WHO Executive Board Agrees On Actions To Boost R&D, Access To Medicines

After long deliberations, the World Health Organization Executive Board agreed this morning to ask member states and the organisation to implement recommendations aiming at improving innovation and access to medicines. Three recommendations, specifically aimed at member states, including on the transparency on the cost of research and development of medicines, met resistance by some countries and were left hanging, to be discussed by member states with no timeframe.

A drafting group co-chaired by Colombia and Malta worked into the evening yesterday and this morning trying to reconcile two very different positions on the recommendations of an expert group, which reviewed the 2008 WHO Global Strategy and Plan of Action on Public Heath, Innovation and Intellectual Property (GSPA – also called GSPOA) (IPW, WHO, 25 January 2018).

This morning, according to sources, only two paragraphs were left to agree on, in an advanced version of a draft decision [pdf], one highlighted in yellow, the other in bracket.

Among the 33 recommendations in the report [pdf] of the expert review group (which gather the 108 of the original GSPA), some are addressed to member states, some to the WHO secretariat, and some to both. The pending decision concerned recommendations to member states.

The consensus language was found in the plenary session of the Board this morning, which adopted the decision. The final language of the first two (of four) provisions reads:

Paragraph 1: “To urge member states to implement, as appropriate and taking into account national contexts the recommendations review panel addressed to member states and consistent with the GSPOA.”

Paragraph 1bis: “To urge member states to further discuss the recommendations in the review panel not emanating from GSPOA.”

The Brazil Ambassador noted that the recommendations designated in paragraph 1bis are the following (out of 33 total provided by the review panel):

The 4^th one in the list of recommendations by the expert review group: “Member States to support the WHO Secretariat in promoting transparency in, and understanding of, the costs of research and development.”

The 27^th: “Member States to identify essential medicines that are at risk of being in short supply and mechanisms to avoid shortages, and disseminate related information accordingly.”

The 28^th: “Member States to commit to dedicating at least 0.01% of their gross domestic product to basic and applied research relevant to the health needs of developing countries.”

Brazil added that it is “by far” not what it would argue for, but the decision is a “good compromise,” hoping that the favour would be reciprocated later when those recommendations are further discussed.

The United States, which had signalled opposition to those recommendations earlier in the week, today also took the floor to say they agreed with the compromise. A number of Board members voiced their approval.

WHA Decision to Come

The decision has to be confirmed by the annual World Health Assembly in May, and questions remain about where to find the financing for the implementation of the recommendations of the expert review group, estimated at US$ 31.5 million over the period 2018–2022.

WHO to Report in 2020, to Implement Recommendations

On the other two actions in the final decision, one asks that the WHO implement the recommendations addressed to the organisation as prioritised by the review panel, in an implementation plan, “consistent with” the GSPA.

“(2) to request the Director-General to implement the recommendations addressed to the WHO Secretariat as prioritized by the review panel, in an implementation plan, consistent with the GSPoA.”

The WHO secretariat is also requested to provide a report on progress to the WHA in 2020.

“(3) to further request the Director-General to submit a report on progress made in implementing this decision to the Seventy-third World Health Assembly in 2020, through the Executive Board 146.” Board meeting 146 will be held in January 2020.

Among the recommendations that relate to intellectual property from the review to the WHO, one asks that the WHO secretariat “provide guidance to Member States on promoting and monitoring transparency in medicine prices and on implementation of pricing and reimbursement policies.”

The WHO secretariat is also to “work with the secretariat of the World Trade Organization to identify how Article 66(2) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) could be implemented more effectively in relation to health technology transfer in countries.”

The WHO also is asked to “advocate for the development of national legislation to fully reflect the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health.”

US Position at Odds with National Context?

According to sources, the strong position of the US on transparency is seemingly at odds with the push at the national level for more transparency on prices of medicines.

For example, Scott Gottlieb, US Commissioner of Food and Drugs Administration recently advocated for transparency, without reducing incentives to innovate.

On this side of the Atlantic, countries in the European Union appear to have added water to the wine in terms of their positions, as high prices of new medicines and shortages have started to bite their health systems and their citizens.

Reactions

James Love, director of Knowledge Ecology International, said in a statement, “The decision has a broad mandate for the WHO to act, and the recommendations to the member states are very good. We are happy to see support to expand the medicines patent pool, and that WHO member states continue to support delinkage of R&D costs from the prices of drugs and other products.”

“Transparency is at the core of the debate,” said Peter Grabitz, European coordinator for Universities Allied for Essential Medicines. “Only once reliable information on the true cost of Research and Development of drugs is available, solutions can be found.”

Other reaction statements will be added here as they are received.

 

Image Credits: William New