Analysis Pandemic preparedness and response: beyond the Access to COVID-19 Tools Accelerator Abha Saxena ,1 Brook K Baker,2 Amanda Banda,3 Anders Herlitz,4,5 Jennifer Miller,6 Karrar Karrar,7 Marc Fleurbaey,8 Esther Chiwa,9 Caesar Alimisnya Atuire ,10 Iwao Hirose,11 Nicole Hassoun 12 To cite: Saxena A, ABSTRACT Baker BK, Banda A, et al. Nationalism has trumped solidarity, resulting in SUMMARY BOX Pandemic preparedness unnecessary loss of life and inequitable access to ⇒ To date, more than 6 million people have died from and response: beyond the vaccines and therapeutics. Existing intellectual property the pandemic (with COVID- 19-p eriod excess mor- Access to COVID-19 Tools (IP) regimens, trade secrets and data rights, under which tality much higher) and some estimate that a more Accelerator. BMJ Global Health pharmaceutical firms operate, have also posed obstacles equitable distribution of vaccines could have saved 2023;8:e010615. doi:10.1136/ bmjgh-2022-010615 to increasing manufacturing capacity, and ensuring 61% of the deaths. adequate supply, affordable pricing, and equitable access ⇒ The world has agreed to strengthen the Handling editor Seye Abimbola to COVID-1 9 vaccines and other health products in low- International Health Regulations and to thrash income and middle- income countries. We propose: out a potentially legally binding instrument that Received 4 September 2022 (1) Implementing alternative incentive and funding would set targets and responsibilities for various Accepted 17 December 2022 mechanisms to develop new scientific innovations to stakeholders involved in pandemic preparedness address infectious diseases with pandemic potential; and response. (2) Voluntary and involuntary initiatives to overcome IP ⇒ To help everyone access essential counter- barriers including pooling IP, sharing data and vesting measures in pandemic times, we propose a six licences for resulting products in a globally agreed entity; pronged approach that argues for an equitable, (3) Transparent and accountable collective procurement to transparent, accountable new global governance enable equitable distribution; (4) Investments in regionally structure that oversees the replacement of the distributed research and development (R&D) capacity financial incentives of intellectual property exclu- and manufacturing, basic health systems to expand sivities by rewards for research and development equitable access to essential health technologies, and but only on the condition that pharmaceutical non-d iscriminatory national distribution; (5) Commitment companies share the intellectual property rights to strengthen national (and regional) initiatives in the necessary to produce and distribute essential areas of health system development, health research, health technologies globally. drug and vaccine manufacturing and regulatory oversight ⇒ We also argue for the global governance structure and (6) Good governance of the pandemic prevention, to oversee collective procurement, and support in- preparedness and response accord. It is important to vestments in regionally distributed research and articulate principles for deals that include reasonable development and manufacturing capacities, and access conditions and transparency in negotiations. We strengthened health systems. argue for an equitable, transparent, accountable new ⇒ Our proposal makes actionable key ideas in section 5 global agreement to provide rewards for R&D but only on of the International Panel on Pandemic Preparedness the condition that pharmaceutical companies share the IP and Response’s recommendations and provides to rights necessary to produce and distribute them globally. the Intergovernmental Negotiating Body drafting the Moreover, if countries commit to collective procurement pandemic prevention, preparedness and response and fair pricing of resulting products, we argue that we can accord an outline of how an accord that supports greatly improve our ability to prepare for and respond to equitable access to essential health technologies for © Author(s) (or their pandemic threats. all might be implemented. employer(s)) 2023. Re- use ⇒ If countries commit to collective procurement and permitted under CC BY- NC. No fair pricing of resulting products, we argue that we commercial re-u se. See rights can greatly improve our ability to prepare for and and permissions. Published by BMJ. INTRODUCTION respond to pandemic threats For numbered affiliations see The global response to the COVID-1 9 end of article. pandemic faltered: Nationalism trumped soli- Correspondence to darity despite a call for joint action against this The joint call made a plea for an interna- Dr Anders Herlitz; and future pandemics signed by 25 heads of tional treaty for pandemic preparedness and a ndersherlitz@g mail.c om state and several international organisations.1 response. The 1-y ear period following that Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 1 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health call has seen significant progress and exposed some stark be global public goods. Now is the time for the interna- political realities. The world has agreed to strengthen tional community to work together to ensure that the the International Health Regulations and to thrash out proposed treaty includes a robust regimen for the devel- a potentially legally binding convention, agreement or opment of, and access to, essential health technologies an international instrument (provisionally called the required for the effective management of any pandemic; “pandemic prevention, preparedness and response such a treaty must also enable health systems strength- accord”) that would set targets and responsibilities for ening so that pandemic countermeasures can actually be various stakeholders involved in pandemic preparedness delivered to all in need. In our opinion, Perehudoff et al and response.2 This is good news. But this pandemic has offer the best worked out proposal for ensuring access also revealed that solipsistic sovereignty and self- interest to essential health technologies. They suggest that a trump existing treaties or agreements if they are not global treaty should be guided by the ethical principles legally binding. of solidarity, transparency and inclusive governance, and Whether or not the proposed accord will live up to propose seven areas for action in order to support global global expectations for fairness and solidarity remains sharing of IP, know-h ow, and technology for equitable to be seen, however, as currently formulated, it does not access to medical countermeasures.7 We agree with these address international and national intellectual property authors, but go beyond their proposals in specifically (IP) regimens (patents, copyrights, industrial designs, responding to the question ‘what provisions or mecha- trade secrets and data rights) that negatively impact nism(s) might ensure that the pandemic accord ensures equitable access to pandemic health technologies. This equitable access to essential health technologies for all?’ means that pharmaceutical firms will continue to enjoy Specifically, we suggest licences for new technologies be IP exclusivities that pose direct obstacles to increasing vested in a well-g overned international organisation and manufacturing capacity, and ensuring adequate supply, that funding for research and development (R&D) of affordable pricing, and equitable access to COVID- 19 and essential health technologies at the international level future pandemic vaccines, diagnostics, therapeutics and be tied to strong access conditions well before the decla- other health products in low- income and middle- income ration of a pandemic of international concern. We also countries (LMICs). Within the World Trade Organization advocate for collective procurement with fair pricing so (WTO) framework, despite a push for a temporary waiver that the international community can help recoup invest- of IP rights on COVID- 19 medical countermeasures by ment costs in R&D and support future development and many LMICs, the recent WTO Ministerial Decision offers basic health systems. Finally, we detail how representa- only a highly conditional compulsory licensing (CL) tive governance efforts can advance not only procedural solution for patents that only covers export of vaccines justice and legitimacy but also enhance equitable alloca- to eligible developing countries.3 4 Though there was an tion and uptake of essential health technologies. initial 6- month window to extend the ‘solution’ to diag- nostics and therapeutics, including the outpatient antivi- rals now widely available in the global North, this deadline OUR PROPOSAL was not met and has been further extended. Thus, the We propose an enhanced global mechanism embodied current state of affairs falls far short of the vision of a in the pandemic prevention, preparedness and response world that works together to fight global health emer- accord that holds everyone accountable (see figure 1). gencies through IP waivers and technology transfer (TT) This mechanism should be well-g overned and requires initiatives that support alternative producers in poorer pooling IP and data, patent, trade-s ecrets and copyright countries in making vaccines, diagnostics, therapeutics waivers, and TT in return for a reward for innovation in and other medical countermeasures and providing them order to speed up R&D of, and fair access to, essential equitably and affordably to their populations.5 Moreover, health technologies. By fair access we mean ensuring a we support investments in basic health systems to buttress robust, affordable, and equitable supply chain of public other aspects of pandemic preparation and response— health related technologies, through collective procure- from surveillance, testing, treatment, tracing and isola- ment, among other provisions, where we take equity to tion capacity for a variety of potential pandemic threats, mean ensuring alignment of health resources with needs. to investments in new manufacturing sites—and detail In our opinion, each of these provisions is interlinked how representative governance at the global level can and essential for our proposal to work. As we have seen in advance not only procedural justice and legitimacy but the COVID-1 9 pandemic and the monkeypox outbreak, also enhance efforts for equitable allocation and uptake IP rights, while providing incentives for innovation, have of these technologies. Our proposal makes actionable key also posed obstacles to equitable access, with a handful ideas in section 5 of the International Panel on Pandemic of companies with the IP rights retaining technological Preparedness and Response’s recommendations.6 knowhow, and the capacity to manufacture vaccines Because the WTO Ministerial Decision does not directly and therapeutics without addressing the majority of the provide a solution for future pandemics, the proposed world’s needs. We propose an alternative regimen to pandemic preparedness and response accord is our next overcome these barriers. But alternative incentives and chance to pre- emptively remove IP barriers to what should funding mechanisms that support pooled IP and shared 2 Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health responsible for implementing its provisions. This organi- sation (or these organisations) would have responsibility for creating target product profiles for new products and negotiating agreements with industry, working with collective procurement organisations and funding hubs, etc. including liaising with pharma and biotech compa- nies (see figure 2). Below, we detail each provision in turn. Implement alternative incentive and funding mechanisms to develop new scientific innovations to address infectious diseases with pandemic potential The idea is to replace the rewards of IP exclusivities with alternative funding for essential health technologies for priority conditions on the WHO list of pandemic threats, including disease X and influenza, where current incen- tives and funding are insufficient to generate R&D and guarantee equitable and affordable access to resulting products. We also believe that all diseases and conditions, Figure 1 Key provisions of the proposed agreement. R&D, on which there are insufficient incentives and innova- Research and Development. tion, such as antimicrobial resistance, HIV, tuberculosis, and malaria should automatically gain eligibility for alter- licensing can also fail, if the technologies developed native funding and incentives. through these mechanisms cannot be shared efficiently The incentives for R&D might come in many forms, and equitably with all. That is why pillars one and two be tailored to different circumstances, and include both need to be supported by the third and fourth pillar. For ‘push’ strategies—like direct funding and grants—and a faster and more coordinated response, and to reduce ‘pull’ strategies—like lump sum or milestone payments duplication and fragmentation, innovation hubs that are or prize funds—for new R&D. interconnected, and share data and knowledge must be We suggest that R&D funding be linked to the many distributed around the world. Such innovation hubs will different proposed, and, current innovative financing necessarily require support and funding from interna- mechanisms for pandemic preparedness, wherein a tional organisations and funders, but unless host coun- proportion of these funds are earmarked for R&D on tries and regions take ownership of these innovation health technology innovations with a shared vision hubs, and take responsibility for supporting them, such on scope.8–10 Fiscal bonds, levies on airlines tickets or top down initiatives may fail. That is why our fifth pillar internet-b ased products, etc., revolving funds from donor is so important. National governments’ and the inter- countries, social impact bonds are all instruments that national community must commit to strengthening not are already being used for specific health programmes, only basic health systems to ensure equitable access to including for R&D and could be reimagined for developed health technologies, but also health research pandemic preparedness and response.11 12 The World systems, including manufacturing and regulatory struc- Bank has recently set up the Financial Intermediary Fund tures, to support the establishment of innovation hubs which might designate resources for the same purpose.10 mentioned in the fourth pillar. The running of such Andrew Lo, an economist from Massachusetts Institute of an interconnected system is however fraught with chal- Technology, has proposed a subscription-b ased funding lenges. Entities that have the knowledge and the data model, where countries would be required to pool a small need assurance that their data and expertise will be used amount per citizen in exchange for access to vaccines responsibly and ethically. Including a neutral and trusted developed from those funds.13 Voluntary contributions broker such as the World Health Organization (WHO) from philanthropic organisations and compulsory contri- or any other similar entity in the deals—our sixth pillar— butions from signatories to any agreement implementing gives confidence and assurance to everyone that sharing this proposal might also help generate the needed funds. expertise, knowledge, and the fruits of that knowledge Funding costs for developing multiple treatments range will be universal and equitable. from US$50 to US$680 billion—much less than the esti- If countries agree to this proposal in negotiating mated cost of the pandemic.14 a pandemic prevention, preparedness and response accord, they have ultimate responsibility for imple- Voluntary and involuntary initiatives to overcome IP barriers menting its provisions but, to do so effectively, they must The international community should, at a minimum, not only create a representative governance structure embrace IP waivers and TT requirements along the lines for guiding these efforts, the agreement should specify of the unsuccessful India/South Africa proposal for a an international health organisation or organisations temporary waiver on IP protections on COVID-1 9- related Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 3 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health Figure 2 Structure of the proposed mechanisms for promoting R&D and access to essential health technologies. R&D, Research and Development. health technologies.15 An expert group has recently technology acquisition at reasonable rates.16 17 However, published seven key recommendations for overcoming as a condition of receiving the incentives, it is essen- IP barriers to address future pandemics with which the tial that companies share IP and all the other relevant authors agree.7 In addition to these more systematic knowledge and data relevant to development (including reforms, the WTO’s Agreement on Trade-R elated Aspects preclinical and clinical trial results) and manufacturing, of Intellectual Property Rights allows CL of patents on and vest the licence in the WHO COVID- 19 Technology multiple grounds, including, with expedited proce- Access Pool (C- TAP) (reorganised as a Pandemic TAP, dures, for public health emergencies. CL guarantees P- TAP) or as specified by a global agreement (though for ‘adequate remuneration’, i.e. incentives for innovation, the remainder of this article we will suppose the selected but it should also be interpreted to allow CLs on trade organisation is C- TAP or P- TAP). This will encourage and secrets and confidential information. However, country- empower companies to build on each other’s scientific by- country, product- by- product compulsory licences research and support and speed up production of new are often administratively burdensome and politically vaccines and technologies.18 C- TAP or its P-T AP alter- risky. Therefore, rules streamlining and broadening CL native would then be able to licence out production to procedures and removing export restrictions should be alternative (eg, generic) manufacturers, including those adopted and mechanisms for coordination of CLs should in LMIC regions as proposed through C-T AP, the WHO also be pursued. mRNA Tech Transfer Hubs, and the Medicines Patent Since IP barriers and TT refusals should not stand in Pool (MPP) for COVID- 19 technologies. P- TAP can the way of equitable access, we also recommend that licence production on specified access (affordable cost rewards/incentives mentioned above be conditional on and equitable distribution) conditions. pooling IP, sharing data, and vesting licence for resulting Current estimates of R&D drug costs range from products in a globally agreed entity. Existing interna- US$43.4 to US$4200 million.19 To ensure that the tional health initiatives and organisations demonstrate incentives are appropriate to guide future R&D invest- that it is possible to provide compensation for IP- free ments, companies must share data on current R&D 4 Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health costs. Incentives for new innovations must cover these stable version of the same), and additional applications costs, the risks of failure and the risk of not being the of mRNA technologies to address other pressing health first to produce a product fulfilling a specific profile, but needs.21 The Hub’s innovations, commercial manufac- calculating the exact size and methodology of awarding turing know-h ow, and clinical trial data will be shared incentives is beyond the scope of this paper. Modelling with at least 15 spoke companies in other underserved of disease infectivity rates, estimates of pandemics’ like- LMIC regions who will be authorised to clone the rele- lihood, and information on interventions’ effectiveness vant technologies. The model combines open access initi- from clinical trials and treatment access may inform atives to expedite and coordinate research and to share rewards for preventative treatments. Incentivising compa- knowledge with a commitment to democratise supply nies in this way delinks companies’ profits from sales and and ensure more equitable access to more affordable ties them to good health consequences instead. More- medical countermeasures. over, some suggest rewarding pharmaceutical companies and other R&D organisations for new innovations based Commitment to strengthen national (and regional) initiatives on their health impact. To this end, good measures of in the areas of health system development, health research, health impact exist. drug and vaccine manufacturing and regulatory oversight To be party to the proposed pandemic prevention, Transparent and accountable collective procurement to preparedness and response accord, countries should enable equitable distribution commit to strengthening their health and community The proposed pandemic accord should support a rational systems, including their health delivery systems, with procurement system that includes pooled procurement, external assistance to help develop health service capacity but under an equitable allocation framework. This frame- in lower income countries. Without such a commitment, work should ensures equitable, timely, and global distri- countries risk perpetuating a colonial model of neglect bution according to allocation principles and at price for health technology delivery. Strong health systems points in LMICs established by C-T AP or P-T AP. Procure- require a robust policy environment, strong health ment efforts should involve pooled contracted negotia- governance and leadership, and coordination mecha- tion on prices of essential health technologies globally nisms at country, regional and global levels. They also as well as information sharing on budgeting, pricing, require investments in data, monitoring, evaluation and forecasting and the legal landscape. However, collec- surveillance systems, and importantly, in both skilled tive procurement may also include pooled contracting, and community health workers. Priority in many LMICs acquisition, logistics, and delivery of these technologies should go to expanding, and strengthening community where helpful to support country efforts and may involve systems and community- led interventions such as health a gradual scale up of UNICEF, regional procurement information, education and communication strategies, organisations such as the African Medicines and Supplies Platform, and/or related distribution efforts.20 We demand generation and outreach. propose C- TAP or P-T AP licence the products to manu- Finally, countries must commit to non-d iscriminatory facturers with licensing fees and conditions that support national delivery of pandemic-r elated health services, collective procurement efforts and at price points that reaching most-v ulnerable and hard-t o-r each popula- allow them to recoup the costs of investment and support tions and ensuring gender equity. The least developed the development of new manufacturing capacity, invest- countries may not have adequate capacities even for ments in cold chains, and other aspects of demand and strengthening their health systems. The proposed legally supply development necessary for vaccine deployment enforceable pandemic accord must include language and uptake. that requires establishing regional centres of excellence to support health systems development in the least devel- Investments in regionally distributed R&D capacity and oped countries of that region, taking into consideration manufacturing and basic health systems to expand equitable their sociocultural needs and economic background. access to essential health technologies and ensure non- These centres could also provide support to the more discriminatory national distribution advanced countries in the area of drug and vaccine R&D, For technologies to be accessible, available, affordable and manufacturing, including regulatory oversight. and adapted for use in LMICs, manufacturing capacity for all necessary medical countermeasures such as vaccines, Good governance of the pandemic prevention, preparedness therapeutics, diagnostics, personal protective equipment, and response accord basic medical supplies, etc. must be distributed globally. The existing global response architecture is not fit for This requires global efforts to strengthen and use LMIC purpose, because it does not represent the interests of all research capacity and regionally distributed biopharma- those affected by pandemics. A pandemic accord should ceutical and diagnostic manufacturing capacity. A very be supported by good governance and enforcement promising initiative that includes both of these features mechanisms to create the proposed incentives for new is the WHO mRNA TT Hub. The Hub is developing a product development and ensure collective procurement Moderna- like mRNA vaccine (an improved, more heat and equitable access to essential health technologies. Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 5 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health The governance for the coordination mechanism, or non- compliance, and benefits for participation, such as independent secretariat, that we propose should embrace capacity building support for LMICs in strengthening decolonisation at its core and fully represent the interests basic health systems, and TT before the onset of major of the global population, especially LMICs; it should be pandemics so that they are prepared to respond. Though accountable, transparent and representative of a wide tax and trade penalties and overcoming IP barriers set of stakeholders such as, but not limited to, patient may require modifying existing rules under the WTO, groups, healthcare provider representatives, civil society, it also requires countries willing, and able, to enforce philanthropic organisations, and policy makers, both in such measures. Civil society may help secure countries’ high- income countries (HICs)s and LMICs.22 Countries participation and address breaches of the agreement by negotiating the agreement should be bound to act in informing public opinion, be part of decision- making the common interest rather than primarily as represen- processes, and contribute important grass root tatives of their own populations. The secretariat must perspectives.24 have proportional representation of LMIC governments Cooperation to develop preventive measures and treat- and experts not only in leadership roles and throughout ments in non-p andemic times may make it easier to sustain the governance structure, but at all levels; not just as cooperation in future pandemics. A well-d esigned legal tokens but in ways that are meaningful and numbers agreement can help provide clarity on what is required by that are proportionate to LMIC populations and diverse member states prior to and during a pandemic, whether LMIC perspectives. Experts and civil society organisation they are conducting themselves in line with their commit- (CSO) voices that represent marginalised populations, ments, and possibly even foster avenues for correcting minorities, populations across the life-c ycle continuum, deviations. It can provide a process for resolving disagree- and diverse gender perspectives must also be included in ments, helping to get people to the table. Moreover, it the governance mechanism; not only towards the end of may be more difficult to deviate from procedures as they the process but early on—for example, in setting priori- become ingrained in many other systems. ties for effective pandemic preparedness and response. The secretariat must be responsive to indigenous and community- based knowledge and beliefs, equitable and DEFENDING THE PROPOSAL: GLOBAL COOPERATION, effective, and transparent and accountable. Terms of SOLIDARITY AND HUMAN RIGHTS reference should be devised for this purpose, stating Principles of solidarity (which we take to be the sympa- clearly who will be entitled to participate in the mecha- thetic and imaginative enactment of collaborative meas- nism’s design, as well as how the processes of deliberation ures to promote everyone’s flourishing and specifically, and decision will take place.23 Ideally, LMIC stakeholders in this context, equitable access to essential health will have sufficient power and control over resources so services), human rights (as articulated in the Universal that the most affected have the largest voice and influ- Declaration of Human Rights and other international ence over decisions and outcomes. It is not enough to treaties and instruments), and justice (which at least be ‘consulted’, or merely ‘informed’, about predeter- requires fair distribution and access to essential health mined decisions. Nor should stakeholders be manipu- technologies), all provide strong ethical reasons to imple- lated, placated, or expected to engage in implementing ment our proposal. As the recent pandemic has shown, decisions over which they have no effective influence. lack of preparedness, cooperation and solidarity leads to Rather, representatives should have full and equal rights unequal distributions of healthcare technologies and, to meaningful participation and co-c reation, which will partly for this reason, inequities in the health impact of engender trust, catalyse political buy- in, and help stimu- the disease. In order to reduce the impact of pandemics late demand for—and uptake of—new technologies. in the future, we must strengthen our pandemic prepar- The Global South has strong grounds for distrusting edness and response in a way that recognises the mutual continuing colonial practices and attitudes given the responsibilities of all stakeholders. Our proposal provides consistent failure of the Global North to share resources a path forward for such preparations. and decision- making rights. If the international commu- Moreover, previous global health initiatives provide nity embodies true inclusion, participation and gover- some reason to believe that the international commu- nance rights in the pandemic prevention, preparedness nity can make the kind of agreement we propose. Some and response accord, it can enhance solidarity and trust. global health organisations like Drugs for Neglected If government and CSO representatives are involved Disease Initiative and Medicines for Malaria Venture from the beginning, and make contributions that are have succeeded in securing licences and good access reflective of the beliefs and knowledge of the people in terms in their R&D investment agreements.16 17 Others the community, rather than being pressured to simply like the MPP have secured significant licences sharing IP endorse the status quo, they can advance equitable access as well as other data and knowledge necessary to ensure to essential health technologies. access to essential health technologies.25 The MPP esti- The accord must also be backed by enforcement mates that its licensing efforts will have saved 36 million mechanisms consistent with existing and evolving inter- patient years by 2027 by yielding lower cost treatments.26 national law.24 Mechanisms might include penalties for Likewise, in 2021, UNICEF delivered approximately 6 Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health 45% of the vaccines for children under five globally, nationalism and supply shortages in less powerful and and other pooled procurement mechanisms—from the less wealthy countries. Similarly, dose reallocation WHO Procurement Platform, Pan American Health deals led to highly inequitable outcomes, perpetuating Organisation, UNICEF, the Global Fund, and the dependencies and the colonial model of global health. African Medicines and Supplies Platform—also provide Vaccine reallocations were often delayed, sporadic, and access to essential health technologies with significant unplanned for and involved disfavored vaccines and near cost- savings.27–29 expiry doses. Poor countries that simply did not have Some might suggest that instead of supporting our the time to distribute the doses before expiry sometimes proposal to remove IP barriers through voluntary and received sanction for destroying them as directed by the involuntary measures, the international community WHO. While sharing innovations with countries that do could just provide more funds for pandemic- related R&D not currently have the capacity or resources for manu- and still let pharmaceutical companies keep the patents, facturing vaccines and therapeutics supports solidarity, trade secret protection, and maintain other exclusive the international community must also strengthen the rights on their technologies. They will point to the rapid agency of populations living in LMIC by supporting the development, and scaled-u p production, of COVID-1 9 development of national or regional innovation hubs in vaccines, diagnostics and therapeutics to argue that the these regions. current IP-b ased incentive system produces consistent Some may worry that a fully multilateral approach along results by providing stable incentives for innovation and the lines we advocate will require too much cooperation contract manufacturing agreements. More recently, they and that we ignore the self- interested power of HICs.32 33 might point to the International Federation of Pharma- Rich countries have undue influence over international ceutical Manufacturers’ Association’s Berlin Declara- health organisations because they pay a great proportion tion, where industry promises to take additional steps to of their budgets and can also exercise significant influ- scale-u p supply to LMICs if a stable IP system is preserved ence over pharmaceutical companies within their bound- and if donors provide guaranteed funding for low-p rofit aries. They may simply exit or renege on international or no-p rofit sales to the poorest countries.30 agreements and, when it is in their best interest to engage The rhetoric that the R&D system works well and we in bilateral deals, pressure pharmaceutical companies to just need to solve the access problem ignores evidence provide them priority access, or issue export prohibitions that the status quo system has consistently produced to secure scarce supplies. rampant health inequality precisely because of the incen- For countries, feasibility of our proposal will be deter- tives it creates. The current R&D system works well for the mined by the terms of the pandemic accord, but we wealthy, but it almost always fails to serve the poor. Even believe that it is in the interest of all countries to collab- during the current pandemic, with minor and recent orate and to implement the mechanism proposed here. exceptions, most pharmaceutical firms simply did not As we have seen in this pandemic—‘No one is safe till voluntarily join C-T AP, the WHO mRNA Tech Transfer everyone is safe’.34 The COVID-1 9 pandemic has shown Hub, or the MPP.31 This pandemic has demonstrated that status quo approaches, where rich countries protect that companies are perfectly willing to accept public the interests of the biopharmaceutical industry and funds through Operation Warp Speed, the Coalition for support existing trade rules, have actually prolonged and Epidemic Preparedness Innovations, and other public intensified the pandemic and its social, economic, and and philanthropic funders, take additional government political impacts. Whether our proposal is feasible will also money to derisk their pandemic-r elated R&D and expand, depend on countries’ ability to reign in unbridled corpo- fill and finish capacity that they control, and then just rate power, but there is reason for optimism. Expanded sell their technologies to the highest bidders. Moreover, public expenditure on R&D, clinical trials, expanded historically, pharmaceutical companies have not invested manufacturing capacity, and advance purchase agree- enough in R&D addressing future pandemic threats. We ments all derisk or actively subsidise R&D, registration, believe public funding must come with stringent access and supply. Implementing these investments in conjunc- conditions. We cannot leave it up to companies whether tion with collective procurement and the other aspects of or not to share their technology and data, whether to our proposal would obviate the need for companies’ to expedite and expand supply, whether to lower prices, invest significantly in marketing and demand creation, or whether to sell on anything other than a first-c ome, lowering their costs. Moreover, our proposal secures the higher- price basis. We must make the rewards propor- benefits of transparency and knowledge-s haring—saving tionate to companies’ actual investments and conditional time and resources throughout product development on their sharing technology and data to ensure adequate and across the supply pipeline. If the rewards for inno- supply, affordable pricing and equitable access.31 vation are sufficient and threats of involuntary measures Yet others might argue for alternatives to our proposal to secure equitable access are credible, pharmaceu- that we believe are demonstrably worse. For instance, some tical companies’ reluctant acquiescence is more likely. may advocate for allowing bilateral supply deals within Agreeing to provide pandemic-r elated health technolo- limits and for dose reallocations.32 Unconstrained bilat- gies at set price points need not threaten their ability to eral purchasing contributed to vaccine and therapeutic develop and sell technologies for non-p andemic-r elated Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 7 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health conditions in normal markets. Moreover, companies medicines. Even those who can access the countermeas- should be willing to forego potential future profits in ures often lack other health system resources they need to pandemic times at reasonable rates as these profits are effectively combat the virus. Moreover, future pandemics discounted by the uncertainty of a pandemic eventuating may prove much more devastating without global coop- for which any particular product might be useful. In any eration. We have argued for an equitable, transparent, case, this is an opportune moment to push for more accountable new global agreement to provide rewards radical change in governments’ regulation over the phar- for R&D but only on the condition that pharmaceutical maceutical sector. Significant civil society action may help companies share the IP rights necessary to produce and get sign on and cooperating countries can use trade, tax distribute them globally. Moreover, if countries commit and other incentives to encourage participation. to collective procurement and fair pricing of resulting Some simply assume that the approach we advocate is not products, we have argued that we can greatly improve feasible, but we believe that what we can achieve together our ability to prepare for and respond to pandemic as an international community is up to us. Significant civil threats. We must work together to overcome the nation- society action may help get sign on and, as noted above, coun- alism undermining our current global response plans to tries can use trade, tax, and other incentives to encourage adequately address and prevent future pandemics. cooperation. Moreover, even the sceptics highlight the importance of many parts of our proposal and acknowledge Patient and public involvement that it is important to articulate principles for investments in This paper did not involve patients or the public because the essential health technologies that include reasonable access paper focuses on all potential pandemic diseases. However, conditions, especially given the public funding provided it is the result of a year-l ong collaboration with scholars and for these technologies. They also stress the importance of public health practitioners from around the world and transparency in negotiations, ensuring productive invest- across the disciplines of law, bioethics, public health, and ments are made in manufacturing capacity, supply chain economics on pandemic preparation and response. Since resilience, and sharing technical knowledge.33 Even aspi- there were no patients involved, the development of the rational or normative proposals that are not fully effective, research question and outcome measures were not informed such as an ideal of collective procurement and R&D guided by patients’ priorities, experience and preferences. by global health interests, can be important in practice— setting standards that allow criticism and civil society action Author affiliations for reform—even if they are never fully implemented. 1Independent Bioethics Advisor, Geneva, Switzerland To date, more than 6 million people have died from the 2Northeastern University School of Law, Northeastern University, Boston, pandemic (with COVID- period excess mortality much Massachusetts, USA3 higher) and some estimate that a more equitable distribution Wemos, Amsterdam, The Netherlands4Department of Philosophy, Linguistics and Theory of Science, University of of vaccines could have saved 61% of the deaths.35 36 Some Gothenburg, Goteborg, Sweden predict that COVID- 19 crisis will cost the world US$12.5 tril- 5Institute for Futures Studies, Stockholm, Sweden lion over the next 2 years.37 Others estimate that vaccine 6Yale School of Medicine, Yale University, New Haven, Connecticut, USA 7 nationalism alone has cost the world US$1.2 trillion.38 So, International Development Department, Save the Children, London, UK8 moving beyond bilateral deals and greatly enhancing the Paris School of Economics, Paris, France9Expanded Program on Immunization, Malawi Ministry of Health, Lilongwe, Malawi global preparedness and response architecture has the 10Philosophy and Classics, University of Ghana, Accra, Ghana potential to save millions of lives and trillions of dollars. 11Philosophy, McGill University, Montreal, Québec, Canada 12Philosophy, Binghamton University, Binghamton, New York, USA Twitter Abha Saxena @SaxenaBioethics and Caesar Alimisnya Atuire @atuire CONCLUSION Acknowledgements The authors gratefully acknowledge the financial assistance What we can achieve together as an international commu- provided for this publication through the University of Gothenburg. We would nity is up to us. We believe that every human being has a also like to thank the Binghamton University Philosophy Department for their stake in the effective management of the next pandemic, support. Moreover, we deeply appreciate the feedback we received from Kaushik and everyone—from states and the private sector to Basu, Larry Gostin, Pedro Villarreal, Steven Hoffman, Johnathan Wolff, and José Szapocznik as well as audiences and colleagues at Drugs for Neglected Disease civil society—must work together and be held account- Initiative, the Pandemic Action Network, Rutgers Center for Population Bioethics, able. Absent this, adequate pandemic preparedness and Cornell University, CRADLE/ Institute of Economic Growth (Dehli) Roundtable on response will remain a distant hope, and securing equi- Law and Economic Development, Bowling Green State University, Regis University, table distribution of pandemic-r elated health technolo- Oxford University, Merrimak College, and a series of virtual workshops organized in conjunction with the Blavatnik School of Government at Oxford University, Center gies to all people of the world, a dream. It is important for Global Development, and IRG- GHJ (https://www.irg-ghj.org/). Finally, we would to articulate principles for deals that include reasonable like to thank Milan Patel, Diana Dedi, Julia Match, Annie Nguyen, and the Global access conditions and transparency in negotiations. Health Impact (https://www.global-health-impact.org/) team for their organization Unfortunately, in the current pandemic, wealthy nations and research assistance. have unethically bought most of the world’s COVID-1 9 Contributors All authors contributed to the conceptualisation of the manuscript. vaccine and therapeutics supplies despite having a small AS, BKB and NH contributed the majority of writing as lead authors. All authors helped shape the analysis, research and manuscript and provided critical proportion of the global population, leaving many feedback on drafts. NH led the discussions, organised the group, and is ultimately countries with late and limited access to vaccines and responsible for the article's content, as the guarantor. 8 Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health Funding The authors have not declared a specific grant for this research from any 15 World Trade Organization. Waiver from certain provisions of the funding agency in the public, commercial or not- for-p rofit sectors. TRIPS agreement for the prevention, containment and treatment of COVID- 19, 2021. Available: https://docs.wto.org/dol2fe/Pages/ Competing interests None declared. SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True Patient and public involvement Patients and/or the public were not involved in [Accessed 05 Nov 2022]. the design, or conduct, or reporting, or dissemination plans of this research. 16 Drugs for Neglected Diseases Initiative. An innovative approach to R&D for neglected patients, 2014. Available: https://dndi.org/wp- Patient consent for publication Not applicable. content/uploads/2009/03/DNDi_Modelpaper_2013.pdf [Accessed 01 Ethics approval Oct 2021].Not applicable 17 World Bank Group. Independent Evaluation Group. The Provenance and peer review Not commissioned; externally peer reviewed. medicines for malaria venture (MMV), 2007. Available: https://ieg. worldbankgroup.org/sites/default/files/Data/reports/gpr_mmv.pdf Data availability statement Data sharing not applicable as no datasets generated [Accessed 01 Oct 2021]. and/or analysed for this study. 18 Miller J, Ross JS, Wilenzick M, et al. Sharing of clinical trial data and Open access This is an open access article distributed in accordance with the results reporting practices among large pharmaceutical companies: Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which cross sectional descriptive study and pilot of a tool to improve company practices. BMJ 2019;366:l4217. permits others to distribute, remix, adapt, build upon this work non-c ommercially, 19 Wouters OJ, McKee M, Luyten J. Estimated research and and license their derivative works on different terms, provided the original work is development investment needed to bring a new medicine to market, properly cited, appropriate credit is given, any changes made indicated, and the 2009- 2018. JAMA 2020;323:844–53. use is non- commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. 20 Nemzoff C, Chalkidou K, Over M. Aggregating demands for pharmaceuticals is appealing, but pooling is not a panacea, 2019. ORCID iDs Available: https://www.cgdev.org/sites/default/files/aggregating- Abha Saxena http://orcid.org/0000-0002-9423-120X demand-pharmaceuticals-appealing-pooling-not-panacea.pdf Caesar Alimisnya Atuire http://orcid.org/0000-0001-6825-6916 [Accessed 05 Nov 2022]. Nicole Hassoun http://orcid.org/0000-0002-5547-1710 21 World Health Organization. The mRNA vaccine technology transfer hub, 2022. Available: https://www.who.int/initiatives/the-mrna- vaccine-technology-transfer-hub [Accessed 05 Nov 2022]. 22 Nikogosian H. A guide to a pandemic Treaty: things you must know to help you make a decision on a pandemic Treaty, 2021. Available: https://www.graduateinstitute.ch/sites/internet/files/2021-09/guide- REFERENCES pandemic-treaty.pdf [Accessed 05 Nov 2022]. 1 World Health Organization. Global leaders unite in urgent call for 23 Usher AD. Health leaders criticise limited ACT-A review. Lancet international pandemic treaty, 2021. Available: https://www.who. 2021;398:650–1. int/news/item/30-03-2021-global-leaders-unite-in-urgent-call-for- 24 Duff JH, Liu A, Saavedra J, et al. A global public health convention international-pandemic-treaty [Accessed 05 Nov 2022]. for the 21st century. Lancet Public Health 2021;6:e428–33. 2 World Health Organization. WHO member states agree to develop 25 Cox K. The medicines patent pool: promoting access and innovation zero draft of legally binding pandemic accord in early 2023, 2022. for Life- Saving medicines through voluntary licenses. Hastings Available: https://www.who.int/news/item/07-12-2022-who-member- Science and Technology Law Journal 2012;4:291. states-agree-to-develop-zero-draft-of-legally-binding-pandemic- 26 Juneja S, Gupta A, Moon S, et al. Projected savings through public accord-in-early-2023 [Accessed 03 Jan 2023]. health voluntary licences of HIV drugs negotiated by the medicines 3 Médecins Sans Frontières. Countries obstructing COVID- 19 patent patent pool (MPP). PLoS One 2017;12:e0177770–15. waiver must allow negotiations to start, 2021. Available: https:// 27 UNICEF. Immunization. Available: https://www.unicef.org/ www.msf.org/countries-obstructing-covid-19-patent-waiver-must- immunization [Accessed 15 May 2022]. allow-negotiations [Accessed 05 Nov 2022]. 28 DeRoeck D, Bawazir SA, Carrasco P, et al. Regional group 4 World Trade Organization. Draft ministerial decision on the TRIPS purchasing of vaccines: review of the pan American health agreement, 2022. Available: https://docs.wto.org/dol2fe/Pages/SS/ organization EPI revolving fund and the Gulf cooperation directdoc.aspx?filename=q:/WT/MIN22/W15R1.pdf&Open=True Council group purchasing program. Int J Health Plann Manage [Accessed 05 Nov 2022]. 2006;21:23–43. 5 Sariola S. Intellectual property rights need to be subverted to ensure 29 The Global Fund. Evolving the w ambo.o rg pilot for non- Global Fund- global vaccine access. BMJ Glob Health 2021;6:e005656–3. financed orders, 2019. Available: https://www.theglobalfund.org/ 6 The Independent Panel for Pandemic Preparedness and Response. media/9049/bm42_04-evolvingwamboorgpilotnon-globalfundfinanc COVID- 19: make it the last pandemic, 2021. Available: https:// edorders_report_en.pdf [Accessed 01 Aug 2022]. theindependentpanel.org/mainreport/ [Accessed 05 Nov 2022]. 30 International Federation of Pharmaceutical Manufacturers and 7 Perehudoff K, 't Hoen E, Mara K, et al. A pandemic Treaty for Associations. Berlin Declaration – biopharmaceutical industry vision equitable global access to medical countermeasures: seven for equitable access in pandemics, 2022. Available: https://www. recommendations for sharing intellectual property, know- how and ifpma.org/wp-content/uploads/2022/07/IFPMA_Berlin-Declaration_ technology. BMJ Glob Health 2022;7:e009709. 8 The World Bank. Pandemic emergency financing facility, 2021. Biopharmaceutical-industry-vision-for-equitable-access-in- Available: https://www.worldbank.org/en/topic/pandemics/brief/ pandemics-1.pdf [Accessed 05 Nov 2022]. pandemic-emergency-financing-facility [Accessed 05 Nov 2022]. 31 McMahon A. Global equitable access to vaccines, medicines and 9 The White House. Fact sheet: targets for global COVID- 19 Summit, diagnostics for COVID- 19: the role of patents as private governance. 2021. Available: https://www.whitehouse.gov/briefing-room/ J Med Ethics 2020;47:142–8. statements-releases/2021/09/22/fact-sheet-targets-for-global-covid- 32 Emanuel EJ, Buchanan A, Chan SY, et al. What are the obligations 19-summit/ [Accessed 05 Nov 2022]. of pharmaceutical companies in a global health emergency? Lancet 10 The World Bank. Financial intermediary for pandemic prevention, 2021;398:1015–20. preparedness and response - engagement, 2022. Available: https:// 33 McAdams D, McDade KK, Ogbuoji O, et al. Incentivising wealthy projects.worldbank.org/en/projects-operations/products-and- nations to participate in the COVID-1 9 vaccine global access services/brief/financial-intermediary-fund-for-pandemic-prevention- facility (COVAX): a game theory perspective. BMJ Glob Health preparedness-and-response-engagement [Accessed 05 Nov 2022]. 2020;5:e003627–7. 11 The I-8 Group. Innovative financing for development, 2009. 34 COVID- 19 Data Futures Platform. Global dashboard for vaccine Available: https://www.un.org/esa/ffd/wp-content/uploads/2014/09/ equity, 2021. Available: https://data.undp.org/vaccine-equity/ InnovativeFinForDev.pdf [Accessed 05 Nov 2022]. [Accessed 05 Nov 2022]. 12 National Academies of Science, Engineering, and Medicines. Global 35 Chinazzi M, Davis JT, Dean NE. Estimating the effects of cooperative health risk framework, 2016 [Accessed 05 Nov 2022]. versus uncooperative strategies of COVID- 19 vaccine allocation: a 13 Nature Research Custom Media, The Influencer Initiative Sabin modeling study, 2020. Network science Institute. Available: https:// Vaccine Institute. Vaccine experts; reshapes R&D pipeline to prevent www.networkscienceinstitute.org/publications/estimating-the- pandemics, 2022. Available: https://www.nature.com/articles/ effect-of-cooperative-versus-uncooperative-strategies-of-covid- d42473-021-00519-3 [Accessed 05 Nov 2022]. 19-vaccine-allocation-a-modeling-study#:~:text=We%20find% 14 Pecetta S, Tortorice D, Scorza FB, et al. The trillion dollar vaccine 20that%20the%20cooperative,the%20vaccine%20is%2065%25% gap. Sci Transl Med 2022;14:2–3. 20effective [Accessed 05 Nov 2022]. Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 9 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright. BMJ Global Health 36 Rotesi T, Pin P, Cucciniello M, et al. National interest may require business/imf-sees-cost-covid-pandemic-rising-beyond-125-trillion- distributing COVID-1 9 vaccines to other countries. Sci Rep estimate-2022-01-20/ [Accessed 02 May 2022]. 2021;11:18253. 38 RAND Corporation. Covid- 19 and the cost of vaccine nationalism, 37 Shalal A. IMF sees cost of Covid pandemic rising beyond $12.5 2020. Available: https://www.rand.org/randeurope/research/projects/ trillion estimate, 2022. Reuters. Available: https://www.reuters.com/ cost-of-covid19-vaccine-nationalism.html [Accessed 06 Jan 2021]. 10 Saxena A, et al. BMJ Global Health 2023;8:e010615. doi:10.1136/bmjgh-2022-010615 BMJ Glob Health: first published as 10.1136/bmjgh-2022-010615 on 17 January 2023. Downloaded from http://gh.bmj.com/ on April 18, 2023 by guest. Protected by copyright.