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

[Malini Aisola]

Emi Maclean has requested me to share this statement that MSF released
yesterday regarding the biologics language in the domestic health care
bill.

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Provisions in U.S. Domestic Health Care Legislation Could Limit Access
to Vaccines and New Class of Drugs

New York, January 12, 2010

The international medical humanitarian organization Doctors Without
Borders/M=C3=A9decins Sans Fronti=C3=A8res (MSF) is concerned that a
little-discussed provision in the proposed U.S. domestic health care
legislation sets data exclusivity standards for biologics that will
further hamper access to vaccines and drugs, in addition to setting a
dangerous worldwide precedent.

The proposed legislation would provide extended monopoly protections for
biologics, a group of therapeutic products that hold great promise for
the future and that include vaccines and medicines created by biological
rather than chemical processes. This would allow originator companies to
extend existing barriers to competition, preventing the development of
similar but more affordable products by other manufacturers.

Experience from AIDS medicines has shown how critical competition is to
reducing prices and improving access. Thanks to generic competition, the
most commonly used combination of AIDS drugs used in developing
countries now costs US$80 per patient per year =E2=80=93 99% less than ten =
years
ago (see: Untangling the Web of Antiretroviral Price Reductions =E2=80=93 1=
2th
edition =E2=80=93 January 2010 =E2=80=93 http://utw.msfaccess.org)

Drug regulatory authorities rely on the test data of the originator drug
or vaccine for the approval of similar products. This has allowed more
rapid entry of competitor products into the market =E2=80=93 without
compromising on safety, efficacy, or quality. Yet extremely restrictive
provisions in the proposed U.S. legislation include 12-14 years of data
exclusivity for biologics, and provisions that would allow companies to
further extend this period almost indefinitely, by making trivial
modifications to medicines.

During the data exclusivity period, if another company wants to register
a similar version of a drug or a vaccine, it has to generate and submit
its own test data. The associated cost and time delays act as a strong
disincentive to price-lowering competition. Data exclusivity therefore
creates a new patent-like barrier to access to medicines and vaccines,
even when these products are not protected by a patent.

As data exclusivity rules can lead to duplicating clinical trials,
humans are subjected to risks in order to establish something that is
already known. This violates the Declaration of Helsinki on Ethical
Principles for Medical Research Involving Human subjects.

The proposed legislation needs urgent revision.

MSF is also concerned that increasingly stringent data exclusivity rules
in the U.S. will be used to further increase existing pressure on
developing countries, through free trade agreements and by
pharmaceutical companies, to either adopt data exclusivity rules or
extend data exclusivity periods in countries where these have already
been adopted.

Crucially, there is no obligation in the World Trade Organization TRIPS
Agreement for countries to provide this protection. Developing countries
should remain vigilant about attempts to introduce data exclusivity
rules or extend existing rules during bilateral free trade agreement
negotiations or under pharmaceutical industry pressure.



--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673