140+ NGOs Urge WTO Members To Grant Extension Of LDC Pharma Waiver

Over 140 [updated] non-governmental organisations, most of them local from developing countries, have co-signed a letter to World Trade Organization members to ask they agree to a request by least-developed countries to extend a waiver on their obligation to enforce intellectual property rights on pharmaceutical products.

The letter (in English) (in Spanish) (in French) [links updated, all pdf] asks that WTO members grant an extension to the waiver on pharmaceutical products enjoyed by least-developed countries (LDCs), due to expire on 1 January 2016. The LDC group in February requested the WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) to agree on this request (IPW, WTO/TRIPS, 25 February 2015).

The LDC extension is expected to be discussed at the upcoming TRIPS Council, from 9-10 June.

The NGOs support an indefinite extension until a country is no longer classified as an LDC. They also support the request from LDCs to waive their obligations under Article 70.8 (Protection of Existing Subject Matter) (so-called mailbox obligation) and under Article 70.9 (exclusive marketing rights).

The waiver on pharmaceutical products, according to the letter, has been “invaluable in enabling prompt access to affordable pharmaceutical products in LDCs.”

“Many LDCs (at least 25 countries) have relied on the 2002 pharmaceutical product extension to declare patents unenforceable as well as to exempt pharmaceutical products from patent and test data obligations, thereby allowing them to import critical treatments such as medicines for their national HIV/AIDs treatment programmes, including those supported by the Global Fund to Fight HIV/AIDS, TB and Malaria and other donors…”

“The widespread use of the mechanism makes it one of the most successful provisions of the Doha Declaration on TRIPS and Public Health,” the signatories added.

The NGOs in the letter said they have concerns that some WTO members are questioning the need for a pharmaceutical exemption since LDCs are benefitting from a general exemption from general TRIPS compliance until 1 July 2021. However, says the letter, “The public health crisis in LDCs is a long-term challenge that will endure at least as long as these countries remain LDCs.” The six years until the 2021 deadline are not enough to help LDCs out of their status and creates uncertainty in the market, they argued.

In 2013, LDCs requested linking the extension to graduation from LDC status, but this was resisted by some developed countries. “A specific pharmaceutical exemption similar to the 2002 pharmaceutical decision will provide suppliers, procurers and donors of affordable medicines in LDCs the clarity and certainty to confidently manufacture, export and import generic medicines,” they said.

According to the letter, Article 70.8 “mailbox obligation” “places considerable financial and administrative burdens on LDCs, which are extremely vulnerable and constrained and which are under no obligations to install patent filing systems.”

Exclusive marketing rights, according to the letter, confer “patent-like rights and monopoly, which limits the value of a pharmaceutical transition period since access to pharmaceutical products could be effectively blocked for at least five years.”

TRIPS Article 66.1 states, “The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period,” which the signatories say “obliges the TRIPS Council to approve without conditions the duly motivated request submitted by the LDCs.”

Last week, the United Nations Development Programme and the Joint UN Programme on HIV/AIDS (UNAIDS) issued a joint statement supporting the request by LDCs (IPW, WTO/TRIPS, 22 May 2015)