E-DRUG: WHO on Intellectual property rights, innovation and public health
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[The WHO Assembly meets this week in Geneva. One of the issues raised is
about intellectual property rights and innovation. The report was requested
by the Executive Board. Below a critical review of the report, which is
available at http://www.who.int/gb/EB_WHA/PDF/WHA56/ea5617.pdf
The comments below are crossposted from IP-Health with thanks. WB]
WORLD HEALTH ORGANIZATION
FIFTY-SIXTH WORLD HEALTH ASSEMBLY A56/17
Provisional agenda item 14.9, 12 May 2003
Intellectual property rights, innovation and
Report by the Secretariat
On May 12, the WHO Secretariat submitted a report on IPR,
innovation and public health to World Health Assembly. This
is a rich and important topic that has been the subject to
enormous attention in recent years, from groups as diverse
as the US Federal Trade Commission, Department of Justice,
and National Academy of Sciences and the UK Commission on
Intellectual Property Rights and the Royal Society, to
mention only a few initiatives from just two countries.
The WHO report is 6 pages, including 24 paragraphs, with
just 11 footnotes. It recommends no action by the World
Health Assembly.
To suggest the report is thin is an understatement. It
seeks to avoid appearing to take sides on controversial
issues, but sometimes the omissions are obvious. For
example, consider paragraph 20 on "Adverse effects on future
innovation," a topic that has received enormous attention
from academic scholars, antitrust authorities, and the
financial press. In the WHO report the issues are simply
and unimaginatively stated as:
20. Adverse effects on future innovation. In some
circumstances, intellectual property rights might have
a perverse effect on innovation. Much depends on the
stage of product development at which protection is
applied, and what, in different jurisdictions, is
admissible under patent law as an invention. The recent
report of WHO�s Advisory Committee on Health Research
notes that: "The current situation has gone too far in
promulgating a culture of ownership, and if it is
allowed to continue it will inevitably lead to further
inequalities in health care". It further suggests that
unless the "complex and chaotic situation� which
currently prevails is addressed, protection of
intellectual property could stifle the very innovation
it is designed to stimulate. As a result "both the
biomedical research community and industry will be
severely disadvantaged in their efforts to translate
the potential of genomics into improvements of global
health." A prudent approach is needed to ensure that
legitimate concerns do not give rise to "solutions"
that have undesirable effects. For example, the
exclusion from patentability of genes would act as a
strong disincentive to the biotechnology industry, just
at a time when significant numbers of new biotechnology-
based pharmaceuticals are coming onto the market. The
way in which current law on intellectual property
rights and regulatory systems operate therefore need to
be carefully examined before changes are sought.
The WHO failed to cite even one outside study or report on
this topic, and more important, it did not discuss the
growing movement among researchers for "open source"
development models (including for example the experience
with the Human Genome Project), the debates in the USA over
the need for a patent research exception, or controversies
over patent protection on research tools, overly broad
biotech patents, or the concerns over poor quality patent
examination in the United States and elsewhere.
Paragraph 15 another example of the limited usefulness of
this report. While a lot could have been said about the
costs to litigate IP claims, and the arbitrary nature of
many legal decisions, it simply states:
15. All the components need to operate in a wider
enabling environment. A sound legal and judicial system
gives innovators confidence that action will be taken
when their rights are infringed, and reassures
consumers that any abuse will be acted upon.
Paragraph 9 addressed the Doha Declaration on TRIPS, but it
actually minimized the essential message from the WTO. The
WTO Doha Declaration actually said:
The [TRIPS} Agreement can and should be interpreted and
implemented in a manner supportive of WTO members'
right to protect public health and, in particular, to
promote access to medicines for all.
This was described by WHO as:
Members may adopt measures necessary to protect public
health and nutrition.
Clearly, the WHO was seeking to water down the more
demanding WTO Declaration on TRIPS and public health.
Here are a few other areas the WHO could have addressed:
- The lack of transparency regarding investment flows in
health care R&D,
- Controversies over the costs of R&D for new drug
development, particularly in the area of clinical trials, an
area the WHO could and should address the lack of a good
evidence base to inform policy discussions.
- The costly nature of IPR based R&D incentives,
particularly when compared to what they produce in terms of
investments,
- The current industry crisis of low productivity in R&D,
such as the tendency to invest in small and incremental
improvements in existing therapies, and the expense of
investment in more innovative products where there are more
pressing needs,
- The relationship between anticompetitive R&D subsidies
in rich countries and the development of R&D capacity in
developing countries.
- The limits of IPR in funding global public goods,
- The several proposals for a treaty or other global
agreements to support the creation of public goods or more
generally R&D in areas of market failure
- The appropriate licensing policies for public sector or
donor supported R&D,
- Practical examples, like SARS. Consider for example
this report from the April 17, 2003 issue of the Washington
Post:
While the sudden emergence of SARS, the severe acute
respiratory syndrome, is a global health emergency
of the highest order, it's not at all clear yet that
it represents a commercial opportunity. Scientists
are announcing breakneck progress, including
isolation and genetic mapping of a new SARS virus,
that may, under the right circumstances, lay the
groundwork for new treatments. But executives in the
pharmaceutical and biotech industries say those
treatments won't come automatically or quickly --
and may not be needed at all, if public health
experts succeed in controlling the virus through the
simpler expedient of quarantine. Only if quarantine
fails and the virus becomes widely established in
the human population, the executives say, will the
numbers of victims rise to the point that it makes
sense to launch programs to discover new drugs and
vaccines. While many experts fear the virus has
already spread too widely to be eradicated, they are
not yet certain. Scores of companies are looking at
the prospects, but few, so far, appear to be
committing large sums to SARS research. "It's only
a good commercial opportunity if worst cases are
realized,� said William A. Haseltine, chairman and
chief executive of Human Genome Sciences Inc.. . .
SARS No Boon for Drug, Biotech Firms, Justin Gillis
and Michael Barbaro, Washington Post; April 17, 2003
If the WHO report A56/17 is the best the WHO secretariat can
do on this topic, it may be time to push for a member driven
effort to better identify areas of concern and the role for
the WHO to promote or evaluate the efficacy, efficiency and
ethical basis of trade frameworks to support innovation in
health care.
--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040
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