LDC Pharma IP Waiver Until 2033 Approved By WTO TRIPS Council

After two weeks of high level negotiations between the United States and the Group of Least-Developed Countries, the World Trade Organization committee on intellectual property rights today agreed to extend a waiver allowing LDCs to avoid applying and enforcing IP rights on pharmaceutical products until 2033.

The Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) met this morning to reconvene the October session which was suspended after no agreement could be found on the LDCs’ request for an unlimited extension of their pharmaceutical products waiver (IPW, WTO/TRIPS, 17 October 2015).

The TRIPS Council adopted the extension of the waiver on pharmaceutical products until 1 January 2033, taking up after the current extension running until 1 January 2016. LDCs benefit from a parallel waiver on all products running until 2021.

[Update:] The WTO issued a press release today on the TRIPS Council decision.

Although general consensus on the request prevailed, the United States, according to sources, disagreed on the timeframe of the extension and argued that TRIPS includes the possibility for LDCs to ask for an extension whenever it is needed.

According to an LDC source, the agreement found on the extension is a better deal than the previous extension dating back to 2002.

In particular, the last extension was for 14 years, this one is for 17 and if one could argue that three years is a meagre victory, the source said, three years can be very important for LDCs having set up pharmaceutical manufacturing.

Also agreed are the request of LDCs to waive paragraph 70.8 and 70.9 of the TRIPS. Paragraph 70.8 requests that a member not applying patent protection for pharmaceutical products still has to provide a means by which patent applications can be filed, and once protection is made available, the protection should apply to those filed applications for the remainder of the patent term.

The former extension did not include a waiver of Paragraph 70.8, but did cover Paragraph 70.9, according to the WTO. The LDC source said it was an improvement over the last extension.

Paragraph 70.9 grants exclusive marketing rights for five years after obtaining marketing approval or until a product patent is granted or rejected in a member territory, whichever period is shorter.

The extension of the waiver under Article 66 (Least-Developed Country members) is under the decision power of the TRIPS Council. On the waiver of Article 70.8 and 70.9, the TRIPS Council today provided a recommendation to the General Council to approve it.

The General Council is expected to meet later this month, according to a WTO source. The LDC extension does not appear to be related to the upcoming WTO ministerial in Nairobi in December.

According to a WTO source, the TRIPS Council decision is timely in view of the adoption by the United Nations of the Sustainable Development Goals (SDGs) in September. The SDG targets on health directly refer to the right to use TRIPS flexibilities, in the spirit of the Doha Declaration, to provide access to medicines for all. Today’s agreement can therefore serve as a concrete step in working towards achieving the SDG health targets by 2030, he told Intellectual Property Watch.

The informal agreement was reached on 29 October between US Amb. Michael Punke and representatives of the LDC Group, Amb. Shameem Ahsan from Bangladesh and Amb. Christopher Onyanga Aparr from Uganda, according to sources (IPW, WTO/TRIPS, 3 November 2015).

NGOs Urge LDCs To Take Advantage of Policy Space

In a collective statement [pdf], non-governmental organisations are calling LDCs to “actively use the created policy space this renewed transition period provides and accordingly to take immediate steps to ament their respective national laws to exclude pharmaceutical products from patent protection and test data protection with explicit provisions that this would be until 1 January 2033 or the expiry of such later transition period that may be granted by the WTO Council for TRIPS.”

Discussions Ongoing On Non-Violation Complaints

The TRIPS Council was also suspended over the issue of non-violation complaints (NVCs) on 15 October (IPW, WTO/TRIPS, 15 October 2015). NVCs refer to situations were country A can start a dispute with country B if country A feels that country B has taken an action depriving A from expected trade benefits, even without having breached any WTO rules.

A moratorium, which has been extended from one WTO ministerial conference to the next, shields IP issues from NVCs. The last WTO ministerial conference in December 2013 asked the TRIPS Council to make a recommendation on the moratorium, and whether it should be made permanent or not.

Most countries have supported a permanent moratorium but the United States and Switzerland have opposed it.

According to sources, discussions are ongoing but positions remain the same so far. A meeting between the proponents of a permanent moratorium is expected to take place on 9 November to evaluate possible scenarios, according to several sources. One source said the US is still evaluating its position on the issue.

European Commission Reaction on LDC Decision

[Update:] The European Commission issued a statement on the LDC extension. It states:

“EU Commissioner for Trade, Cecilia Malmström said: ‘Even if this waiver is not quite as far-reaching as we would have hoped, it is very good news that there is a consensus in favour of a very long waiver period. This should provide the legal certainty and policy space needed by the least developed countries to ensure better access to medicines.’
The European Union supported the initial proposal by least developed countries for a permanent waiver for as long as they remained LDCs.

The WTO decision today complements the Commission funded development programmes for supply of essential medicines in developing countries and reinforces the coherence of the EU approach on development policy. This is also good news in the run up to the WTO Ministerial Conference in Nairobi. We hope this will be the first of a series of decisions that will be taken there in favour of LDCs.”