As promised we are back this Friday, bringing you a comprehensive story that looks at the fertile ground where science meets politics.
This week we bring you the politics around pathogens sharing and why it is essential to discuss the benefits of sharing such information in the throes of a pandemic.
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1. Story of the week
THE POLITICS OF PATHOGENS-SHARING
As much of the world awaits vaccines for COVID-19, discussions on how pathogens should be shared continue to evolve at World Health Organization. This is fundamental for the access to vaccines, diagnostics and therapeutics during a disease outbreak, and for preparedness.
Like its ubiquitous impact on almost every aspect of health policy, COVID-19 will inevitably change the discourse on the sharing of pathogens. Stakeholders hope that the change will be for the better, including by addressing the crucial matter on benefits for those sharing pathogens and biological materials.
This initial story looks at the state of play in these discussions, including a document that will be considered at the Executive Board meeting at WHO next week. We hope to continue to bring you more in-depth coverage on these issues in the future.
The essence of this complex area of global health is the following: there is an overwhelming emphasis on countries to share pathogens and genomic sequences, to help understand these better. After all, the sharing of such information also results in spurring faster research on these pathogens, contributing to early identification, sound risk assessment, initiation of evidence-based interventions and for the development of countermeasures such as vaccines, diagnostics and therapeutics, WHO has said.
While a significant number of countries have openly shared crucial information, many are not always comfortable doing so, especially in the absence of assurances that the shared resources will be regulated and used well, and without a clear understanding on what kind of benefits entail from sharing pathogens. So far, there is no negotiated multilateral agreement on sharing pathogens, barring exceptions on influenza viruses with pandemic potential.
In the past, countries have shared pathogens, without benefiting from vaccines which were developed as a result of sharing virus samples. (Recall Indonesia in the H5N1 crisis)
When public and scientific authorities share viruses and genetic sequences, manufacturers develop medical products based on this information. Usually, these products are patented and sold under commercial considerations.
Countries need to agree on the access and benefits sharing of pathogens, because, as sovereign rights holders of these pathogens, they should also be recipients of any benefits arising from sharing such information (Certain international agreements recognise national sovereignty on pathogens).
PATHOGENS AND PUBLIC HEALTH - THE INTERFACE
These discussions on pathogens sharing is also anchored in the rights negotiated by countries, that flow from the Convention on Biological Diversity (1992), specifically through its supplementary agreement - the Nagoya Protocol on the Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. The protocol, which has a distinct relevance for public health, came into effect in 2014.
Essentially WHO member states, are also signatories to the Convention on Biological Diversity, and a significant number have also ratified the protocol. This means, most countries are bound by an international legal treaty, although negotiated outside of WHO. Countries must ensure fair and equitable benefits from sharing of pathogens as signatories to the CBD and the Nagoya Protocol, experts told Geneva Health Files in extensive interviews. “Many WHO Member States have international and/or domestic obligations regarding access and benefit sharing, including under the Nagoya Protocol for those Member States that are also Parties to the Protocol”, WHO acknowledges.
The protocol creates legal certainty and benefit-sharing mechanisms around genetic resources by establishing legal frameworks at national levels. The system seeks to ensure prior informed consent and mutually agreed terms to ensure fair and equitable sharing of the benefits arising from the utilization of the concerned resources.
Within the context of WHO, the Pandemic Influence Preparedness (PIP) Framework, is one of the organization’s shining success stories that governs access and benefit sharing rules for influenza viruses with pandemic potential. It was negotiated between member states and came into effect in 2011. The framework has helped countries share pandemic influenza virus strains and increased access and capacities of developing countries. The framework requires parties to share flu virus specimens and provide reciprocal benefits to other states.
(Top officials at WHO, have repeatedly highlighted the role of increased surveillance capacities in countries as a result of both the Global Influenza Surveillance and Response System (GISRS) and the PIP framework, which have been put to use in the fight against COVID-19.)
THE IMPORTANCE OF THE PIP FRAMEWORK
Going forward, the lessons and principles from the PIP framework is important. Why? Because the lessons from PIP Framework can be applied and improved upon, while engaging on discussions for other pathogens. Experts believe that WHO must build on this successful model of the PIP framework, and build a stronger model for the governance of sharing of other pathogens. (The PIP Framework does not apply to seasonal influenza viruses or other non-influenza pathogens).
One of the benefits of the PIP framework, apart from building surveillance and other capacities is to prioritize developing countries.
According to the framework,
6.0.2 The PIP Benefit Sharing System will operate to:
prioritize important benefits, such as and including antiviral medicines and vaccines against H5N1 and other influenza viruses with human pandemic potential as high priorities, to developing countries, particularly affected countries, according to public health risk and needs and particularly where those countries do not have their own capacity to produce or access influenza vaccines, diagnostics and pharmaceuticals. Prioritization will be based on assessment of public health risk and need, by experts with transparent guidelines;
In the current pandemic, where developing countries with limited capacities are struggling to cope with burden of COVID-19, having access to vaccines, diagnostics and therapeutics under a similar potential provision, could have proved to be instrumental in addressing widening access gaps. Hence the urgent need on devising ways to prepare for the future.
Sangeeta Shashikant, Legal Advisor to Third World Network who spoke to Geneva Health Files in a number of interviews on this matter, said:
There is a lot of emphasis on pathogen sharing, while WHO has sidestepped the issue of fair and equitable benefit sharing. If pathogens and sequences should be shared in situations of public health emergencies, then we need a clear multilateral framework for the sharing of pathogen and related sequences, and concrete commitments for fair and equitable sharing of benefits. That is the only way we can have equitable allocation of therapeutics, diagnostics and vaccines. Without binding commitments on sharing of benefits, like the way it has been enshrined in the PIP framework, simply sharing samples of pathogens is grossly insufficient and inequitable to address the global needs of the pandemic.
We are in an access crisis right now, with much of the world without access to vaccines during this pandemic. We need to talk about pathogen sharing and benefit sharing on an equal footing. To just stress on the sharing of pathogens and genetic sequences, without addressing benefits, is really a disservice to public health, and undermines the rights member states have under the Convention on Biological Diversity and its Nagoya Protocol.
So while there is a lot of emphasis on sharing information expected of countries, but isn’t enough discussion and action on addressing IP monopolies of the pharmaceutical industry that are artificially limiting supply and jeopardising global public health.
In an update to the Executive Board next week, WHO has said that during the first six months in 2020, labs in USA, Germany, Russia, UAE, Senegal, Switzerland, France, Japan, The Netherlands, Australia, Italy, Brazil, Mexico, Oman, among others, have received 100 shipments of specimens (multiple specimens per shipment, relating to COVID-19) from the following 61 countries:
Afghanistan, Albania, Algeria, Bahrain, Belarus, Belize, Bosnia and Herzegovina, Burkina Faso, Cameroon, Colombia, Comoros, Costa Rica, Côte d’Ivoire, Cyprus, Czech Republic, Democratic Republic of the Congo, Estonia, Eswatini, Ethiopia, Fiji, Guatemala, Iceland, India, Islamic Republic of Iran, Jamaica, Kazakhstan, Kenya, Kyrgyzstan, Lao People’s Democratic Republic, Latvia, Lebanon, Liberia, Lithuania, Luxembourg, Mauritius, Mongolia, Mozambique, Nepal, New Zealand, Niger, Nigeria, North Macedonia, Pakistan, Paraguay, Qatar, Republic of Moldova, Romania, Serbia, Slovakia, South Africa, South Sudan, Sri Lanka, Sudan, Tajikistan, Timor-Leste, Tunisia, Uganda, Ukraine, Uzbekistan, Viet Nam and Zimbabwe.
A significant number of these countries which have shared specimens are from the developing world.
WHO’S CURIOUS STANCE ON THE NAGOYA PROTOCOL AND THE PIP FRAMEWORK
To understand the direction, these discussions can take, see this recent report cited above by the Director General of WHO, to the Executive Board, which will be discussed next week.
While WHO recognizes that “Establishing mechanisms for fair and equitable sharing of the benefits arising from the utilization of the concerned resources has become a central element of ensuring expedited pathogen sharing,” it seems that it is of the opinion that the protocol is slowing down the process of sharing pathogens between labs, some countries and collaborating centres.
In this report by the DG, to the Executive Board next week, WHO cites a prior report. (Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits ( Decision WHA72(12), paragraph 1(a) Report on influenza virus sharing Report by the Director-General February 2020)
According to WHO, as a result of the Nagoya protocol:
“… required lengthy bilateral negotiation of a material transfer agreement between a national influenza centre and a WHO collaborating centre. New legislation created uncertainty for national influenza centres and national focal points due to a lack of clarity about access and benefit-sharing or Nagoya Protocol requirements.
In the influenza context, lengthy delays in virus sharing due to national access and benefit-sharing and Nagoya Protocol requirements have implications for public health because they jeopardize the vaccine virus selection process, the timely development of candidate vaccine viruses and access to vaccines. Navigating a system in which each country has different access and benefit-sharing requirements that must be negotiated bilaterally is burdensome and inefficient, and could cause inequities in benefit sharing and limit virus access for research and development of improved influenza vaccines.
WHO DG report to the EB, January 2021
Further, there also seems to be a lack of consensus within WHO on owning the successes of the PIP framework in the wider discussion on the public health implications of the Nagoya Protocol. (There is no discussion on the positives of the PIP framework in this document, an expert familiar with this process pointed out.)
Experts and civil society members have contested this.
In a briefing paper, Access and benefit sharing for pathogens: An overview of the issues facing the 2021 World Health Assembly and WHO Executive Board, in December 2020, Edward Hammond, from Third World Network, says, “…. the narrative of the Nagoya Protocol posing a threat to public health by complicating access to pathogens is a false one.”
The reality is that WHO’s experience implementing the Nagoya Protocol has been positive. The ABS approach of the PIP Framework is harmonious with the Nagoya Protocol, and it has raised a considerable sum of money for public health. It has also promoted reliable virus transfers, and stabilized the previously faltering WHO Global Influenza Surveillance and Response System (GISRS). It has even helped the response to COVID-19. By WHO’s own judgement, the investment in influenza pandemic preparedness enabled by the PIP Framework’s Nagoya Protocol implementation has paid off in the present pandemic by bolstering the capabilities of respiratory virus labs in developing countries in ways useful for responding to SARS-CoV-2.
(Edward Hammond, Third World Network)
It is not entirely clear why WHO would not celebrate the successes of the PIP framework. (We will following up to understand these dynamics more.)
WHO has been a direct beneficiary of the PIP Framework. “The annual Partnership Contribution (PC) is a cash contribution of US$ 28 million given to WHO by influenza vaccine, diagnostic and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System. This money is used to prepare for--and respond to--an influenza pandemic,” according to the framework’s webpage on the website of WHO. It is understood that since 2012, more than US$ 200 million has been collected.
In his paper on the issues facing member states at the upcoming EB and the World Health Assembly in May 2021, Hammond argues, “…it can be expected that many developed countries, and industry, will argue against using a PIP Framework-type approach for other pathogens. Why? It’s very simple. They don’t want to pay for something that they might be able to cajole and convince the WHA to give them for free.”
A number of questions have also been raised by civil society actors and others, on the kinds of actors that have come to host and run databases that house genomic information. While these organizations have come to provide a crucial service, critics suggest that it is WHO that must take the lead in housing such critical information. This could improve countries’ confidence in sharing information more readily, if it is hosted by a multilateral organization, one expert said.
WHAT TO WATCH OUT FOR
Going forward it is important to watch how discussions on benefit-sharing are discussed at WHO. As we reported last week, consultations around potential reforms at WHO in the context of preparedness, include aspects on pathogen samples sharing.
In their proposal for reform, the U.S. and Brazil for example, have discussed the sharing of pathogens in the context of preparedness. In their proposal they say “"…promote safe and rapid sample sharing of pathogens of pandemic potential or high risk, including during the assessment phase."
Japan has said countries should be encouraged to notify the WHO of significant information including samples of pathogens in the early stages of an outbreak. “The following two actions should be given as soon as possible, even during the assessment phase: (i) promptly reporting to the WHO once the Member State(s) obtain information, especially of an unknown virus or suspicious cases, and (ii) sharing important information, including samples of pathogens, with the WHO.”
(Also note that Japan also suggested the involvement of the international organizations, such as the Secretariat of the Convention on Biological Diversity (CBD Secretariat), the Food and Agricultural Organization (FAO), and the World Organization for Animal Health (OIE) in the context of the One Health Collaboration approach towards reforms in pandemic preparedness.)
India has suggested the development of a global framework or specialised protocols for benefit sharing for non-influenza pandemics on the lines of PIP Framework consistent with the objectives of the CBD and its Nagoya Protocol. India has also called for the creation of a Global Framework for Management of Infectious Diseases & Pandemics.
By discussing pathogens sharing in the context of preparedness, while not committing on elaborating on how benefits will be shared between countries and participating stakeholders, developing countries could lose their leverage, if these issues are split, critics fear. “These issues must be addressed in a single package. You cannot about one, without discussing the other.”
Further, by linking it to issues around the reform of IHR, countries will be obliged to commit to sharing information on pathogens, without committing on sharing benefits. (Do note that the Nagoya Protocol in its Preamble recognizes the International Health Regulations (2005) and “the importance of ensuring access to human pathogens for public health preparedness and response purposes”.)
Consider for example, what the Lancet Commission on global health law has said emphasizing the importance of binding commitments in the PIP framework:
WHO’s PIP Framework uses a combination of nonbinding norms and legally binding contracts to achieve its aims. The PIP Framework was devised to forge a compromise among higher and lower-income countries on virus sharing and equity. The associated contracts, known as Standard Material Transfer Agreements (SMTAs), are used to bind non-state actors who would not usually be subjects of international law, such as pharmaceutical companies or academic institutions. The SMTAs include a binding arbitration clause: “if a dispute cannot be resolved through negotiations or other non-binding means of the parties’ choice, disputes shall be subject to binding arbitration on conditions that are mutually agreed by the parties.
Basically, it is not realistic to have downstream vaccines without upstream frameworks on how samples are shared; whether and how countries are rewarded for it.
In order to prepare for the next pandemic, the world needs to negotiate and agree on these rules of sharing information and on benefits now.
As Hammond reminds member states, “Fairness and equity in this commercial use of pathogens is at the root of the policy questions that the EB and WHA must confront.”
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