TWN Info Service on Intellectual Property Issues (May10/01)
4 May 2010
Third World Network

US access-to-drugs policy contravenes human rights, say groups
Published in SUNS #6911 dated 26 April 2010

Geneva, 23 Apr (Kanaga Raja) -- The United States has been using trade agreements, foreign aid, technical assistance and diplomatic pressure to promote intellectual property and pharmaceutical regulations that restrict access to affordable medicines in developing countries, health advocacy organizations have said.

In a submission to the United Nations Human Rights Council this week, the health advocacy groups said that the US move is coming at the expense of human rights.

The groups called for a human rights review of US trade policy on access to medicines.

Under the auspices of the Human Rights Council, the Working Group on the Universal Periodic Review (UPR) reviews the human rights records of all 192 UN member states once every four years.

In November-December this year, the Working Group (at its ninth session) will review the human rights record of the United States for the first time since the UPR mechanism was established in 2006.

Under the UPR process, the Council asks for comments from the public, including universities, research institutions and non-governmental organizations in order to assess whether the member state has complied with its human rights obligations under the UN Charter, the Universal Declaration of Human Rights, human rights treaties ratified by the member state, its voluntary commitments, and international law.

The deadline to submit public comments and reports concerning the review of the United States was 19 April.

The report submitted to the UPR Working Group this week by the health advocacy groups Health Global Access Project (HealthGAP, an organization of US-based AIDS and human rights activists) and European Community Advisory Board (ECAB, a volunteer, community-based structure aimed at broadening access to HIV treatment) was authored by Sean Flynn, Associate Director of the American University Washington College of Law's Programme on Information Justice and Intellectual Property (PIJIP).

In their submission, PIJIP, HealthGAP and ECAB said that the Working Group on the UPR should call on the United States to account for its foreign policy that encourages developing countries to adopt intellectual property norms that restrict access to medicines.

They also called on the Working Group to encourage the United States to use its trade and foreign assistance programmes to promote full use of flexibilities under the WTO TRIPS Agreement to promote access to medicines.

The groups' submission says that the United States has "a long history of using trade agreements, foreign aid, technical assistance and diplomatic pressure to promote intellectual property and pharmaceutical regulations that restrict access to affordable medications in developing countries."

These policies are continuing in the present administration, and cause grave and needless suffering around the world, the groups add.

According to the submission, the World Health Organization estimates that the deaths of about 18 million people, one third of all human deaths, are caused by medical conditions that could be treated or cured. "A primary reason for this avoidable carnage is the lack of access to affordable and effective treatments in poor countries."

Promoting access to affordable medicines for the poor is a widely recognized human rights duty, emanating from the recognition of civil and political as well as social and economic rights that bind the United States, said the groups.

Health and social policies which increase mortality and morbidity implicate the right to life in Article 6(1) of the International Covenant on Civil and Political Rights as well as Articles 22 and 25.1 of the Universal Declaration of Human Rights.

States are bound to promote and protect the rights to life and health not only of their own citizens, but also of the citizens of other countries affected by their foreign policy, trade and assistance programmes.

Intellectual property is a prime determinate of access to needed medicines because it is a form of social regulation that, by design, raises prices through monopoly rights, says the submission, adding that the negative social impact of intellectual property on access to medicines in developing countries can be particularly severe.

"In countries with high income inequality, which defines most poor countries, intellectual property monopolies provide economic incentives to price needed medicines so high that only the richest sliver of populations can afford access."

Thus, said Flynn of PIJIP, in the late 1990s, it was common (and rational) for patent holding companies to charge over $10,000 a year for AIDS treatments in rich and poor countries alike, even though generic versions can now be obtained for less than $100 a year (an indication of the true cost of competitive production).

The submission cites the UN Special Rapporteur on the Right to Health, as describing in his report to the Human Rights Council last March that to promote access to medicines and the right to health while complying with the minimum standards of the TRIPS agreement, developing countries "should incorporate the flexibility to: (a) Make full use of the transition periods; (b) Define the criteria of patentability; ( c) Issue compulsory licences and provide for government use; (d) Adopt the international exhaustion principle, to facilitate parallel importation; (e) Create limited exceptions to patent rights; (f) Allow for opposition and revocation procedures. In addition, countries need to have strong pro-competitive measures to limit abuse of the patent system."

After passage of the TRIPS agreement, said Flynn, the US pressed many countries to give up their rights to use many of these pro-access policies, including to issue compulsory licenses (i. e. authorization to use a patent in return for compensation) and to "parallel import" less expensive versions of patented drugs from other countries.

The submission cites two particular cases - pressure on South Africa to give up parallel importation and pressure on Brazil to give up compulsory licenses - which threatened to doom AIDS treatment programmes and stoked international outrage and a popular movement on access to medicines.

According to Flynn, the WTO's 2001 Doha Declaration on TRIPS and Public Health was passed in direct response to US pressure and sought to clarify the ability of countries to use exceptions and limitations to intellectual property rights to promote public health. The agreement affirmed "the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility [to promote access to medicines for all]."

"UN human rights officials and bodies have repeatedly found that the globalization of intellectual property rights can only be squared with human rights if countries are permitted and encouraged to utilize the full scope of intellectual property exceptions and limitations provided for in the TRIPS agreement to promote access to medicines," says the submission.

Examining the human rights duties of states to take advantage of TRIPS flexibilities to promote access to medicines has been a frequent subject of human rights treaty monitoring bodies. Such reviews have included analysis of the duties of wealthy countries to promote the use of TRIPS flexibilities in poor countries.

The submission adds that this body of human rights law was summarized by UN Special Rapporteur Paul Hunt as meaning "that no rich State should encourage a developing country to accept intellectual property standards that do not take into account the safeguards and flexibilities included under the TRIPS Agreement. In other words, developed States should not encourage a developing country to accept TRIPS-plus' standards."

Despite the Doha Declaration, clear human rights duties and the demands of global health, said Flynn, the US has continued to pressure developing countries to give up TRIPS flexibilities.

During a brief period at the end of the Clinton Administration, US trade policy was altered to reduce TRIPS-plus pressure on access to medicines. The US Trade Representative announced a new policy that "should a government determine to avail itself of the flexibility [in] the TRIPS Agreement" to address a public health need, "the United States will raise no objection."

President Clinton's Executive order 13155 ordered that "the United States shall not seek, through negotiation or otherwise," alteration of any intellectual property or pharmaceutical regulation that "promotes access to HIV/AIDS pharmaceuticals or medical technologies" and complies with the minimum standards of TRIPS.

According to the groups' submission, the Bush Administration assented to the Doha Declaration in 2001, but ignored its intent through vigorous promotion of TRIPS-plus standards on medicines, including in Sub-Saharan Africa. The administration's public position was that it could pressure developing countries to give up TRIPS flexibilities because "IP rights ultimately enhance public health."

According to Flynn, one of the central tools used by the US to promote "TRIPS-plus" policies on access to medicines has been the "Special 301" programme. The programme requires the US Trade Representative 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, even in the absence of violation of any trade agreement.

The submission cites several notable examples of the use of the Special 301 programme to sanction countries for access to medicines policies that do not violate international trade commitments. One example is that before TRIPS was enacted, Brazil, Thailand and India were sanctioned through GSP benefit withdrawals for not granting product patents for pharmaceuticals (a policy of Switzerland, Japan and other developed countries well into the 1970s).

In addition, in 1998, South Africa was listed on 301's watch lists and GSP benefits were revoked for passing a law authorizing TRIPS-compliant parallel importation.

Up to and including the 2009 report, Brazil, India, Thailand and other countries were threatened with sanctions under Special 301 for taking advantage of TRIPS flexibilities, including utilizing transition periods and compulsory licenses - a move criticized by members of the US Congress as sending "a troubling message ... that the exercise of recognized public health flexibilities in trade obligations is frowned on by the United States."

In 2003, said Flynn, the report announced that the US would interpret TRIPS to require an additional form of "data exclusivity" monopoly protection for pharmaceuticals, even though such a provision was explicitly amended out of the TRIPS agreement in the negotiation.

The United States has a long history of using pressures on countries to adopt special marketing monopolies called "data exclusivity." Data exclusivity prevents the registration of generic products for a period of time, even if the brand name company does not have or cannot obtain a patent.

The submission cites research by the Centre for Policy Analysis on Trade and Health (CPATH) that has shown that TRIPS-plus data exclusivity provisions advanced by the US have granted marketing monopolies for products that were already on the market as generics in Guatemala (leading to withdrawal of supplies), including for medicines that never filed for a patent in the region and are off-patent in the US.

To comply with US-promoted policies, the Guatemalan public sector now faces higher prices - up to 846 percent higher - for important drugs to fight diseases such as diabetes and HIV/AIDS.

The advocacy groups also noted that free trade agreements signed with developing countries after the Doha Declaration pressed those countries to adopt numerous TRIPS-plus intellectual property standards that threaten access to medicines.

The submission concluded that TRIPS-plus trade pressures are continuing under the current administration.

The 2009 Special 301 Report, the first issued in the Obama Administration, presses developing countries to limit grounds for compulsory licenses, restrict freedom to define the scope of patentability, prohibit parallel importation, extend patents beyond 20 years, implement "linkage" between drug registration and assertions of patent protection, adopt US or EU-style "data exclusivity" rules that create drug monopolies independent of patents, and do away with evidence-based formularies and other price and competition restrictions on pharmaceutical monopoly power. +