The World Health Organization has provided a list of suggestions to the United Nations Secretary General’s High-Level Panel on Access to Medicines, highlighting WHO activities in this area and making suggestions on areas the WHO has not yet been able to complete. It also describes several new proposals by WHO, including a global “fair pricing forum,” a pooled health product R&D fund, and a global antibiotic research and development facility.
The High-Level Panel held closed-door consultations with a range of players on March 9 and on March 10 held a public global dialogue from London. The webcast can be viewed here.
The 20-page (with cover letter) WHO submission [pdf] clarifies that the HLP mandate “focuses on the current innovation model and its impact on access to health products. It does not include the many other complex challenges countries are facing in designing robust health systems and ensuring delivery of primary care.”
“The Panel is looking both for possibilities for incremental improvements of the current system and for alternative or complementary models through which to research and develop new medical treatments, vaccines and diagnostics,” it states.
The WHO submission hails the UN’s 2030 Agenda for Sustainable Development and Sustainable Development Goals (SDGs) adopted last autumn, which include a key goal in public health.
It also asserts that “improving access to medicines is core to WHO,” and says its work on intellectual property rights issues falls under the World Health Assembly-mandated Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. That effort, however, has dragged on for years and has so far had little effect on the global problem of medicines not being developed or being too expensive for poor populations. The submission lists the many resolutions on this issue taken by the WHO membership since 2003.
The submission describes the market failure situation, noting that under the current R&D model tied to pricing, without the promise of IP rights protection to keep low-priced competitors out of the market, companies do not invest in pharmaceutical R&D. It notes that two WHO expert working groups have explored alternative or complementary innovation models.
Highlighted Points for the HLP to Consider:
The importance of the WHO Model List of Essential Medicines “as a tool to advocate for access to priority medicines in all countries.”
Calling for “transparency of the patent status of all essential medicines worldwide, as this information is not presently easy to obtain. This would allow countries to assess whether they can procure generic copies, or produce them locally.”
The “further expansion of the mandate of the Medicines Patent Pool to all disease areas, and for all patented essential medicines on the WHO Essential Medicines List to be licensed into the Pool.”
Call for “more work to be done to assess which models provide an appropriate balance between affordability and maintaining incentives for investment, including into R&D.” Here it notes that “the median availability of essential generic medicines in developing countries has been found to be disturbingly low.”
Call for “more work to be done to assess which models provide an appropriate balance between affordability and maintaining incentives for investment, including into R&D.”
Look into the many factors contributing to poor availability and affordability of medicines for non-communicable diseases, such as weak health systems, supply chain issues or lack of insurance.
The question of “how to draw the line between what advancements should be considered patentable and what is part of lifecycle management.”
Advocate for “closer cooperation, under the leadership of WHO, between the different organizations within the UN system and other relevant organizations working on access to medicines. This enhanced collaboration could facilitate the integration of each organization’s respective mandate regarding access to essential medicines.”
The findings of the WHO Consultative Expert Working Group (CEWG) on Research and Development report and the separate submission by the Special Programme for Research and Training in Tropical Diseases (TDR) on “the possibility of hosting a pooled fund for voluntary contributions toward R&D.”
The R&D Blueprint for pathogens likely to cause severe outbreaks in the near future.
The use of the product development partnership approach to address the issue of antimicrobial resistance.
Other Initiatives
Meanwhile, in the annexes, the WHO submission details several new initiatives related to these issues.
The first is a “fair pricing forum” that states: “WHO aims to carry out work on high-priced medicines through a series of landscape analyses and a forum in 2016 to provide a global platform for relevant stakeholders to discuss and develop effective strategies towards universal health coverage.”
“Funding is being sought to carry out the analytical work and convene the forum,” it says.
“The underlying concept of this consultation would be ‘fair pricing’ – that is, pricing models that ensure greater affordability and access while also providing industry with the necessary incentives for sustaining R&D.”
It lists a range of topics for preparatory research and landscape analyses, and says that ideally, “it should result in global agreements on different strategies as well as identifying options that can be implemented at the global or regional level.”
The paper also mentions a “Health Product Research & Development Fund: financing and operation.” It mentions a report from WHO’s newly energized Tropical Disease Research (TDR) entitled, “Health Product R&D Fund: a proposal for financing and operation,” to be released on 17 March.
This report “describes how a potential pool fund would operate under the governance of the WHO Member States, and how the tools, some of which will be published later in 2016, could be used for transparent and efficient operation of the proposed framework.”
Tools in the report include a “portfolio-to-impact model” – a new financial modelling tool; an online compendium of target product profiles; and “operational mechanisms for efficient and transparent management of the fund as well as the portfolio of health product R&D projects.”
And a further annex describes the WHO “Blueprint for R&D preparedness and response to emerging pathogens likely to cause severe outbreaks in the near future, and for which few or no medical countermeasures exist.”
The key elements of the blueprint are to: identify top threats (11 so far); identify research priorities; global coordination and expansion of capacity; continuous monitoring and assessment; and mobilise funding.
Source: Intellectual Property Watch