Daily dose of pills for Hekim, 40, a XDRTB patient from Myanmar currently staying in Moreh, a town in Manipur that borders Myanmar, for her treatment from MSF. Moreh, Manipur, India, 25 October 2012. Photograph by Sami Siva
Report |

2011 Special 301 Review

Photograph by Sami Siva

Executive Summary

Doctors Without Borders/Médecins Sans Frontières (MSF) would like to submit the following comments to the 2011 Special 301 Review Process and request to testify at the hearing that USTR has announced for March 2, 2011.

MSF is an independent, international medical humanitarian organization that delivers medical care to patients in over 60 countries, our projects focus on the medical needs of poor people living in developing countries whose medical needs are often the most neglected.

MSF is concerned about the effects that heightened intellectual property regimes and high prices being imposed on developing countries by the United States Trade Representative (USTR) will have on access to affordable generic medicines for our patients and medical operations, as well as on the lack of innovation adapted to the needs of the resource-poor settings where we work. Populations in developing countries are denied access to medicines, vaccines, and diagnostic tools either because they do not exist due to inadequate incentives for the development of appropriate and effective tools; or because they exist but are not available in their countries due in part to intellectual property barriers and high costs.

MSF is concerned by the U.S. Government’s continued use of trade pressures to challenge efforts by developing countries to ensure access to medicines for their populations, and to drive countries to implement intellectual property measures into their domestic laws above those required by international trade law. The Special 301 mechanism is only one tool that the U.S. government has used to this end.

We urge the U.S. Government to abstain from threatening with trade sanctions developing countries that are trying to respond to public health needs using policies and flexibilities allowed under international trade law.

The United States Trade Representative (USTR) demands not only directly undermine the commitments made by the U.S. government under the WTO Doha Declaration on the TRIPS agreement and public health and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, but also create a fundamental contradiction between U.S. trade policy and the U.S. government commitments and priorities on global health and development.

We further urge USTR to align itself with the access to medicines policies pursued by the U.S. government. During the January 2011 128th Executive Board of the World Health Organization the U.S. government made a very powerful intervention in support of generic competition to lower the price of HIV/AIDS treatment in developing countries. Recognizing that pharmaceutical price discounts do not always have as much impact on bring down prices as robust generic competition does, it urged companies to join the recently created Medicines Patent Pool in order to increase generic competition for newer HIV/AIDS drugs, as the U.S. National Institute of Health (NIH) has recently done. We welcome these statements and the NIH leadership.

PEPFAR itself has reported cost savings of up to 80 percent through the purchase of Indian generic medicines. Other U.S. Government-funded schemes, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, are heavily reliant on the cost savings realized through competition between quality generic medicines. Yet the USTR continues to undermine both PEPFAR and the Global Fund and treatment providers such as MSF by threatening trade repercussions against countries who use the flexibilities in international trade law that allow for generic competition to continue.

The USTR presents the Special 301 process and its efforts to demand stronger regimes of intellectual property protection to developing countries as a tool to protect innovation. MSF recognizes the importance of innovation and the need to finance research and development processes. We are a humanitarian medical organization that needs and welcomes biomedical innovation to better treat our patients. However the reality is that intellectual property protection in the medical field creates access problems due to high prices and does not stimulate innovation for many of the diseases affecting people in developing countries, where patients have limited purchasing power. By seeking greater and higher intellectual property norms in developing countries, the U.S. government through USTR is perpetuating a failed business model that links innovation costs to high prices and does not address the innovation needs of developing countries. Higher intellectual property norms are a sledgehammer designed to protect commercial interests in the possibility of monopolizing richer segments in developing countries, not public health, and its weight falls on the poorest. It is too blunt an instrument as currently applied to serve the health needs of millions of people in the developing world.

There are better and newer ways for the U.S. government to protect and promote innovation currently being piloted and under discussion at the WHO. Ways that would combine innovation and access, instead of denying access to affordable medical technologies and delaying the adaptation and innovation of better products to allow our medical teams to better serve the needs in the poor-resource environments where we work. For all the reasons stated in this submission, MSF urges USTR in its 2011 Special 301 Review Process to refrain from:

  • using the Special 301 process to increase pressure on developing countries to implement intellectual property measures into their domestic laws beyond the requirements contained in international law, including TRIPS Plus provisions like data exclusivity;
  • using the Special 301 process against developing countries acting within their legal rights to overcome intellectual property barriers in response to the health needs of their populations, or against countries embracing TRIPS flexibilities to ensure access to medicines such as compulsory licenses or patentability criteria’s; and
  • using the Special 301 process to impose new intellectual property enforcement norms that would hurt access to medicines, such as those included in the ACTA agreement.

Rather than using the Special 301 Review Process as a unilateral tool to impose a heightened intellectual property regime on developing countries, the U.S. government should use its laws, policies, and financial resources to ensure that developing countries exercise the full flexibilities available to them to ensure access to medicines for all. This will mean:

  • that the Doha Declaration play a prominent role in shaping U.S. policy on access to medicines in developing countries;
  • that the U.S. government encourages countries to fully implement the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, including the use of incentive mechanisms that separate research and development incentives from high prices, for example through the use of innovation inducement prizes that reward innovations that improve health outcomes and permit open competition for products; and the creation of new global norms on research and development, including a possible biomedical R&D treaty.
  • that the U.S. government advance an agenda supportive of both innovation and access to affordable medicines in developing countries, and ensure that U.S. trade policy is aligned with the U.S. global health and development agenda;
  • that the U.S. government conducts impact assessments of the effects that USTR demands would have not only on access to medicines and innovation by patients living in developing counties but also in U.S. supported donor efforts like PEPFAR and the Global Fund.
  • that the U.S. government supports a system capable of delivering adapted and affordable drugs that respond to patients’ needs. This should include continue with the promotion of open licensing of all publically funded biomedical research and development for use in the developing world, following up with NIH recent announcement of its license on a AIDS medicines to the Medicines Patent Pool.

Finally, MSF would like to also request that the USTR facilitate that other civil society and interested stakeholders from around the world, especially from developing countries where USTR policies have greater effect, are allowed to express their views in the public hearing.