A closed-door group of negotiators reached agreement late Monday (May 27) evening on a game-changing resolution to support greater public disclosure of prices in medicine markets, as well as costs of related R&D investments.
One country delegate signaled “white smoke,” saying that a drafting group meeting behind closed doors had reached a tentative agreement, after a week of grueling negotiations.
A dedicated core of about 30 delegates led by Italy, and including Spain, Brazil, Norway, Sweden, Switzerland, Thailand, Japan, the United Kingdom, and the United States, among others, continued working late Monday night to put the final touches on revisions to the earlier draft version, whose final form will only be made public on Tuesday.
But some countries, including delegates from Germany, which had mounted stiff opposition, headed to the Geneva lakeside or back to their hotels.
Turkey also was reported to have withdrawn its previous co-sponsorship of the resolution, a move that some linked to the objections from Germany.
Lingering concerns remained that any one of the countries absent from the final evening session might raise last-minute objections to the resolution when it is brought to the floor for approval on Tuesday, the final day of the 72nd World Health Assembly.
WHA resolutions are usually approved by consensus, with delegates rarely resorting to a vote.
If approved, the resolution, “Improving the transparency of markets for medicines, vaccines, and other health-related products and other technologies,” could be a redefining milestone in the way drug prices are negotiated by governments and national health systems.
Spearheaded by Italy, and now supported by some 19 countries, the resolution has captured the attention of the Assembly this year. It aims to untangle the net of secrecy built around pharmaceutical markets, from the cost of research and development, including clinical trials, to the prices negotiated by countries and the amount of public funding provided at different stages of the value chain.
Opposition to the resolution centred upon its most core principles – transparency of prices in medicines markets and more public disclosure of R&D costs that are often used to justify high prices paid by national health services and consumers.
The first breakthrough came early Monday evening, when delegates, closeted away into an ad-hoc drafting group, reached agreement on the final text regarding more public sharing by member states of information on net prices of medicines, vaccines, and other health-related products sold on global markets.
Debate then continued over the clause focusing on more transparency for R&D costs. This clause, in Paragraph 1.2. of a draft circulated over the weekend, urges member states to “support dissemination of and enhanced availability of and access to information about… results [and costs, where available,] from human subject clinical trials regardless of outcomes…” The brackets reflect the disagreement between delegates over the “cost” reference.
Sources told Health Policy Watch Monday that a critical moment came when France shifted positions to support a reference to costs of clinical trials – breaking ranks with the powerful triangle of the United Kingdom, Germany and the USA that have been more reluctant to tread on what is now regarded as the private domain of pharmaceutical companies, which make the key investments in pharma innovation.
Reportedly, the finalised compromise text refers to some form of voluntary cost disclosure for R&D, sources said.
Number of Sponsors Swells to 19, Others Express Support in Public WHA Statements
But while delegates haggled, the number of official country co-sponsors of the draft transparency resolution continued to grow, numbering 19 as of Monday, an Italian government spokesperson confirmed to Health Policy Watch. The newcomers included the Asian regional powerhouse Republic of Korea, as well as Malta – in addition to the 17 other countries that have already come on board.
Other regional leaders including Norway, the Netherlands and Switzerland, as well as Brazil, Ecuador, and Thailand, publicly expressed support in principle for the transparency resolution during a related discussion today on WHO’s Draft roadmap for access to medicines, vaccines and other health products. The public statements by European delegates from Oslo, Berne and Le Hague were significant insofar as the transparency debate has sometimes been seen to pit northern European countries, such as the United Kingdom and Germany, against a bloc of southern European nations.
The prices of some medicines, including cancer medicines, are “reaching unacceptable levels,” Norway said, during discussions on the WHA floor. Thailand voiced sharp concerns “that some member states act as if they are representing the interests of the drug companies, not the people.”
Along with newcomers Korea and Malta, other formal co-sponsors of the resolution include Andorra, Greece, Luxembourg, Portugal, the Russian Federation, Serbia, Slovenia, and Spain from the European Region; Egypt from the Eastern Mediterranean Region; India and Sri Lanka from the South East Asian Region; Malaysia from the Western Pacific Region, and Eswatini, Kenya, South Africa, and Uganda from the African Region.
A WHO statement today noted that: “The affordability of medicines has long been a concern for developing countries, but today it is also a global one. Each year, 100 million people fall into poverty because they have to pay for medicines out-of-pocket. High-income countries’ health authorities are increasingly having to ration medicines for cancer, hepatitis C and rare diseases. The problem extends to older medicines whose patents have expired, such as insulin for diabetes.”
WHO Roadmap Noted, Wide Agreement on Goals, Some Push Transparency
As debate over the transparency resolution continued, however, countries expressed wide support for WHO’s Draft roadmap for access to medicines, vaccines and other health products, reviewed today in WHA’s Committee A. The roadmap etches a five-year (2019-2023) plan of action focusing on two strategic areas: greater access to health products and more quality assurance.
Better quality assurance would include provisions for: strengthening of regulatory systems; a stronger WHO “pre-qualification” system for assessing quality, safety and performance; and better market surveillance. In terms of access, the roadmap sets out measures for WHO to support more public health-focused R&D, intellectual property management, procurement and supply chain management, rational use of medicines, and “evidence-based selection and fair, affordable pricing.”
“Access is a global concern, given the high prices of new pharmaceuticals and rapidly changing markets for health products that place increasing pressure on all health systems’ ability to provide full and affordable access to quality health care,” the WHO roadmap states.
In a first-ever initiative, Botswana delivered a joint statement of the African Group of member states and the European Union, which together represent some 89 of WHO’s 194 member states, stating that access to medicines and vaccines is a concern shared by all regions. The statement mentioned the need to strengthen health systems, the use of flexibilities permitted by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the strengthening of regulatory capacities in countries.
Countries stressed the need for wider use of generic and biosimilar medicines, and to promote research and development more in tune with public health needs. High prices were also regularly pointed out as a solid barrier to access to medicines, as well as frequent shortages and stock-outs of medicines.
Civil Society and Industry Express Views
Civil society and industry groups took the opportunity of the Roadmap discussion to air their views too – particularly on the sensitive transparency resolution.
“Transparency is not a goal in itself,” remarked one group, Health Action International, “but a means to an end, and can be a multiplier of government efforts to improve universal access to medicines in areas such as health technology assessment, pricing decisions, procurement and reimbursement mechanisms.”
The Drugs for Neglected Diseases initiative (DNDi), which works with private sector partners, said that “transparency on costs of R&D is a central element of DNDi’s policy. We put as much information into the public domain as possible, including all clinical trial data, our actual R&D costs and related financing flows, including the in-kind contributions from our partners where they provide them.”
And the Washington DC-based Knowledge Ecology International, which has lobbied hard for the transparency measure, put in a plea for greater public reporting of R&D costs for expenses such as clinical drug trials, saying “if you fail to address R&D cost, the entire argument for high price becomes an evidence-free narrative.”
However, a representative of the International Federation of Pharmaceutical Manufacturers and Associations (IFMPA), warned countries to “carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential price negotiations across countries.”
Such information-sharing could actually drive up prices in less developed countries that now get special discounts, if developed countries were to see what they are paying and then demand greater price parity, IFPMA has said.
In reference to reporting on R&D costs, the IFPMA representative said that medicine prices should reflect the therapeutic value of medicines and positive outcomes for patients and society, “rather than simply the cost ‘input’ of an individual medicine.”
At the same time the IFMPA representative noted that pharma manufacturers hear and “understand the call for more information about our scientifically complex, and high-risk business model.”
By Catherine Saez