Since 1988, the USTR has been coming out with its “Special 301” report, a unilateral measure which essentially patronises the rest of the world by ranking countries based on how much the USTR appreciates their IP regimes, and based on those rankings, threatens lower placed countries with sanctions. (See our previous posts on the
301 process here). As usual, TRIPS-plus policies are the ones US considers desirable and are the ones that are promoted. They are considered ‘adequate’, while IP regimes which make use of TRIPS flexibilities are often targeted.
(
Image at right taken from here)Earlier last week, a group of 19 public interest organizations, including some from India, represented by Sean Flynn of
PIJIP, filed a
complaint with Anand Grover, UN Special Rapporteur on the Right to Health, stating that the the Special 301 Report is being used to threaten countries into complying with higher standards than required by international agreements, and that this is adversely affecting access to medicines especially in low and middle income countries. They allege that the US has violated human rights of poor people all around the world with its implementation of this 301 process and other foreign policy coercion tactics. In summary, the complaint alleges the following: (as taken from
PIJIP’s site here)
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.
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 programs.
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 rights to exclude competitors – in effect monopoly rights.
In recognition of the foreseeable impact of monopolies on needed medicines, particularly in developing countries, the globalization of intellectual property for pharmaceutical products through the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) included a full range of permissible limitations and exceptions. These include rights to use compulsory licenses to break patent monopolies, rights to define criteria for patentability to limit the grant of patents for products that are not sufficiently innovative, rights to allow generic firms to use the registration data of originator firms to speed regulatory approval, and the lack of any duty to “link” registration and patent review processes in ways that can slow generic approval.
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.
This body of human rights law was summarized by Special Rapporteur Paul Hunt as meaning that “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.”
The United States continues to breach these international human rights obligations by using its ‘Special 301’ program to threaten trade sanctions against countries that do not agree to increase intellectual property protections beyond those required by the WTO TRIPS agreement. The 2009 and 2010 Special 301 Reports issued in the Obama Administration press developing countries to limit compulsory licenses for needed medicines (e.g. Thailand, Ecuador), restrict freedom to define the scope of patentability (e.g. in India, Brazil and Philippines), implement “linkage” between drug registration and assertions of patent protection (e.g. Chile, Dominican Republic, Pakistan, Columbia), and adopt U.S. or EU-style “data exclusivity” rules that create drug monopolies independent of patents (in dozens of countries).
While it’s about time that this unilateral and arrogant process of the US is challenged, and looking through the grounds on which it is being challenged, it seems to me even if successful, this is but a minor step in the bigger picture of enabling accessible medicines. By no means do I intend to undermine the importance of challenging barriers such as this, yet however, removing a barrier to what is proving to be an grossly inefficient process (referring to the patent system in its current form – and grossly inefficient for low and middle income countries particularly), simply makes it a smoother journey through that same grossly inefficient process. Ideally, we would have a system which develops and provides for necessary medicines as well as ensures that they are affordable to those who need them. Although indeed, till there is a remedy to that process or a better alternative innovation system, challenges to existing policy measures are probably the best way forward.
Coming back to the Special 301 Report, Sean Flynn has also examined the Special 301 Reports and Global Access to Medicines in a working paper
available here. The complaint to the Special Rapporteur on the Right to Health is available
here.
Health GAP’s Press Release is available
here.
