Italy Floats Proposal For New Deal On Drug Pricing At World Health Assembly

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 [pdf] 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.

Pricing of Cancer Medicines and its Impacts (WHO 2018).

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 propaganda.”

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 said.

“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.”

 

Image Credits: WHO.

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