[Ip-health] Health Policy Watch: World Health Assembly Approves Milestone Resolution On Price Transparency

Thiru Balasubramaniam thiru at keionline.org
Tue May 28 10:35:42 PDT 2019

Health Policy Watch published this wrap up story on the dramatic conclusion
of the 72nd World Health Assembly's negotiations on the transparency
resolution. This article is best viewed on the Health Policy Watch website
which provides colorful photos of the transparency resolution's denoument:


World Health Assembly Approves Milestone Resolution On Price Transparency
28/05/2019 by Elaine Ruth Fletcher

The World Health Assembly today approved a milestone resolution to support
greater public disclosure of prices for medicines and other health products
– capping a nail-biting series of negotiations that continued until the
very moment the measure came to the floor.

In a highly unusual move, Germany, the United Kingdom and Hungary
“disassociated” themselves from the measure, “Improving the transparency of
markets for medicines, vaccines and other health products,” complaining
that its far-reaching implications were not fully appreciated, and that the
four-month review period since the draft resolution’s submission by lead
sponsor Italy had been insufficient.

The public expression of dissent followed a last-minute attempt by the UK
delegation Tuesday morning to postpone review until January 2020, observers
told Health Policy Watch. That would have pushed formal consideration to
May 2020, at next year’s World Health Assembly.

The UK attempt to pull the resolution from the floor of the WHA’s Committee
A, just as members were convening this morning, visibly delayed proceedings
for nearly an hour as the resolution’s 19 co-sponsors, led by Italy,
huddled with other delegates to decide what to do.

The UK initiative was finally quelched after Spain, one of the
co-sponsoring countries, said that any UK proposal would be met with a
request to put the measure to a formal vote – something that WHA member
states usually seek to avoid at all costs.

“They were compelled to stand down,” said one observer to Health Policy
Watch, noting that UK delegates had been part of the ad-hoc “drafting
group” that only the night before had agreed on the resolution’s final

Ultimately, the measure was brought to the floor and approved, maintaining
a semblance of unity in WHA halls. Opposing remarks by the UK, Germany and
Hungary were aired verbally along with comments from co-sponsors and
supporters, including lead sponsor Italy, as well as Spain, Brazil, Japan,
Switzerland, Norway, Thailand, the large African bloc of member states, and
the United States.

Despite the controversy that it triggered, the final resolution remains a
somewhat watered-down version of the original, emphasising the purely
voluntary nature of disclosures for sensitive information on research and

But senior WHO officials called it a landmark measure, which could have a
lasting impact lowering prices in markets for urgently needed health
products, ranging from treatments for cancer and hepatitis to insulin,
which today are unaffordable in many low- and middle-income countries.

The resolution asks WHO member states to: “Take appropriate measures to
publicly share information on the net prices of health products,” which it
defines as the “net price or effective price or net transaction price or
manufacturer selling price [that] is the amount received by manufacturers
after subtraction of all rebates, discounts, and other incentives.”

The most hotly-contested phrase urging disclosure of R&D costs,
particularly for clinical trials, which are sometimes used to justify
consequently high drug prices, was cautioned with language underlining its
voluntary nature.

The finalised paragraph asks WHO member states to: “Take the necessary
steps, as appropriate, to support dissemination of and enhanced
availability of and access to aggregated results data and, if already
publicly-available or voluntarily-provided, costs from human subject
clinical trials regardless of outcomes or whether the results will support
an application for marketing approval, while ensuring patient

Lucas Li Bassi, director of the Italian Medicines Agency, who spent most of
the week-long WHA, including evenings and weekends, in a series of
closed-door negotiations with the ad-hoc “drafting group” of countries,
acknowledged that there had been “hiccups” in talks over the “sensitive”

“We had to build constructive dialogue around sensitive topics,“ he said,
adding that he was ultimately satisfied “to see how many countries and
member states around the world have gathered around these important topics
with an open mind and willingness to identify [a] way forward.”

Li Bassi said he also had been “pleased and surprised” with the interest
generated “not only [among] policy-makers, regulators and government
officials but also [in] the academic world, science, medical doctors, and
health professionals all around the world.”

Li Bassi said he was equally “surprised to see how this topic is considered
so important for normal people, for patients and for civil society groups,
which also desire to participate in dialogue,” a reference to the
widespread media and social media attention that the negotiations received.

Spain’s representative Martin Remon, meanwhile, called the resolution a
“reasonable step forward in the face of a problem that affects everyone,”
adding, as one of the co-sponsoring countries: “Of course we would have
preferred fewer reservation and greater clarity regarding R&D costs and
clinical trials.”

Remon, however, sounded a note of warning to industry forces, whom some
perceived as working behind the scenes to weaken or delay the passage of
the transparency measure: “Industry has to be aware that this must be a
path from which we cannot turn away. It is fair, it is necessary and

For its part, the International Federation of Pharmaceutical Manufacturers
and Associations (IFPMA), which has largely stayed in the background during
the debate between WHO member states, issued a statement that sounded a
conciliatory note, expressing strong support for “improving affordability
and access to medicine and vaccines,” but noting that the issue was more
complex than publication of market prices.

“The single focus on price falls far short of the complexity of access
issues at large,” IFPMA said, adding, “improving affordability and access
to medicines and vaccines is a multidimensional challenge that requires
collaborative and holistic solutions from all stakeholders, including the
industry, to reduce the out of pocket payments for patients, tackle
inefficiencies in supply chains, fight against fake medicines, improve
procurement practices, and allow for differential pricing for LMICs.”

IFPMA added that it remains to be seen how “transparency on net prices
across very different markets will impact patient access to medicines,” but
added that “IFPMA and its members will work constructively with WHO, member
states and other stakeholders to reach shared values around innovation,
access and affordability of health products for the benefit of patients
across the globe, especially in the LMICs (lower and middle-income

Catherine Saez contributed reporting to this story.

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

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