[Ip-health] MSF statement on biologics language in domestic health care bill

[Emi Maclean]

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Please see below a statement that MSF released this week regarding the=0D
biologics language in the domestic health care bill.=0D
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Provisions in U.S. Domestic Health Care Legislation Could Limit Access to=
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Vaccines and New Class of Drugs=0D
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New York, January 12, 2010=0D
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The international medical humanitarian organization M=C3=A9decins Sans=0D
Fronti=C3=A8res (MSF)=0D
is concerned that a little-discussed provision in the proposed U.S.=0D
domestic health care=0D
legislation sets data exclusivity standards for biologics that will=0D
further hamper access to vaccines and drugs, in addition to setting a=0D
dangerous worldwide precedent.=0D
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The proposed legislation would provide extended monopoly protections for=0D
biologics, a group of therapeutic products that hold great promise for=0D
the future and that include vaccines and medicines created by biological=0D
rather than chemical processes. This would allow originator companies to=0D
extend existing barriers to competition, preventing the development of=0D
similar but more affordable products by other manufacturers.=0D
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Experience from AIDS medicines has shown how critical competition is to=0D
reducing prices and improving access. Thanks to generic competition, the=0D
most commonly used combination of AIDS drugs used in developing=0D
countries now costs US$80 per patient per year =E2=80=93 99% less than ten =
years=0D
ago (see: Untangling the Web of Antiretroviral Price Reductions =E2=80=93 1=
2th=0D
edition =E2=80=93 January 2010 =E2=80=93 http://utw.msfaccess.org)=0D
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Drug regulatory authorities rely on the test data of the originator drug=0D
or vaccine for the approval of similar products. This has allowed more=0D
rapid entry of competitor products into the market =E2=80=93 without=0D
compromising on safety, efficacy, or quality. Yet extremely restrictive=0D
provisions in the proposed U.S. legislation include 12-14 years of data=0D
exclusivity for biologics, and provisions that would allow companies to=0D
further extend this period almost indefinitely, by making trivial=0D
modifications to medicines.=0D
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During the data exclusivity period, if another company wants to register=0D
a similar version of a drug or a vaccine, it has to generate and submit=0D
its own test data. The associated cost and time delays act as a strong=0D
disincentive to price-lowering competition. Data exclusivity therefore=0D
creates a new patent-like barrier to access to medicines and vaccines,=0D
even when these products are not protected by a patent.=0D
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As data exclusivity rules can lead to duplicating clinical trials,=0D
humans are subjected to risks in order to establish something that is=0D
already known. This violates the Declaration of Helsinki on Ethical=0D
Principles for Medical Research Involving Human subjects.=0D
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The proposed legislation needs urgent revision.=0D
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MSF is also concerned that increasingly stringent data exclusivity rules=0D
in the U.S. will be used to further increase existing pressure on=0D
developing countries, through free trade agreements and by=0D
pharmaceutical companies, to either adopt data exclusivity rules or=0D
extend data exclusivity periods in countries where these have already=0D
been adopted.=0D
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Crucially, there is no obligation in the World Trade Organization TRIPS=0D
Agreement for countries to provide this protection. Developing countries=0D
should remain vigilant about attempts to introduce data exclusivity=0D
rules or extend existing rules during bilateral free trade agreement=0D
negotiations or under pharmaceutical industry pressure.=0D
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