[Ip-health] Health Policy Watch: Negotiators Agree On Game-Changing WHA Resolution For Medicine Price Disclosure

Thiru Balasubramaniam thiru at keionline.org
Mon May 27 14:17:53 PDT 2019


Negotiators Agree On Game-Changing WHA Resolution For Medicine Price

27/05/2019 by Catherine Saez

A closed-door group of negotiators reached agreement late Monday evening on
a game-changing resolution to support greater public disclosure of prices
in medicine markets, as well as costs of related R&D investments.

One country delegate signaled “white smoke,” saying that a drafting group
meeting behind closed doors had reached a tentative agreement, after a week
of grueling negotiations.

A dedicated core of about 30 delegates led by Italy, and including Spain,
Brazil, Norway, Sweden, Switzerland, Thailand, Japan, the United Kingdom,
and the United States, among others, continued working late Monday night to
put the final touches on revisions to the earlier draft version
<http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2-en.pdf>, whose
final form will only be made public on Tuesday.

But some countries, including delegates from Germany which had mounted
stiff opposition, headed to the Geneva lakeside or back to their hotels.

Turkey also was reported to have withdrawn its previous co-sponsorship of
the resolution, a move that some linked to the objections from Germany.

Lingering concerns remained that any one of the countries absent from the
final evening session might raise last-minute objections to the resolution
when it is brought to the floor for approval on Tuesday, the final day of
the 72nd World Health Assembly

WHA resolutions are usually approved by consensus – with delegates rarely
resorting to a vote.

If approved, the resolution “Improving the transparency of markets for
medicines, vaccines, and other health-related products and other
technologies,” could be a redefining milestone in the way drug prices are
negotiated by governments and national health systems.

Spearheaded by Italy, and now supported by some 19 countries, it has
captured the attention of the Assembly this year. It aims to untangle the
net of secrecy built around pharmaceutical markets from the cost of
research and development, including clinical trials, to the prices
negotiated by countries, and the amount of public funding provided at
different stages of the value chain.

Opposition to the resolution centred upon its most core principles –
transparency of prices in medicines markets and more public disclosure of
R&D costs that are often used to justify high prices paid by national
health services and consumers.

The first breakthrough came early Monday evening, when delegates closeted
away into an ad-hoc drafting group reached agreement on the final text with
regard to more public sharing by member states of information on net prices
of medicines, vaccines, and other health-related products sold on global

Debate then continued over the clause focusing on more transparency for R&D
costs. This clause, in *Paragraph 1.2.*of a draft circulated over the
weekend, urges member states to “support dissemination of and enhanced
availability of and access to information about… results [and costs, where
available,] from human subject clinical trials regardless of outcomes…” The
brackets reflect the disagreement between delegates over the “cost”

Sources told *Health Policy Watch* Monday that a critical moment came when
France shifted positions to support a reference to costs of clinical trials
– breaking ranks with the powerful triangle of the United Kingdom, Germany
and the USA that have been more reluctant to tread on what is now regarded
as the private domain of pharmaceutical companies, which make the key
investments in pharma innovation.

Reportedly, the finalized compromise text refers to some form of voluntary
cost disclosure for R&D, sources said.

Number of Sponsors Swells to 20, Others Express Support in Public WHA

But while delegates haggled, the number of official country co-sponsors of
the draft transparency resolution continued to grow, numbering 19 as of
Monday, an Italian government spokesperson confirmed to *Health Policy
Watch*. The newcomers included the Asian regional powerhouse Republic of
Korea, as well as Malta – in addition to the 18 countries from Asia and
Africa that have already come on board.

Other regional leaders including Norway, the Netherlands and Switzerland,
as well as Brazil, Ecuador, and Thailand, publicly expressed support in
principle for the transparency resolution during a related discussion today
on WHO’s Draft roadmap
<http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf> for access to
medicines, vaccines and other health products. The public statements by
European delegates from Oslo, Berne and Le Hague were significant insofar
as the transparency debate has sometimes been seen to pit northern European
countries, such as the United Kingdom and Germany, against a bloc of
southern European nations.

The prices of some medicines, including cancer medicines are “reaching
unacceptable levels” Norway said, during discussions on the WHA floor.
Thailand voiced sharp concerns “that some member states act as if they are
representing the interests of the drug companies, not the people.”

Along with newcomers Korea and Malta, other formal co-sponsors of the
resolution include Andorra, Greece, Luxembourg, Portugal, the Russian
Federation, Serbia, Slovenia, and Spain 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.

A WHO statement today noted that: “The affordability of medicines has long
been a concern for developing countries, but today it is also a global one.
Each year, 100 million people fall into poverty because they have to pay
for medicines out-of-pocket. High-income countries’ health authorities are
increasingly having to ration medicines for cancer, hepatitis C and rare
diseases. The problem extends to older medicines whose patents have
expired, such as insulin for diabetes.”

WHO Roadmap Noted, Wide Agreement on Goals, Some Push Transparency

As debate over the transparency resolution continued, however, countries
expressed wide support for WHO’s Draft roadmap for access to medicines,
vaccines and other health products, reviewed today in WHA’s Committee A.
The roadmap etches a five-year (2019-2023) plan of action focusing on two
strategic areas: greater access to health products and more quality

Better quality assurance would include provisions for: strengthening of
regulatory systems; a stronger WHO “pre-qualification” system for assessing
quality, safety and performance; and better market surveillance. In terms
of access, the roadmap sets out measures for WHO to support more public
health-focused R&D, intellectual property management, procurement and
supply chain management, rational use of medicines, and “evidence-based
selection and fair, affordable pricing.”

“Access is a global concern, given the high prices of new pharmaceuticals
and rapidly changing markets for health products that place increasing
pressure on all health systems’ ability to provide full and affordable
access to quality health care,” the WHO roadmap states.

In a first ever initiative, Botswana delivered a joint statement
the African Group of member states and the European Union, which together
represent some 89 of WHO’s 194 member states, stating that access to
medicines and vaccines is a concern shared by all regions. The statement
mentioned the need to strengthen health systems, the use of flexibilities
permitted by the World Trade Organization Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS), and the strengthening of
regulatory capacities in countries.

Countries stressed the need for wider use of generic and biosimilar
medicines, and to promote research and development more in tune with public
health needs. High prices were also regularly pointed out as a solid
barrier to access to medicines, as well as frequent shortages and
stock-outs of medicines.

Civil Society and Industry Express Views

Civil society and industry groups took the opportunity of the Roadmap
discussion to air their views too – particularly on the sensitive
transparency resolution.

“Transparency is not a goal in itself,” remarked one group, Health Action
International, “but a means to an end, and can be a multiplier of
government efforts to improve universal access to medicines in areas such
as health technology assessment, pricing decisions, procurement and
reimbursement mechanisms.”

The Drugs for Neglected Disease initiative (DNDi), which works with private
sector partners, said that “transparency on costs of R&D is a central
element of DNDi’s policy. We put as much information into the public domain
as possible, including all clinical trial data, our actual R&D costs and
related financing flows, including the in-kind contributions from our
partners where they provide them.”

And the Washington DC-based Knowledge Ecology International, which has
lobbied hard for the transparency measure, put in a plea for greater public
reporting of R&D costs for expenses such as clinical drug trials, saying
“if you fail to address R&D cost, the entire argument for high price
becomes an evidence-free narrative.”

However, a representative of the International Federation of Pharmaceutical
Manufacturers and Associations (IFMPA), warned countries to “carefully
consider potential risks to patients, particularly in less developed
countries, of sharing outcomes of confidential prices negotiations across

Such information-sharing could actually drive up prices in less developed
countries that now get special discounts, if developed countries were to
see what they are paying and then demand greater price parity, IFPMA has

In reference to reporting on R&D costs, the IFPMA representative said that
medicine prices should reflect the therapeutic value of medicines and
positive outcomes for patients and society, “rather than simply the cost
‘input’ of an individual medicine.”

At the same time the IFMPA representative noted that pharma manufacturers
hear and “understand the call for more information about our scientifically
complex, and high-risk business model.”

*Beatrice Marone and Elaine Ruth Fletcher contributed reporting to this

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

More information about the Ip-health mailing list