E-DRUG: Health Policy Watch: Medicine Prices: Secrecy of R&D Costs Remains Issue In Near-Final World Health Assembly Resolution
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Medicine Prices: Secrecy Of R&D Costs Remains Issue In Near-Final World
Health Assembly Resolution
26/05/2019 by Elaine Ruth Fletcher
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not be published until at least Monday, as negotiators raced to get a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. closed-door talks
Nevertheless, the latest version of the negotiating text - that had been
reached 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
*Paragraph1.2,* 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, and a with a note
indicates 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
<https://www.who.int/medicines/access/fair_pricing/en/>, 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 that
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.
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru@keionline.org