A wide array of stakeholders are looking toward the upcoming World Health Assembly this May to conclude negotiations on a new pandemic accord that seeks to make the world more prepared for the next pandemic.

And most would agree that the primary task of the Intergovernmental Negotiating Body (INB), established by the World Health Assembly (WHA) in December 2021 to negotiate the draft agreement, is to address the inequities observed in the distribution of COVID-19 vaccines, medicines, diagnostics and other  countermeasures to low- and middle income Countries (LMICs).

In this respect our collective response failed, in particular to Africans, and this should never be allowed to happen again. With this in mind, the biopharmaceutical industry, represented by IFPMA, tabled the Berlin Declaration in July 2022, committing to early and equitable access by reserving an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower-income countries, as well as taking measures to make them available and affordable.

Solutions being proposed by the INB negotiators must undeniably put equity front and centre. However, in doing so, we should not jeopardize the elements of the COVID-19 response that worked well, notably, the rapid development and scale up of medical countermeasures and the unprecedented public-private partnerships that helped end the pandemic by May 2023.  Without these successful elements, there will be life-threatening delays in developing the medical countermeasures that will be needed to fend off the next pandemic.

Pathogen Access Benefit Sharing (PABS) System proposal is deeply flawed

As INB negotiators discuss a Pathogen Access Benefit-Sharing (PABS) System as part of an overall Pandemic Agreement, it is critical to preserve the innovation system and research incentives that were so successful in the fight against COVID19 and supported the rapid development of vaccines, treatments and tests at record speed and unprecedented scale. Failing to do so will mean we do not effectively tackle the biggest shortcoming of the COVID-19 pandemic – the inequitable rollout of medical countermeasures.

It is essential that provisions of the pandemic accord regarding access to pathogens and genetic sequences provide a decoupled solution, with no strings attached.  During the COVID-19 pandemic, access to pathogens and genetic data was swift and unconditional. Thankfully, no country tried to impose national legislation, related to the Nagoya ABS Protocol, to such sharing – something that could have considerably slowed rapid scientific response.

Unimpeded sharing of SARS-CoV-2 pathogen data enabled the development of a safe and effective COVID-19 vaccine within a record 326 days from the release of the virus’ genetic sequence. Without this principle, private sector engagement will be disincentivized and the measures will prove counterproductive.

Creating a “closed system” that centralizes pathogen access under one organization’s control, as some parties have proposed, would introduce considerable bureaucratic hurdles and could require years, if not decades, to implement.

This centralized approach offers no evident benefits whereas a more realistic approach involves bolstering collaboration among established networks such as European Virus Archive Global (EVA-G), American Type Culture Collection (ATCC), or the German Collection of Microorganisms and Cell Cultures (DSMZ).

Stringent requirements for sharing or accessing pathogen data would also severely hinder responses to future pandemics and basic research and development (R&D). Conditions, uncertainties, and negotiations surrounding pathogen access will cause delays in the developing medical countermeasures, leading to significant public health consequences, including loss of lives and unnecessary economic pressures. In the COVID-19 pandemic context, even a one-month delay could have meant an extra 400,000 lives lost.

Four key criteria for a PABS System

To prevent future delays in critical R&D of countermeasures, the WHO Pandemic Accord must include four key criteria:

• Enable a flexible, decentralized pathogen sharing system leveraging existing networks and databases,
• Establish a legally enforceable obligation for all countries to promptly share pathogen samples and sequence data,
• Implement a legally binding presumption of consent for accessing pathogens,
• Legally recognize the Accord as a Specialized International Instrument under Article 4, Paragraph 4 of the Nagoya Protocol. This would avoid any delay that could otherwise be created from national ABS laws, which are designed to protect claims by countries to their indigenous biological resources – not dangerous pathogens.

Moreover, pathogens or their genetic sequences aren’t “owned” by any single country; they quickly traverse borders. The idea of incentivizing or paying royalties to countries for spreading dangerous pathogens is outright absurd.

In instances where the Nagoya Protocol was applied, the results have been negative, as demonstrated in a 2023 report by the consultancy firm Covington, which reviewed the application of the Nagoya Protocol, for example in the case of the outbreak of Zika virus in 2015 and seasonal influenza in 2021.

Governance and implementation

Effective governance and implementation are also important.  This means involving all of those parties which will contribute to the success of any Pandemic Accord, including through consensus-based decision making. Conversely, top-down decision making, without clear criteria, would undermine the trust that is necessary for the system to function. Excluding manufacturers from serious discussions about the PABS viability during the ongoing negotiations, especially given that most public health emergencies of international concern (PHEIC) are of no commercial interest, is simply wrong.

The private sector must be involved, and we must avoid overlaps, whereby manufacturers willing to sign up to the public-private partnerships created by the Pandemic Accord would be exposed to benefit sharing obligations and to national Nagoya ABS provisions.

To be practicable, the partnership should reach a critical mass to come into force – the idea of coercing companies to engage is unrealistic. Considering the free movement of pathogens and the potential refusal of major jurisdictions to join the PABS framework, this would create an uneven playing field for manufacturers based on their origin.

PABS cannot be built like the Influenza Preparedness System

Another issue is that the current draft text introduces very problematic clauses on mandatory contributions to finance the PABS, likely conflicting with several national constitutions.

National tax regimes are a matter beyond the constitutional jurisdiction of WHO, and any concept of “annual monetary contributions based on size and nature of the manufacturer” essentially amounts to a corporate tax.

While some may argue this mirrors the Pandemic Influenza Preparedness (PIP) system, which is designed to with “voluntary” contributions, this model is not suitable for pathogens in general and will not work.

Unlike the seasonal influenza market, where WHO and its Global Influenza Surveillance and Response System (GISRS) are basically the sole repository of biological influenza samples and the small number of companies involved in the seasonal influenza market rely on access to the WHO-owned samples, the landscape for known or unknown pathogens, let alone genetic sequence data, is vastly different.

The fact that the SARS-CoV2 Omicron variant was rapidly sequenced in parallel in South Africa, Botswana, and Hong Kong, is a prime example.  Restricting access to such data would hamper public health objectives by undermining the fast development of medical countermeasures (MCM). While companies do support surveillance and health systems strengthening, their contribution must remain voluntary.

Ensuring a more equitable rollout

Moreover, the PABS system should provide a credible solution to ensure a more equitable rollout of medical countermeasures, which the current proposal before the INB would fail to achieve. Achieving equitable access to vaccines, drugs, diagnostics and other tools demands a comprehensive approach, free from linking access to pathogen samples and sequence data to benefit-sharing obligations.

Through the Berlin Declaration, the industry has already expressed its commitment to early and equitable access by reserving an allocation of real-time production of vaccine, treatments, and diagnostics for priority populations in lower-income countries and to take measures to make them available and affordable. Such commitments should not hinge on the conditionalities of access to pathogens.

The Pandemic Accord should seek to engage companies and solidify the commitments made in the Berlin Declaration – not disincentivize them.

Proposals that include unrealistic conditionalities for pathogen access, and that disregard the ubiquity of pathogens that travel across borders, would fail to achieve a fairer distribution of medical countermeasures and risk significant delays to any pandemic response.

Towards equitable access

An effective agreement would follow a fundamental principle ingrained in medical practice: do no harm. It is essential to preserve successful elements from the fight against COVID-19 – such as fast, unhindered access to pathogens, a robust innovation ecosystem and unprecedented public-private partnerships – and focus on how to address the inequitable rollout of medical countermeasures. Conversely, an Accord that creates multiple barriers to pandemic preparedness and response, would do more harm than good.

Industry supports a comprehensive partnership involving GAVI, CEPI, the Global Fund, the WHO, and the private sector to enhance equity. The private sector is integral in the co-creation of solutions, and therefore must be consulted in a meaningful way – particularly given the role the sector will play in responding to future pandemics.

Companies have been stating for over a year that they are prepared to commit to pre- and during- pandemic measures including: improving surveillance; research on pathogens of pandemic potential; voluntary licensing and technology transfer based on mutually agreed terms to improve geographic diversity of manufacturing’; and real-time allocation of part of production, and equity-based tiered pricing.

For the Accord to succeed, constructive strategies to enhance pandemic prevention and preparedness through health systems strengthening, improved surveillance, and a decoupled approach to accessing pathogens and genetic sequences are critical.  Additionally, we need joint commitments from countries to procure additional medical countermeasures for the Accord partnership. Similar commitments from the industry should be accompanied by regulatory convergence and removal of trade barriers.  Furthermore, decentralized governance and implementation of the Accord through a partnership approach that includes the private sector are other crucial elements.

It’s not too late. An effective pandemic agreement will require the contribution of all stakeholders, acting in cooperation. Industry is keen to provide evidence and experience to the negotiators and we are eager to take our responsibility and make a positive contribution to a practical agreement. The world cannot afford to miss this opportunity.

Thomas Cueni is the Director General of the International Federation of Pharmaceutical Manufacturers and Associations. 

Image Credits: NIAID-RML , Pfizer, NPHCDA.