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:
- 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:
- 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;
- the 2001 WTO Doha Declaration on TRIPS and Public Health;
- 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
- 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.
- 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.
- 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.
- 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 “conclusive proof of positive and beneficial results,” 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.
- 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.
- 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.
- 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.
- 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.