On Monday, 11 January 2021, the secretariat of the World Health Organization (WHO) published an 18 page report on the Global strategy and plan of action on public health, innovation and intellectual property (EB148/10). The Director-General’s report contains a detailed implementation plan of the recommendations of the overall programme review panel directed at the Secretariat (for the period 2020-2022). KEI will provide analysis of WHO’s implementation plan in a separate piece.
The secretariat report makes a passing reference to an informal consultation convened by the Director-General on 3 December 2020 to discuss recommendations dealing with the “transparency of medicines prices and actions to prevent shortages” (Source: EB148/10). For a deep dive into the tortuous negotiations that led us here, please see: (The drafting error plaguing decision WHA73(11) – Global strategy and plan of action on public health, innovation and intellectual property).
Intriguingly, the board paper notes that the “results of the [informal] consultation are summarized in a report available online” and provides the following link. Unfortunately, at the time of publication, the WHO page on the overall programme review of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property does not contain the summary report of the December 2020 informal consultations. Fortunately, KEI has obtained the summary report prepared by WHO and will provide a walkthrough of the WHO consultation on transparency of medicines prices and actions to prevent shortages. The WHO summary report can be accessed here: https://www.keionline.org/wp-content/uploads/Summary-Report-GSPA-PHI-Informal-Consultation-3-December-2020-as-at-12-January-2021.pdf.
The WHO summary report recorded that more than one hundred Member State representatives participated in the informal 3 December 2020 consultation to discuss the “recommendations of the review panel referred to in paragraph 2 of decision WHA71(9) (2018) as “not emanating from the global strategy and plan of action on public health, innovation and intellectual property” and the “recommendations of the review panel on promoting and monitoring transparency of medicines prices and actions to prevent shortages” referred to in paragraph 3 of decision WHA73(11) (Source: Summary report).
The report noted that Mariângela Simão, Assistant Director-General for Access to Medicines and Health Products, WHO, highlighted the role of the global strategy and plan of action on public health, innovation, and intellectual property (GSPA-PHI) in providing an “agreed common response to the areas of interface between public health, innovation and intellectual property which are now, more than ever, part of a global agenda on access to health” especially in the face of the COVID-19 pandemic. Dr. Simão adumbrated that the informal consultations would “trigger collective dialogue in the spirt of collaboration around areas of the GSPA-PHI overall programme review where broad consensus is yet to be met, points raised in governing bodies meetings such as funding for R&D, and the linkages between costs for development and final prices” (Source: Ibid).
Maria Nazareth Farani Azevêdo, Ambassador, Permanent Mission of Brazil to the United Nations in Geneva provided the following perspective stressing that COVID-19 has provided impetus to the “importance of ensuring equitable access to vaccines, therapeutics and diagnostics, catalyzing initiatives such as COVAX, ACT-A and C-TAP” (Source: Ibid). Ambassador Azevêdo expressed concerns over the prohibitive costs of cutting-edge cell and gene-based therapies which were beyond the reach of many in poor and developed countries; she pointed out that the WHO’s GSPA-PHI could be a tool to address inequity of access in this field.
The summary report provide the following record of the first panel on transparency
Transparency of pricing of health products and elements throughout the value chain”
began with a presentation by Kiu Tay on behalf of the WHO Secretariat. Kiu presented
recommendations relating to promoting price transparency included in the September 2020 “WHO
Guideline on Country Pharmaceutical Pricing Policies.” He noted that the Guideline Development
Group made two conditional recommendations on promoting price transparency, including that
countries improve the transparency of pricing and prices through 1) sharing the net transaction prices of pharmaceutical products with relevant stakeholders, within and external to the country; disclosure of prices along the supply and distribution chain; reporting publicly the R&D contributions from all sources and communicating pricing and reimbursement decisions to the public, and through 2) a clear description of pricing approaches and their technical requirements.
Fatima Suleman, CoChair of the WHO Guideline Development Group on Country Pharmaceutical Pricing Policies and Director of the WHO Collaborating Center for Pharmaceutical Policy and Evidence Based Practice at the University of KwaZulu-Natal elaborated three justifications by the Guideline Development Group to support their recommendations on promoting price transparency, namely 1) overall balance of effects favors the policy, 2) urge stakeholders to take the necessary steps in line with WHA72.8, and 3) serve multiple purposes for improving pricing policies.
Anban Pillay, Deputy Director-General Department of Health in South Africa shared national experiences on transparency of pricing of health products from an implementation perspective. He highlighted the need for political support and noted that South Africa has specific legislation relating to transparency. He supported the Guideline Development Group’s recommendations, drawing specific attention to the need to disclose prices along the entire supply and distribution chain, noting that net transaction price rather than manufacturing price must be shared. He cautioned the principle of alternative reimbursement models, noting their potential to undermine transparency. He emphasized that the system must reward low prices in order to incentivize competition on prices.
Nora Kronig Romero, Global Health Ambassador, Switzerland, shared national experiences using the example of vaccines.She remarked on the important role of the rule of law in providing a protective environment for all stakeholders. She highlighted issues of infrastructure and logistical challenges, noting vaccine cold chain storage as a particular challenge for low-income countries. Regarding price transparency, she reiterated Switzerland’s steadfast support, noting the country’s strong regulation and legal obligation for price transparency. In Switzerland, the prices of medicines for rare diseases present a challenge to the social contract around health insurance schemes. She emphasized the need for international cooperation around issues of price differentiation and shortages as well as Switzerland’s commitment to play a role in facilitating discussions with private sector in her country. Sonia Caldeira, National Authority of Medicines and Health Products INFARMED, Portugal, presented the Portuguese experience on the topic. She outlined the country’s pharmaceutical pricing policies and reviewed the Health Technology Assessment process (pharmacotherapeutic assessment, pharmacoeconomic assessment, negotiation and managed entry agreements, decision, monitoring, and reassessment) for pricing and reimbursement. She concluded by sharing steps the country is taking toward promoting and achieving greater transparency in pharmaceutical policies.
The summary report provided the following record of the panel on shortages.
Panel 2 on “The concern with shortages to health products” began with a presentation by Lisa
Hedman on behalf of the WHO Secretariat. Lisa presented WHO’s activities to support Member
States on shortages and stock outs of medicines and vaccines. WHO will work to expand the use of
the WHO Shortages Notification Portal; reinforce national capacity to use data to detect and report
and to respond with short/medium term solutions via sharing and training on best practices,
including regulatory reliance, and; identify chronic, long-term shortages for strategic intervention.
Claudia Chamas of FIOCRUZ, Brazil, elucidated the challenges that remain despite progress in
the field of access to medicines over the past decade. Highlighting that all regions of the world face problems with regular access to medicines, vaccines and other health products, she reflected that inequitable access affects the poorest more severely. She reflected that the COVID-19 crisis has brought to light longstanding vulnerabilities in the availability and supply of health products, noting the concerns and risks of patients of shortages. She called tackling the global problem of access with the seriousness it requires to ensure the right to health and other fundamental human rights.
Valerie Jensen, Food and Drug Administration, USA, presented an overview of FDA’s role in mitigating
and preventing drug shortages. She outlined the notification requirements under section 506C of the
FD&C Act and FDA regulations and described the current challenge of increasing new shortages and persistent shortages and introduced the responsibilities of the US Interagency Drug Shortage
Task Force. She explained the key findings from the FDA Drug Shortage Report which identified
three root causes for drug shortages and offered three recommendations for enduring solutions. She
concluded by outlining next steps relating to current legislative and related FDA initiatives.
The WHO report provided the following record of Dr. Philippe Duneton’s (Executive Director, Unitaid) remarks on the relationship between the work of the GSPA-PHI and the COVID-19 response.
Philippe Duneton began by relating the GSPA-PHI to the core business of Unitaid’s operations to prevent, diagnose and treat HIV/AIDS, tuberculosis and malaria more quickly, affordably and effectively. He highlighted the importance of specific elements of the GSPA-PHI such as “Building and improving research capacity” for adapting products to the realities of countries. He highlighted the continued relevance of recommendations relating to transfer of technology and management of intellectual property, noting the experience and achievements of the Medicines Patent Pool (MPP) to cover more than 20 million people with more than USD 1.5 billion in savings. He emphasized that access requires an end-to-end solution from what is needed, what should be developed, the quality of it, creating the demand at the country and scaling up. As co-convener, with Wellcome Trust, of the ACT-A therapeutics pillar, and in working closely with FIND and the Global Fund on the diagnostics pillar, he highlighted the importance of access-oriented thinking at the fore of acceleration efforts. He noted the involvement of the Unitaid-funded MPP in ACT-A and the COVID-19 Technology Access Pool (C-TAP) and emphasized requisite industry support for increasing capacity of production at low cost through voluntary mechanisms such as MPP and C-TAP.
Following the presentations, Member States addressed the need for collective action in the wake of the COVID-19 pandemic, the lack of price transparency for medicines, vaccines, and other health technologies, weaknesses in supply chains, the need to use TRIPS flexibilities, and a call to join the WHO’s COVID-19 Technology Access Pool (C-TAP) to promote the “collective sharing of related knowledge, intellectual property and data” (Ibid).