8 November 2016 – TRIPS Council – India’s intervention on the Paragraph 6 Mechanism

On 8 November 2016, India delivered the following statement on Review under Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.

India’s Interventions at the TRIPS Council meeting (08-09 November 2016)

Agenda Item 7: Review under Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

Mr.Chairman, India attaches high importance to the Doha Declaration on Public Health, the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol Amending the TRIPS Agreement. India had notified its acceptance of the Protocol in March 2007. We would like to congratulate Papua New Guinea, Peru and Belize who have deposited their instrument of acceptance of the Protocol since the last TRIPS Council meeting held in June 2016. So far, over 64 per cent of WTO members have submitted their instruments of acceptance for the TRIPS protocol and 5 more members have to submit their instruments of acceptance for entry into force of the 2005 Protocol Amending the TRIPS Agreement.

Mr.Chairman, we have always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the short history of the WTO because it recognized the primacy of public health needs and the preparedness of the Organization to take up the problems faced by the poor in developing countries. Along with several other Members, India had worked relentlessly on the Doha Declaration and the Decision. The Decision established a framework for special compulsory licences, which is an additional flexibility aimed at enabling exports of medicines to WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector. However, the export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 had been the first and only use of the system so far.

Mr.Chairman, the experts at the side-event held during lunch time today has broadened our understanding on the various aspects of the Paragraph 6 System, especially on the implementation of the Paragraph 6 System so far, the challenges and opportunities involved as well as ways of improving the system to make it effective and meaningful.

Ms. Yuanqiong Hu, Medicines Sans Frontiers mentioned they were the organisation who imported ARV medicines for AIDS/HIV treatment in Rwanda from Canada under paragraph six mechanism. The process took up to three years due to time taken by the Apotex company in Canada to get regulatory approval, time taken to negotiate with originator companies etc. They could supply ARV medicines available from Indian generic companies before they could get the supplies from Apotex company.

The Canadian Representative said that Canadian Access to Medicines Regime (CAMR) is the first to implement the paragraph six system waiver and allowed Apotex, a generic manufacturer to supply medicines. The company has made loses from the order as it supplied at a cost of 39 US cents per pill and informed that they will not venture into supplying of medicines under para six mechanism waiver in the future.

Mr. Denis Broun, representative of CIPLA company, a generic producer said that so much red-tape was built into the paragraph six system for it to fail. He mentioned they will never come forward to manufacture under the special compulsory license as they cannot achieve operations of scale, requirements of special labelling and markings, creation of a special website, remuneration to patent holder etc. They urged for more simpler and faster procedures.

Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate Institute of International and Development Studies said that Para six system is not a good system and should be renegotiated before it enters into force as the System is not workable in the current form. She said that patenting in exporting countries like India is on the rise as it is implementing the patent system, and the need for workable para six system has risen.

Based on the experts opinion at the side-event held today, we reiterate our concern that the Paragraph 6 System is too complex, cumbersome and administratively unwieldy for further use. I conclude by quoting the recommendation on the special compulsory license by the UNSG HLP on Access to medicines in its report release in September this year. The recommendation was also endorsed by many experts at the side-event held today afternoon. Recognizing the Para 6 system as complex and cumbersome, the UNSG High Level Panel on Access to Medicines has recommended that “WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform.”

Thank you Chair.