[Ip-health] Health Policy Watch: Italy Floats Proposal For New Deal On Drug Pricing At World Health Assembly

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 18 09:20:08 PST 2019


Italy Floats Proposal For New Deal On Drug Pricing At World Health Assembly
18/02/2019 by William New

Italian Health Minister Giulia Grillo has proposed that sweeping reforms be
considered by the World Health Organization and its member states to
increase global transparency of drug prices — which may be unaffordable to
most people in the developing world and increasingly costly for patients
and health systems in high-income countries.

The Italian proposal, floated as a “first draft” of a possible resolution
to the World Health Assembly (WHA) in May would ask national governments to
“require as a condition for registration for drugs and vaccines” more
detailed data from industry on drug R&D costs, public subsidies, sales
revenues and marketing outlays. WHO would be asked by the WHA, the annual
meeting of WHO member states, to play a larger role as a clearinghouse of
available data on actual drug R&D and clinical trial costs, manufacturing
costs, and other key factors influencing pricing.

The proposal was contained in a 1 February letter from Grillo to WHO
Director General Tedros Adhanom Ghebreyesus.

The draft resolution would “provide WHO with the mandate to: collect and
analyse data on clinical trial outcomes and adverse effects of health
technologies; provide a forum for governments to share information on drug
prices, revenues, R&D costs, the public sector investments and subsidies
for R&D, marketing costs, and other related information” the letter from
Grillo said.

“We aim to provide you, Director General, with an authoritative mandate to
strengthen WHOs technical work on the transparency of the costs of research
and development, and the transparency of prices,” it added.

The draft resolution, “Improving the transparency of markets for drugs,
vaccines and other health-related technologies,” was proposed as part of
the planned discussion on Addressing the global shortage of, and access to,
medicines and vaccines during the 72nd session of the World Health Assembly
to be held on 20-28 May.

An Italian government spokesman told Health Policy Watch that the
initiative being advanced by the minister of health is still at a
“preliminary stage,” but that this signalled Italy’s willingness to put
forward a draft resolution on the issue at the Health Assembly.

Drug prices were a significant focus at the recent WHO Executive Board
meeting of 34 member states, with the spotlight on a recent WHO report on
cancer drug prices, which noted that millions of people worldwide lack
access to many mainstream cancer therapeutics.

The NGO Knowledge Ecology International (KEI), which posted the text of
Grillo’s letter along with the proposed draft resolution online, welcomed
the Italian initiative.

“The resolution seeks to address the large asymmetries in information about
the economics of drugs and other medical technologies,” said KEI Director
James Love. “This provides a road-map for ensuring that government policies
are based upon reliable evidence, rather than speculation, confusion and

Initial reaction from industry, however, was negative. A comment by the
International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA) said that the proposed resolution “would divert attention and
resources away from finding sustainable solutions to [drug] access,”
hinting that greater price transparency might also have “unintended
consequences” that diminished the capacity of pharmaceutical companies to
offer preferential pricing on certain medicines to developing countries.

“We share the goal of the World Health Organization (WHO) and its Member
States to ensure appropriate access to affordable and quality-assured
medicines, vaccines and health products as a key component of Universal
Health Coverage (UHC) and for achieving targets of the Sustainable
Development Goals (SDG).  We also acknowledge the concerns about
affordability and understand the calls for disclosure of more information
about our scientifically complex, and high risk business model,” the IFPMA

“However. …. Improving access can only be achieved through collaboration,
investment in strengthening health systems including regulatory systems,
reducing financial hardship and out of pocket expense for patients, while
supporting innovation that delivers breakthrough treatments and the
generics of tomorrow.

IFPMA further stated that there is “broad agreement that prices should
reflect the therapeutic value of medicines rather than simply the cost
“input” to developing and bringing a medicine to market.”

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

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