28 May 2019: 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 reportedly 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 the UK move, led by Julian Braithwaite, Britain’s UN Ambassador in Geneva, was unexpected since the British delegation had been part of the ad-hoc “drafting group” that only the night before had agreed to the resolution’s final language.
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 development.
But senior WHO officials called it a landmark measure, which could have a lasting impact on 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.
WHO Director-General Dr Tedros Adhanom Gheyebresus called the resolution a “landmark agreement to enhance the transparency of pricing for medicines, vaccines and other health products,” in his closing remarks before the close of the WHA today, just an hour after the vote.
Norway, while not a sponsor, described it as “a milestone – the first step in a process that will result in better access to data on pricing of medicines – and we hope it will contribute to lower prices.”
The language of 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 provide such cost data when it is “publicly available or voluntarily provided.”
The complete text urges 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 confidentiality.”
Country Positions on the Final Resolution
Despite the UK’s participation in yesterday’s late-night compromise on this very text, Braithwaite, in his remarks today, complained that the resolution should have first been reviewed by WHO’s Executive Board.
He said that the UK was concerned about ensuring that “price transparency does not threaten” differential pricing arrangements, whereby low- and middle-income countries can purchase certain medicines and health products at lower prices than those paid in developed nations.
“The UK has long supported access to medicine, in particular in low- and middle-income countries [LMICs], through access strategies including voluntary patent-sharing, licensing and market-shaping to promote generic market entry,” Braithwaite said. “Given these complexities and the need to take an evidence-based approach,” he added, “we believe more time should have been allowed… to carefully consider the potentially far-reaching implications of the resolution… [so] the United Kingdom is left with no option but dissociate itself from the resolution.”
However, among the countries that stand to gain or lose the most, the African bloc of member states voiced unanimous approval for the transparency measure. A delegate from Botswana, speaking on behalf of the group said that the “African group is in full support of the adoption of the resolution, seeing it as a key to achieving universal health coverage.”
The other key opponent, Germany, asserted that the resolution had been “rushed through, bypassing the Executive Board.”
“We have major concerns regarding the process that has led to the current resolution,” Germany said. “Like many other delegations we share the view that transparency of prices is a highly complex issue that calls for sufficient assessment of potential implications for the involved health-care systems.”
The German delegate also complained of the civil society campaign – which included letters to health ministers of the UK, France and Germany, as well as social media posts – saying that member state negotiators were “targeted” through publicised leaks of their “perceived positions,” breaching what he described as “a culture of respectful negotiations.”
However, Brazil’s delegate noted that along with the prolonged negotiations at the WHA, there had been two rounds of WHO-hosted informal country consultations earlier in May. “This process, given its open-ended, transparent, inclusive, and exhaustive nature has given all WHO member states the proper opportunity to participate, to make their views clear and transparent to everyone, including the civil society,” he said, adding that other WHA decisions had been made without first being submitted to the Executive Board.
The delegate from Switzerland underlined the importance of transparency of prices of medicines and vaccines, and described the resolution as “the fruit of very delicate negotiations,” while expressing regret “that it has not been unanimously supported.”
As for the US position, delegate Garett Grigsby said today in the WHA that the “United States enthusiastically welcomes the resolution’s focus on improving price transparency for health technologies and encourages other governments around the world to take steps to improve their healthcare systems and promote competition by publishing prices of medicines and other health products.”
On the R&D front, Grisby also said the US supports “transparency of patent information and clinical trial results,” but he stopped short of adding trial costs to that list.
Lucas Li Bassi, Director of the Italian Medicines Agency, who led the week-long, closed-door negotiations of the WHA “drafting group,” acknowledged that there had been “hiccups” in talks over the “sensitive” measure.
“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.”
In contrast to the German delegate’s remarks, Li Bassi said he had been “pleased and surprised” with the interest generated by the resolution – “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 also 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.”
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 democratic,” he said.
Industry and Civil Society Respond
For its part, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which had remained largely in the background during the debate between WHO member states, issued a statement expressing concern about the impacts of the resolution on developing countries – although it also sounded a conciliatory note.
“IFPMA and its member companies stand together with the global health community to support Member States in accelerating efforts to achieve Universal Health Coverage (UHC),” the statement said, adding that “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.”
“The single focus on price falls far short of the complexity of access issues at large,” continued the IFPMA statement, adding that it remains to be seen how “transparency on net prices across very different markets will impact patient access to medicines.”
“Nevertheless, 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.”
On the other side of the fence, Knowledge Ecology International (KEI), a Washington DC-based NGO credited with working extensively behind the scenes to sell the resolution initiative to member states, in a statement called it “an impressive achievement, at a time when non-disclosure agreements [between health providers and industry regarding medicines purchases] have become increasingly common and problematic.”
KEI added that the “resolution creates a mandate for Member States and the WHO to create systems to collect and share information about prices, sales, units sold, patents, public and private sector R&D costs, R&D subsidies and other items.”
“The largest failure was in the area of clinical trials costs,” KEI said in the statement, noting that there “was broad and enthusiastic support for the disclosure of trial costs from many countries, but a small number of industry-friendly countries blocked a consensus on mandates for trial cost disclosures,” referring in particular to opposition from US Health and Human Services Secretary Alex Azar, a former president of the Pharma firm Lilly, USA.
“This resolution is an important first step in making markets more transparent, and is the beginning rather than the end of a process,” said KEI.
By Elaine Ruth Fletcher