TRIPS IP Rules Amended to Implement Doha Ministerial 2001 Decision

· Generics at Reasonable Prices Export to Developing Countries Possible under Compulsory Licensing

An amendment to the agreement on intellectual property entered into force today (23 January) securing for developing countries a legal pathway to access affordable medicines under WTO rules.

The amendment to the WTO Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement marks the first time since the organization opened its doors in 1995 that WTO accords have been amended.

Notifications from Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Viet Nam finally bring in two-thirds the number of WTO members which have now ratified the amendment. The two-thirds threshold was needed to formally bring the amendment into the TRIPS Agreement.

Members took the decision to amend the TRIPS Agreement specifically to adapt the rules of the global trading system to the public health needs of people in poor countries. United Nations General Assembly High-Level Meeting on Ending AIDS in June 2016. Too passed a resolution in support of this (Amendment) gives legal certainty that generic medicines can be exported at reasonable prices to satisfy the needs of countries with no pharmaceutical production capacity, or those with limited capacity. Helps with diseases such as HIV/AIDS, tuberculosis or malaria, as well as other epidemics force,” said WTO Director-General Roberto Azevêdo. In video statements available here, some of the key players share their thoughts on the TRIPS amendment.

Unanimously adopted by WTO members in 2005, the protocol amending the TRIPS Agreement makes permanent a mechanism to ease poorer WTO members’ access to affordable generic medicines produced in other countries. The amendment empowers importing developing and least-developed countries facing public health problems and lacking the capacity to produce drugs generically to seek such medicines from third country producers under “compulsory licensing” arrangements.

Normally, most medicines produced under compulsory licences can only be provided to the domestic market in the country where they are produced. This amendment allows exporting countries to grant compulsory licences to generic suppliers exclusively for the purpose of manufacturing and exporting needed medicines to countries lacking production capacity.

The amendment provides a secure and sustained legal basis for both potential exporters and importers to adopt legislation and establish the means needed to allow countries with limited or no production capacity to import affordable generics from countries where pharmaceuticals are patented.

Background

Flexibilities such as compulsory licensing are written into the TRIPS Agreement – governments can issue compulsory licences to allow companies to make a patented product or use a patented process under licence without the consent of the patent owner, but only under certain conditions aimed at safeguarding the legitimate interests of the patent holder.

Some governments were unsure of how these flexibilities would be interpreted, and how far their right to use them would be respected. At the Doha Ministerial Conference in November 2001, WTO members struck a deal which clarified the accords and provided governments in the developing world with greater clarity and certainty that protection of patents does not and should not prevent members from taking measures to protect public health.

But one more element was needed – how to guarantee that countries lacking the capacity to produce generic drugs could still procure them affordably. Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health recognized that “WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement”, and instructed the Council for TRIPS to find an expeditious solution to this problem.

In August 2003, WTO members decided to remove an important obstacle to affordable drug imports by waiving the limitation in the TRIPS Agreement to predominantly supply the local market. The decision says that if the importing country could not secure access to needed medicines at affordable prices, these medicines could be produced under compulsory licence by drug makers in third countries, and be imported to poorer countries unable to manufacture the medicines themselves.

Two years later, WTO members agreed on 6 December 2005 to permanently incorporate the 2003 waiver decision into the TRIPS Agreement subject to the acceptance of two-thirds of WTO members. Through the entry into force of the amendment, the flexibility to protect public health becomes an integral part of the TRIPS Agreement. Against concerns some have voiced that use of this option may be challenged politically, the amendment provides legal certainty that any member can export the entirety of pharmaceutical products made under a compulsory licence to countries confronted with limited domestic capacity.