[Ip-health] KEI comments on U.S.T.R. Special 301

[Malini Aisola]

http://keionline.org/node/786

KEI comments on U.S.T.R. Special 301

KEI is one of several public health groups working with Sean Flynn on
filing comments in the current U.S.T.R. request for comments on the
Special 301 process (Federal Register Notice USTR-2010-0003-0129). In
addition, KEI filed these comments:

KEI comments on Special 301

18 February 2010

KEI provides the following comments regarding the 2010 Special 301
Review, including but not limited to the Identification of Countries
Under Section 182 of the Trade Act of 1974.

Our comments include the following points:

   1. The USTR policy on the protection of intellectual property rights
should be consistent with other US policies and commitments, including
for example the following global norms:
         1. The elements of the World Trade Organization (WTO) Agreement
on Trade Related Aspects of Intellectual Property Rights (TRIPS) that
address the importance of balance, national discretion in implementing
global norms and the protection of consumer, social and public
interests, including example, Articles 1, 6, 7, 8 and 40;
         2. the 2001 WTO Doha Declaration on TRIPS and Public Health;
         3. the 2008 World Health Organization (WHO) Global Strategy on
Public Health, Innovation and Intellectual Property Rights (hereafter
referred to as the Global Strategy), as set out in WHA61.21; and
         4. the provisions of the World Intellectual Property
Organization (WIPO) Development Agenda.

      In the past, the U.S.T.R. has undermined protections of many
important consumer, social and public interests, in order to press for
an unbalanced advocacy of selective intellectual property right owners.

      While KEI can appreciate the pressure on the U.S.T.R. to promote
the interests of some right-owner groups, U.S.T.R. must also recognize
the legitimacy of norms that protect consumers, promote freedom, and
advance various social agendas, and also appreciate the fact that the
U.S. national interest is much broader than the concerns of some owners
of intellectual property rights.

      The United States has an interest in obtaining low cost medicines
to address its global obligations to support treatments for HIV/AIDS and
other diseases. Millions of persons who live in the United States will
benefit from expanded access to foreign collections of copyrighted works
in accessible formats, and from the sharing of U.S. collections with
persons with disabilities who live outside of the the United States. The
U.S. benefits from increased levels of education in developing
countries. The U.S. globally shares access to published research that
was funded by the NIH, and will benefit from expanded access to research
funded by our trading partners. The U.S. has benefited more than any
other country from the development of new information technologies,
including those that depend upon considerable flexibilities in copyright
or patent laws.

      In these and in many other areas, the U.S. national interest is
not well defined by the asks and demands of the Pharmaceutical Research
and Manufacturers of America (PhRMA), the Motion Picture Association of
America (MPAA), the Recording Industry of Association of America (RIAA),
the Association of American Publishers (AAP), or other right-owner
groups who routinely lobby the U.S.T.R.

   2. The U.S.T.R. should never place a developing country on the
Special 301 list for having issued or threatening to issue a compulsory
license on a medical technology, so long as the compulsory licensing is
compliant with the WTO TRIPS Agreement.

   3. The U.S.T.R. should never place a developing country on the
Special 301 list for a failure to grant exclusive rights to rely upon
pharmaceutical test data to register a drug, when such a policy runs
counter to the policy of promoting access to medicine for all. This is
relevant to the 2001 Doha Declaration on TRIPS and Public Health and
WHA61.21. In this regard, the U.S.T.R. needs to acknowledge the obvious,
in all or nearly all developing country markets, the freedom to issue a
compulsory licensing on a patent is meaningless in cases where the
lawful sale of a product will be blocked by exclusive rights in test
data. For this reason, every public health group that has been active in
protecting the interests of poor people in developing countries has
opposed the U.S.T.R. policy to pushing for exclusive rights in
pharmaceutical test data in developing countries. To the extent that the
U.S.T.R. believes there are legitimate trade interests involved, it has
many alternatives to the use of exclusive rights, such as reasonable
cost sharing, a practice actually used in the United States in cases
involving chemicals that are used to protect crops. No intellectual
property rights for data should be implemented without safeguards for
public health, and the U.S.T.R. should not demand such policies.

   4. The U.S.T.R. should reflect upon the meaning and consequences of
element 6.2 (g) of the WHO Global Strategy (WHA61.21), as it concerns
intellectual property for pharmaceutical test data and the ethical
principals for clinical trials. Specifically, this element calls upon
governments to:

          promote ethical principles for clinical trials involving human
beings as a requirement of registration of medicines and health-related
technologies, with reference to the Declaration of Helsinki, and other
appropriate texts, on ethical principles for medical research involving
human subjects, including good clinical practice guidelines.

      The Declaration of Helsinki on Ethical Principles for Medical
Research Involving Human Subjects includes the following principle:

          20. Physicians may not participate in a research study
involving human subjects unless they are confident that the risks
involved have been adequately assessed and can be satisfactorily
managed. Physicians must immediately stop a study when the risks are
found to outweigh the potential benefits or when there is conclusive
proof of positive and beneficial results. [Emphasis added]

      One plain meaning of this provision is as follows. If a generic
drug maker is required, in order to register a drug for sale, to
replicate an experiment where there is already =E2=80=9Cconclusive proof of
positive and beneficial results,=E2=80=9D the generic drug company will be
violating Article 20 of the Declaration of Helsinki. The remedy is not
to prohibit a generic drug company from replicating the trial, but
rather to eliminate the unethical requirement in the first place. The
U.S.T.R. Special 301 List cannot continue to demand that unethical
policies be imposed by government regulators.

   5. According to foreign government trade negotiators, the U.S.T.R. is
perceived as opposing a WIPO treaty for persons who are blind or who
have other disabilities, on the grounds that such a treaty would set an
unwelcome precedent in favor of consumer interests, and harm U.S.
exporters of copyrighted works. KEI hopes these reports are wrong. In
any event, the U.S.T.R. should not in any way use its discretion to
include a country on the Special 301 list on the grounds that the
government of that country supports new global norms to expand access to
copyrighted works for persons who have disabilities.

   6. The biggest challenge for U.S.T.R. in terms of the enforcement of
laws on copyright or patents is to improve the perception that such laws
are reasonable and fair. To that end, national laws that provide for
extensive exceptions and limitations to the exclusive rights of
copyright or patent owners can be seen as a constructive development, in
that they may improve the perception that the new norms should be
respected by the public and enforced by governments and courts.

   7. U.S.T.R. should evaluate the benefits of a more balanced trade
policy that encourages policies that expand access to knowledge, or the
supply of knowledge as a global public good, when such policies enhance
our welfare and national interest. In this respect, KEI would like to
meet with the U.S.T.R. to discuss, with other interested parties, the
benefits of new global norms on access to government funded research, on
possible strategies to move forward the various proposals for a
biomedical R&D treaty, and on the proposal for a WTO agreement on the
supply of public goods.

   8. U.S.T.R. should be more sensitive to the role that intellectual
property rights can play as a barrier to legitimate competition, and as
an enabler of unwanted protectionist activity. China and other countries
have discussed the issue of patents on standards in the WTO Technical
Barriers to Trade Committee, and KEI encourages the U.S.T.R. to support
more research on this topic.

      KEI is concerned about reports that spurious assertions of
copyright in pharmaceutical drug information (the information regulators
require be provided to consumers) are being used in Australia to block
legitimate trade in generic medicines.

      There are many reports that countries have using complex court
procedures to undermine efforts to invalidate poor quality patents, with
the aim of protecting domestic markets from foreign imports.




--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673