Industry Asks For Clarity On LDC Request To Extend TRIPS Pharma Waiver

Least developed countries (LDCs) at the World Trade Organization have requested that a waiver allowing them to not enforce intellectual property rights on pharmaceutical products be extended beyond its deadline of 1 January 2016. The brand pharmaceutical industry has published a statement that it supports access to medicines for LDCs but does not see the need for this extension as LDCs already benefit from a WTO waiver on all products until 2021.

This points to an inherent disagreement over whether the LDC pharmaceutical products extension is needed. In June 2013, WTO members in the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreed to extend a waiver allowing LDCs to defer their application of TRIPS provisions until 1 July 2021.

LDCs are also the beneficiaries of a separate waiver on pharmaceutical products, which comes to an end on 1 January 2016.

At the last TRIPS Council in February, Bangladesh on behalf of the LDCs requested an extension of the waiver on pharmaceutical products. For the moment both waivers run in parallel.

The difference is that LDCs asked for the pharmaceutical waiver to be extended until countries graduate from LDC status.

That request was also made for the general waiver but was not accepted by some developed countries (IPW, WTO/TRIPS, 25 February 2015).

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in the statement said it “firmly supports the efforts of governments and civil society to increase access to medicines in developing countries, particularly in LDCs.”

However, it said, “The vast majority of essential medicines are not protected by intellectual property (IP) and therefore IP plays no role in limiting access to these medicines.”

The IFPMA statement is available here.

The pharmaceutical industry supports the 2013 WTO decision to extend the waiver until 2021, and, according to the statement, “recognizes that LDCs may in due course need certain additional flexibility to implement TRIPS, [but] additional waivers or extensions do not appear to be necessary at this stage, as the current waiver is in force until 2021.”

The debate over the extension may be a moot point, however. Article 66 of the 1994 WTO TRIPS Agreement (Least-Developed Country Members) granted a 10 year exemption for LDCs, and specifies that “The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period.”