147. 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 instruments of acceptance of the Protocol since the last TRIPS Council meeting held in June 2016. So far, over 64% of WTO Members have submitted their instruments of acceptance for the TRIPS Protocol and five more Members have to submit their instruments of acceptance for entry into force of the 2005 Protocol Amending the TRIPS Agreement.
148. 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 has been the first and only use of the System so far.
149. The side event which was held today to discuss the challenges and problems associated with this Paragraph 6 Mechanism and the comments by experts has broadened our understanding on aspects related to the Paragraph 6 System, especially as regards its implementation so far, the challenges and opportunities involved, as well as the ways of improving the System to make it effective and meaningful.
150. Ms. Yuanqiong Hu from Medicines Sans Frontiers said that her organization had requested the HIV/AIDS medicines from Canada to supply Rwanda, but it had taken three years for the whole process to deliver because there were delays associated with regulatory approval, as well as discussions with patent holders which took a lot of time. At the same time, the HIV/AIDS medicines were available and supplied by Indian generic companies before Rwanda accorded supplies from the Canadian company Apotex.
151. The representative from Canada who spoke at the side event confirmed that the regulatory approval had taken close to six months, as compared to one year under the normal procedure, to ensure the quality, safety and efficacy of the drugs. The company had made losses and had supplied the tablets at a very cheap rate. He was also informed by some companies that they would never venture into providing medicines under this special compulsory licensing scheme.
152. Mr. Denis Broun, the representative of CIPLA, shared the experiences of a generic producer to manufacture under the System. There was no way to achieve economies of scale because of the limited quantities of medicines to be procured by the importing countries. He also noted requirements like special labelling and markings and the need for the generic company to host a special website and to pay remuneration to the patent holder. According to him, there was so much red tape built into the System that it was difficult for the Paragraph 6 Mechanism to achieve its intended purpose. Unless the procedures were simplified, his company would never use the System.
153. Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate Institute of International and Development Studies opined that this was not a good System. It should be renegotiated before it entered into force as it was not workable. She also said that patenting in exporting countries like India was on the rise. In her view, the Paragraph 6 System needed to be made more workable for it to be used by countries.
154. 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 mechanism by the UN Secretary General's High-Level Panel on Access to Medicines in its report released in September. The recommendation was also endorsed by many experts at the side event. Recognizing the Paragraph 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 licence. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform."
