[Ip-health] MSF response to GSK announcement

[James ARKINSTALL]

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Dear all=0D
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Please find below the statement by Michelle Childs, Director of Policy and=
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Advocacy at MSF's Access Campaign, in response to GSK CEO Witty's address=
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at Harvard.=0D
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Press contacts are at the foot of the email.=0D
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Thanks=0D
James=0D
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Statement by Michelle Childs,=0D
Director of Policy and Advocacy, Campaign for Access to Essential=0D
Medicines, M=C3=A9decins Sans Fronti=C3=A8res=0D
in response to the speech by Andrew Witty, CEO, GlaxoSmithKline (GSK) at=0D
Harvard Medical School=0D
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Geneva, 16 February 2009=0D
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A welcome first step - but HIV is also a neglected disease=0D
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M=C3=A9decins Sans Fronti=C3=A8res welcomes Mr. Witty=E2=80=99s recognition=
 that patents act=0D
as a barrier to research and development and that patent pools offer new=0D
ways to stimulate research into neglected diseases. Promises now need to be=
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turned into action. The terms of any licences attached to the patent pool=
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will be critical and more detail is needed. Funding sources also need to be=
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identified to develop any products that result from this research.=0D
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MSF calls on all other pharmaceutical companies to lift patent barriers and=
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make their molecule compounds and process available to help develop=0D
treatments for neglected diseases and open up their compound libraries to=
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researchers.=0D
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But GSK must extend this thinking to include HIV: HIV is also a neglected=
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disease=0D
Mr. Witty claims that a patent pool is meant to focus on diseases with a=0D
severe lack of treatments and that there is sufficient innovation for HIV.=
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He is wrong. In the field of HIV/AIDS treatment, the gap between what is=0D
needed and what is available is large. A patent pool can help address that=
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gap and encourage innovation in areas where it=E2=80=99s not happening toda=
y.=0D
=C2=A7 We need new fixed-dose combinations: We desperately need new fixed-d=
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combination drugs that combine multiple compounds into one pill, especially=
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those including newer drugs. But today, patents on individual compounds can=
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stand in the way of the development of fixed-dose combinations.=0D
=C2=A7 We need new paediatric formulations and accelerated paediatric studi=
es.=0D
With 90% of HIV-positive children living in sub-Saharan Africa, paediatric=
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formulations are not a priority for pharmaceutical companies: of the 22=0D
antiretrovirals approved by the U.S. Food and Drug Administration, eight=0D
are not approved for use in children and nine do not come in any kind of=0D
paediatric formulations. And when versions for children do exist, they are=
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often not adapted for use in resource-limited settings (e.g. they need=0D
refrigeration or access to safe drinking water or are difficult for=0D
caregivers to administer in correct doses). Generic companies have=0D
expressed the interest and will to develop AIDS medicines in tablet=0D
formulations more suitable for children. But again patent barriers can=0D
currently prevent them from doing so, particularly for newer drugs.=0D
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Innovation is meaningless if there is no access.=0D
Research alone will not ensure that people living in poor countries will=0D
receive new treatments. In order to ensure access to the fruits of=0D
innovation, the resulting products must be affordable. Yet MSF, along with=
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others providing HIV/AIDS treatment in developing countries, continues to=
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struggle with the affordability of antiretrovirals.=0D
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Mr. Witty=E2=80=99s prescription is to offer discounts of at least 75% on d=
rug=0D
prices. While any lowering of prices is welcome, this is by no means a=0D
panacea. Experience has shown that competition among multiple generic=0D
producers is the tried and tested way to drive prices down -by between 95=
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and 98% since 2000 for the first generation of antiretrovirals.=0D
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The limitations of company discounts are particularly evident when they are=
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restricted to least-developed countries only, and exclude middle-income=0D
countries =E2=80=93 countries such as China, where in the absence of compet=
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GSK charges over US$3,000 for the antiretroviral lamivudine; or Thailand,=
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where Abbott refused to drop the price of heat-stable lopinavir/ritonavir,=
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and it is only after the country issued a compulsory licence that the price=
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fell from close to $3000 to around $500 today.=0D
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MSF is thus concerned to see that Mr. Witty appears to be separating out=0D
middle-income countries, offering little more than a promise of ill-defined=
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pricing flexibility for these countries.=0D
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The price crisis in AIDS medicines is set to return.=0D
Yet as more and more newer drugs are being patented in key generic=0D
producing countries, generic competition will no longer be able to act as=
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the catalyst for price reductions as it did in the recent past.=0D
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HIV/AIDS is a disease that requires life-long treatment and people need=0D
access to newer more potent, and less toxic drugs when they experience side=
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effects, or when they develop drug resistance.=0D
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The improved WHO-recommended regimen for first-line AIDS treatment costs,=
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at best, between $613 and $1,033 using originator products. This is a seven=
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to twelve-fold increase compared to older first-line treatments - which=0D
thanks to the effects of generic competition, are now available for $87 for=
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one patient=E2=80=99s yearly treatment. For second-line treatments, the pri=
ces are,=0D
at best, up to 17 times more expensive, in countries that cannot access=0D
generic versions because of patent protection.=0D
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New ways to keep medicines affordable must thus be set in motion. Increased=
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competition is the best way to do that. This can either happen through=0D
compulsory licences, by countries following Thailand=E2=80=99s lead. Or it =
can=0D
happen without the need for confrontation and litigation, through a patent=
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pool, such as the recent proposal by the drug purchasing facility UNITAID=
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to establish a voluntary patent pool for HIV medicines for use in lower and=
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middle income countries.=0D
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MSF calls on GSK to collaborate with the UNITAID and make relevant=0D
intellectual property available through a voluntary patent pool for AIDS=0D
medicines.=0D
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For press enquiries please contact Guillaume Bonnet, MSF Press Officer on=
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+41 79 203 13 02