MANILA — A majority of countries cheered the World Health Organization's draft roadmap on access to medicines presented this week, applauding its relevance in the struggle to achieve universal health coverage. But several stakeholders think the draft requires continued consultations on key — and controversial — issues.
Addressing shortages and access to medicines have been at the center of debates at WHO’s executive board meetings for several years, and have often caused heated exchanges between countries. At the 2018 World Health Assembly, countries requested that WHO leadership develop a roadmap elaborating the organization’s actions and deliverables on access to medicines and vaccines.
“We urge … [that] WHO focus on areas where it is uniquely positioned to lead. We note with caution the proposed expansion of activities in the areas of intellectual property management and pricing.”— Representative for PATH at the 144th WHO executive board meeting
On Tuesday, the agency presented a draft roadmap to WHO member states at the 144th executive board meetings in Geneva, Switzerland. Actions and deliverables outlined in the document include promoting transparency in health product research and development costs, which several countries and nonstate actors stressed could help ensure taxpayers are not paying twice for medicines.
The representative from the Netherlands praised WHO during the meeting, noting that with the creation of the roadmap it has proven itself to be a “well-informed, normative organization.” The roadmap will also help member states discuss other aspects related to access to medicines, such as building countries’ regulatory capacity and ensuring the fair pricing of medicines, the representative noted.
Several other member state representatives welcomed the report, but offered recommendations for improvement. Australia suggested expanding coverage of the roadmap to include diagnostic technologies. There is also room to strengthen WHO’s collaboration with relevant stakeholders, in particular the World Trade Organization and the World Intellectual Property Organization, given their expertise on issues relating to intellectual property, said the representative from Canada.
A WHO official clarified that the agency has been engaging with both bodies for years.
The roadmap included that WHO will provide technical support to countries that aim to make use of the trade-related aspects of intellectual property rights, or TRIPS, provisions. TRIPS recognize the rights of member states to protect public health and promote access to medicines for all, including the possibility of overriding patents for the manufacture of lower-cost drugs. Because of the complexity involved in doing this, lower-income WHO member states have increasingly asked the body for assistance in navigating it.
Others, including Romania and India, asked WHO to clarify timelines and budget estimates against the actions and deliverables it identified in the roadmap report. In addition, how will the work be distributed between headquarters, regional, and country offices of the organization? And what will “support” to countries look like?
A few stakeholders, notably the United States, expressed reservations: “We appreciate its emphasis on strengthening systems for regulation, procurement, collecting and reporting data, and supply chains [but] we remain disappointed on a number of points. First, WHO still has not illustrated how each proposed area of work is tied to a resolution or other member state corrective, [and] we still don't know how much time and resources WHO will spend on the various areas of work,” the U.S. representative said.
The representative reiterated that some of the deliverables WHO mentioned, such as providing countries technical support on the use of the provisions contained in TRIPS to promote access to pharmaceutical products, “fall outside of WHO’s area of subject matter expertise, and … risk going beyond WHO’s mandate.”
WHO has had a mandate to work on the issue since the adoption of the TRIPS agreement in 1996, according to WHO Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals Mariângela Simão.
“And in subsequent years, we had several resolutions we can name one by one that work on this,” she said.
International nonprofit PATH, which works with different stakeholders to help scale up global health innovations, shared U.S. sentiments on WHO’s proposed work relating to intellectual property.
“We urge … [that] WHO focus on areas where it is uniquely positioned to lead. We note with caution the proposed expansion of activities in the areas of intellectual property management and pricing. As a nonprofit product developer with 40 years of experience in developing and scaling health technologies, we have seen that there is no single correct solution. Each technology requires a unique approach to ensuring equitable access,” a PATH representative stated, urging WHO to ensure any new activities don’t negatively impact existing research initiatives or partnerships.
Similar debates ensued when the discussion turned to WHO’s cancer medicines report, in which the agency states that its analysis “suggests that the costs of research and development and production may bear little or no relationship to how pharmaceutical companies set prices of cancer medicines. Pharmaceutical companies set prices according to their commercial goals, with a focus on extracting the maximum amount that a buyer is willing to pay for a medicine.”
The U.S. supported policy options mentioned in the report promoting increased competition in the pharmaceutical industry and strengthening regulatory systems, but balked at text that mentions the use of the TRIPS flexibilities and promoting transparency in R&D costs, which the representative argued require more careful consideration, particularly their potential impacts on public health and innovation.
The U.S. also questioned why WHO did not consult the pharmaceutical industry for the report, adding “the lack of private sector consultation leaves a large hole in the report and reduces its impact.” The representative requested for WHO to schedule a member-state information session, which Japan seconded, while also suggesting WHO engage in dialogue with the industry.
WHO’s Simão said that they can only involve pharmaceutical companies when there are no perceived conflicts of interest, which was not the case in developing the report.
“But it would have been valuable if we had had access to some information directly from pharmaceutical companies … [such as] individual cancer drugs’ net transaction prices, and so on,” she added, noting that WHO would welcome such information and provide an addendum to the report, should such data be made available to the organization.
The roadmap will likely be revised to include suggestions and add clarifications made during the meeting ahead of the World Health Assembly in May. In the meantime, member states have requested WHO’s proposed budget allocations to carry out the roadmap, which WHO Regional Director for South-East Asia Poonam Singh said will likely be a challenge given the long list of deliverables identified.