E-DRUG: IFPMA reaction to R&D Treaty proposal
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dear E-druggers,
Below is the Scrip story on the IFPMA reaction of the Medical R&D
Treaty. I will comment on the statement in the Scrip story that
"intellectual property rights, particularly those based on open-access
research would be restricted." It is true that the treaty proposes a
mechanisms to deal with problems of patents on data from open public
databases, like the HapMap project, or calls for governments to support
open access research archives. However, I also note that the US/NIH has
already supported such restrictions in important areas. The Treaty
provisions on the research exceptions are also in tune with best
practices in Europe and the United States. In general, the Treaty gives
countries great flexibility experiment with intellectual property
regimes, including the patent system (TRIPS-Plus if they want). But it
does not rely *entirely* on the patent system, as does the TRIPS, to
provide a global framework for Medical R&D, nor does it force countries
to use a particular IP regime, as do TRIPS or TRIPS-Plus trade agreements.
I'm not sure of the source of Harvey Bale's assertion that "90% of
medicines on the WHO's essential drug list were developed by industry
under a patent system," or what that actually means. For cancer drugs,
up to 1996, 50 of 77 new cancer agents registered for sale in the US
were approved on the basis of US government funded clinical trials,
according to the NIH (the Wittes study,
http://www.cptech.org/ip/health/econ/ncirole.html). The US government
role in AIDS, Malaria, etc are well known, but maybe less so the
importance of NIH research for drugs for glaucoma, diabetes, and many
other illnesses. Consider, for example, the this May 17, 2000 report of
the Joint Economic Committeeon "The Benefits of Medical Research and the
Role of NIH,"
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A study of the 21 drugs introduced between 1965 and 1992 that were
considered by experts to have had the highest therapeutic impact on
society found that public funding of research was instrumental in the
development of 15 of the 21 drugs (71 percent). Three-captopril
(Capoten), fluoxetine (Prozac), and acyclovir (Zovirax)-had more than $1
billion in sales in 1994 and 1995. In addition to these drugs, other
members of the group of 21 drugs, including AZT, acyclovir, fluconazole
(Diflucan), foscarnet (Foscavir), and ketoconazole (Nizoral), had NIH
funding and research to help in clinical trials.
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This does not mean that patent incentives did not play an important role
also. They did. So an interesting question for Harvey Bale would be:
where would the world be without *any* public sector medical R&D? I
don't think anyone is proposing a world with zero public sector funding
or zero intellectual property funding, and I also don't think innovative
funding mechanisms (like HR 417, the Medical Innovation Prize Fund) are
attacks on the patent system, but rather new (and better) way for
remunerating patent owners (than exclusive rights on medicines), often
addressing gaps or inefficienies in the current (very expensive, and
some say only marginally productive for the money spent) system.
Jamie
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SCRIP NEWS, 3/11/2005 - The international pharmaceutical industry
federation, the IFPMA, has rejected the idea of a treaty on R&D, which
wants to see less focus on patents for stimulating research for new
medicines, especially for neglected diseases.
The treaty was submitted by activists, scientists and politicians to the
World Health Organisation for consideration last week. Some of the
signatories included the US-based Consumer Project on Technology, Oxfam,
South Africa's AIDS NGO, the Treatment Action Campaign, and France's
SIDACTION.
James Love of CP Tech, who is taking the lead on the treaty, says it
addresses major trade issues concerning pharmaceuticals, providing an
alternative system to the World Trade Organisation's TRIPS agreement and
various TRIPS-plus trade agreements on intellectual property and drug
prices.
Countries would have obligations to support R&D, with incentives for
research into areas such as neglected disease therapies, while
intellectual property rights, particularly those based on open-access
research would be restricted.
The treaty proposes a system for assigning tradable "Kyoto-style"
credits to countries, companies and researchers for projects that are
considered socially important.
The credits would be given to a variety of projects including R&D into
neglected diseases, open public goods, such as free and open public
databases, projects that involve the transfer of technology to
developing countries and preservation and dissemination of traditional
medial knowledge.
However, Dr Harvey Bale, director general of the IFPMA, told Scrip that
the proposal attacked the patent system under the "cover of an R&D treaty".
He said there was no need for such a treaty and research could be
boosted if there were R&D tax credits for companies or for example,
European countries ratified the biotech Directive.
90% of medicines on the WHO's essential drug list were developed by
industry under a patent system, he stated. "The patent system is working
to develop critically needed medicines for the developing world.".
He questioned the motives of some of signatories to the treaty, claiming
that some of them were "purely anti-innovation" activists. Who would
make the decision whether a disease was considered "socially important"
and why set up an unworkable system that will probably collapse? he asked.
SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 4 March 2005