[Ip-health] US statement to SCP 18 on the United States proposal on Patents and Health
james.love at keionline.org
Wed May 23 10:20:13 PDT 2012
US statement to SCP 18 on the United States proposal on Patents and Health
The following is the statement read today by USPTO during the 18th
meeting of the WIPO Standing Committee on the Law of Patents (SCP), on
the agenda item for patents and health. I'll provide more commentary
later, but in general, this was seen an aggressive attack on a
proposal for work by the Development Agenda Group (DAG), and on the
notion that countries should grant compulsory licenses on patents or
use other flexibilities to address concerns over access or
affordability of drugs. The US statement follows:
Talking points on the United States proposal on Patents and Health
SCP/17/11 Patents and Health: Proposal by the Delegation of the United
States of America
* Thank you Mr. Chairman.
* The availability of medicines is a topic of great importance and
interest, and the United States continues to be a global leader in
promoting availability of medicines throughout the world. The US is
pleased to contribute to this discussion.
* Some of the public health issues facing developing and least
developed countries (DC/LDCs) include neglected diseases, the spread
of TB, malaria and HIV/AIDS, and availability of medicines to treat
these and other ailments. There is no easy solution to these problems.
Reducing patent protection is not likely to solve these thorny issues.
Furthermore, the notion that all developing countries face identical
challenges and should apply the options that exist under international
agreements in a single way – or that access to medicines would be
enhanced by such an approach – has been rejected by many WIPO member
states, including developing nations.
* To the contrary, the lack of effective patent protection can be one
of the many factors which prevent the appropriate medicines from
reaching the neediest patients in DC and LDCs. Weakening the patent
rights granted to pharmaceutical researchers and manufacturers in
certain markets not only removes or reduces the incentive to develop
new medicines, but also reduces the incentives for innovative medicine
developers to invest in those countries and harness their innovation
to solving the public health challenges that disproportionately affect
developing countries, and are not being solved in other ways.
* Weakening patent protection for innovative medicines is not a
productive approach to improving availability of health care, because
many other factors other than patents more directly affect the
availability of medicines.
* The proof of the weakness of that argument is that although most
medicines on the World Health Organization’s List of Essential
Medicines are not protected by patents, their availability in many
markets is still limited. This is particularly true in DC/LDCs. Many
other factors affect the availability of all medicines, patented or
* Consequently, assessing the extremely complicated challenges of
public health with respect to the patent system as the primary point
of intervention, without recognizing the indisputable facts affecting
access to medicines, is an imbalanced and ultimately unproductive
approach. If not viewed in context, such an approach will invest
WIPO’s limited resources to inaccurately quantify the impact of the
patenting system on the availability of medicines, and will not help
the member states make informed decisions About how to view their
patent system in the context of their efforts to address the specific
and unique health challenges each country must overcome.
* Mr, Chairman, the United States had set forth at the last meeting
of the SCP for consideration by the member states two basic elements:
1) Conducting a study on the positive impact of patent systems in
providing lifesaving medicines to developing countries. The study
would help restore balance to the discussion by evaluating the role of
patent protection in providing incentives for research and development
leading to innovative medicines, and in fostering the technology
transfer necessary to make generic and patented medicines available in
2) Then, Conducting a study to examine the availability of lifesaving
medicines that are currently provided in generic form, and of the
reasons for their lack of availability. We see this study as a
necessary and responsible way to ensure that evaluation of the role of
patents in affecting public health outcomes is properly informed and
not obscured by the many other important challenges that exist that
will not be affected by any patent regime.
* Alternative approaches seek to evaluate patent systems in a vacuum,
and draw conclusions about patent protection and public health without
acknowledging the complexity of the problem. The United States
believes that an isolated and partially-informed inquiry cannot help
in the evaluation of how patents do or do not affect extremely serious
and important challenges, and therefore would be an inappropriate use
of limited resources.
* The US has taken note of the preliminary comments to our proposal
that were voiced during the 17th session of the SCP and in the
comments received by the secretariat, and compiled in documents
SCP/18/inf/3 and SCP/18/inf/3 add.
* Many of the comments have indicated that some issues raised in the
US proposal fall outside of the mandate of the SCP, as they involve
aspects of national laws, infrastructure, and issues that may be
better handled by other UN agencies. One example may be the trilateral
cooperation framework maintained by WIPO, the WTO and the WHO.
* If this body chooses to meaningfully address the profoundly serious
and complicated issue of public health, it would be a disservice to
that effort to ignore the facts that are necessary to understanding
how patent regimes can advance public health.
* Without gathering the information that places the role of patent
systems in context, no reliable or informed conclusion about how
patent systems can or should respond to public health challenges can
* Should a forum better equipped to evaluate this complicated issue
be agreed upon to conduct studies on the protection of public health
and on access to medicines, we would, of course, be amenable to
considering the discussion in that forum.
* In light of these issues, if any work programs on health related
issues are retained within WIPO and particularly within the SCP, care
will have to be exercised to avoid duplication of efforts between the
various WIPO committees, in particular with the committees more
directly addressing development agenda issues, such as the CDIP.
* In particular, the trilateral framework undertaken by the WHO, WIPO
and WTO, is currently finalizing a joint study on the promotion of
access and medical innovation at the intersection between public
health, intellectual property and trade, which intends to provide a
holistic presentation of the full set of issues, including a
comprehensive consolidation of their technical cooperation activities
in the field.
* To this end, the United States believes that a thorough discussion
of the WHO-WIPO-WTO joint study must take place before additional
work, if any, is undertaken within the SCP on the subject of Patents
* Regardless of the forum chosen, the US believes that work on this
issue that ignores the interaction of the patent system with the many
other factors affecting access to medicine is unproductive and will
not result in the stated goal of understanding how patent regimes can
improve public health. A balanced approach must, at a minimum,
evaluate all the contributions patents have on the availability of
medicines, including the development of life-saving medicines and
medicines tailored to public health challenges in developing
* The United States believes that reduction in patent protection for
innovative medicines is not the solution to overcoming public health
challenges. The challenges to access to generic medicines make that
clear, and that the one-size-fits-all approach advocating reduction of
patent protection is inappropriate.
* Given the resources and expertise of this body, great care will
have to be taken to add value, rather than duplicate efforts, by other
competent bodies, to the consideration of public health challenges
* Thank you Mr. Chairman
James Love. Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
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