Exemption from pharmaceutical patents agreed for LDCs

The WTO has exempted the least developed countries from having to apply, until 2033, patent protection on pharmaceuticals, after the US objected to extending the exemption for as long as these countries remain LDCs.

by Sangeeta Shashikant

LONDON: The WTO’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 6 November adopted a decision granting least developed countries (LDCs) a pharmaceutical patent exemption for a duration of 17 years.

With this exemption, the world’s poorest nations will not be obliged “to implement or apply” or “to enforce” patents as well as test data protection for pharmaceutical products until 1 January 2033.

The decision was based on an agreement reached during a high-level meeting on 29 October between US Ambassador to the WTO Michael Punke and representatives of the LDC Group at the WTO, Ambassador Shameem Ahsan from Bangladesh and Ambassador Christopher Onyanga Aparr from Uganda.

In accordance with the agreement, the TRIPS Council also adopted a recommendation to the WTO General Council for waivers from “mailbox” and exclusive marketing right obligations. With these waivers, the LDCs will not be obliged to make available a mechanism for filing patent applications for pharmaceutical products (mailbox) or to grant exclusive marketing rights to such applications until 1 January 2033, although the waivers would have to be reviewed by the WTO General Council annually.

Falling short

“The deal reached is a slight improvement over the previous transition period which was for 14 years and without a mailbox waiver, but it is a far cry from the LDC Group’s original request to the TRIPS Council for a pharmaceutical patent exemption linked to a country’s graduation from LDC status, and what is needed to deal with the public health problems in LDCs,” said Chee Yoke Ling from Third World Network.

The LDCs’ original request received widespread unconditional support from developing countries, European Union members, various UN and international agencies (WHO, UNITAID, UNAIDS and UNDP), suppliers of generic medicines to LDCs, civil society organizations from across the world and even members of the US Congress and Senators including  Senator  Bernie  Sanders, a contender in the US presidential campaign.

However, none of this moved the US administration, which continued to stand largely alone in its opposition to the motivated requests of the poorest nations. Instead, the US offered a paltry 10-year duration, which was firmly rejected by the LDC Group.

According to trade diplomats, following the 10-year offer, the LDC Group hopefully countered with a 30-year duration, but even this was not acceptable to the US.

“By insisting first on 10 years and then drawing the line at 17 years, the US once again reveals itself as the bully-boy for Big Pharma, willing to do any dirty work needed to champion its global hegemony over the elixirs of life or death,” said Professor Brook K. Baker from Health GAP (Global Access Project) and Northeastern University School of Law, Program on Human Rights and the Global Economy.

Prerna Bomzan from the LDC Watch civil society network, based in Kathmandu, Nepal, said, “It is outrageous that the most vulnerable segment of the international community had to struggle to defend their basic right to health. Such negotiations make a mockery of Special and Differential Treatment for LDCs and of justice, human rights and sustainable development which are purportedly championed by the US.”

James Love from Knowledge Ecology International, reacting to the deal, said, “The decision to extend the WTO waiver of drug patent rules for 17 years is a better outcome than the 10-year waiver proposed by the US Trade Representative Ambassador Michael Froman, but it is also a disappointment, and falls short of what was asked and needed.”

He added, “The Obama Administra-tion’s trade policy continues to favour drug companies over poor people, and to prop a system that needs to be fixed and changed, and not defended.”

It is “puzzling that the US felt it had to play hard-to-get with the 34 poorest countries of the world instead of joining the consensus to grant the request,” said Ellen t’Hoen, an expert on intellectual property and access to medicines.

In a joint statement issued in response to the TRIPS Council decision, several health and development NGOs from developing and developed countries called on all LDCs to “actively use the created policy space this renewed transition period provides and accordingly to take immediate steps to amend 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”.                                                       

Third World Economics, Issue No. 603, 16-31 October 2015, pp11-12, 14