa outside South Africa to commence commercial
production of ARVs.  Several other Kenyan companies, including Laboratory
and Allied, which have also expressed an intention to manufacture the drugs,
are expected to follow suit.

Compulsory licenses are provided for in the World Trade Organisation's
treaty on intellectual property, TRIPS, to enable countries facing a medical
crisis to circumvent patents to produce life-saving drugs.

Also provided for in the WTO treaty is a provision known as parallel
importation, which allows countries facing a medical emergency to source for
drugs anywhere in the world irrespective of patent protection.  Last week, a
tender for the supply of AIDS drugs awarded to two Indian generic drug
manufacturers was cancelled, further delaying the roll-out of the government
treatment programme.

The EastAfrican reported last week that several unsuccessful companies in
the said bid had complained to the Ministry of Health over its award to the
two Indian companies, Ranbaxy and Emcure.  The $2 million tender was
cancelled.

Emcure had been awarded the first part of the tender to supply 57,600 doses
of a drugs combination comprising of the ARVs stavudine, lamivudine and
nevirapine, which will comprise the second line of treatment to treat AIDS
patients also on treatment for tuberculosis.

According to sources in the ministry, also cancelled was a tender worth at
least $1 million to supply viral load machines, used to check the amount of
HIV in the bloodstream, to several government hospitals earmarked for the
treatment programme.

Cancellation of the tenders now means that the earliest the much-heralded
government treatment programme can start is in May.