E-drug: NIH Director, Harold Varmus
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[Khalil Elouardighi of Act Up - Paris suggests there are some questions
that could be put to Mr Varmus in response to his letter that was
circulated last week. BS]
Mr Varmus,
Considering the degree of urgency of the AIDS crisis in developing
countries, you will certainly allow us to question you regarding some
controversial points in your letter to Mr Weissman, in which you decline to
promote the granting by the NIH to the WHO of standing authiority to
contract for the production of USG-supported inventions for patients in
developing countries.
You wrote :
This proposal, if implemented, would have powerful repercussions on the
current framework for drug development arising from federally supported
basic research.
Please offer a detailed rationale for this statement.
You wrote :
The question of the supply of drug products must be considered in the
context of the equally important issues of medical infrastructure, public
health programs, treatment monitoring and compliance, and emergence of
drug-resistant HIV strains. Unilateral action by NIH with regard to
NIH-supported patent rights would consequently be ill-advised and unlikely
to succeed.
Do you contend, in the face of the astounding scale of the AIDS crisis
in developing countries, that limited public health concerns must tackle
each issue equally and at the same time ?
Postulating that one has to start somewhere, do you challenge the
assessment by an overwhelmingly majority of patients and public health
workers in developing countries that financial access is the most urgent
obstacle to overcome ?
Please clarify the NIH position on these points.
You wrote :
Many of these countries can issue compulsory licenses, and those that
have not enacted that authority to date can do so if they choose. The
economies of scale you [Mr Weissman] mention could be achieved by
cooperation among these countries or direct interaction with WHO.
Considering the long-standing bad faith of US Trade Representatives
regarding the legality of actual resort to compulsory licensing by
developing countries, right now many concerned governments see
compulsory licensing as a legal and diplomatic hazard - which they
cannot risk. Thus, compulsory licensing cannot be a solution for all
AIDS-ridden countries, which will further impede economies of scale.
Granting WHO standing authority to contract would circumvent these legal
and economic obstacles to a response to the AIDS crisis.
More importantly, in most countries where the AIDS crisis is at its worst,
public health institutions are grossly and famously deficient. As a person
involved with public health, can you deny that in such situations WHO is
far better suited to address new drug production needs on time for patients
to survive ?
You wrote :
In those countries where NIH or its grantees have neither sought nor
obtained patent protection, NIH has no intellectual property rights to
be licensed or otherwise granted.=20
Could the NIH accept from a licensee that it claim ownership of the NIH
invention abroad (only to grossly overprice the product) ?
Because it is the rule rather than the exception that multiple patents
cover final drug products, NIH's granting of rights to the early compound
or invention would be unlikely to significantly improve access to drugs.
Certainly, not all patents to cover a final product are equal in the face
of drug production requirements. Do you challenge the experience by the
generics industry in developed countries that rights to the molecule only
can often be enough to allow legal manufacturing of an alternative product,
despite multiple patent use in original product
As a practical matter, it is reasonable to assume that companies will
not undertake the development costs of these inventions if they believe the
Government will readily allow third parties to practice the
inventions.
Please clarify how it is reasonable to think that allowing the WHO to
practice inventions in countries where licenses are virtually not worked
(Africa accounts for 1.3% of world pharmaceuticals sales) can adversely
impact companies' bottom-lines, which is the industry's only rational
concern.
Critical to successful technology transfer is the assurance that the
Government will exercise its intellectual property rights in a responsible,
prudent, and consistent manner. Undermining licensed intellectual
property rights would, I believe, unnecessarily jeopardize
the development of important therapeutic drugs.
No one so far has succeeded in proposing a sound rationale to support the
notion that 'undermining intellectual property rights' in virtually
patent-unworked territories could possibly 'jeopardize the development of
important therapeutic drugs'. Please substanciate your belief.
Thank you for clarifying your position on this issue.
Khalil Elouardighi,
Act Up-Paris.
gerrold@wanadoo.fr
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