TRIPS AND PUBLIC HEALTH
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO) lays down minimum standards for the protection of Intellectual Property Rights (IPRs) as well as the procedures and remedies for their enforcement, which are to be adopted by all the Member countries of WTO in their national laws governing IPRs. Under the provisions of the TRIPS Agreement, One of the IPRs i.e. patent shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.
With the introduction of product patent, it was feared that because of patent monopolies in the pharmaceutical sector the prices of medicines and drugs in general, would witness an increase. However, the TRIPS Agreement under Article 31 provides for compulsory licensing procedures to make available patented medicines and drugs at affordable price. Compulsory licensing refers to the practice by a Government to authorize itself or third parties to use the subject matter of a patent without the authorization of a patent right holder. The TRIPS provisions on compulsory licensing were however seen as inadequate to address the concerns of access to medicines at affordable price, primarily because they placed several conditions to be complied with prior to their exercise.
It was this basic concern that prompted the African Group (representing countries in the African continent), supported by several developing countries including India, to raise the issue of intellectual property rights and access to medicines at the WTO’s TRIPS Council meeting in June 2001. The negotiations culminated in the adoption of the Doha Declaration on TRIPS and Public Health in November 2001, which mandates that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health and that each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licences are granted as well as the right to determine what constitutes a national emergency or other circumstances of extreme urgency and that each Member is free to establish its own regime for exhaustion without challenge.
One aspect of compulsory licensing under the TRIPS Agreement is that such licenses can be granted only for the supply in the domestic market of the country issuing the license. An issue that remained unresolved at the Doha conference was that of addressing problems of countries that have insufficient or no manufacturing capacity in the pharmaceutical seactor. Accordingly, Doha Declaration on TRIPS and Public Health under para 6 while recognising this problem directed the TRIPS Council of WTO to find a solution to this problem before the end of 2002.
Various proposals were submitted in the TRIPS Council by the developing as well as developed countries. This led to the Decision in the WTO General Council meeting held on 30 August, 2003 regarding grant of waivers from the obligations under Article 31(f) and 31(h) of the TRIPS Agreement (WT/L/540 dated 2nd September 2003). This Decision is aimed at easing the problem being faced by the developing countries as well as LDCs having no or insufficient manufacturing capacities in the pharmaceutical sector in using the flexibility of compulsory license. This mechanism is intended to be a temporary one which is to be followed by an appropriate amendment to the TRIPS Agreement. This Decision would enable manufacture and export of pharmaceutical products under compulsory license to countries with limited or no manufacturing capacities in the pharmaceutical sector. The Decision is to be read along with the Chairman’s Statement in this regard contained under para 29 of WT/GC/M/82 dated 13 November 2003.
The General Council Decision instructed the TRIPS Council to initiate by the end of 2003 work on the preparation of such an amendment with a view to its adoption within six months, i.e. by June 2004. Work in this regard is going on in the TRIPS Council. As per Decision, WTO has dedicated a web-page on its website (www.wto.org) for Members to notify their intention to use the system.