KUALA LUMPUR, May 29 — World Health Organization (WHO) member countries have agreed to support greater transparency of medicine pricing, but stopped short of forcing pharmaceutical companies to disclose research and development (R&D) costs.
A draft of a resolution at WHO’s annual assembly on drug pricing transparency published yesterday omitted wording from an earlier May 20 draft that gave the WHO powers to collect and analyse clinical trial data and the procurement prices of drugs and vaccines.
The agreed text of the resolution at the 72nd World Health Assembly, which ended yesterday, also changed initial wording about seeking more information on R&D and clinical trial costs, now simply saying that WHO states seek to improve the transparency of public and private funding for “health products’” R&D “across the value chain”.
The adopted resolution — which Italy had initially introduced and was co-sponsored by Malaysia and several other countries — urged member states to publicly share information on the net prices of “health products”.
WHO member states also promised to support dissemination of and access to the costs of clinical trials “if already publicly available or voluntarily provided”, regardless of outcomes.
James Love, head of US-based social justice non-profit Knowledge Ecology International, said this wording would be seen by the industry as “language making costs data confidential information”.
While the initial resolution urged member states to require the public disclosure of information like sales revenue, prices, and units sold; marketing costs; clinical trial costs; grants, tax credits and other public sector subsidies for medicines, vaccines, cell and gene-based therapies, and other relevant technologies, the adopted resolution urged countries to “work collaboratively to improve the reporting of information” by suppliers on “registered health products”. Wording on clinical trial costs was removed.
The final resolution also empowered the WHO to “analyse the availability of data on inputs throughout the value chain, including on clinical trial data and price information”, which Love described as “one of the tortured dances around R&D costs”.
He described the resolution as a “solid start”, pointing out that this was the first time the WHO has been asked to engage in transparency as a high-level issue.
“Overall, the resolution is, as expected, weaker overall than the version from May 20 sponsors text, but represents an impressive statement on price transparency, at time when non-disclosure agreements have become increasingly common,” Love said.
“For the large majority of countries and the NGOs that supported making R&D costs and clinical trial costs in particular more transparency, this resolution is at best, mixed, on R&D costs.”
WHO said in a statement that the adopted resolution urged member states to enhance public sharing of information on actual prices paid by governments and other buyers for health products, besides greater transparency of pharmaceutical patents, clinical trial results, and other pricing determinants along the value chain.
“It requests the WHO secretariat to support efforts towards transparency and monitor the impact of transparency on affordability and availability of health products, including the effect of differential pricing.
“The aim is to help Member States to make more informed decisions when purchasing health products, negotiate more affordable prices and ultimately expand access to health products for the populations”.
Health Policy Watch previously reported that the most contentious issue in the initial resolution was the public disclosure of the costs of pharmaceutical companies’ R&D, including any public subsidies received, during a drug’s regulatory approval.
The Guardian reported that the UK, Germany, and Hungary disassociated themselves from the resolution, a rare move as World Health Assembly resolutions are normally adopted by consensus.
