251. The representative of India appreciated the positive references that had been made to the Indian generic industry. The latter had undoubtedly brought a paradigm shift in changing the global discourse about access to life-saving medicines at affordable prices. A recent study, published in the Journal of the International AIDS Society of September 2010, had noted that, over the last seven years, 80 per cent of donor-funded AIDS medicines had been supplied by Indian generic manufacturers to developing countries. The same study had also mentioned that the cost of the Indian generic version of the most commonly used first-line adult regimen for HIV/AIDS treatment (Lamivudine/Nevirapine/Stavudine) had dropped from USD 404 per person per year in 2003 to USD 74 per person per year in 2008. However, the credit could not be entirely attributed to the Indian generic industry, given that the largest generic manufacturer was in the European Union and the second largest in Israel. But these manufacturers might not be price-competitive in all generics. He cautioned that the Indian generic industry was not a panacea for addressing the reasons which had necessitated the establishment of the System. Many life-saving medicines were off-patent in India and therefore were readily available as generics. He noted that most first-line antiretroviral medicines predated the TRIPS Agreement and were therefore not patented in India. This situation might change in the future, as more product patents were filed and block-buster drugs were invented. This might lead to a decline of the present generic advantage, making the developing world, including the LDCs, dependent on high-priced patented drugs. Switching to second-line antiretroviral medicines was at least three times more expensive, costing about USD 465 per person per year. Possible third-line drugs like Etravirine, for which there was no generic alternative, cost USD 3,204 per person per year. Those medicines represented the real challenge for the System and other TRIPS flexibilities that could be invoked for public health reasons.
252. With respect to voluntary contributions and tiered pricing by some developed Members, he noted that, while these attempts were appreciated, they were not lasting solutions. The Report of the UN Special Rapporteur had indicated that one third of the world's population did not have access to affordable medicines. The number of patients being treated for HIV/AIDS in developing countries had jumped to 5.2 million in 2010 from 400,000 in 2003. Given the breadth of the problem, he noted that, while voluntary efforts and tiered pricing made an important contribution, they could not be the entire solution and did not obviate from the need to use the System. He wondered whether the futile attempts of MSF and Ghana to use the System through CAMR had had a chilling effect.
253. The representative of India said that Articles 30 and 31(k) of the TRIPS Agreement represented possible alternatives to the use of the System to achieve the objective of access to medicines. During the preparatory work in the TRIPS Council which had led to the adoption of the System, the European Union had presented a concept paper (IP/C/W/339). One of the two possible solutions proposed had been the interpretation of "the limited exceptions clause of Article 30 of the TRIPS Agreement in a way which would allow production for export, to certain countries and under certain conditions, of products needed to combat serious public health problems". The EU had acknowledged that "the advantage of this approach would be that it could fit within the flexibility offered by the existing TRIPS Agreement, without there being a need to amend any of its provisions". He noted that this option was always available to Members. In the September 2002 meeting of the TRIPS Council, the WHO representative had said that "the solution... that was most consistent with the principle was the provision of a limited exception under Article 30. Such an exception would meet the mandate of the Declaration and provide expeditious authorization to third parties to make, sell, and export patented drugs and other technologies to meet public health needs" (IP/C/M/37).
254. He noted that Article 31(k) performed the same purpose as the Decision in that it waived the restriction imposed by Article 31(f) on compulsory licensing for export when a Member issued a compulsory licence "to remedy a practice determined after judicial or administrative process to be anti-competitive". This provision had been used three times in the last five years by a developed country Member of the EU. Interestingly, the Member concerned had opted out as an importing country under the System. Both Articles 30 and 31(k) were existing provisions in TRIPS and were covered by Paragraph 4 of the Doha Declaration which stated that "we reaffirm the right of WTO Members to use, to the full, the provisions of the TRIPS Agreement, which provide flexibility for this purpose".
