What the trilateral report on public health, IP and trade, says on the pandemic?
A range of policy options drawn from different disciplines, is shaping the response to the pandemic, particularly in making medical products more accessible.
From the use of flexibilities in copyrights for text and data mining to help drug discovery, to the use of competition policy to improve access to testing; from temporarily relaxing procurement rules, to easing regulatory processes; among many others.
Many may lament that the pandemic is yet to witness any meaningful sharing of information and technologies. And yet, these limitations are in part due to the way such frameworks have been built so far. Despite the continuing resistance among stakeholders and the lack of political will in many countries, the pandemic will inevitably change how trade and health policy officials will work together in the future.
Public policy wonks call it “policy coherence”, to address the multi-dimensional challenge that public health is. Policy coherence entails addressing a challenge that inhabits several distinct spheres, by drawing on solutions in a coordinated manner using different approaches.
International cooperation among countries can be better on so many fronts as this pandemic has shown. What is as crucial is cooperation among key technical, multilateral organizations.
How trade, health and intellectual property, converge to shape global public health and how these areas strive towards policy coherence, has been captured in the recently released report – Promoting Access to Medical Technologies and Innovation, Intersections between public health, intellectual property and trade. The report, a second edition, is a joint collaboration between WHO, WTO and WIPO.
This trilateral effort of three major organizations coming together to work “at the interface of intellectual property, trade and public health” to improve innovation in health technologies and availability of affordable drugs, is not new. The first edition of this report was published in 2013.
Authors of the study say “The World Health Organization (WHO) is the directing and coordinating authority for health, but the interaction between health issues and other policy domains – human rights, development policy, intellectual property (IP) and international trade – creates a strong rationale for cooperation and coordination between the WHO and other international organizations, in particular the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO).” The need for cooperation and coherence at the international level has intensified over the past decades, as successive multilateral decisions have confirmed, they say.
The report describes the roles and mandates of these three organizations; discusses the global disease burden. It also outlines the elements which constitute this international framework, composed of policies on health, intellectual property and trade; including regulatory issues; technical barriers to trade, sanitary and phytosanitary measures, health services and procurement rules. It not only examines the innovation and access dimensions; but also, the economics of medical technology innovation and access.
The report notes that “…innovation and access are inevitably intertwined – both are indispensable ingredients to meeting an evolving global disease burden.”the trilateral report on health, trade and ip [second edition]
While the report was wrapped up before the pandemic hit, there is a brief analysis on how existing tools may be contributing towards policy coherence in the global response to the pandemic. (Some experts believe that WHO failed to treat the pandemic more comprehensively within the scope of this report.)
The ubiquitous impact of the pandemic, in one stroke, has illustrated the need for wide, broad-based approaches rooted in different policy traditions to respond to the crises. Although the pandemic has morphed into an economic, social and political crises in many parts of the world, first and foremost, it continues to remain a health policy challenge.
The report lists out the simultaneous policy challenges that authorities and governments have had to face as a result of the pandemic: including monitoring and containing the spread of the virus; understanding relevant virology and epidemiology and mobilizing and coordinating the requisite resources; deploying the necessary health care system infrastructure. In addition, kick-starting parallel efforts to ensure that health care products, technologies and protective equipment are available and can be accessed equitably in sufficient quantities worldwide; and working towards developing, testing, manufacturing and ensuring equitable access to diagnostics, vaccines and therapeutics, medical devices and other relevant technologies.
This story takes a quick look, specifically, at the gamut of policy options available for COVID-19 response, as described in the report. [A subsequent story will review insights from the wider report.] This discussion in the report – on the policy responses to the pandemic – is also supported by cross-references to the wider report linking it to some of the historical evolution and new developments in these issues. The report also has certain examples from the last few months that might indicate what “policy coherence” could look like. This post has tried to put together some of the relevant policy responses.
The report points out that the surge in the demand on existing health technologies as a result of the pandemic, has put pressure on public procurement systems. The report says, “Authorities in many jurisdictions have expedited procurement of essential products via emergency procedures, such as shortening public procurement timelines and issuing direct contract awards. A number of countries have put in place transparency mechanisms with regard to emergency procurement following best international practices in this regard. Some countries and regional groupings have used pooled procurement for select goods.”
Later in the report, authors say, “Procurement policies favouring open and competitive tendering, coupled with the rational use of medicines, become all the more important in ensuring continued access in a fiscal climate in which national budgets are under pressure and philanthropic programmes face funding constraints.” This is particularly true in the context of COVID-19 given the resultant economic crises and its impact on government revenues.
Further, governments have adapted manufacturing capacities to deal with demand and shortages of essential products. It cites the example of generic manufacturers in Bangladesh who have begun producing a generic version of remdesivir to treat COVID-19. Remdesivir is patented in many other countries. But Bangladesh benefitted from the transition period under the WTO TRIPS Agreement [Agreement on Trade-Related Aspects of Intellectual Property Rights]. This currently exempts least-developed countries (LDCs) from implementing patent protection for pharmaceutical products and from protecting clinical trial data, the report said.
In order to keep health systems operational, some countries have considered facilitating the movement of health workers, for example through visas or work permits and recognition-of qualifications programmes. (Health services are subject to the WTO General Agreement on Trade in Services (GATS) – specifically four modes of supply including cross-border supply; consumption abroad; commercial presence; and movement of natural persons.)
Services such as telemedicine may be used to overcome geographical limitations and physical distancing requirements, the report says. WTO has already said that some jurisdictions have reviewed laws to enable such services on a provisional basis. The report discusses the state of play in software licensing and eHealth.
Competition policy has also been used as a tool – one among the many approaches to fight the pandemic. The report points out that a few competition authorities across the globe have launched investigations relating to COVID-19 health products “including into price hikes for health products and diagnostic manufacturing information held as a trade secret.” It cites the example of the Netherlands, where an investigation forced, pharma major Roche into eventually sharing formula for a for a liquid solution [lysis buffer solution, a reagent used to break open cells] that laboratories in The Netherlands needed to conduct testing for COVID-19. Autoriteit Consument en Markt, the Dutch competition authority (“ACM”), had said that Roche had a key position for testing equipment and materials in the country.
“Several competition authorities have issued guidance on the application of competition policy in times of urgency and limited supply and clarified whether and when coordination between firms in order to respond to crisis needs could be permitted, at least temporarily,” according to the trilateral report.
Elsewhere in the report, it notes “Competition policy is relevant to all stages in the process of supplying health technologies to patients, from their development to their sale and delivery. The creation of sound, competitive market structures through competition law and enforcement thus has an important role to play in both enhancing access to health technologies and fostering innovation in the pharmaceutical sector. It can serve as a corrective tool if IP rights hinder competition and thus constitute a potential barrier to innovation and access.”
KEEPING TRADE GOING
The report notes that “While low- and middle-income countries face particular challenges caused by the global scarcity of key health technologies, the vast majority of countries are net importers of all categories of health technologies, including those needed to address COVID-19.” During this period, “governments have concomitantly implemented both trade-restrictive measures (e.g. restrictions on exports of key products) and trade-facilitating ones to reduce costs and delays (e.g. facilitation and simplification of customs procedures),” the report adds. (See recent post by Geneva Health Files which discussed in detail, the trade in medical products.)
The report notes that some countries have reduced or eliminated tariffs on certain imported health technologies or deferred payment deadlines for the same. In addition, regulatory conformity checks have been streamlined through international cooperation and standards, as well as through mutual or unilateral recognition of third country approvals, it says.
While recognizing that the global IP system provides an incentive framework to boost innovation in the context of COVID-19, the report also lists existing tools within the IP framework that make technologies more accessible.
The report acknowledges that “lack of access to health technologies is rarely due to a single factor”. Authors suggest that the “value chain” of medicines and health products includes R&D, regulation, selection, procurement and supply, distribution, prescribing of medicines and diagnostics, dispensing, and responsible use.the trilateral report on health, ip and trade [second edition]
Among the tools available, making information on patents accessible, is an important one. It can be crucial during a health emergency such as the current pandemic, when stakeholders can easily check patent status and underlying information that can help with R&D. The disclosure requirement and dissemination of patent information can ensure access to technical information, the report notes. (As reported earlier, even the access to patent information can be political and contentious]
It lists a number of initiatives including the World Intellectual Property Organization (WIPO) COVID-19 search facility within its global PATENTSCOPE database. In addition, it also mentions examples including European Patent Office (EPO), authorities in China, the Republic of Korea Argentina, Brazil, Chile, Colombia, Ecuador, Peru and Uruguay, that have made patent information more accessible. The United States Patent and Trademark Office (USPTO) and The Brazilian National Institute of Industrial Property have also introduced procedures to fast-track related processes. Medspal of Medicines Patent Pool, includes information about a number of medicines in trials to treat COVID-19: remdesivir, lopinavir/ritonavir, favipiravir and ruxolitinib, as well as biotherapeutics tocilizumab, sarilumab and siltuximab, the report says.
The report highlights existing features that have contributed to widening the access to medical technology and encouraging innovation. Specifically, certain exclusions from patentable subject matter and limited exceptions to patent rights. Some of the key provisions of use during this pandemic as discussed in the report, are as follows:
- It points out that national IP systems have certain options with respect to patenting material that exists in nature. On patentable subject matter, it says “Patentability may have relevance for biotechnological R&D on the SARS-CoV-2 virus.”
- Domestic IP laws frequently provide for research exceptions. Where a research exception is available, R&D on patented COVID-19-related technologies does not constitute patent infringement, it says.
- In countries where a regulatory review exception exists, a patented invention can be used without the consent of the patent holder for the purposes of developing information to obtain regulatory marketing approval, the report points out.
- Some national patent systems also provide options for addressing the further development, and repurposing, of existing medicines, including incremental innovation, medical indication claims and limiting evergreening.
- It also mentions policy options including on issuing compulsory licences and government-use licences, citing the recent legal measures in countries such as Canada, Hungary, Germany and Israel.
- It notes that some civil society organizations have submitted oppositions against patents on technologies that could be potentially used in a new COVID-19 medicine; some have requested patent revocation. Such measures have traditionally been used more often by commercial competitors, the report says.
- It highlights the use of text and data mining exceptions which have been used in initial research into COVID-19, including for tracking and predicting its spread. In addition, they are being used in the search for treatments. Later in the report it elaborates on text and data mining (TDM) understood as “automated analytical techniques” that work by “copying existing electronic information, for instance articles in scientific journals and other works, and analysing the data they contain for patterns, trends and other useful information”. This technique has been valuable in drug discovery and working with vast amount of genetic information. “Balanced copyright flexibilities for the development of medical innovations can make this technique accessible in the current pandemic,” it says.
- The report focuses on open licensing models, as a key tool. From private actors (AbbVie on MedsPal) committing to non-exclusive and royalty-free licensing or issuing non-enforcement declarations of patent rights in some or all jurisdictions, to publishing scientific data on a free-to-use basis, publishing technical specifications of vital equipment (e.g. ventilators) and sharing knowledge to enable others to manufacture and use such technologies (Medtronics).
In other examples of IP management, the report notes the case of the vaccine candidate being developed by the University of Oxford, supported by US$ 750 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance. The originator company AstraZeneca has committed to supplying the vaccine globally on a no-profit basis (the exact contract terms are not public). The company has also signed an agreement with an Indian-based manufacturer allowing the latter to supply low- and middle-income countries.
The report also mentions the European Commission led “Coronavirus Global Response” pledging event that had yielded EUR 15.9 billion by the end of June 2020 to rapidly fund R&D and streamline access to COVID-19 health products. The report notes that the Commission instituted a “temporary framework” to allow state aid to go to COVID-19-related R&D with certain conditionalities:
“..Aid for coronavirus relevant R&D can only be granted, if beneficiaries commit to grant non-exclusive licences under non-discriminatory market conditions to third parties in the European Economic Area. This will ensure that progress concerning the medical treatment and confinement of coronavirus benefits all European citizens.”european commission, temporary framework on covid-19 response
Citing another example of linking investments in R&D to conditionalities on technology transfer, the report notes the recent investment in the Coalition for Epidemic Preparedness Innovations (CEPI).
The CEPI, a key player in WHO’s ACT Accelerator, “has to date received US$ 1.4 billion from governments for COVID-19-related work, an unprecedentedly large investment in a PDP”, the report notes.
CEPI requires that producers provide equitable access to any vaccine developed through its funding. It further requires product developers to be willing to undertake technology transfer to enable production by a global network of manufacturers, the report says. [Although there have been concerns, raised by civil society groups, on whether CEPI can ensure that manufacturers will respect conditions on equitable access.]
In the absence of an effective COVID-19 treatment, the report notes the efforts by researchers exploring the repurposing of older medicines, and “compassionate use” of medicines.
It cites the example of COVID Box, a free access initiative of the Medicines for Malaria Venture (MMV), that seeks to contribute to research on COVID-19, by compiling more than 150 compounds, including ones in development and marketed drugs that have a known or predicted activity against SARS-CoV-2. Researchers who use it are expected to place any resulting data in the public domain.
Finally, the report also underscores the role of the WHO’s Emergency Use Listing (EUL) procedure that aims to streamline the process by which new or unlicensed products can be used during public health emergencies. This system provides “a time-limited listing for unlicensed products in an emergency context when limited data are available and products are not yet ready for application for WHO prequalification”. During the pandemic, the EUL has been open to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2.
Vaccine nationalism; countries reneging on their obligations under International Health Regulations; countries imposing export restrictions – all these may seem that the pandemic is far from witnessing policy coherence. But this just may be the opportunity to design “policy coherence” for future emergencies and more.
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