Minutes - TRIPS Council - View details of the intervention/statement

Mr. Martin Glass (Hong Kong, China)
F.5 Any alternatives to the use of the Paragraph 6 System to achieve the objective of access to medicines, procurement policies, and other related aspects affecting access to medicines
269. The representative of Canada said that the trilateral Symposium jointly organized by the WTO, WHO and WIPO had been very useful. He disagreed with India's characterization of the Ghana case as having had a "chilling effect". According to his information, when Indian generic firms had first brought TriAvir to the market, the triple ARV combination which had eventually been exported to Rwanda had been priced between 30 and 40 cents. There had also been shipments from Indian generic firms to African countries. When Apotex had become a viable option and CAMR could be exercised by interested parties, the price of TriAvir from Indian firms had dropped substantially to 19 to 20 cents per pill. Instead of a chilling effect, CAMR and the System as a whole could have had a beneficial effect on price. 270. Since the System had come into existence, a number of international procurement systems had been developed, such as the Clinton Foundation, which had been key to delivering medicines to people in need. He asked potential importing countries whether they had taken advantage of such international procurement systems and if they could relate their experiences in this regard. Many pharmaceutical companies also had charitable programmes by which they donated medicines. This alternative was actively promoted by Canada through tax incentives made available to brand name and generic pharmaceutical companies which donated medicines. However, tariffs had a chilling effect on such initiatives. It would therefore be interesting to hear from potential importing Members whether they still imposed tariffs or duties on donated medicines which were imported. There also continued to be growing manufacturing capacities of the pharmaceutical industry in developing countries which were able to produce drugs at lower costs. This had been a factor in the Rwanda case. His delegation was interested to learn whether Members had increased their domestic manufacturing capacities since 2003. 271. Voluntary licences were another available alternative for obtaining essential medicines. Although the information was difficult to obtain, as these were transactions between private parties, there was some evidence that voluntary licences were being successfully deployed. In the Rwanda case, if a voluntary licence had been secured by Apotex, it would not have been necessary for Apotex to request an export authorization from the Commissioner of Patents. Nevertheless, this would still have constituted a success for CAMR. With respect to Canada's 2007 Statutory Report on CAMR, he noted that it had stated that Canada should continue to pursue non-legislative measures to improve access to medicines in the developing world. The Canadian International Development Agency (CIDA) was working with the global community to address health needs in developing countries. ClDA worked with qualified, experienced organizations and partners to improve health in the most effective and cost-efficient way. For example, Canada was a founding donor of the global drug facility in 2001 and had been the largest single donor country for first-line tuberculosis drugs since the facility had been created. The global drug facility, a programme of the "Stop TB" Partnership, worked to improve access, supply and distribution of low-cost quality-assured anti-tuberculosis drugs in developing countries and was the only bulk procurer of such drugs. CIDA also provided significant support for initiatives such as the GAVI Alliance, the WHO's universal access plan, and the Global Fund to fight AIDS, tuberculosis and malaria. He was pleased to note that Canada's commitment to the Global Fund had recently been enhanced. In September 2010, Canada had announced that an additional commitment of USD 540 million would be provided over the next three years. This was in addition to the USD 978.4 million that Canada had already committed and disbursed to the Global Fund since 2002. 272. Under its G8 Presidency in 2010, Canada had championed the Muskoka initiative, a major global effort to improve maternal, newborn and child health in developing countries. Eighty per cent of Canada's contribution of USD 1.1 billion would go to sub-Saharan Africa which had the greatest burden of maternal and child mortality. However, some countries simply could not afford essential medicines, no matter how low the costs were. Moreover, the health delivery systems in some developing countries were inadequate to deliver and administer medicines, among others, because of an insufficient number of well-trained medical staff and lack of modern infrastructure. This was another reminder that the main problems of access to medicines were the result of poverty, not patent laws. 273. With respect to counterfeit and sub-standard medicines, the representative of Canada referred to a statement by Minister H.E. Prof. Dr. Hatem El-Gabaly of Egypt. At a conference in 2009, the Minister had provided some important remarks regarding the scourge that counterfeit and sub-standard medicines had had with respect to their effect on the health of citizens. He had also made some remarks about the economic aspects. He quoted the Minister who had said: "counterfeit medicines also inflict serious damage and injury to national economies and manufacturers. These negative economic consequences are not limited to depriving legitimate businesses and their workers of income. Discouraging innovation and creativity can provide an easy source of revenue for organized crime, but they also entail loss of national tax revenues. As such, both governments and the private sector stand to lose from proliferation of trade in counterfeit medicines. As part of our collective endeavours to address this global challenge, we must be cognizant of the underlying factors that feed such illicit trade. These factors can be technical, economic or legal. However, the inescapable fact is that counterfeiting of medicines is a lucrative business due to the continued high demand for medicines and low production costs. Experts indicate that when prices of medicine are high and price differentials between identical products exist, there is a greater incentive for the consumer to seek medicines outside the normal supply system. In this context, poverty and lack of awareness appear as important issues to be addressed in our fight against counterfeit medicines. No country is immune from the threat posed by counterfeit medicine, and Egypt is no exception. Therefore it is our firm conviction that counterfeiting medicines, including the entire range of activities, from manufacturing to providing them to patients, is a serious criminal offence that puts human lives at risk and undermines the credibility of health systems. Let me shed some light on our response strategy. At the international level, Egypt supports global efforts aiming at eradication of the threat of counterfeit medicines. In the face of this trans-boundary threat, we continually coordinate with our international partners to design more effective collaboration mechanisms that involve international organizations, enforcement agencies, national drug regulatory authorities, customs and associations for consumer protection. We also promote sharing of information and exchanging best practices amongst all stakeholders. More importantly, tightening border controls to diminish the risk of trans-shipment of counterfeit medicines should be a priority for regional and international cooperation." The representative of Canada asked whether the delegation of Egypt could expand upon these timely initiatives of the Egyptian Government. 274. He also quoted the Indian Minister of Health and Family Welfare, Ghulam Nabi Azad, who had stated: "I propose to introduce a whistleblower policy to involve the public to provide information on any kind of unlawful activity in the manufacture of drugs. There is no dearth of good intentioned people who may wish to work for his country's interests as a whistleblower in eradicating this menace. People's participation is imperative in this regard." The media report had also indicated that a country-wide survey in India was under way to assess the exact size of India's spurious counterfeit drug industry. The study had apparently already identified 61 popular drug brands from nine therapeutic drug categories that were being tested. Canada asked the delegation of India whether there were any specific results from this study that could be shared with Members. Apparently, the Indian Health Ministry had estimated that 5 per cent of the drugs sold in India were counterfeit while 0.3 per cent were spurious. A counterfeit medicine was one that had no active ingredient or was an expired drug that had been relabelled or sold. It was different from a fake drug which might resemble the original in any way, according to the report. The Minister had also stated that the Drugs and Cosmetics Act had recently been amended to provide stricter penalties for offences under the Act, particularly to those engaged in making spurious, adulterated, misbranded and sub-standard drugs. The maximum penalty was life imprisonment and a fine of three times the value of confiscated goods. Some of the offences were now cognizable and non-bailable. His delegation was interested in any updates about this particular Act and any other Indian initiatives.