Medicine Prices: Secrecy Of R&D Costs Remains Issue In Near-Final World Health Assembly Resolution

The latest working draft World Health Assembly resolution calling for game-changing public disclosure of the prices paid for medicines, vaccines and other health products by countries and health systems shows a broad coalition of countries from Europe, Latin America, Africa and Asia forming around the compromise draft. The draft, obtained Sunday by Health Policy Watch, was close to finalisation following protracted weekend negotiations [see Medicines Prices – Delegates Near Agreement].

Some 19 countries are now co-sponsors of the draft resolution, said a spokesperson for the Italian Government, reflecting the growing political momentum in support of what advocates hope could lower the price bar and increase access to medicines.

The Italian government spokesperson said that a final draft of the resolution on “Improving the transparency of markets for medicines, vaccines, and other health-related products and other technologies” would not be published until at least Monday, as negotiators raced to get a finalised version ahead of the closing session of the WHA on Tuesday.

Negotiators have increasingly become nervous about discussing the draft. Even while the issue at stake is transparency, they said that public disclosure of the contentious points of the draft could make agreement more difficult to reach.

Negotiators entering Room 24 of Geneva’s UN headquarters at the Palais des Nations, where closed-door talks on the draft price transparency resolution resume on Monday.

Nevertheless, the latest version of the negotiating text – reached by negotiators as of 7 p.m. Saturday evening, when the ad-hoc “drafting group” adjourned after nearly 34 hours of non-stop talks – was circulating widely among WHA representatives over the weekend, as they, in turn, consulted over finalisation.

The copy obtained by Health Policy Watch reflects the tough fight over R&D costs as the most substantive outstanding issue.

This, as well as other technical comments and caveats, leaves negotiators with considerable work to complete when they resume at 9 a.m. Monday morning in Room 24 of Geneva’s UN Headquarters at the Palais des Nations.

The word “costs” is still hanging by a thread in the critical draft Paragraph 1.2, which asks WHO member states to support enhanced access to information on human clinical drug trials, regardless of whether the results were positive or negative. But the sensitive “costs” reference is bracketed – meaning that it hasn’t been agreed to widely – with a note indicating that the United Kingdom, Japan, Belgium, Switzerland and the USA have particular reservations, yet to be resolved.

The complete text of the paragraph asks member states to:

“Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to information about [procedure and] results [and costs, where available,] from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring [patient/appropriate] confidentiality.”

Countries noted as having reservations about the term “costs,” or in the case of the US, the entire section, are listed as follows: “UK (costs), Japan (costs), Belgium (costs), Switzerland (costs), US (paragraph and costs).”

Germany, another country that had previously balked at detailed revelations of R&D costs, was not at the closed-door negotiations Saturday due to the European elections, observers said.

A more general reference to R&D in the text preamble seems to have wider agreement, although it avoids using the sensitive “c” word. That paragraph notes “the importance of both public and private sector funding for research and development of health products, and seeking to improve the transparency of such funding across the value chain.”

Market Price Disclosure Has Wider Consensus

On the second key issue addressed – more systematic public disclosure of the prices of bulk drug sales to governments and health systems – Saturday’s draft seemed to reflect a consensus that is more nearly complete.

Only two countries, Germany and the United Kingdom, are noted as having reservations about Paragraph 1.3, which urges WHO member states to “work collaboratively… to improve the reporting by suppliers of information on registered medicines, vaccines, and other health-related products and other technologies, such as reports on sales revenues, prices, units sold, …and subsidies and incentives.”

Paragraph 1.1, which asks member states themselves to “publicly share information on net prices of medicines, vaccines and other health related products and other technologies,” still has reservations noted by the UK, Japan and Belgium.

Paragraphs 1.4 and 1.6, asking countries to “facilitate improved public reporting of patent status information covering health products as well as marketing approval status,” and “improve national capacities on research and development of health products, especially in developing countries and LMICs,” both appear to have wide agreement, with no reservations noted.

Agreement Coalescing on WHO Role

Similarly, consensus seemed to be emerging around WHO’s role in the transparency initiative.

WHO would receive a significant mandate to “analyse the availability of data on inputs throughout the value chain, including on clinical trial data and price information, with a view to assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.”

Draft language further asks WHO to support member states in a series of other measures including:

  • “Collecting and analysing information on economic data across the value chain for health products and data for relevant policy development and implementation towards achieving Universal Health Coverage (UHC)” (although the UK is noted as having reservations);
  • “Developing and implementing their national policies relevant to the transparency of markets for health products, including national capacities for the local production, quick and timely adoption of generic and biosimilar products, cost-effective procurement and supply-chain management of health products;”
  • Research on and monitoring of “the impact of price transparency on affordability and availability of health products;”
  • Continue working on patent landscapes and “user-friendly patent status information databases for public health actors,” in collaboration with the World Intellectual Property Organization, the World Trade Organization and others;
  • Convene the biennial Fair Pricing Forum, and report back to the WHA in two years time on this resolution.

However, on the sensitive matter of global reporting about research and development costs, there are also apparent concerns about expanding the WHO role too much.

A paragraph providing for WHO to report back to the WHA next year on “measures that are needed… to enhance the reporting on pre-clinical investments in R&D by both the public and the private sectors,” was earmarked by Germany for deletion.

As reflected in the working draft as of Saturday evening, the 18 countries that had signed onto the resolution, along with the resolution leader Italy, included Andorra, Greece, Luxembourg, Portugal, the Russian Federation, Serbia, Slovenia, Spain and Turkey from the European Region; Egypt from the Eastern Mediterranean Region; India and Sri Lanka from the South East Asian Region; Malaysia from the Western Pacific Region, and Eswatini, Kenya, South Africa, and Uganda from the African Region. Notably there were no co-sponsors reported yet from the Americas.

Country number 19 also remained a mystery.

Beatrice Marone contributed to this story.

Image Credits: Catherine Saez.

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