On 23 January 2017, an amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) entered into force enabling poorer countries to import generic medicines made under compulsory licensing if they are incapable to manufacture the medicine themselves. It was Article 31(f) of the TRIPS Agreement impeding the poorer countries' access to affordable medicines which stipulates that a compulsory license must be issued predominantly for the supply of the domestic market of the member country granting the license. Consequently, many countries incompetent to manufacture the medicines have not been able to import the medicines made under compulsory licensing provisions of the TRIPS. This was a big challenge for the poor world combating against the contemporary public health crisis.
In November 2001, the WTO Ministerial Conference affirms that the TRIPS Agreement “should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all” (Doha Declaration on the TRIPS Agreement and Public Health). Paragraph 6 of the said Declaration recognised 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. Consequently, on 30 August 2003, General Council adopted a waiver 'Decision' that waives countries' obligation under Article 31(f) of the TRIPS Agreement. The Decision allows WTO members to export pharmaceutical products made under compulsory licenses within the terms set out in the Decision. Therefore, the poorer countries are allowed to import the medicines made under compulsory licensing provision of the TRIPS Agreement.
In 2005, WTO members agreed to insert the 2003 waiver Decision into the TRIPS Agreement permanently (“TRIPS Amendment Decision"), which culminated to the adoption of new Article 31bis after Article 31 of TRIPS. However, the members adopted the protocol amending the TRIPS Agreement (the “Protocol”), and the amendment was subjected to the acceptance of two-thirds of the WTO members in order to entry into force. Finally, in 2017, the “Protocol” receives satisfactory ratifications that make the amendment effective. Members who are yet to accept the TRIPS amendment have time until December 2017 to do so. In the meantime, 2003 waiver Decision is dominant for them to secure the access to affordable medicines.
However, it is positive for our citizen that Bangladesh already has accepted the amendment on 15 March 2011. As a least-developed country, Bangladesh is an 'eligible importing member' who can import generic medicines made under compulsory licensing “in the case of national emergency or other circumstances of extreme urgency or in the cases of public non-commercial use”. Even the growing development of Bangladesh in export sector will be benefited by this amendment. Bangladesh can also be an “export member” subject to the fulfillment of certain obligation of this Agreement.
Overall, this is one of the most significant amendments the WTO has ever experienced which would certainly ameliorate the sufferings of the backward people. Concerning this amendment, WTO Director-General Roberto Azevêdo commented- “[T]his is an extremely important amendment. It 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. By doing so, it helps the most vulnerable access the drugs that meet their needs, helping to deal with diseases such as HIV/AIDS, tuberculosis or malaria, as well as other epidemics”. It is to expect that a future waits for us where no one will die without medicine.
The writer is a Lecturer at Department of Law and Human Rights, Ranada Prasad Shaha University.