3
Pathogen Sharing for Influenza Vaccine Production
THE ESSENTIAL NEED FOR PATHOGEN SHARING
Rapid sharing of information on pathogens is essential for effective pandemic preparedness and response (PPR). Prompt access to pathogen samples can help provide early warning about novel infectious disease threats and enable the rapid development of pathogen-specific vaccines, diagnostic tests, and medicines. Sharing viral pathogens, either the organisms themselves or their genetic sequence data, provides the means to identify vaccine targets. Modern molecular techniques allow faster development of effective vaccines, as demonstrated by the production of COVID-19 vaccines in 1 year in 2020 using platform technologies (Agrawal et al., 2021). Timely access to pathogen samples and their genetic sequence data—which can originate anywhere in the world—is therefore critical, so that organizations such as the World Health Organization (WHO) can accurately assess the risk these pathogens pose to global health, initiate the development of new medical countermeasures, and mount an appropriate international response (Elbe and Buckland-Merrett, 2017).
However, pathogen sharing has had a long and troubled history. Until roughly the early twenty-first century, it was associated with exploitative scientific and commercial practices. High-income countries (HICs), or multinational corporations in those countries, were seen as extracting resources, such as pathogen samples, from low- and middle-income countries (LMICs) to be able to manufacture and sell vaccines, diagnostics, and therapeutics while failing to share the benefits derived from those resources (Rourke, 2020).
The situation came to a brief but significant impasse in the mid-2000s during an outbreak of H5N1 influenza in much of Southeast Asia. In a 2018 workshop on Exploring Lessons Learned from a Century of Outbreaks: Readiness for 2030 at the National Academies of Sciences, Engineering, and Medicine (the National Academies), Ambassador Makarim Wibisono explained that a relatively small number of human cases of avian influenza (H5N1) in Sumatra, Indonesia, resulted in a public panic, which was heightened by the global concern about H5N1 and poultry deaths. This panic gave rise to questions about the ability of the Indonesian Ministry of Health to contain the virus (NASEM, 2019). The Indonesian government had initially complied with the Global Influenza Surveillance Network (GISN) regulations related to sharing the virus. The GISN (the precursor of the current Global Influenza Surveillance and Response System [GISRS], described in Chapter 2) required affected member countries to submit samples of their virus to WHO Collaborating Centres (WHO CCs) for identification as a potential candidate vaccine virus. The CCs then disseminate their findings to pharmaceutical companies for vaccine manufacturing. However, despite the Indonesian government’s willingness to share virus samples with the GISN, it experienced great difficulty accessing the H5N1 vaccines that those samples helped produce (Rourke, 2020). When requested to provide vaccines to Indonesia, WHO responded that it did not have a process in place to supply countries directly with vaccines. In December 2006, a frustrated Indonesian government announced that it would no longer share its H5N1 virus samples with WHO CCs. Dr. Wibisono said that the Indonesian Minister of Health then pronounced the GISN process inequitable because vaccines produced from samples shared by LICs were less likely to be available to their populations (NASEM, 2019).
The 2009–2010 H1N1 pandemic also exposed several gaps and weaknesses in pathogen sharing (see Chapter 2). These reinforced that the world needed a reliable, predictable, sustainable, and timely mechanism for identifying and characterizing influenza and other viruses and sharing, or providing access to, these samples beyond the countries in which the viruses or sequences originated. At the same time, it also reinforced that timely sharing of viruses and associated information, such as genetic sequence data, requires attention to the benefits that may be derived from them. These events resulted in a major change. In May 2007, the World Health Assembly (WHA) passed a resolution to create a process for discussions that would lead to the creation of the Pandemic Influenza Preparedness (PIP) Framework, the first pathogen-specific access and benefit sharing (ABS) system, in 2011 (WHO, 2007).
According to Anne Huvos, the leader of the PIP Framework Secretariat at WHO (NASEM, 2019), the spark that drove the PIP Framework’s creation process was the LMICs’ loss of trust in the global system for
virus sharing and access to vaccines. The LMIC governments believed that the WHO-coordinated system of virus sharing was inequitable because it failed to provide reasonable protection for their people. The initiation of the PIP Framework discussions marked the start of the trust-rebuilding process among countries. Ultimately, the process successfully facilitated virus sharing in the years after the framework was adopted.
THE CRITICAL IMPORTANCE OF ACCESS AND BENEFIT SHARING
ABS systems are designed to balance speed of access to viral information with equity in access to medical products and other assets derived from that information. This is a delicate balancing act that relies on buy-in from the governments of LMICs, HICs, and private stakeholders, such as pharmaceutical companies. Most LMICs will not support an information-sharing system for viruses that does not guarantee access to a certain percentage of vaccines. However, wealthier countries and industry are unlikely to support a system that delivers these benefits to LMICs at a significant loss of profits through mechanisms such as intellectual property (IP) waivers. Cost is a central question in the sharing of medical products and includes more than the cost of procuring vaccines themselves:
It is not sufficient to claim these products should be shared: a mechanism to pay for and distribute them needs to be found. In some cases, charitable donations or nongovernmental organizations such as Gavi, the Vaccine Alliance, can serve this function. In others, it may be governments or drug companies that provide therapeutics or vaccines at reduced or no cost to those who need them—as did Merck, the manufacturers of the rVSVZEBOV Ebola vaccine, working with the U.S. Department of Health and Human Services. Nevertheless, cost is not simply a matter of the cost of producing a vaccine or therapeutic procedure. Benefit sharing may also require necessary infrastructure, such as cold chains to store and deploy products once shared, research facilities and laboratories, or basic utility systems and roadworks. (Evans et al., 2020, p. 32)
Evans and colleagues suggest that for vaccines and therapeutics, better national implementation and support for the International Health Regulations (IHR) can provide an equitable basis for sharing data and information necessary for research and later manufacturing that is negotiated ahead of time. Infrastructure investments in health care (e.g., for laboratories, roads, water, and power) before epidemics emerge can also help prevent outbreaks from becoming health emergencies.
Technology is central to this issue and often progresses more rapidly than legal frameworks. Today, the concept of pathogen sharing has
expanded due to the new genetic technologies. During the 2014 Lassa outbreak in Nigeria and the 2015 Ebola outbreak in the Democratic Republic of the Congo, for example, rapid sequence sharing replaced sharing whole viruses. These trends have also accelerated during the SARS-CoV-2 pandemic but also led to complications with international collaborations.
According to Elbe and Buckland-Merrett, three main reasons remain that pathogen samples may not be shared quickly or comprehensively: concerns about acknowledgment of scientific contributions, negative economic ramifications of being identified as the source of an outbreak, and retaining ownership over IP and the monetary value of products associated with it (Elbe and Buckland-Merrett, 2017). Regardless of one’s position in this balancing act, careful consideration of the components of ABS systems for pathogens, such as influenza, is essential for reliable and sustainable global delivery of vaccines in a pandemic.
EQUITY AND HUMAN RIGHTS
Infectious disease outbreaks produce at least three broad classes of benefits for individuals and communities. First, patient treatment leads to clinical data that are useful in understanding disease and improving diagnostics and surveillance of public health. Second, samples provide sequence data for surveillance technologies, diagnostics, and medical interventions. Third, experimental interventions offer both information and tangible products, such as vaccines and therapeutics (Evans et al., 2020). WHO’s Guidance for Managing Ethical Issues in Infectious Disease Outbreaks (WHO, 2016a) suggests that all three benefits should be shared and places a “fundamental moral obligation” on researchers and other actors involved.
The discourse on the right to health and the accumulation of national and international practice and jurisprudence are gaining increasing importance in public health. They have been used as a normative tool to claim national obligations to facilitate access to essential medicines and the “determinants” of health. The right to health, as interpreted by the United Nations (UN) monitoring bodies, also has an international dimension requiring states to assist each other and not to preempt the enjoyment of the same right for the people of other countries (OHCHR, 2008). Although it would be unrealistic to argue that the right to health positively requires states to share pathogen samples and benefits, human rights considerations can be part of more detailed policy and legal considerations used to advocate cooperation or censure obstructionist behavior.
Sovereignty is one of the few influence levers that countries in the Global South have to try to create more equitable access to benefits, including vaccines. Given the reality of vaccine nationalism during the COVID-19 pandemic, it is likely that these governments will fight to retain sovereign
control over pandemic strains and genetic sequence data. This reality and existing inequities must be acknowledged and addressed as ABS mechanisms are refined.
EXISTING INTERNATIONAL INSTRUMENTS FOR ABS
Four governance instruments are of particular relevance to pandemic influenza pathogen sharing and vaccine access: the IHR (revised in 2005), the UN Convention on Biological Diversity (adopted in 1992) and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization (adopted in 2010), and the PIP Framework (adopted in 2011). The impact of the latter two on vaccine preparedness and response is yet to be tested by a major influenza pandemic (see Box 3-1). Yet, over the past decade, these governance instruments’ effectiveness has been increasingly challenged by technological advances. As noted, creating vaccines, therapeutics, and diagnostics now relies more heavily than ever on sharing the genetic sequence data from physical pathogen samples.
The IHR are fundamentally predicated on the concept that a coordinated multilateral response among countries is necessary to prevent and respond optimally to a pandemic threat. WHO substantively revised the IHR in 2005. Before this revision, the IHR only required case reporting and response measures justified on public health grounds for a limited number of infectious diseases, such as cholera and plague (NASEM, 2019), and influenza was not included as a reportable disease. The revised IHR now require countries to notify WHO about any disease outbreaks that could constitute a Public Health Emergency of International Concern (PHEIC). It calls on countries to develop the national capacities necessary to prevent and respond to a pandemic and to share critical information in a timely fashion. The IHR require its parties to share public information on health events that could constitute a public health emergency to enable WHO to alert the international community and to determine when to declare a PHEIC and issue consequential recommendations and guidance (Mullen et al., 2020). It does not explicitly cover sharing viruses or genetic sequence data, although some have suggested that the reference to “information” in Articles 6 through 10 can be interpreted as including sequencing data (NASEM, 2019).
As the only existing formal ABS mechanism for pathogens of pandemic potential, the PIP Framework is unique in global health governance. It emphasizes that nations, WHO, and industry have distinct and mutual responsibilities to work together to ensure that rapid sharing of potential pandemic influenza viruses and the benefits derived from this sharing are on an equal footing. WHA adopted it as a nonbinding instrument designed
to govern pandemic influenza pathogen sharing and the distribution of vaccines, diagnostics, and therapeutics using an innovative model that engages industry through prenegotiated contracts (WHO, 2011). It sets the amount of real-time supply under contracts that companies agree to provide for a pandemic and explicitly requires industry to pay an annual fixed partnership contribution of $28 million, which was originally calculated as covering 50 percent of the operating costs of the GISRS. (Chapter 5 discusses GISRS funding further.)
However, the scope of the PIP Framework is restricted to influenza viruses of pandemic potential. In 2016, an expert review found that the PIP Framework is “a bold and innovative tool for pandemic influenza preparedness, is being well implemented, and that the principle of the PIP Framework of placing virus sharing and benefit sharing on an equal footing remains relevant today” (WHO, 2016b, p. 12). Its implementation has resulted in greater confidence and predictability in global capacity to respond to an influenza pandemic. Its success is partially due to regular engagement by WHO and its member states with key stakeholders, including industry and civil society. However, key issues remain, including how genetic sequence data should be handled, whether the Framework could be expanded to include seasonal influenza, and whether it could be used as a model for sharing of other pathogens.
Given the flexibility and agility of GISRS to respond to COVID-19, WHO is assessing the opportunities to expand GISRS so that it addresses other respiratory viruses with epidemic and pandemic potential more regularly and systematically (see Chapter 2). “GISRS+” would build from the influenza backbone to provide an integrated platform for the surveillance and monitoring of respiratory viruses and serve as a global alert mechanism for the emergence of novel respiratory viruses. In an unpublished communication to the National Academies, the WHO Influenza Group also noted1 an opportunity to create a new ABS system that establishes fair and equitable benefit sharing taking into account (1) timeliness of access to benefits, (2) affordability to the end user, and (3) quantity of benefits shared. It stated that any new system should incorporate the “real time” dimension of access to pandemic products by WHO; maintain the status of vaccine supply from manufacturers as largely (80 percent) donations so that WHO can continue to donate these supplies to countries based on need; and preserve WHO’s 10 percent access to future pandemic vaccine production in real time.
The Nagoya Protocol under the Convention on Biological Diversity (CBD) spells out in detail the general benefit-sharing provisions of the CBD.
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1 Considerations and input from the WHO Influenza Group to address questions from the National Academies Global Coordination Study Working Group on Pathogen Sharing, May 2021.
The CBD codified the principle of national sovereignty over biological and genetic resources, which has increasingly included pathogens, through national practice. The CBD and Nagoya Protocol’s provisions were developed as a reaction to IP debates in the 1990s. The protocol was not initially designed with public health in mind and did not explicitly consider the pandemic context. Under the protocol, a pathogen with pandemic potential is viewed in the context of national sovereignty; the approach is based on negotiated country-to-country two-party agreements as the basis for sharing genetic materials and the benefits resulting from their use. It recognizes the sovereignty of a country to determine how its genetic resources are used, requires that access to genetic resources must have the prior informed consent of the effective or originating country, and specifies that those resources can only be accessed by negotiating mutually agreed terms that include benefit sharing.
In May 2019, the WHA requested that the WHO Director-General prepare a report on the public health implications of implementation of the Nagoya Protocol. In response, the Office of WHO’s Chief Scientist surveyed all key internal stakeholders, including the Secretariat of the PIP Framework, focal points for the IHR, and the food safety and communicable disease teams. The WHO Secretariat also contacted member states and other stakeholders, including the Secretariat of the Convention on Biological Diversity; UN agencies, funds, and programs such as the Food and Agriculture Organization; other international agencies, such as the World Organisation for Animal Health (OIE); and civil society and public-sector entities.
The resulting report, The Public Health Implications of Implementation of the Nagoya Protocol (WHO, 2021a), was released in January 2021. The overall view in survey responses was that pathogen sharing is positive for public health if well regulated and transparent and the benefits are agreed upon and shared among both the data generators and receivers. Similarly, there was convergence that pathogen sharing enables multijurisdictional and international outbreak investigations and improves the quality of laboratory surveillance. This can provide major benefits in relation to R&D; diagnostic test validation in public health emergencies; transfer of technologies and expertise, including opportunities for laboratories to work with pathogens to which they would not ordinarily have access; and due recognition and protections for the source provider. Respondents in general noted that pathogen sharing is easier when bilateral agreements already exist between institutions and the researchers know and trust each other. Most respondents also indicated that genetic sequence data should be differentiated from physical sample sharing. Differences that were highlighted included risks of handling physical samples; the broader potential for sharing genetic sequence data; and the logistical differences
related to biosafety and biosecurity, cold-chain storage equipment, qualified personnel, correct certificates, and adequate transportation. Sharing genetic sequence data is often more complex because of the difference in scale and multiple ways of sharing, altering, and resharing. Issues of public availability for genetic sequence data are more concerned with ensuring appropriate credit for the work and data privacy issues.
The report also raised two broad challenges for human pathogen sharing. First, respondents noted an absence of a harmonized system across countries and unclear domestic guidelines and that this gap is exacerbated by recipient laboratories that are not aware of, do not have time to understand, or do not comply with ABS arrangements. Second, lack of awareness of the Nagoya Protocol and its requirements and the individualized implementation mechanisms unique to each state party to the protocol add complications. More general concerns include bureaucratic delays; overlapping, conflicting, or unclear processes for customs clearance and other regulatory requirements; lack of international couriers qualified to handle shipments; multiple approval levels for sharing with external parties; lengthy negotiations; lack of procedures for unified national biosafety regulations and harmonization across jurisdictions; language barriers; and restrictions regarding dual use (WHO, 2021a).
Article 4(4) of the Nagoya Protocol stipulates that
Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to, the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument. (Convention on Biological Diversity, 2011)
In addition, under Article 8(b) of the protocol, parties shall
pay due regard to cases of present or imminent emergencies that threaten or damage human … health, as determined nationally or internationally. Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources….
These two provisions appear to allow for a special international instrument to address a need for rapid pathogen sharing during a pandemic.
BARRIERS AND GAPS THAT AFFECT ABS FOR INFLUENZA
Each of the four governance instruments discussed above has gaps as well as some provisions that establish barriers to ABS.
The IHR: The IHR gaps could pose barriers to pathogen sharing. The challenge is to operationalize collaboration under Article 44, which requires countries to collaborate and assist each other in meeting their obligations and WHO to collaborate with state parties to the same end. What is missing is an explicit definition of what the “obligations” for member states and WHO are. Article 44 encourages states to collaborate “to the extent possible” to detect and respond to potential public health emergencies and share “technical, logistical, financial, and legal support to help other states implement the IHR” (Fischer et al., 2011). However, donor nations have been slow to distribute comprehensive assistance packages to help resource-constrained countries achieve the core IHR capacities. One reason is that the scope of this challenge is tremendous and requires strengthening public health surveillance and response systems, producing a trained health workforce, creating infrastructure and tools, and developing cross-sector communications and coordination. A standard global blueprint to accomplish these competencies is lacking, so national public health authorities must map their own courses. Just figuring out where to start can be daunting (Fischer et al., 2011). Perhaps more important is competing priorities: both donors and domestic governments find it hard to prioritize strengthening IHR core competencies over more immediate health needs, such as combating the epidemics of HIV, TB, and malaria.
Although the IHR do not specifically mention genetic sequence data, it would be possible for the WHA to interpret Articles 6–10 to include that as part of the “information” or “data” that states parties are required to submit to WHO or share among themselves.
The PIP Framework: The Framework’s gaps also could obstruct pathogen sharing. As already noted, its scope is restricted to pandemic influenza. Despite suggestions that it be expanded to encompass seasonal influenza, discussions of this at WHO have been inconclusive. The pharmaceutical industry also opposes this. The consequences are the absence of benefit-sharing provisions for seasonal influenza viruses (WHO, 2016b). If the framework were expanded to include seasonal influenza, the benefits to be shared would need to be more clearly defined. The Third World Network (TWN) has noted that seasonal and pandemic influenza have different dynamics—for seasonal influenza, countries decide to either use or not use vaccines, but during a pandemic, all nations want them. The Framework also does not specifically encompass genetic sequence data in its definition of what is covered by its benefit-sharing provisions.
Contemporary global governance structures, such as the multilateral commitments under the PIP Framework, have yet to be tested by a serious influenza pandemic (NASEM, 2019). How would benefit-sharing function, and is it vulnerable in such circumstances? Stronger multilateral commitments could help. However, the PIP Framework also has no requirements
for developing its norms, no oversight beyond the advisory role played by the PIP Advisory Group, and no reminder for governments of the commitments they have undertaken. Vaccine “nationalism,” as expressed in advance purchase agreements and export controls, may undermine the operations of benefit distribution during a pandemic. A gap may also occur between when PIP partner distributions are activated and contributions must be received. Furthermore, even when donations are realized, what distribution of vaccines and other products is equitable? Under COVAX, the “vaccine pillar” of the Access to COVID-19 Tools (ACT) Accelerator, which is a global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines, the target is 20 percent of the population in a receiving country. Under the PIP Framework, partner contributions can also be allocated for building manufacturing capacity, but the intended financing for this purpose may be insufficient.
The CBD and the Nagoya Protocol: These instruments can be barriers in themselves; they present a strong tension between sharing viruses for public health reasons and sharing other benefits for countries that provide biological information about disease organisms. The Nagoya Protocol’s strong emphasis on benefit sharing is a potent tool to ensure ABS, but public health emergencies suggest that benefit sharing be balanced by pathogen sharing.
The extent to which the Nagoya Protocol is applicable to the pandemic influenza context is an open question. Many aspects of the protocol are not necessarily incompatible with the IHR and PIP Framework and the specific needs of global health security. However, conflicting principles and severe operational incompatibilities exist. In a pandemic, responses must happen quickly over hours, days, or weeks, but negotiating bilateral agreements under Nagoya can take much longer. As noted, one of the more common concerns about its compatibility with the more urgent needs for public health threats is the potential for delays in virus sharing. In 2021, the WHO Director-General prepared a report for its executive board where he discussed how virus sharing delays can negatively impact the vaccine virus selection process (WHO, 2021a). The GISAID argues that it is important to not only think of the impacts of the Nagoya Protocol in the future but also reflect on its past consequences (GISAID, 2019). With a reported 6–9-month delay in accessing influenza samples (IFPMA, 2019), the suitability of bilateral negotiations in a pandemic setting where viruses may spread quickly is highly questionable (WHO, 2021a).
National sovereignty can also be a barrier for influenza and other respiratory pathogens with pandemic potential. Industry, TWN, and other nongovernmental organizations have noted that if an entire society is affected by a pandemic, as with COVID-19, a new procedural paradigm for decision making in this context is needed. Country-by-country negotiations
are likely to get in the way (Correa, 2021; TWN, 2020). As COVID-19 has shown, vaccine nationalism can be counter to public health needs and undermine the positive aspects of pathogen and benefit sharing (Abbas, 2020). Weak leadership and politics can also pose barriers. Considerations of equity and the broader human right to health could be balanced against the considerations and procedural requirements of the Nagoya Protocol. Fragmentation, or lack of effective global coordination, can also be a barrier. Other forums and accountability mechanisms could be used to achieve the benefit sharing sought under Nagoya. ABS may fall under different legal regimes that are not always easy to reconcile, including considerations on biodiversity, the IHR, trade law, biosecurity due to concerns about dual use of pathogens, and human rights.
HOW HAS THE “COVID-19 LENS” CHANGED THE WAY GOVERNMENTS, ORGANIZATIONS, AND INSTITUTIONS LOOK AT ABS INSTRUMENTS?
These governance instruments represent a unique influenza “ecosystem” of pre-existing global networks, standards, and practices. This ecosystem was largely not activated for the COVID-19 pandemic; the IHR did not cover sample, genetic sequence, or benefit sharing; little attention was paid to the Nagoya Protocol in the extreme situation posed by COVID-19 largely because the virus’ fast and wide spread bypassed the protocol’s sovereignty-based foundation; and the PIP Framework was not applicable because its scope is restricted to pandemic influenza (and no similar ABS mechanism exists for other pathogens with pandemic potential). Instead, COVID-19 vaccine development has been dominated by unilateral or bilateral decision making by national governments and companies and the support of ad hoc and newly created mechanisms, such as the ACT Accelerator and COVAX; the intensification of existing mechanisms, such as the GISAID Initiative, a public–private partnership; and the proliferation of scientific collaborations and publications by members of the global scientific community.
Initiatives such as the U.S. Operation Warp Speed (described in Chapter 4) have demonstrated the advantages of an approach where pharmaceutical companies that are supported by national funding can respond quickly using multiple and often new technologies to produce vaccines rapidly. However, it has also shown that rich countries, as usual, receive vaccines ahead of all others, distribution is largely subject to current political priorities, and provision of viruses and genetic sequence data is not predictable or necessarily reliable. Furthermore, it spotlighted ABS issues with new mechanisms advanced or proposed, including COVAX, WHO’s BioHub System, and discussions of IP waivers and a potential pandemic treaty. In many respects, these discussions are being driven by the same issues
underlying the urgent discussions after the emergence of H5N1 influenza in 1997 and 2003, SARS in 2003, and Ebola in West Africa in 2014. As discussed, some of these events led to the adoption of the revised IHR in 2005 and the PIP Framework in 2011.
Three evolving initiatives are of particular relevance to ABS for pathogens with pandemic potential. First, in May 2021, the Swiss Confederation and WHO signed a memorandum of understanding to launch the first WHO BioHub Facility as part of the new WHO BioHub System, which was first announced in November 2020. This will be based out of Spiez, Switzerland, and its purpose will be to enhance the rapid sharing of viruses and other pathogens globally between laboratories and partners. It will be a center for the safe receiving, sequencing, storage, and preparation of biological materials for distribution to other laboratories. These materials will be used to inform risk assessments and sustain global preparedness against SARS-CoV-2 and other emerging pathogens. The BioHub System is intended “to address the fact that, currently, most pathogen sharing is done bilaterally between countries and on an ad hoc basis, which can be slow, and leave some countries without access to the benefits and tools.” It is intended to enable member states to share biological materials with and via the BioHub under pre-agreed conditions and in compliance with biosafety, biosecurity, and other applicable regulations to ensure timeliness and predictability in response activities (WHO, 2021b,c). WHO plans to broaden BioHub for the use of biological materials by qualified entities—such as manufacturers—to develop medical products for fair allocation to member countries. WHO is running a pilot phase using SARS-CoV-2 to test the feasibility and operational arrangements for sharing such materials with BioHub. It is intended to expand to other pathogens, and, in 2022, to connect partners with other repositories and laboratory networks. However, the proposal has been criticized by some, such as TWN and South Centre, for lacking specific reference to equitable sharing of benefits, a concept that is an integral part of the discourse on biodiversity law and policy (Hammond, 2021; South Centre, 2021).
Second, much recent discussion and debate has taken place on IP waivers. The proposed Agreement on the Trade-Related Intellectual Property Rights (TRIPS) waiver resulted from concerns about the impact of IP barriers on the scale-up of manufacturing of lifesaving tools, including vaccines, for COVID-19. World Trade Organization (WTO) members can invoke a waiver of certain IP rights due to exceptional global crises. In October 2020, India and South Africa proposed that the WTO allow all countries the legal right under international trade rules to choose not to grant or enforce patents and other IP related to COVID-19 drugs, vaccines, diagnostics, and other technologies and materials until widespread vaccination is in place globally and the majority of the world population has developed an immunity (Menezes, 2021). This proposal gained momentum,
and 64 countries had cosponsored it as of September 2021. However, vaccine patenting involves complex issues. For example, some of the main platform technologies for COVID-19 vaccines had already been used for previous vaccines and are under patent control. A large portfolio of IP also exists on mRNA technology, although Moderna has elected not to enforce its patents during the pandemic.
The perspectives on IP waivers are, as might reasonably be anticipated, very different for governments, civil society organizations (CSOs), and industry. In a 2021 research paper, the South Centre represented the views of CSOs, arguing that to be in line with the May 2020 WHA-approved “COVID-19 Response” Resolution (WHA 73.1), WHO member states need to recognize COVID-19 responses as a global public good and “any unjustified obstacles must be removed, and TRIPS flexibilities should be strengthened” (Menezes, 2021). The UN General Assembly also passed resolutions emphasizing the need to rapidly scale up manufacturing and strengthen supply chains for efficient, timely, fair, transparent, and equitable access to and distribution of diagnostics, drugs, and COVID-19 vaccines. The president of Costa Rica proposed the COVID-19 Technology Access Pool early in the pandemic for voluntary, nonexclusive licensing. It was received with apparent enthusiasm, but it collapsed without widespread buy-in. Its failure to attract support underscores how voluntary mechanisms depend on the participation and direct collaboration of “Big Pharma” to be successful.
The industry perspective, as represented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), in May 2021 expressed disappointment with the U.S. decision to support an IP waiver as “the simple but the wrong answer to what is a complex problem.” In IFPMA’s words,
Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis. On the contrary, it is likely to lead to disruption; while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally: namely elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials and ingredients in the supply chain, and a willingness by rich countries to start sharing doses with poor countries. (IFPMA, 2021)
Thus, industry opposition to imposed IP waivers is clear. Such waivers could also act as a disincentive for vaccine development and manufacturing or result in manufacturing that is not up to standards.
Third, as described in Chapter 2, discussions are ongoing about developing a new “pandemic treaty” that would address the gaps in existing governance instruments. It could articulate key principles, roles, and responsibilities for sharing viruses and benefits and potentially establish
penalties for failure to comply. However, a global treaty negotiation is likely to require many years because so many constituencies, including civil society, industry, national and international health organizations, and North- and South-associated country groupings, would have to be involved. Such negotiations would also require consistent and committed political leadership that supports a strong multilateral approach that could bring together all interests. At the WHA in May 2021, over two dozen countries signed on to support a global treaty, while the United States, Russia, and China held off. This conversation will be continued in a special session of the WHA in November 2021 (Furlong, 2021). Nevertheless, a new treaty represents an opportunity to incorporate earlier diplomatic gains and agreed-upon principles in the PIP Framework into a new long-term multilateral agreement.
KEY FINDINGS AND CONCLUSIONS
- The PIP Framework is built on the needs for transparency, equity, efficiency, and accountability of countries, industry, and WHO. Beyond access to vaccines and medicines at reduced prices, other essential benefits can include capacity building, training, and publications.
- The PIP Framework’s ability to ensure the availability of vaccines and antiviral medications under pandemic conditions and to distribute them equitably remains untested.
- There is a major gap regarding sharing genetic sequence data due to uncertainty about whether it falls under the PIP Framework, the CBD, and the Nagoya Protocol. It is still necessary for the PIP Framework to be modified to include genetic sequence data.
- While it remains theoretically possible for the PIP Framework to be expanded to include seasonal influenza, other viruses, and genetic sequence data, it does not appear to be a realistic option to scale up the pandemic influenza–specific framework to encompass other respiratory pathogens with pandemic potential.
- The underlying core principles of the PIP Framework remain highly relevant and should be incorporated into a pandemic treaty or other future international instrument. These principles include (1) giving equal weight to sharing of viruses and of benefits, which are equally important, (2) sharing responsibility and accountability among countries, WHO, and the private sector (although, under the framework, both industry and civil society operate through member states), (3) recognizing that responding to country needs is fundamentally important, particulary for LMICs, and (4) ensuring benefits flow multilaterally and not bilaterally.
- Secondary PIP Framework issues include the specific ways that it is implemented. These can be modified and negotiated for future multilateral agreements covering ABS for pathogens with pandemic potential.
- Delays in sharing samples, sequences, and information have serious implications for delaying a pandemic response. Every player—including National Influenza Centres, countries, vaccine manufacturers, and WHO—can have both immediate self-serving and collaborative behavior. It is therefore critical to encourage and enable rapid sharing and characterization of samples.
- Seasonal pathogen sharing has increasingly been negatively impacted by the Nagoya Protocol, resulting in the need to choose alternate virus strains for vaccines. In a potential pandemic situation, this behavior in sharing viruses and associated information could have very serious implications for delaying a pandemic response.
- A new agreement should address and resolve issues raised by the Nagoya Protocol for sharing influenza viruses and other pathogens with pandemic potential, including genetic sequence data.
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