EU calls for indefinite extension of WTO TRIPS waiver on pharma products for LDCs

18 September 2015

The European Commission announced this week that it will support the least developed countries' (LDCs) request for easier access to cheaper medicines through an indefinite exemption from WTO intellectual property rules for pharmaceuticals.

"Although patents stimulate innovation in developed and emerging economies, intellectual property rules should be a non-issue when the world's poorest are in need of treatment,” declared EU Trade Commissioner Cecilia Malmström. 

The exemption “will give the least developed countries the necessary legal certainty to procure or to produce generic medicines,” she said.

The announcement has drawn praise from some civil society groups, who have also called for other WTO members to do the same.

“We applaud this important change in the EU position since the last time this issue was discussed at the WTO,” said Rohit Malpani, Director of Médecins Sans Frontières, who also urged “other countries that have not yet fully supported the request, especially the United States and Switzerland, to follow the lead of the EU.”

In a letter addressed to the Office of the US Trade Representative (USTR) and the US Patent and Trademark Office (USPTO), several civil society representatives urged Washington to disclose its LDC pharmaceutical extension policy positions. These representatives included Brook K. Baker from Health GAP, James Love from Knowledge Ecology International, Peter Maybarduk from Public Citizen, Judit Ruis from Médecins Sans Frontières, and Stephanie Burgos from Oxfam America.

“It would simply be unacceptable for the US to oppose the duration requested by LDCs and to instead require LDCs to return repeatedly to the TRIPS Council every few years for successive short-term extensions,” reads the letter.

The TRIPS Council is the WTO body tasked with administering the organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Access to cheaper medicines

Earlier this year, the WTO’s poorest members tabled a proposal for extending indefinitely their transitional period for enforcing global trade rules protecting pharmaceutical patents and clinical data, as well as a related waiver involving patent protection and exclusive marketing rights for pharmaceutical and agricultural chemical products.

Should this transitional period expire in January 2016, as it is currently set to do, some WTO members argue that requiring LDCs to enforce these rules could constrain their capacity to make or procure low-cost generic medicines. (See Bridges Weekly, 5 March 2015)

The proposal tabled by Bangladesh on behalf of the LDC Group back in February requested that the transition period for LDCs remain in force for as long as those countries remain under that category, citing among other reasons the health burdens that result from high rates of HIV and other diseases in their countries.

“It is imperative for LDCs to retain maximum policy space to enable them to confront their health burdens with effective and affordable strategies,” reads the proposal.

The proposal was discussed again in more detail at a meeting of the TRIPS Council in June, though no solution was reached at that time. 

Parallel processes

Currently, WTO members that are considered to be LDCs under the UN classification are exempted from having to implement the provisions of the TRIPS Agreement relating to the protection of pharmaceutical patents and clinical data, notably to enable their access to low-cost generic antiretroviral treatments in light of the high prevalence of HIV in some LDCs.

In June 2013, WTO members agreed to extend the transition period for LDCs to implement the overall TRIPS agreement until July 2021. That extension, according to the same decision, noted that it occurred “without prejudice to another WTO Council Decision of 2002 on the extension of the LDC transition period for “certain obligations with respect to pharmaceutical products” that expires in 2016.

The LDC Group in that instance had also originally requested for the extension to last so long as a member was a least developed country, a move that had been met with resistance from some other WTO members. In the end, the extension was granted until 2021 following negotiations with the rest of the global trade body’s membership. (See Bridges Weekly, 13 June 2013)

The next TRIPS Council is scheduled to take place from 15-16 October.


ICTSD reporting.

18 September 2015
East Africa is emerging as a promising hub for international and intra-regional trade to rival sub-Saharan Africa’s two ‘heavyweight states’ of South Africa and Nigeria, according to the inaugural...
23 September 2015
Over 100 US companies participated in a week-long trade mission to Africa with stops in the continent's eight leading economies, including South Africa. The delegation, part of the Trade Winds...