By Katy Athersuch [1] and Thiru Balasubramaniam
In May 2018, the World Health Assembly (WHA) adopted decision WHA71(8)
requesting WHO’s Director-General to “elaborate a roadmap, in consultation with Member States, outlining the programming of WHO’s work on access to medicines and vaccines for the period 2019-2023, including activities, actions and deliverables” (Source: Decision WHA71(8), 25 May 2018). Decision WHA71(8) requests the WHO Secretariat to “submit this roadmap report to the Seventy-second World Health Assembly [May 2019] for its consideration in 2019, through the Executive Board at its 144th session” in January 2019. The proposed WHO roadmap will serve as the implementation plan for the organization’s activities, actions and deliverables on access to medicines and vaccines from 2019-2023. The WHO roadmap is intended to complement the Global Programme of Work (GPW) 2019-2023. In the words of the WHO, the overall mission of WHO identified in the GPW is three-fold:
(i) promote health, (ii) keep the world safe and (iii) serve the vulnerable. Specifically, these goals are the “triple billion” to be achieved by 2023: 1 billion more people enjoying better health and well‐being, 1 billion more people protected from health emergencies, and 1 billion more people benefitting from universal health coverage (Zero draft, Roadmap for access 2019-2023).”
In July 2018, WHO published the zero draft of the roadmap on access to medicines. In its rationale for designing a roadmap, WHO stated:
Access to medicines and vaccines is a multidimensional problem. It therefore requires comprehensive national policies and strategies, together with legal and regulatory frameworks that meet health system needs and cover the entire product lifecycle—from R&D to quality assurance, regulatory approvals and market authorization, supply chain management, and prescribing, dispensing and use. These policies and strategies should balance public health needs with economic and social development objectives, and promote collaboration with other sectors, partners and stakeholders.
WHO takes a comprehensive health systems approach to increasing access to health products. Activities are guided by a series of World Health Assembly and Regional Committee resolutions spanning the decade from 2007 to 2017 and earlier. These resolutions, numbering almost 100 (Annex 1) were used to develop the report on ‘Addressing the global shortage of, and access to, medicines and vaccines’ presented to the 71st World Health Assembly in May 2018 (Ibid).
The roadmap contains ten areas of action for prioritization: 1) Research and Development for medicines and vaccines that meet public health needs, 2) Fair pricing and financing policies, 3) Application and management of intellectual property to contribute to innovation and promote public health, 4) Procurement and supply chain management, 5) Appropriate prescribing, dispensing and use, 6) Health workforce capacity for access to medicines and vaccines, 7) Preparedness for emergencies, 8) Collecting, monitoring and using key data, 9) Good governance, and 10) Regulatory systems that ensure quality, safety and efficacy of medicines and vaccines.
From 9 July 2018 to 16 August 2018, the WHO secretariat held an online consultation for its Member States to provide contributions; non-governmental organizations and intergovernmental organizations were not provided such recourse. Consequently, sixteen public health groups (including Knowledge Ecology International) wrote an open letter to Director-General Dr. Tedros Adhanom Ghebreyesus on 3 August 2018 expressing their priorities in relation to 5 topics: 1) Transparency, 2) Excessive Pricing, 3) Biologics, 4) Intellectual Property Rights, and 5) Delinkage.
Fifty-six member states completed WHO’s online survey to evaluate the zero draft of the roadmap on access to medicines and vaccines; seven countries (Burundi, Germany, India, Panama, the United States, the United Kingdom and Zimbabwe) provided additional written comments .
What is particularly striking in reviewing the feedback submitted, is the degree to which the United States appears to be out on a limb and isolated in its positions compared to most other Member States including those considered ‘traditional allies’ such as European Union Member States, Japan and Switzerland.
This blog post will zero in on three topics where divergences were particularly striking:
A) Research and Development for medicines and vaccines that meet public health needs
B) Fair pricing and financing policies, and
C) Application and management of intellectual property to contribute to innovation and promote public health.
In the area of research and development for medicines and vaccines that meet public health needs, of the 56 Member States that responded, only two stated that they did not consider that this should part of the roadmap: the United States and Panama. The United States opposed the inclusion of this workstream claiming, WHO’s “expertise and capacity” in R&D in medicines and vaccines was “extremely limited in this area”. The United States held that WHO should “prioritize work on specific, measurable activities that would have a high and immediate impact on global access to medicines.”
The United States does not believe that this issue should be included in the Roadmap, because it should not be one of WHO’s core activities on access to medicines. Given WHO’s many competing priorities, WHO should use this Roadmap to prioritize work on specific, measurable, activities that would have a high and immediate impact on global access to medicines. Additionally, the United States does not believe that this item is a consensus-based area of work. Many other actors are working in this space and WHO’s expertise and capacity is extremely limited in this area, limiting the potential impact of any actions under this item (Ibid).
While Germany supports the inclusion of the activity areas on ‘Research and development for medicines and vaccines that meets public health needs’, they stated that research prioritization and activities related to unifying principles for biomedical R&D, designing R&D models or sustainable financing mechanisms models should not be included into the roadmap. Germany proposed introducing regular reporting by Member States on concrete capacity development activities through their international cooperation in this field.
The United Kingdom approved the inclusion of R&D for medicines and vaccines that meet public health needs, they stressed that the roadmap should “cover more on commercialisation and market entry (Ibid).” The United Kingdom welcomed the action point to “develop sustainable financing mechanisms models for R&D where the market does not attract sufficient investments” and indicated its commitment to seeing successful models developed (Ibid). The United Kingdom called for strengthening the WHO’s gap analysis on R&D for antibiotic pipelines.
With respect to fair pricing and financing, the United States and Panama were again the only two Member States that did not support the inclusion of this activity area as framed. Instead the United States proposed that pricing and financing be addressed separately. On pricing, the United States called for WHO to engage in work on pricing and reimbursement policies including value-based pricing and maintained that term fair pricing did not “have a commonly understood definition and seems inherently subjective (Ibid).”
On fair pricing and financing policies, Germany supported the inclusion of the activity area and stated that the listed activities are sufficient to ensure impact. In terms of deliverables they suggested adding the following, ‘support development of policy guidance for the control of price developments along the supply chain.’ The United Kingdom underscored that fair pricing was the “core dimension of access to medicines (Ibid).” On fair pricing in relation to antimicrobial resistance (AMR), the United Kingdom proposed that the “explanatory text could be enhanced by stating that lack of affordability is a driver of AMR” and that “patients may go untreated (resulting in infection of others), their treatment may be foreshortened, or they may receive / use a sub-optimal drug for financial reasons (Ibid).”
The United States opposed the inclusion of the application and management of intellectual property to contribute and promote public health in the roadmap given “WHO’s many competing priorities, as well as the work in this area by other organizations”. Furthermore, the United States asserted that there was no consensus on this area of work. It is important to note that the United States was one of only three Member States who shared this position. 48 Member States responded favourably to the inclusion of this activity area, whereas five were unsure.
With respect to the management of intellectual property, the United Kingdom stressed that the development of best practice should be a “Member State driven process” performed in conjunction through the trilateral cooperation of WHO, WIPO, and WTO.
The Roadmap will come before the Executive Board in January 2019. An updated draft, incorporating the comments and feedback gathered from Member States and non-state actors is expected to be released in December this year. It remains to be seen what speed bumps and roadblocks may arise, but we hope the Roadmap will provide a clear plan setting out the WHO’s activities, actions and deliverables on access to medicines and vaccines between now and 2023.
Endnotes
[1] Katy Athersuch, Senior Policy Adviser – Medical Innovation & Access, Médecins Sans Frontières- Access Campaign