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[e-drug] MSF response to GSK announcement

E-DRUG: MSF response to GSK announcement
----------------------------------------

Dear all

Please find below the statement by Michelle Childs, Director of Policy and
Advocacy at MSF's Access Campaign, in response to GSK CEO Witty's address
at Harvard.

Press contacts are at the foot of the email.

Thanks
James
---------------------------

Statement by Michelle Childs,
Director of Policy and Advocacy, Campaign for Access to Essential
Medicines, Medecins Sans Frontieres
in response to the speech by Andrew Witty, CEO, GlaxoSmithKline (GSK) at
Harvard Medical School

Geneva, 16 February 2009

A welcome first step - but HIV is also a neglected disease

Medecins Sans Frontieres welcomes Mr. Witty's recognition that patents act
as a barrier to research and development and that patent pools offer new
ways to stimulate research into neglected diseases.  Promises now need to
be turned into action. The terms of any licences attached to the patent
pool will be critical and more detail is needed. Funding sources also need
to be identified to develop any products that result from this research.

MSF calls on all other pharmaceutical companies to lift patent barriers and
make their molecule compounds and process available to help develop
treatments for neglected diseases and open up their compound libraries to
researchers.

But GSK must extend this thinking to include HIV: HIV is also a neglected
disease. Mr. Witty claims that a patent pool is meant to focus on diseases with 
a severe lack of treatments and that there is sufficient innovation for HIV.

He is wrong. In the field of HIV/AIDS treatment, the gap between what is
needed and what is available is large. A patent pool can help address that
gap and encourage innovation in areas where it's not happening today.
- We need new fixed-dose combinations: We desperately need new
fixed-dose combination drugs that combine multiple compounds into one pill,
especially those including newer drugs. But today, patents on individual
compounds can stand in the way of the development of fixed-dose
combinations.
- We need new paediatric formulations and accelerated paediatric
studies. With 90% of HIV-positive children living in sub-Saharan Africa,
paediatric formulations are not a priority for pharmaceutical companies: of
the 22 antiretrovirals approved by the U.S. Food and Drug Administration,
eight are not approved for use in children and nine do not come in any kind
of paediatric formulations.  And when versions for children do exist, they
are often not adapted for use in resource-limited settings (e.g. they need
refrigeration or access to safe drinking water or are difficult for
caregivers to administer in correct doses). Generic companies have
expressed the interest and will to develop AIDS medicines in tablet
formulations more suitable for children. But again patent barriers can
currently prevent them from doing so, particularly for newer drugs.

Innovation is meaningless if there is no access.
Research alone will not ensure that people living in poor countries will
receive new treatments. In order to ensure access to the fruits of
innovation, the resulting products must be affordable.   Yet MSF, along
with others providing HIV/AIDS treatment in developing countries, continues
to struggle with the affordability of antiretrovirals.

Mr. Witty's prescription is to offer discounts of at least 75% on drug
prices. While any lowering of prices is welcome, this is by no means a
panacea.  Experience has shown that competition among multiple generic
producers is the tried and tested way to drive prices down -by between 95
and 98% since 2000 for the first generation of antiretrovirals.

The limitations of company discounts are particularly evident when they are
restricted to least-developed countries only, and exclude middle-income
countries - countries such as China, where in the absence of competition
GSK charges over US$3,000 for the antiretroviral lamivudine; or Thailand,
where Abbott refused to drop the price of heat-stable lopinavir/ritonavir,
and it is only after the country issued a compulsory licence that the price
fell from close to $3000 to around $500 today.

MSF is thus concerned to see that Mr. Witty appears to be separating out
middle-income countries, offering little more than a promise of ill-defined
pricing flexibility for these countries.

The price crisis in AIDS medicines is set to return.
Yet as more and more newer drugs are being patented in key generic
producing countries, generic competition will no longer be able to act as
the catalyst for price reductions as it did in the recent past.

HIV/AIDS is a disease that requires life-long treatment and people need
access to newer more potent, and less toxic drugs when they experience side
effects, or when they develop drug resistance.

The improved WHO-recommended regimen for first-line AIDS treatment costs,
at best, between $613 and $1,033 using originator products. This is a seven
to twelve-fold increase compared to older first-line treatments - which
thanks to the effects of generic competition, are now available for $87 for
one patient's yearly treatment.   For second-line treatments, the prices
are, at best, up to 17 times more expensive, in countries that cannot
access generic versions because of patent protection.

New ways to keep medicines affordable must thus be set in motion. Increased
competition is the best way to do that.  This can either happen through
compulsory licences, by countries following Thailand-s lead.  Or it can
happen without the need for confrontation and litigation, through a patent
pool, such as the recent proposal by the drug purchasing facility UNITAID
to establish a voluntary patent pool for HIV medicines for use in lower and
middle income countries.

MSF calls on GSK to collaborate with the UNITAID and make relevant
intellectual property available through a voluntary patent pool for AIDS
medicines.

For press enquiries please contact Guillaume Bonnet, MSF Press Officer on
+41 79 203 13 02

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