Regulatory Focus™ > News Articles > US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

Posted 14 October 2015 | By Zachary Brennan 

US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides.


Since the initial WTO agreement on Trade-Related Aspects of IPRs (TRIPs) in 1995, least-developed countries (LDCs) have been granted exemptions from implementing intellectual property (IP) rules for pharmaceuticals.

The exemption allows local manufacturers and other international programs to supply necessary drugs, such as HIV treatments, in affected countries without having to deal with patent infringement lawsuits. 

As the current exemption on medicines is set to expire at the end of this year, Bangladesh, on behalf of the 48 LDCs, requested that the WTO change the exemption to last as long as such countries remain LDCs. Only four countries have so far graduated out of this category of LDC, including Botswana in 1994; Cape Verde, in 2007; Maldives in 2011 and Samoa in 2014.

EU Support

The European Commission on Wednesday issued a report on its trade and investment strategy, saying it will support a permanent waiver for LDCs under TRIPs.

The commission also made a similar move last month, saying the proposal, which must be signed off on by the European Council, would allow generic drugs to be imported and manufactured locally, regardless of patents.

The World Health Organization, the United Nations Development Program, Norway and a number of Democratic representatives, as well as presidential hopeful Sen. Bernie Sanders (D-VT), have also offered their support for a permanent exemption.

However, some are concerned that the public support for the permanent exemption in Europe may not be substantiated by its actions.

Health Action International (HAI) and Médicines Sans Frontières (MSF) – both supporters of the permanent exemption -- released a report on Wednesday saying there's a gap between the European public position to support access to affordable medicines in LDCs and the reality of its trade policies.

"Looking at the Commission’s current access to medicines commitments in more detail, these have proven to be empty words and gestures, contradicted and undermined by a long history of including substantive damaging TRIPS-plus provisions in EU free trade agreements, and other damaging EU trade policies," the report adds.

US, Others Against

The public support from the EU and others also comes as the US, Australia, Canada and Switzerland have expressed opposition to an indefinite exemption, particularly since some US stakeholders in the pharmaceutical industry, were disappointed with what they considered to be concessions made during the final stages of the Trans-Pacific Partnership (TPP) over biologics exclusivity.

Last week, US Ambassador to the WTO Michael Punke met with representatives from 15 countries, including five ambassadors, from a group of LDCs and indicated that the US would not back an indefinite exemption, according to the NGO Knowledge Ecology International.

HAI's EU Policy Advisor Tessel Mellema also told RAPS that she sees "considerable pushback, in particular from the US."

US industry group Pharmaceutical Research and Manufacturers of America (PhRMA) seemed to offer a more moderate position, saying it recognizes there will be some sort of extension to the WTO waiver for LDCs, though the question will be the length of that extension.

There should be a time limit as in the past because "IP is essential to driving innovation and economic growth," PhRMA spokesman Mark Grayson told RAPS. He also said he has not heard anyone linking the terms of the TPP deal to the WTO negotiations.

HAI and MSF report on EU's Trade and Investment Policy

European Commission Report on Trade




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