By Deborah Layton, Principal and Drug Safety Lead at LCP
Lessons from the Covid-19 response
The Covid-19 pandemic made it abundantly clear: our global healthcare systems must become more robust, agile, and interconnected. Effective pandemic preparedness demands unprecedented levels of coordination and collaboration among key stakeholders: pharmaceutical industry, academia, public health organisations, international agencies, non-government organisations (NGOs), and regulatory authorities worldwide. Only through sustained, multi-stakeholder partnerships can we build a healthcare ecosystem prepared to rapidly adapt and respond to future crises.
In Europe, the EMA (European Medicines Agency) has outlined a comprehensive strategy for pandemic preparedness. This strategy focuses on ensuring that medicines and medical devices are available and safe during public health emergencies. Key parts of the EMA’s strategy includes:
Monitoring and reducing vaccine shortages.
Providing scientific support evaluating scientific data on products that have the potential to address, or are being developed for a public health emergency.
Ensuring expertise across EU partners for crisis preparation and management.
Creating a regulatory framework to help the EU better prepare for and respond to health crises.
Similarly in the UK, the NHS has a structured framework detailing the roles and responsibilities of NHS England during a pandemic, focusing on command, control, coordination, communication, and governance. However, both the EMA and NHS initiatives focus largely on the operational preparedness leaving critical gaps around ensuring the quality, effectiveness and safety of vaccines during pandemics.
Also, the Covid-19 pandemic underscored a critical insight: preparedness plans become less effective without meticulous implementation or are not well aligned to tackle the underlying cause of the pandemic. This is why practical actions which deliver on implementing these plans such as strengthening vaccine effectiveness and safety surveillance systems in a pandemic setting must be prioritised and robustly executed.
A five-year vision: Beyond Covid Monitoring Excellence (BeCOME)
Recognising these needs, the BeCOME initiative recently published a call to action outlining a five-year vision for pandemic preparedness and response. Established in 2022, BeCOME serves as a collaborative platform bringing together global experts in pharmacovigilance and pharmacoepidemiology from industry, public health organisations, regulatory bodies, and academia to advance innovations for post-marketing monitoring of benefits and risk of vaccines. The key priorities include:
Expanding global research platform infrastructure and using innovative methods such as artificial intelligence (AI), intelligent automation, and machine learning to improve safety surveillance and effectiveness measurement.
Improving the quality and speed of actionable evidence to inform timely regulatory and payer decision-making.
Enhancing global data management capabilities and implementing digital innovations directly into healthcare systems for enhanced active surveillance capabilities.
The role of transformative technologies
Under the BeCOME initiative, there is an expectation to develop sustainable public-private partnerships to deliver on these key priorities, including transformational technologies. As BeCOME emphasises: “There is an equal if not more important need to enhance the global data management capabilities and implement digital innovations that can further integrate reporting tools into healthcare systems, thereby allowing active surveillance through primary and secondary data analysis.”
Establishing a robust digital infrastructure requires significant investment in terms of time and money and clear delineation of responsibilities among regulators, manufacturers, and payers—a discussion that is ongoing and essential.
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