WHO Board Recommends Extension Of Plan For Health Innovation, IP

The World Health Organization Executive Board this week recommended the extension of an important strategy and plan of action on health, IP and innovation. It also set out steps to resolve questions over evaluation and review of the strategy and plan of action before the annual World Health Assembly in May.

The 136^th WHO Executive Board met from 26 January to 3 February.

The IP and innovation issue relates to the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA), which was adopted to “foster innovation and improve access for people in developing countries,” according to the WHO. The GSPA (WHA Resolution 61.21) and related documents are available here [pdf].

EB Decision

Today, the Executive Board agreed to an extension of the GSPA until 2022, and an extension of an “overall programme review” until 2018.

The decision includes language drafted yesterday by a working group (including government IP specialists) asking the WHO secretariat to report on options for the establishment of a management evaluation group, terms of reference, sequencing and other specifics, participants said.

The 3 February decision, EB136/CONF./7 Rev.2, [pdf] recommends that the 68^th World Health Assembly (WHA) in May extend the deadline of the overall programme review of the strategy and plan of action “on its achievements, remaining challenges and recommendations on the way forward to 2018, recognizing it was not presented in 2015, as requested by resolution WHA62.16.”

The decision further requested:

“the Director-General to provide a report for the Sixty-eighth World Health Assembly on options, in consultation and with the involvement of Member States, for the conduct of the comprehensive evaluation and the overall programme review of the global strategy and plan of action on public health innovation and intellectual property, on its achievements, remaining challenges and recommendations on the way forward, including whether to combine the two instruments, sequencing, terms of reference, timing and options for establishing an evaluation management group with the goal of completing this exercise by 2018.”

The decision reflects language deleted by the working group, as well as language added (in bold).

The language that was struck could be seen as reducing the involvement of member states, one government source said.

The addition at the end reflects efforts to decide whether to address the evaluation and review separately or together, as well as other details.

Discussions were oriented around a proposal from several developing countries (Argentina, Brazil, India and South Africa, with Ecuador later) for a 2 February draft decision [pdf] recommending that the annual May World Health Assembly extend the timeframe of the GSPA from 2015 to 2022.

The draft proposal also suggested to extend the deadline of the overall programme review of the GSPA to 2018, as it was not presented in 2015.

This draft decision follows an earlier version [pdf] tabled by the same countries on 27 January.

Secretariat Perspective

“The decision shows how much member states are engaged with this process of evaluation of the GSPA and how much they are concerned” about the implementation, Zafar Mirza, coordinator for Public Health, Innovation and Intellectual Property, told Intellectual Property Watch.

“Member states have also created a space between the Executive Board and the WHA to work out the best way forward for the evaluation of the GSPA,” he said.

The secretariat submitted a report, EB136/31, to this week’s Board meeting, proposing a timeline for the evaluation to be completed by the 2017 WHA. The secretariat approach asked this Board meeting to establish an “evaluation management group” to work on terms of reference and to guide selection of the evaluation team. The team would begin work this summer.

The past GSPA resolutions had indicated that the evaluations and comprehensive review would be separate. According to sources, the secretariat considered the 133^rd Executive Board meeting in 2013 to have approved a plan to proceed with the evaluation and review as one.

The secretariat report to the 133^rd EB, document EB 133/7 [pdf] said the difference between the evaluation and review was not clear in the GSPA, so it suggested combining the two. And it proposed to have the secretariat select an independent external evaluator.

The secretariat report to the 133rd EB requested the Board to “note and endorse” the report.

The 133^rd EB chair had said that her understanding was that the Board noted and endorsed the report, so the secretariat understood it was working on a combined evaluation/review. But some member states at this year’s EB said that was not their understanding and reopened the issue, which is still being worked out.

The report of EB 133 [pdf] shows the summary of the chair:

“The CHAIRMAN said that it was her understanding that the Board wished to request the Secretariat to prepare a progress report for consideration by the governing bodies in 2015, on the understanding that a report on a comprehensive independent evaluation would be submitted for consideration in 2017. If there was no objection, she would assume that, the Board, taking into account the discussion at its 133rd session, was prepared to note the report and endorse the suggested approach for the evaluation exercise, including in respect of reporting arrangements.”

Some developing countries this week noted that there was a great deal of divergence of opinions in the EB133, and did not agreed that the evaluation and review should be combined. They also sought more involvement in the evaluation process.

Marie-Paule Kieny, WHO assistant director general for Health Systems and Innovation, told the Board this week that the secretariat is due to give a progress report every second year. The last was provided in 2014, she said, and the next one would be due in 2016 if the action plan is extended.

The 2014 progress report on the GSPA is available here (A67/40 item I, pp. 17-21).

The timing of the evaluation stems from the EB133 decision, she said. She said it was not possible to come up with an evaluation in 2015, and should be postponed until 2017.

The WHO legal counsel was consulted on the issues and said that the GSPA extension should be decided by the WHA “because that is a normative instrument, which was adopted by the health assembly.”

The extension is neither an evaluation nor an assessment, he added, “It is the applicability of a major policy and normative instrument adopted by the health assembly.”

But the legal counsel said issues pertaining to the evaluation can be legitimately decided by the board.

Member State Involvement

In the 30 January board discussion on the issue, Brazil asked why the WHO “was not able to provide the overall programme review this year, in the WHA.” Brazil also said the evaluation procedure should involve member states and should not be done “solely by external evaluation, especially since there are implementation responsibilities for member states.”

Saudi Arabia for the Eastern Mediterranean Region concurred and said only EB members should form the evaluation management group. The Maldives for the Southeast Asia region also said the evaluation management group should include member states, as did China which said that member states from different regions should be represented in the group to reflect different interests.

Brazil requested that the secretariat provide for the next WHA the methodology and terms of reference of the review process.

A number of countries supported the extension sought by the draft decision, such as Gambia for the Africa region, the United States, and China.

South Africa sought to clarify the actions by the secretariat in relation to the 133^rd EB. On the evaluation management group, the South African delegate said no specific decision was taken at that time. Referring to paragraph 6 of WHA Resolution WHA62.16 [pdf] (page 30), she said the director general was requested to continue monitoring the plan of action and conduct an overall programme review.

The United States said this week it supported the GSPA extension, but also supports “following evaluation policy adopted by the Executive Board in May 2012 and further elaborated through the WHO evaluation practice handbook in 2013.” Norway concurred.

“For us,” the US delegate added,” part of reform means sticking to agreements that we have reached, and we think that should apply to evaluations including sensitive and important ones, like the [GSPA].” However, the delegate said, “the US agrees on the importance of transparency and engagement of member states as described in the draft decision.” He said the US proposed some edits, in particular including the participation of the EB Bureau in the evaluation management team. But a US official later said these were not agreed.

GSPA Implementation

The GSPA [pdf] (consolidated version), as agreed upon in 2008, includes eight elements:

• prioritizing research and development needs
• promoting research and development
• building and improving innovative capacity
• transfer of technology
• application and management of intellectual property to contribute to innovation and promote public health
• improving delivery and access
• promoting sustainable financing mechanisms
• establishing and monitoring reporting systems

The GSPA notably refers to intellectual property rights, stating that they are an important incentive for the development of new health care products. However, “this incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain.”

The strategy further underlines the fact that the Doha Declaration on the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “does not and should not prevent Members from taking measures to protect public health.”

The plan of action of the global strategy details specifics actions to be taken on each element and its sub-elements, and which stakeholder these actions fall to.

Persistent High Prices of Medicines

Gambia for the Africa region said public health-oriented research and development (R&D) is needed as well as access to affordable health products. The Maldives said de-linking the cost of R&D from products would promote access to medical products.

The North Korean representative said IP enhances innovation but should not be “cold blooded” and have some flexibility, in particular in public health. Intellectual property has been seen as a barrier to a better and healthier world, he said. The high prices of pharmaceutical products is an essential issue for poor populations, he said.

Médecins Sans Frontières (MSF, Doctor without Borders), in its statement, called on governments to extend the mandate of the GSPA to 2022. “We are a long way from fully implementing the Global strategy,” it said. “Every day, Médecins Sans Frontières continues to see the importance and role that the Global Strategy, if fully and properly implemented, could play in ensuring access and innovation to medicines,” the representative said.

“Today, we see increasing failures with our current system of research and development, whether with respect to Ebola, antibiotic resistance, or a range of neglected diseases. We also see unaffordable prices for essential new medicines, including up to US$1,000 per pill for new medicines to treat hepatitis C,” she added.

Instead of considering new R&D approaches, “some some governments, pushed by multinational pharmaceutical companies, are instead seeking to increase intellectual property protection worldwide, which will only deepen the challenges that MSF and others will face in accessing treatments, diagnostics and vaccines,” she said.

Image Credits: WHO