3rd July 2002
TRIPS COUNCIL AGREES ON EXTENSIONS FOR LDCS ON PHARMACEUTICAL PATENTS
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WTO Members at the 25-27 June meeting of the Council for Trade-related Aspects of Intellectual Property Rights (TRIPs) adopted a decision to extend the period until 2016 during which least-developed countries (LDCs) do not have to provide patent protection for pharmaceutical products. They furthermore agreed on a waiver for LDCs that would exempt them from having to give exclusive marketing rights for any new drugs in the period when they do not provide patent protection. Animated discussions also continued on paragraph 6 of the Doha Declaration on TRIPs and public health.
Paragraph 7 on LDC extensions resolved
Following on from discussions at an informal meeting of the TRIPs Council in May (see BRIDGES Weekly, 22 May 2002), WTO Members approved the decision to allow LDCs to delay patent protection for pharmaceuticals until at least 2016, thereby formalising part of para.7 of the Doha Declaration on the TRIPs Agreement and public health. Members furthermore resolved the contentious issue of whether the extension also exempted LDCs from implementing the “mail box” provisions of the TRIPs Agreement, which require Members to provide means for inventors to submit patent applications (Art. 70.8) and exclusive marketing rights for approved products (Art. 70.9) while patent protection is not implemented. LDCs had strongly advocated that both provisions be covered by the extension, but in the end accepted the waiver covering only Art. 70.9 due to concerns that Members opposed to the extension would drag on the discussion on the rest of para.7. The waiver, which would need to be reviewed by the Ministerial Conference and thereafter annually, will now be submitted to the WTO General Council on 8 July for approval.
Diverging proposals on Paragraph 6
Members continued their exchange of views regarding para.6 of the Doha Declaration based on a number of proposals submitted to the Council, including one by the EC (IP/C/W/352) advocating an exception under Art. 31(f); one by the US (IP/C/W/358) favouring a moratorium for dispute settlement or a waiver of the obligation in Art. 31(f); and one by Brazil on behalf a group of developing countries (IP/C/W/355) proposing an authoritative interpretation of Art. 30 (see BRIDGES Weekly, 26 June 2002). Para.6 of the Declaration instructs Members to find an “expeditious solution” to the problem that Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face in making effective use of compulsory licensing. Art. 31(f) requires that production under compulsory licensing must be primarily for the supply of the domestic market (see BRIDGES Weekly, 12 March 2002).
A fourth submission was received by the African Group (IP/C/W/351), which put forward a comprehensive approach encompassing several elements. Regarding Art. 31, the Group proposed three options, namely an amendment of the Article, a deletion of 31(f) or an addition to 31 (f) stating that the paragraph does not apply to measures adopted to protect public health. The submission furthermore proposed that “domestic market” in 31(f) should also refer to customs unions or free trade areas, and that 31(f) should be interpreted to mean that up to 49.9 percent of production could be exported. In addition, the Group proposed that transition periods should be extended for developing country Members with insufficient manufacturing capacity to delay patent protection in order to allow for the implementation of measures to address health concerns; and a moratorium on disputes against Members that take such measures.
With respect to preventing re-exportation, the Group proposed labelling of relevant pharmaceuticals as intended for consumption within the designated domestic markets. Regarding the scope of the “expeditious solution”, the submission stressed that any Member should be allowed to take measures “for exports of necessary pharmaceutical products to any countries, particularly developing and least developed Members that need support to address public health concerns”. Any solution should be part of the broader implementation of TRIPs provisions, including those related to transfer of technology.
The two developing country groupings stressed during the meeting that their submissions were meant to complement rather than oppose each other, and that they would carefully look into the various elements of the respective proposals. As one source pointed out, the African Group’s proposal aimed to provide a more comprehensive solution with various options, taking into account the concerns of the EC, US and Switzerland. The source also noted that the approaches of the two groupings should be seen in light of the different circumstances, i.e. the Brazil-led group included several countries with generic industries (in particular Brazil and India), while the African Group was likely to focus their efforts on overcoming the considerable difficulties they faced in accessing affordable drugs to treat epidemics such as HIV/AIDS.
The Secretariat will prepare a note on possible common elements of a decision on para.6, which will be discussed at an informal TRIPs Council meeting on 25 July.
The next (regular) meeting of the TRIPs Council is scheduled for 17-19 September.
WTO documents are searchable at http://docsonline.wto.org. The US submission is available at http://www.ustr.gov/sectors/doha-trips-graph6second.pdf.
ICTSD reporting; “TRIPS and public health council approves LDC decision with additional waiver,” WTO, 28 June 2002.
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[...] continue their discussions on paragraph 6 of the Doha Declaration on TRIPs and Public Health (see BRIDGES Weekly, 3 July 2002). Countries mainly elaborated on previously-made proposals, with major shifts in [...]