E-DRUG: Health GAP Comments on IGWG
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To Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG)
Health GAP (Global Access Project) supports efforts in the IGWG to find new
solutions to the challenge of ensuring both innovation and access for new
medicines, microbicides, diagnostic tests, and vaccines needed to respond
to the HIV/AIDS crisis and to other pressing public health needs in
developing countries.
As AIDS activists, we have long opposed excessive pricing and restricted
supplies that are endemic in a patent-based system. This regime has
literally killed millions of people with HIV in developing countries for
the simple reason that neither they nor their governments could afford
medicines and because high prices deterred intervention by bilateral and
multilateral donors.
Likewise, while opposing the imposition of the TRIPS regime on developing
countries, we have fought against any and all efforts to deny developing
countries the right to use TRIPS flexibilities to the fullest to advance
the cause of access to medicine for all. Thus, we urge the delegates to
find a way to ensure that every paragraph of the 2001 Doha Declaration on
TRIPS and Public Health is actually implemented and that no TRIPS-plus
measures are adopted as part of the negotiations. We also urge the
delegates to decry the negotiation of trade agreements with TRIPS-plus
provisions or the utilization of bilateral trade pressures and threats to
extort the same.
It is certain that people with HIV, and that global health in general, will
benefit from and depend upon the development of new medicines,
microbicides, diagnostic tests, and vaccines. In this respect, there are
good ways and bad ways to finance new drug development. A completely
unacceptable way is to rely upon 20-year (or longer) patent-based
monopolies, data-related barriers to registration, and high prices
affordable to only a few, as the sole drivers for R&D for medicines
addressing pressing public health needs.
We have to find ways that de-link R&D investment decisions from drug prices
affordable only to the rich in upper, middle, and lower income countries,
and which are consistent with the widest possible access to new drugs. We
have to find ways to target innovation efforts towards therapeutic need,
including the on-going need for new more tolerable, durable, and effective
treatments for HIV/AIDS and for new prevention technologies. And to ensure
access for all, we have to incentivize a competitive generic market for the
production and sale of new as well as very old medicines.
Fortunately, there are many promising proposals in the IGWG process to do
just that. For example, the proposal from India for a global research fund
for global health problems is one such measure, so long as this is
implemented in a way that is consistent with robust competition and open
licensing of products, so that the poor benefit to the maximum extent
possible.
In addition to the important role of up-front government and foundation
grants in funding research, many countries have proposed the use of prizes
to simulate R&D. The most concrete of these proposals are the five
proposals for prizes by Barbados and Bolivia. Each of these proposals
appears to have much merit, not only because they speed innovation through
open-source collaboration, but also because they promote R&D targeted at
therapeutic priorities. In addition, the request by Barbados and Bolivia
for a meeting on the prize proposals in early 2009 seems achievable, and
would be a strong expression of support for finding new ways to think about
stimulating R&D while protecting access to eventual innovations.
Lastly, we urge IGWG to turn its attention to ways to ensure more rapid and
coordinated registration of new medicines in developing countries.
Processes like the WHO Prequalification Programme are promising, but in
general it is simply unacceptable that the registration of medicines is
left to the cold calculations of profit alone whether by the R&D-based or
generic industry. It is particularly outrageous that pharmaceutical
companies are currently permitted to withdraw or delay registration
applications or withdraw products because a country lawfully uses
TRIPS-compliant flexibilities. Although we are wary of registration
harmonization at too high a standard, we urge the IGWG to consider multiple
alternatives for incentivizing and speeding up the registration process for
essential new medicines, not only for HIV/AIDS but for all diseases.
Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)
E-mail: B.Baker@neu.edu