WHO Members Set To Debate Transparency Of R&D Costs

World Health Organization Executive Board members and observer countries today are preparing to discuss recommendations on ways to make medicines more accessible. This includes a new proposal to increase transparency in research and development costs that is reportedly causing concern among some developed countries.

The relationship between intellectual property, innovation and public health is not the easiest one at a global policy level. Board members this week are finding it difficult to agree on a series of actions to promote new thinking on innovation and access to medicines.

A review group of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA, also called GSPOA) delivered a report in November, with a set of recommendations. One of these is that member states support the WHO secretariat in promoting transparency in, and understanding of, the cost of R&D.

A recommendation (p.20, Promote Research and Development) states: “Member States to support the WHO Secretariat in promoting transparency in, and understanding of, the costs of research and development. (Indicator: Reports on the costs of research and development for health products prepared in 2019 and 2021.)”

The GSPA was originally negotiated and approved by the full WHO membership in 2008, included 8 elements and 108 actions, and was reviewed by an outside sub-contractor, chosen by the WHO, that did not meet the approval of some WHO members, in particular India and Brazil.

The 108 GSPA actions generally languished during the years and was set to expire by 2018 and members agreed last year to extend the GSPA until 2022. A panel of 18 experts, made up of 3 approved experts from each of the six WHO regions, was appointed to conduct a review of the global strategy and plan of action.

The Executive Board, which is meeting from 22-27 January, is expected to adopt a draft decision [pdf] validating the recommendations and findings of the expert review group.

The expert group was given the mandate [Decision EB/140/(8)] to review the 108 actions to: “recommend a way forward, including details of what elements or actions should be added, enhanced or concluded in the next stage of implementation of the global strategy and plan of action on public health, innovation and intellectual property, until 2022.”

In its November 2017 recommendations, the review panel recommended to streamline the 108 actions into 33, 21 high priority, 12 priority, including two new ones: add transparency, and to resurrect a proposal from a pre-existing committee (CEWG) to ask governments to dedicate 0.01 percent of their budgets to health R&D.

EU Split

The transparency recommendation is the one reportedly facing opposition from the United States, and possibly Germany, the United Kingdom, Switzerland, Sweden, and Japan. One argument they may make is that the expert review was not mandated to introduce new recommendations not included in the carefully negotiated GSPA. But others will likely argue that the mandate of the review group was to make changes, cut out any no longer relevant, and also add any new ones.

Meanwhile, the European Union has developed a schism on the issue of R&D costs and pricing, as Portugal, the Netherlands and Austria and others have begun taking action to address high health costs.

The irony of this opposition has been pointed out by health advocates, as in those countries, including the US, debates are raging domestically over the high prices of medicines and the lack of transparency on how prices are set. A US delegate could not comment by press time.

Proponents of the adoption of the decision note that the original 108 actions are still valid until 2022, but the sheer number of actions make the GSPA non-implementable without prioritisation, making the expert review actions useful for the WHO, sources said.

William New contributed to this report.

 

Image Credits: Catherine Saez