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NGOs Seek UN Governance of U.S. Intellectual Property Trade Agreements


by Jim Kelly

Wednesday, July 21, 2010

 Frustrated by successful bi-lateral trade agreements entered into between the United States and developing countries that encourage the adoption of sound national intellectual property policies and the waiver of the provisions of an international agreement that offers developing countries flexibility in securing access to generic medicines, two separate groups have submitted an allegation letter and declaration with several United Nations agencies requesting that they intervene. These two recent submissions evidence the larger role that non-governmental organizations ("NGOs") want the UN to play in globally governing national domestic policies and transnational corporations for the redistribution of wealth and property rights without respect for democratic processes and the rule of law.

The allegations made in the two submissions reflect the broader conflict between the desire of NGOs and the UN to guarantee access to medicines in developing countries by encouraging them to rely on flexibility provisions within the World Trade Organization's ("WTOs") Trade Related-Aspects of Intellectual Property Rights Agreement

("TRIPS Agreement") to secure generic drugs; and, the desire of developed countries and their pharmaceutical industry representatives to encourage developing countries to adopt intellectual property legal and regulatory systems that protect the significant financial investments that pharmaceutical companies make in researching and producing patented medicines.

Although the substantive debate reflected by the two submissions is an important one, of equal or greater importance is the attempt by the NGOs and UN officials to vest UN agencies with more significant human rights review and enforcement authority than that which is contained in relevant international human rights treaties and special procedures. First and foremost, the NGOs base the assertions made in the allegation letter and declaration entirely on a "right to access to medicines" that is only in the embryonic stages of development. Yet, it is clear that the "right to health" from which these groups claim the "right to access to medicines" emanates is itself an ambiguous and inconclusive human right. To date, only a handful of Geneva, Switzerland-based UN human rights experts, human rights treaty body committee members, academics, and NGO activists have been involved in the early cultivation of these so-called "emerging" rights. Yet, this reality does not prevent NGOs and the UN from acting as though there is an established "right to access to medicines" which can serve as a means for negating the right of sovereign nations to enter into bi-lateral trade negotiations regarding drug patent protection policies and voluntary arrangements for the provision of life-saving medicines at a reasonable price.

For instance, on July 20, 2010, a group of NGOs, led by Health Gap (Global Access Project), filed an Allegation Letter with the United Nations Special Rapporteur on the Right to Health (the "Special Rapporteur"). The Allegation Letter criticizes the U.S.'s use of its Special 301 program, which requires the U.S. trade representative ("USTR") to publish a list of countries that deny "adequate and effective protection of intellectual property" and permits the unilateral imposition of trade sanctions against such countries. The Allegation Letter also claims that U.S. pharmaceutical companies and their trade association, PhRMA, violate human rights norms when they pressure the USTR via their Special 301 submissions to list countries that adopt and use the flexibility provisions of the TRIPS Agreement to increase access to medicines in the form of generic drugs. In conclusion, the Allegation Letter asserts that:

The Special Rapporteur for the Right to Health should call on the U.S. to halt its use of the Special 301 program and other elements of its foreign policy to encourage and coerce developing countries to adopt intellectual property norms that restrict access to medicines, including access to antiretroviral medicines for people living with HIV/AIDS. The Special Rapporteur should encourage the U.S. to use its trade and foreign assistance programs to promote full use of TRIPS flexibilities and to otherwise revise its foreign policies to promote access to medicines. The Special Rapporteur should call on the U.S. to provide a procedure for the appeal of human rights issues within the Special 301 report, to reverse its unlawful unilateral threats of trade sanctions via Special 301, and to reconsider and reverse the many decisions it has made that violate the right to health of poor people around the world.

The assertions contained in the Allegation Letter are baseless and the grievance mechanism engaged in by the complaining NGOs is a very questionable one.

First, the U.S. and developing countries engaging in voluntary bi-lateral negotiations relating to patent protection and the provision of medicines on a reasonable basis is not a violation of the TRIPS Agreement or any other international agreement.

Second, the U.S. is not a party to the International Covenant on Economic, Social and Cultural Rights ("ICESCR") in which the right to health is listed. Although, once in effect, the new Optional Protocol to the ICESCR will permit individual communications alleging violations of human rights to be submitted to the Committee on Economic, Social and Cultural Rights (the "Committee"), because the U.S. is not subject to the ICESCR or the Optional Protocol, the Committee would have no authority to consider a communication filed against the U.S.

Third, it would hardly be the case that, what NGOs could not accomplish directly by filing an individual communication with the Committee alleging a U.S. violation of the right to health could be accomplished indirectly by filing an allegation letter with the UN Special Rapporteur. Although paragraph 5(a) of the Commission on Human Rights' Resolution 2002/31 creating the mandate of the Special Rapporteur (the "Resolution") requests the Special Rapporteur "to gather, request, receive and exchange information from all relevant sources" on the realization of the right to health, the Resolution does not contemplate the submission by NGOs of allegation letters containing allegations of a country's interference with the right to health. Of course, this omission has not prevented the Special Rapporteur from creating a mechanism for the filing of individual complaints pertaining to alleged violations of the right to health. Nevertheless, this complaint process requires a degree of specificity as to the description of the alleged violation of the right to health that the NGOs that filed the Allegation Letter failed to meet.

In any event, the entire exercise of the NGOs submitting the Allegation Letter against the U.S. government is just a foretaste of what travesties might occur if the U.S. ever decides to ratify the ICESCR and the Optional Protocol and subject itself to UN governance of U.S. domestic policies relating to the realization of economic, social, and cultural rights, including the right to health, right to food, right to water, right to energy, right to housing, right to social security, right to education, and right to water.

Similar in purpose to the submission of the Allegation Letter, on July 15, 2010, a self-described "coalition of public-interest groups and academic experts" submitted the "Berkeley Declaration on Intellectual Property Enforcement and Access to Medicines " to the participants in a joint technical symposium on access to medicines convened by the World Health Organization ("WHO"), World Intellectual Property Organization ("WIPO"), and the World Trade Organization ("WTO") on July 16, 2010 in Geneva, Switzerland (the "Symposium") (the "Berkeley Declaration"). The Symposium, which was titled "Access to Medicines: Pricing and Procurement Practices," provided participants with an opportunity "to learn what international and regional agencies have experienced in the pricing and procurement of medicines as important determinants of access" to medicines. The opening remarks of WHO Director-General, Dr. Margaret Chan, encapsulated the sensitive nature of the Symposium's subject area:

Of all the issues discussed at WHO governing bodies, access to medicines consistently sparks the most heated debate, sometimes divisive, and potentially explosive debates. This is all the more so since these discussions almost inevitably turn to questions of prices, patents, intellectual property protection, and competition.

Of course, for the authors of the Berkeley Declaration, in regards to the steps that developed nations and transnational pharmaceutical corporations are taking to enforce their intellectual property rights vis-à-vis developing countries, there is no room for debate:

The enforcement agenda threatens the last decade of efforts to achieve access to medicines for people in low- and middle-income countries, and compromises the attainment of health-related Millennium Development Goals. We make this Declaration to call upon policy makers in governments and international organizations to reject the cynical and dangerous efforts that have been made through this agenda to prioritize commercial interests over the right to health.

In the Berkeley Declaration, the NGOs recommend that, "all developing countries approach IP enforcement and ‘anti-counterfeiting' initiatives with caution and reject any such initiatives that affect the ability to produce, export, import, and use generic medicines." The signatories of the Berkeley Declaration submitted it to the heads of the WHO, WIPO, and WTO and, presumably, the Symposium participants.

Together, the submission of the Allegation Letter and the Berkeley Declaration represent one more attempt by NGO activists and academics to encourage the UN and its related agencies and experts to engage in the global governance of national domestic and foreign policies in a manner that places primary emphasis on the realization of an ambiguous international human rights agenda to the detriment of future scientific research and product development, free trade, democracy, the rule of law, and national sovereignty.

Jim Kelly is the President of Solidarity Center for Law and Justice, P.C., a public interest civil and human rights law firm based in Atlanta, Georgia. The opinions expressed herein are his own.