[Ip-health] The Lancet: Abbott accused of refusing access to HIV drug

[Sheila.SHETTLE@geneva.msf.org]

Lancet Infectious Diseases, Current Issue, Volume 6, Number 9, September

Abbott accused of refusing access to HIV drug

Khabir Ahmad

International charity, M=E9decins Sans Fronti=E8res (MSF), has accused
pharmaceutical company Abbott of denying access to its tablet formulation
of
Kaletra (lopinavir/ritonavir) in Thailand and other developing countries.

=B3Despite repeated calls from MSF, many HIV experts and patient
representatives from 18 different groups, the company has no plans to make
the new version available in the country,=B2 MSF's spokesperson, Nathan For=
d,
explained. MSF complains that Abbott's response has been that Thailand can
make do with the old version that costs over US$3000 per patient per year,
an amount more than double the average annual wage of an office worker, and
well beyond the reach of most people with HIV/AIDS in Thailand.

=B3This is a clear example of why monopolies on medicines are dangerous, an=
d
why we need checks and balances. A single company should not be in a
position to decide who gets what drug when,=B2 Ford said.

The tablet form of protease inhibitor lopinavir/ritonavir needs no
refrigeration and can be stored at temperatures of up to 30=B0C, fewer pill=
s
are required per day, and can be taken with or without food. By contrast,
its old version Kaletra capsules did not offer these benefits and it was
almost impossible to use them in many resource-limited settings with hot
climates. Jiraporn Limpananont (Chulalongkorn University, Bangkok,
Thailand)
believes that the need for the new version in Thailand is very obvious: the
average temperature in the country is about 30=B0C and poor compliance to
antiretroviral is a big problem. =B3So any refusal to register this version
in
Thailand must be condemned as a serious violation of human right to
health,=B2
she noted.

According to Limpananont, if Abbott cannot introduce the drug in the Thai
market, it will automatically lose market exclusivity on this drug. =B3So i=
n
this case I urge the Royal Thai Government to withdraw the patent and
market
exclusivity right on this drug,=B2 she concluded.

But Abbott's spokesperson, Jennifer Smoter, dismissed accusations by MSF
and
others as =B3completely false=B2. =B3We are registering the tablet formulat=
ion of
Kaletra in China, Thailand, and Guatemala very soon. But in order to be
able
to register, we are waiting for a Certificate of Pharmaceutical Product
(CPP) that must be issued from Europe,=B2 she said. MSF disagrees,
maintaining
that under WHO guidelines the CPP needs to be issued by the exporting
country. If Abbott wants to export this product from the USA, the CPP could
be issued by the US Food and Drug Administration, it said.