In November 2017, the World Health Organization (WHO) published a report charting a path forward for the expansion of WHO’s work on the transparency of R&D costs and medicines prices while rekindling the prospects for WHO to assume the mantle of leadership in the progressive implementation of delinkage of R&D costs from the prices of and incentives to invest in products. These recommendations are contained in the report of the review panel of the WHO overall programme review of the global strategy and plan of action on public health, innovation and intellectual property published on 30 November 2017. A previous KEI piece published on 27 November 2017 highlighted the recommendations on delinkage and transparency (Source: Expert panel recommends that the WHO move forward on transparency and delinkage).
The high-priority actions on transparency include the following recommendations:
- Member States to support the WHO Secretariat in promoting transparency in, and understanding of, the costs of research and development. (Indicator: Reports on the costs of research and development for health products prepared in 2019 and 2021.)
- The WHO Secretariat to provide guidance to Member States on promoting and monitoring transparency in medicine prices and on implementation of pricing and reimbursement policies. (Indicator: Guidance developed and disseminated in countries by 2020.)
The high-priority action on delinkage includes the following recommendation:
- Member States to encourage the implementation of schemes which partially or wholly delink product prices from research and development costs, including actions recommended by the Consultative Expert Working Group on Research and Development: Financing and Coordination. (Indicator: New schemes to partially or wholly delink product prices from research and development costs developed, approved and implemented by 2022.)
For negotiators, activists, patients, scientists, drug developers, scholars, and other stakeholders, the 84 page WHO report is a must-read. The report of the overall programme review (OPR) is a result of an expert process, shepherded by the WHO Secretariat. The mandate for the report is provided by resolution WHA68.18 (2015) which requested the Director-General to establish a “panel of 18 experts” to conduct an OPR of the global strategy and plan of action on public health, innovation and intellectual property. (Source: EB142/14). The composition of this expert panel can be found here: http://www.who.int/medicines/innovation/gspa-review/members-list/en/
In anticipation of next steps, the expert panel provided the following guidance to WHO member countries:
We consider that WHO Member States should review our recommendations and incorporate them, with any amendments they wish to make, in a draft resolution for discussion by the World Health Assembly. Although not within our terms of reference, we consider that Member States should start thinking now about whether the GSPA-PHI should be extended in a more focused manner, in line with the recommendations of the present review, or succeeded by a new strategy in 2022. A necessary condition for success is adequate, sustainable funding by Member States, including for activities to be conducted by WHO.
In preparation for the 142nd session of the WHO Executive Board (22 January 2018 – 27 January 2018), the WHO Secretariat published a draft decision on Tuesday, 9 January 2018 to take these recommendations forward. The text of the draft decision prepared by the Secretariat states:
Global strategy and plan of action on public health, innovation and intellectual property
Draft decision proposed by the Secretariat
The Executive Board, having considered the report by the Director-General regarding the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, and its annex, decided to recommend to the Seventy-first World Health Assembly the adoption of the following decision:
The Seventy-first World Health Assembly, having considered the report by the Director-General regarding the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, and its annex, decided to request the Director-General:
(1) to take forward the recommendations of the review panel following the drawing up of a detailed implementation plan, in accordance with the review panel’s recommendations;
(2) to submit a report on progress made in implementing this decision to the Seventy-third World Health Assembly in 2020, through the Executive Board. (Source: EB/142/14 Add 1)
If the World Health Assembly adopts this decision in May 2018, the Secretariat’s “detailed implementation plan” needs to be done right. Consequently, it is imperative that the Executive Board recommend to the World Health Assembly the adoption of a decision to implement the 33 recommendations of the Overall Programme Review.
The report generated the following responses from public health experts.
The report offers a strategy for the implementation of the GSPA – PHI by prioritizing key recommendations for action before 2022. These can be summarized as follows: Change the way priorities in pharmaceutical R&D are set and change the way innovation is financed so we get the medicines we need at a price we can afford. A clear call for action at the next WHA and by member states. Access to medicines is now a truly global issue so perhaps this time these recommendations will not be so easily ignored. (Ellen ‘t Hoen, LLM, Medicines Law & Policy)
HAI welcomes the WHO high-priority actions on access to medicines: Transparency in all its forms is essential, including open data, and it WILL be at the core of any effort to delink the price of medicines from the reported costs of R&D. At the same time, the intention to support governments to embed TRIPS flexibilities into national legislation is a major step forward and we look forward to a time when flexibilities are the norm and not the exception in the interest of public health. (Tim Reed, PhD., Executive Director, Health Action International)
In tracing the origins of the GSPA-PHI, the expert panel report recalls the contentious nature of the deliberations:
it is important to remember why it [the GSPA-PHI] was established and the main sources of controversy during the sometimes tortuous negotiations. A key issue was how the IP regime affects both innovation and access. The basis of the concern of many nongovernmental organizations and a number of governments, exemplified by earlier controversies over access to patented antiretroviral medicines for HIV infection, was the extent to which IP rights restrict affordable access to life-saving health products. (Source: Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, Report of the review panel, November 2017).
The report provides a succinct account of the inception of the concept of delinkage:
[S]ome countries were concerned that attempts to weaken IP rights would undermine not just the business model of pharmaceutical companies but also incentives for innovation, which depend on recovering the costs of R&D from the prices charged for health products.
A solution to this conundrum, proposed by a number of nongovernmental organizations and countries, was the concept of “delinkage”, whereby recovery of R&D costs was delinked from the price of products. (Ibid, Page 26).
Chapter 2 of the 2017 report provides an overview of the evolving context of innovation and access that would influence the implementation of the GSPA-PHI.
There have been a number of important developments since 2008 in innovation for, and access to, medicines and health products in both developing and developed countries, many of which have implications for our review. In spite of the financial crisis of 2008, economic growth and poverty reduction have been rapid in many developing countries, which has improved health and made more resources available for health care. Yet, overall, countries’ health budgets have not risen as fast as general public expenditure, and resources for R&D for diseases that mainly affect developing countries are for the most part no higher now than in 2008.
There has also been a continuing shift in the global burden of disease driven by an ageing world population and rapid urbanization, amidst heightened concern about the world’s ability to deal with infectious disease outbreaks and other health emergencies and the threat posed by AMR. (Source, Ibid, page 32).
The GSPA-PHI review highlights the acute challenges posed by high-priced cancer and hepatitis medicines as problems faced by governments in the global North and the global South thus contrasting the developing country-only focus of the 2008 GSPA-PHI.
In elaborating on the agenda of the Sustainable Development Goals (SDG), the OPR traces an arc between the SDG agenda, the Universal Declaration of Human Rights, the WHO constitution and the mandate of the United Nations High-Level Panel on Access to Medicines.
WHO’s only objective in Article 1 of the Constitution is “the attainment by all peoples of the highest possible level of health” (27). For the GPSA, a key issue is the balance to be achieved between the two statements in Article 27 of the Universal Declaration on Human Rights (28):
1. Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.
2. Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
This article is quoted without comment in the preamble to GPSA-PHI (paragraph 10) but is not mentioned elsewhere. It is also at the root of the “policy incoherence” referred to in the terms of reference of the United Nations High-level Panel on Access to Medicines. (Source: Ibid, Page 33).
In chapter 2, the report describes new thinking on innovation and access including providing brief accounts of the work of the United Nations Secretary General’s High-level Panel on Access to Medicine (HLP) and the Lancet Commission on Essential Medicines Policies. The OPR identified the following recommendations from the HLP that are addressed by the WHO GSPA-PHI:
- Countries should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that curtail the
“evergreening” of patents, to ensure that patents are awarded only when they include genuine innovation. - Governments should adopt and implement legislation to facilitate the issuance of compulsory licences.
- Governments and the private sector should refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use flexibilities in the TRIPS Agreement.
- Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the
right to health. - Universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.
- Building on current discussions at WHO, the United Nations Secretary-General should initiate a process whereby governments can negotiate global agreements on the coordination, financing and development of health technologies. This includes negotiations for a binding R&D convention that delinks the costs of R&D from end prices to promote access to good health for all. As a preparatory step, governments should form a working group to begin negotiating a code of principles for biomedical R&D.
- Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to: (i) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval, with each expense category separated; and (ii) any public funding received in the development of the health technology, including tax credits, subsidies and grants. (Source: Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, Pages 34-35).
In relation to the five core challenges identified by the Lancet Commission on Essential Medicines policies, the following two comport with the objectives of the GSPA:
- Making essential medicines affordable: Recommendations include better monitoring of prices and availability and a comprehensive set of policies to make both patented and generic medicines more affordable, use of health technology assessments (HTAs) and greater transparency in sharing information on health and medicines.
- Developing essential medicines that are lacking: Recommendations include identifying a list of essential medicines that are lacking through the WHO Global Observatory on Health Research and Development, a global R&D policy framework with financing and delinking mechanisms, a patent pool for all essential medicines and better alignment of pharmaceutical research. (Source: Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, Page 35).
The 2017 report of the GSPA review documents the epidemiological transition from 2008 noting the emergence of pandemic threats, AMR and non-communicable diseases as areas for intervention. The GSPA review acknowledges that the WHO GSPA did not include AMR or sufficient focus on non-communicable diseases. Consequently, the expert review recommends that the “GSPA-PHI should place more emphasis on addressing noncommunicable diseases and should include elements to address outbreaks, environmental challenges and AMR.” (Source: Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, Page 36).
With respect to developments in innovation and access, the OPR reports on the emergence of promising technologies including CRISPR and CAR-T while signalling the spiraling costs of new health technologies to address cancer and hepatitis.
Concerns that have arisen since 2008 are related to the price of new patented medicines and, in some cases, also medicines on which patents have expired. This is a concern in both developed and developing countries. New cancer drugs and combinations exemplify these concerns. While there are many new medicines to treat cancer, most cost over US$ 100 000 per treatment, and one combination is priced at US$ 252 000. This raises serious questions about the financial sustainability of cancer treatments, as cancer rates rise in ageing populations. Correspondingly, it raises questions about the sustainability of a business model that results in such high prices, which do not always reflect the health benefits procured (82). Similar considerations apply to the introduction of directly acting antiviral agents to treat hepatitis C. These are transformative drugs, which offer the promise of a cure for hepatitis C, in many cases after a 12-week course; previous treatments, which were less successful, involved courses of up to 48 weeks. A course of one drug, sofosbuvir, which was introduced in the USA in 2014, initially cost US$ 84,000.(Source: Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, Page 40)
The Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property marks an important inflection point for the WHO and its member states in terms of the Organization’s future work on innovation and access. The 142nd session of the WHO Executive Board’s discussion of this document, and the recently published Secretariat document on “Addressing the global shortage of, and access to, medicines and vaccines” (EB/142/13) will serve as a barometer for how serious the global health community is in achieving universal health coverage. If the World Health Assembly adopts this decision in May 2018, the Secretariat will need to get its “detailed implementation plan” right if it wants to expand the Organization’s work program on transparency, delinkage and TRIPS flexibilities.