WTO Members Discuss UN High-Level Report On Medicines Access That WHO Declined To Discuss

The World Trade Organization intellectual property committee this week discussed the report of United Nations Secretary General’s High-Level Panel on access to medicines which offered recommendations regarding the use of intellectual property in international trade. Developing countries taking the floor accentuated the use of flexibilities under trade rules, and the World Health Organization gave an overview of how its activities follow the panel’s recommendations, and its future projects. Civil society meanwhile criticised the WHO’s decision to dismiss a request by some developing countries to include discussions on the UN report at the next Executive Board Meeting. WHO then used this WTO meeting to make a statement about the UN report.

The WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) took place from 8-9 November.

Brazil, China, India and South Africa added the item to the Council agenda to discuss the UN High-Level Panel Report [pdf] on Access to Medicines published in September (IPW, Public Health, 14 September 2016). The report provides direct recommendations regarding the TRIPS Agreement and in particular the flexibilities that were enshrined in the agreement for the use of developing countries.

A number of countries took the floor to provide comments on the report, as did the WHO and the UN Conference on Trade and Development (UNCTAD). According to a WTO source, many developing countries, including Egypt, Indonesia, Bangladesh and Bolivia welcomed the discussion in the TRIPS Council.

Brazil, one of the co-sponsors of the agenda item, said in its statement that the report calls for WTO members to commit, at the highest political levels, to respect the letter and the spirit of the 2001 Doha Declaration on TRIPS and Public Health. That declaration clarified the right of WTO members to use flexibilities in TRIPS.

The UN report also recommends that WTO members make full use of the policy space available in TRIPS Article 27 (Patentable Subject Matter), “by adopting and applying rigorous definitions of invention and patentability that curtail the evergreening to ensure that patents are only awarded when genuine innovation has occurred,” according to the Brazilian statement.

The Brazilian delegate also underlined the report’s recommendation calling on governments to adopt and implement legislation that facilitates the issuance of compulsory licences, in particular for essential medicines. He also highlighted the recommendation that governments and the private sector refrain from “explicit or implicit threats, tactics or strategies that undermine the right of WTO members to use TRIPS flexibilities.”

Brazil said it understands that it is important for the TRIPS Council to “pay due attention to the issues and recommendations raised” by the report and called for continued discussion at the next TRIPS Council.

India in its statement underlined the fact that although the TRIPS provides “substantial degree of flexibility” to members, the full use of these flexibilities is in the hands of member states. “However, many developing countries are constrained by limited technical capacity to make full utilization of the TRIPS flexibilities and therefore they need appropriate technical assistance from relevant multilateral organizations in order to fully utilize the TRIPS flexibilities from the perspective of specific sectors of their economies such as agriculture, manufacturing, public health, environment, etc.,” the Indian delegate said in his statement.

He added that some attempts by developing countries to use flexibilities to address public interest objectives through measures fully consistent with TRIPS have been challenged legally as well as politically.

“A slew of regional trade agreements containing TRIPS-plus standards of IP protection and enforcement have the potential to significantly undermine the effective and full use of the TRIPS flexibilities,” he said, adding that investor-state disputes under regional or bilateral investment protection agreements are also emerging as a major challenge to the use of TRIPS flexibilities in the public interest.

Incoherence, Distraction, Some Countries Find

According to a WTO source, the United States although it said it is strongly committed to life-saving medicines around the world, voiced disappointment on the report which it found “distracts rather than benefits” the objective of achieving universal health. Underlining the importance of IP to promote new research and innovation, the US delegate said there can be no access to drugs that have not been developed.

The EU underlined the fact that the work of the panel is grounded in an assumption that there is a policy incoherence (between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies), according to a WTO source.

The EU noted that the panel focused exclusively on alleged conflict between research and access to medicines, remarking that the European Commission adopted a “holistic approach” to balance the need to finance research and to ensure that affordable medicines reach those in need, the source said.

Switzerland, Japan and Korea also underlined the “narrow scope” of the report, and remarked that the use of compulsory licences must not discourage innovation, the source said.

In its statement, Switzerland said that improving access to medicines, strengthening global health research, protecting intellectual property and promoting human rights are priorities for the country.

The Swiss delegate remarked on the fact that the high-level panel was commissioned by the UN Secretary General, without a mandate from UN member states, and commented on the “very narrow” scope of the mandate of the panel. Switzerland would have preferred a more holistic approach, he said.

Switzerland said the report makes a number of interesting proposals that are already being explored in international organisations, such as the creation of a publicly accessible database with patent information status.

The panel’s report “fails to fully recognise the key role that intellectual property rights play in incentivising research and development of medicines,” he said, adding that a “systematic weakening of intellectual property rights … risks to discourage bio-medical innovation.”

The TRIPS Council agreed to continue the conversation on the matter at the next Council meeting in February 2017, according to the WTO.

UNCTAD: Importance of Flexibilities

UNCTAD, which was a member of the Expert Advisory Group to the High Level Panel, was involved in the expert discussions that fed into the High Level Panel’s report, the UNCTAD representative said, according to its statement.

UNCTAD’s “advisory and capacity building work over the past ten years shows that these flexibilities, such as the recourse to strict patenting requirements, certain exceptions to patent rights and the availability of compulsory licenses play an important role in promoting generic competition and thus decreasing drug prices,” it said.

In light of UNCTAD research, “many of those countries that now enjoy a fully developed pharmaceutical sector in the past relied on many of those flexibilities that the High Level Panel Report recommends in order to strike a balance between inventors’ rights and the realization of certain development objectives,” the representative said.

WHO Activities Meeting Panel Recommendations

The WHO, providing feedback on the report, said WHO was also a member of the Expert Advisory Group. The conclusions of the report “are sobering,” said the WHO representative, according to his statement. The report states that “Millions of people continue to suffer and die from treatable conditions … because of a lack of access to health technologies,” he said.

The report underlines many recommendations already found in the WHO Global Strategy and Plan of Action on public health, innovation and intellectual property, he said. Many of the report’s recommendations are in line with a number of WHO resolutions, he said, “including those that encourage WTO Members to make full use of TRIPS flexibilities.”

The panel recommends that UNCTAD, the UN Development Programme, WHO, the World Intellectual Property Organization and WTO cooperate with other relevant bodies to support governments to apply patentability criteria that are sensitive to public health concerns, he said, adding that the WHO is already working closely with its UN partners.

WHO, WTO, WIPO, and UNCTAD have joined forces to provide advice to the South African government “as it rethinks its intellectual property policy,” he said.

The WHO shares the view of the panel that new incentives for R&D of health technologies are needed, he said, adding that the report acknowledges two recent WHO initiatives: the Global Antibiotic Research and Development Partnership, a joint venture of WHO and the Drugs for Neglected Diseases initiative (DNDi), and the R&D Blueprint for action to prevent epidemics.

The representative also underlined the report’s recommendation reiterating the main recommendations of the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which is a binding R&D convention that delinks the cost of R&D from end prices to promote access.

An R&D treaty has earned strong support from civil society organisations, “and may be again discussed in the coming months in WHO Governing Bodies’ meetings,” he said.

The WHO also underlined its Global Health R&D Observatory to provide data on R&D activities and identify R&D gaps. Once those gaps are identified, priority-setting will be undertaken by a new independent WHO Committee on R&D Coordination, which will be established in the first quarter of 2017. The observatory and the new R&D Coordination Committee will be discussed by the upcoming WHO Executive Board meeting in January, he said.

The report calls for an expansion of the WHO Global Price Reporting Mechanism which has already been expanded to include hepatitis C, he said, and WHO will consider expanding it to include more patented essential medicines.

However, he said, “it is not practically feasible to establish a database of all prices worldwide of all patented and generic medicines in the public and private sector and given that many prices currently are not transparently available.”

On the recommendations of the panel to provide more transparency on patent information, he said that it is important to draw on the experience of other organisations, and existing databases such as the one managed by the Medicines Patent Pool, to avoid duplication of effort “and ideally create a one-stop shop for the public-health community.”

Civil Society Demands WHO Discussion on UN High-Level Panel

On 8 November, some 17 civil society groups called on WHO Director General Margaret Chan, in a letter [pdf], to reconsider a decision taken in September not to include an agenda item on the High-Level Panel report for the next WHO Executive Board (EB) meeting in January.

The draft agenda for the Executive Board is here [pdf].

According to the letter, on 12 September, 11 WHO member states of the South-East Asian Region and supported by Brazil, Iran, and South Africa, requested the item be placed on the agenda of the upcoming Board meeting.

However, the letter mentions a Note for the Record of a teleconference with the Officers of the Board meeting regarding the draft provisional agenda of the 140th session of the EB, in which Chan along with five officers of the Executive Board rejected that request.

“This rejection represents a slap in the face to UN Secretary-General Ban Ki-Moon’s efforts to comprehensively review and assess ‘proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies’,” the authors wrote.

 

Image Credits: USTR