Writing in response to a 2023 lecture “Regulation in the Age of Calamity” by CEPI’s Dr Richard Hatchett, authors in Clinical and Translational Science explore the role of regulation in an “age of calamity”. They suggest that this period of “polycrisis” demands evolution of the health regulatory paradigm to enable the “advancement and application of science”. Regulatory considerations are a recurring theme at our Congresses, so we explored the perspective to learn more about the authors’ concerns.
Calamity
“We have entered an age of calamity in which the forces that have disrupted and defined our world in recent decades, not least the forces of infectious diseases, will continue in an ever accelerating fashion.”
The authors refer to the COVID-19 pandemic as the “epitome of a perfect storm of mutually potentiating crises” or the “harbinger of an era characterised by increasingly severe and frequent zoonotic spillover events”. If we are to continue the “alarmingly accelerating” trajectory, we are expected to experience 4 times as many spillover-driven outbreaks and 12 times as many deaths by 2050, compared to 2020.
“To be better prepared in this age of calamity, the health regulatory paradigm should continue to evolve, with smart and agile regulation as a key enabler to proactively guide the advancement and application of science.”
Fit-for-crisis
Emphasising the need to review the context and way that regulatory processes and procedures are applied, the authors state that regulation should “proactively” direct science. They refer to the recent example of COVID-19, during which traditionally lengthy processes were achieved in 326 days; this success is partly attributed to “accelerated regulatory response”.
Emerging from the COVID-19 pandemic, CEPI issued a call to accelerate the development and delivery of a pandemic vaccine within 100 days of identifying an infectious disease threat. The 100 Days Mission is an “aspirational and necessary goal”. Although the metrics are the same, the risk threshold is “very different”; the efficient delivery of a pandemic vaccine and other interventions in a crisis demands “complementary real-world scientific evidence” in the post-market phase to “better manage risks”.
“In the context of such crises, the challenge for regulators is to recognise their critical, creative, and generative role. Regulators can proactively guide and support the adoption of innovation through the deployment of smart and agile regulatory strategies that science and industry, properly directed, can provide.”
Agility
In the context of health product regulation, the authors use “agility” to describe the “adoption of risk-based, context-driven innovative approaches and regulatory cooperation based on sound scientific evidence and information”. They state that this was “well demonstrated” by regulatory agencies in response to the COVID-19 pandemic as they used risk-based adjustments to modify existing frameworks, expedited regulatory approvals, and gathered confirmatory real-world scientific evidence after roll-out.
Coordination
This agility was not an isolated event, and the authors suggest that many national regulators had been “increasing their collaborations” in the decades before the COVID-19 pandemic. An example of this is the International Coalition of Medicines Regulatory Authorities (ICMRA), formed in 2012. ICMRA describes itself as a “voluntary, executive-level, strategic coordinating, advocacy, and leadership entity of regulatory authorities”. It works to:
- Address current and emerging human medicine regulatory and safety challenges globally, strategically, and in an on-going, transparent, authoritative, and institutional manner
- Provide direction for areas and activities common to many regulatory authorities’ missions
- Identify areas for possible synergies
- Wherever possible, leverage existing initiatives/enablers and resources
In June 2021, members convened to address regulatory steps to support COVID-19 vaccine development, which resulted in “consensus on innovative strategies to ascertain the effectiveness of second generation COVID-19 vaccines”.
Innovation
Some regulatory strategies have been “sustained and further improved”, but it is “paramount” to sustain this “momentum of continuing innovation”. The perspective presents a handful of “relevant developing domains”:
- Immunobridging – inferring the effectiveness of a candidate using an immune correlate of protection that is reasonably likely to predict efficacy or by using immune markers to compare with an established comparator.
- Clinical trial diversity – to address the need for diverse representation under pandemic circumstances, an evaluation of a vaccine with a particular platform could be conducted “during peacetime” and extrapolated on a needs basis to special populations during emergencies for another vaccine on the same platform.
- Digital health technologies in decentralised clinical trials – digital health technologies can facilitate access to trials in “previously under-represented population segments”.
Pandemic preparedness
“If there is one key takeaway from COVID-19, it is that pandemic preparedness is a sine qua non in this age of calamity.”
CEPI is leading global efforts with “prescient investments” in the development of vaccines and biological countermeasures. It also proposes the establishment of a Global Vaccine Library (GVL) to “facilitate rapid and equitable information sharing with artificial intelligence integration”. This Library would focus on pathogens with pandemic potential, collecting information on pathogens, vaccine platforms, vaccine technologies, and products”.
“In this age of calamity, regulators must step up as key collaborators with scientists in guiding the development and application of science to strengthen regulatory systems, prepare for future public health emergencies, and promote regulatory innovation and agility to help prevent future cycles of panic and neglect.”
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