A framework for trust and global solidarity for the next pandemic

Diplomats from around the world are convening again in Geneva to finalize marathon negotiations set up in 2021, to agree a new global framework that seeks to govern the global response to future pandemics.

The stakes couldn't be higher. This framework will set out how international collaboration will take place to prevent, prepare and respond to future pandemics. The pharmaceutical industry supports this goal and is determined to be part of the solution.

This time, the negotiators are meeting as the latest mpox outbreak spreads in the Democratic Republic of the Congo and neighboring African countries, and as cases of H5N1 "bird flu" continue to be detected around the world.

The key question is what shape this agreement should take, and where negotiators should focus their efforts for maximum impact. Put simply, a successful conclusion must enable both equitable access to vaccines and treatments in the event of pandemics and maintain the scientific discovery that makes them possible. There needs to be a clear focus on how to achieve these twin aims to mount a more effective response to future global health threats.

Each pathogen of pandemic potential is unique, and so too will be the response of each pharmaceutical company. The situation and countries concerned may also require different interventions, at different times of a pandemic emergency. That's why it is critical that negotiators look to establish an agile system that enables companies to bring their relative strengths to facilitate equitable access.

Alongside this, it is important that we also focus on measures - in both pre pandemic time and during a pandemic - to support healthcare systems, boost surveillance mechanisms, improve regulatory procedures, develop accurate forecasts and ensure pharmaceutical companies receive the orders they need to ramp up production. This preparedness and response system must also work across a global, regional, and country level if it is to be effective.

The biopharmaceutical industry bought forward vaccines against SARS-CoV-2 in record time during the last pandemic, scaling to historic production levels, and implementing access plans that included donations, equity-based tiered pricing and voluntarily transferring manufacturing technology to partners in other geographies. Despite these efforts, there were significant gaps and delays in access, particularly in many low and middle-income countries. The Pandemic Agreement that is currently being negotiated aims to help address those shortcomings.

In parallel, international organizations are already working to build up the infrastructure needed to deliver vaccines to developing countries. GAVI, a public-private partnership to increase global immunizations, recently created a $2.5 billion financing facility for the purpose of purchasing and rapidly distributing vaccines. It also established a $500 million first-response fund to create better access to vaccines - which is already accelerating the response to mpox.

Pharmaceutical companies have made firm commitments too. Companies have pledged to reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable. And the voluntary transfer of technology and capacity building in low-income countries has continued.

As part of the pandemic agreement, companies would enter "Partnerships for Equitable Access" allowing them to adopt legally binding and enforceable "Equitable Access Commitments[2]", in a way that they would be able to best support future pandemic responses.

It's critical that the final text of any treaty supports this approach, so that companies from large manufacturers to small biotech firms can collaborate with academics, health systems, NGOs and governments - as well as with each other - to develop and distribute vaccines, tests and treatments that we will need to respond to the next pandemic.

Much of the debate so far has focused on how to enact such a framework for "benefit sharing" in exchange for access to the materials and information that is needed for the rapid development of vaccines and treatments. If too rigid and formulaic, such a system could delay and discourage the research that the world desperately needs to be prepared for the next pandemic and would run counter to an approach that would maximize the way in which companies can support the response.

Equally important is ensuring that intellectual property is respected, as it plays a critical role in fostering the innovation necessary for developing new treatments and vaccines. Voluntary technology transfer based on mutually agreed terms (VMAT) is essential to striking the right balance between incentivizing R&D and ensuring equitable access. This approach ensures that companies are encouraged to invest in high-risk research while also facilitating the sharing of knowledge and expertise to enhance global preparedness for pandemics. Governments can foster the conditions to attract and enable technology transfers by ensuring that the right infrastructure is in place, including a sustainable innovation ecosystem that promotes local talent and economic growth, attracts investors and skilled workers, as well as companies that have the capacity to absorb the knowledge.

Consider how the first COVID-19 vaccine was developed and made available just 326 days after the COVID-19 genomic data was voluntarily shared. That was far faster than almost anyone anticipated in the early days of the pandemic. The first treatment for COVID-19 was approved by the FDA within 100 days of the outbreak being recognized.

But the speed was no accident. A body of research on coronaviruses already existed - and scientists had been working on mRNA technology for 30 years. Information and research were quickly shared, and vaccine candidates were quickly tested, approved, and distributed, thanks to voluntary collaboration between private and public actors. Many antivirals were repurposed and tested against COVID-19, again to deliver as fast as possible.

But it is important to remember that not all companies embarking in R&D for COVID-19 vaccines or treatments were successful. Data demonstrates that of 500 COVID-19 vaccines in preclinical development, only 16 have been approved by the WHO. Analysis of the antiviral pipeline shows how much R&D is needed: most viruses with pandemic potential do not have any treatments in clinical development. This serves as a reminder that we need to ensure we attract as many companies as possible to pandemic related research and development if we are going to maximize chances of having the safe and effective products we will need.

A successful pandemic agreement must be one which maximizes the contribution of the whole global health community, including pharmaceutical companies. This should be a guiding principle as negotiators look to turn the remaining text green. Successfully preparing and responding to the next pandemic will depend on it.

Author

• David ReddyDirector General, IFPMA

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