The LDC Medicines Extension Question: Contemplating next steps

The LDC Medicines Extension Question: Contemplating next steps

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Paragraph 7 of the World Trade Organization Doha Declaration on the TRIPS Agreement and Public Health adopted in 2001 recognized the special situation of least-developed WTO members and directed the TRIPS Council to take the necessary action to assure that LDCs would not be obligated with respect to pharmaceutical products to implement or enforce those parts of the TRIPS agreement relating to patent and regulatory data protection. The TRIPS Council approved a decision extending until January 1, 2016, the transition period during which LDCs do not have to provide or enforce patent and regulatory data protection for pharmaceuticals. As a related matter, on July 8, 2002, the WTO General Council acted to waive any obligation on the part of LDCs to grant “exclusive marketing rights” on newly approved patented drugs during the period until January 1, 2016 (hereinafter collectively the “2016 medicines extension”).

On June 11, 2013, the TRIPS Council adopted a related general extension in favor of LDCs. It provides that LDCs are not required to apply the provisions of the TRIPS agreement until July 1, 2021. That is, an 8 year extension from the previous extension with July 1, 2013 expiration (hereinafter the “2021 general extension”). Despite pressure from some developed country members, the new extension does not include a no-rollback commitment.

Assuming that the extension until 2021 is properly interpreted as providing maximum flexibility to LDCs, including the potential to roll back existing IP commitments, is there a need to further extend the 2016 medicines extension? Or, are all the flexibilities that LDCs enjoy under the 2016 medicines extension included within the scope of the 2021 general extension?

In the absence of a firm basis of legal security, LDCs and suppliers to LDCs may find that doubts are raised as the January 1, 2016 deadline approaches regarding whether flexibility to import low-cost generic drugs will continue after that date. Legal insecurity imposes a cost, and in this case the cost may be an adverse impact on public health. To put it plainly, suppliers of medicines, including intermediaries and funding agencies, have a strong bias against being the subject of patent infringement litigation. The 2016 medicines extension provided legal security for these suppliers. Will these same suppliers find sufficient assurance in the 2021 general extension if doubts are raised about its interpretation, such as have raised by the EU Delegation and USTR?

There is no “easy answer” to this diplomatic and real world question. It is a question that the LDCs will have to answer prior to January 1, 2016 so that they may make an informed decision about whether to seek extension of the 2016 medicines extension from the TRIPS Council and General Council of the WTO.This essay suggests a few options for LDCs.


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