[Ip-health] Essential Action Statement on IGWG

[Sarah Rimmington]

Essential Action Comment on the negotiations of the World Health
Organization's Intergovernmental Working Group on Public Health,
Innovation and Intellectual Property (IGWG)

April 2008

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The great promise of the IGWG exercise is that it will be innovative in
its own right -- that country negotiators will leave ideological
predispositions aside, and advance experiments with new institutional
arrangements to promote the complementary public health objectives of
innovation and access. The country negotiators have it in their power to
realize this promise.

Essential Action encourages IGWG negotiators to support systemic
approaches to support R&D that do not rely on patent monopolies or the
prospect of charging high drug prices as a reward, and mechanisms to
make the fruits of R&D widely accessible. We encourage negotiators to
achieve consensus around the Bolivia/Barbados prize fund proposals, and
other concrete, common-sense measures to promote innovation and access.
These include a global patent database covering medical technology,
improved medicine registration systems, patent pools, and mechanisms to
spur generic competition for biologics and vaccines.
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Medical research and development breakthroughs have made the world a
better and healthier place. Vaccines, antibiotics and drugs for HIV/AIDS
have kept countless millions alive and reduced untold suffering.

The world -- and especially developing countries -- needs more
innovation. To have public health benefit, however, the fruits of the
innovative process must be available to people who need them.

The current patent monopoly-based system of R&D has proven inefficient
at advancing a needs-driven public health agenda. This is true for rich
countries as well as poor, though the situation is much worse in poor
countries.

Whether the system works for rich countries is controversial, although
our view is that the evidence is overwhelming that it does not.

But if ideology and industry defensiveness are set aside, there is
really no debate about the failure of the patent monopoly-based system
of R&D for developing countries. This was a key message of the
Commission on Intellectual Property, Innovation and Public Health. The
current corporate sector system of R&D is driven by the prize offering
of a patent monopoly. That prize is not worth much if it offers a
monopoly on sales to a population that -- no matter how large -- has
little buying power. And if the prize incentive is too small, it will
not induce R&D, no matter how much it may be needed as a public health
matter. This has nothing to do with the ethics of Big Pharma. It is how
the system is designed.

The value of the patent monopoly is based on the holder using it to
profit maximize as a monopolist. It is therefore no surprise that
companies holding patent monopolies charge high prices. This is what the
patent enables. High prices are an increasing problem in rich countries,
but the brand-name pharmaceutical industry's current pricing model --
which commonly runs into the thousands of dollars a year for a single
medicine, and may involve charges of over $100,000 -- leaves new
medicines completely out of reach of the vast majority in developing
countries.

Apart from ignoring these realities, there are two basic alternative
responses. One is to rely on charity. Private foundations and companies
seeking good will may contribute to R&D for products targeting diseases
in developing countries, or modifications to existing treatments
designed to meet developing countries' particular needs. They may offer
discounted versions of their drugs, or give some away. Charitable
initiatives may accomplish quite a bit, but in general they suffer from
being ad hoc, unsustainable, erratic, episodic, short-lived and
insufficiently resourced. Charity may be helpful, but it is no solution
to meeting public health priorities on a sustained basis.

The second option is to examine systemic approaches to support R&D that
do not rely on patent monopolies or the prospect of charging high drug
prices as a reward, and mechanisms to make the fruits of R&D widely
accessible.

Bolivia and Barbados have put forward a series of concrete proposals for
prizes to incentivize R&D, with the resulting fruits of the innovation
made available at competitive prices. These are simple and compelling
proposals. Will they work in creating innovation where now there is none
or much too little? There is no guarantee. The prospect of huge riches
for breakthrough cancer or Alzheimer's treatments, to take just two
examples, has with few exceptions not succeeded in generating important
innovations. Sometimes the scientific problems cannot easily be overcome
even with large investments. But incentives do matter, and the prizes
included in the Bolivia/Barbados proposals, if adopted, may lead to
life-saving innovations. It is also worth noting that they have an
additional advantage over the existing patent monopoly-based system:
they would encourage open research and sharing of information.

Apart from the funds involved -- which are not especially large in
development aid terms, and could make existing aid programs much more
efficient, were new products to emerge from the prize systems -- what
possible reason is there, on the merits, not to adopt these proposals?
What conceivable rationale, on the merits, is there for opposing ongoing
discussion of these ideas, as Bolivia and Barbados propose? Those with
an ideological commitment to maintaining patent monopolies, at the
expense of public health, should recuse themselves from participating in
the debate.

There is a long list of common-sense proposals on the IGWG agenda. Along
with efforts to achieve consensus on broad principles, hopefully the
final IGWG negotiation will reach agreement on several specific,
concrete measures, or at least resolve to further investigate specific
proposals. In addition to the Bolivia/Brazil prize fund proposals, these
should include creation of a publicly accessible, global patent database
covering medical technology; mechanisms, perhaps building on WHO's
pre-qualification program, for expedited registration of new medicines,
taking into account the potential perils of harmonized standards, and
seeking to address the problem of firms' refusing to register drugs out
of retaliatory animus; and ongoing discussion of patent pool proposals,
including the very attractive Bolivia/Barbados proposal. Attention
should also be paid to creating competitive, generic markets for
biologics and vaccines, including through the Bolivia/Barbados proposal
on cancer treatments.

The great promise of the IGWG exercise is that it will be innovative in
its own right -- that country negotiators will leave ideological
predispositions aside, and advance experiments with new institutional
arrangements to promote the complementary public health objectives of
innovation and access. The country negotiators have it in their power to
realize this promise.

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For More Information, contact:

Sarah Rimmington, (Geneva, week of April 28, 2008 only)
(+41)(0)76-269-2246, srimmington@essentialinformation.org

Robert Weissman, (Washington, DC) (+1) 202-387-8030, rob@essential.org

Essential Action
PO Box 19405
Washington, DC 20036
www.essentialaction.org/access

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Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/