Some learnings from the COVID-19 pandemic

This week I attended a very interesting conference on Health Security in the EU organised by the European Commission . At this event experts discussed lessons learned from the European response to the #COVID19pandemic and how we can better prepare ourselves for future health threats. I had the opportunity to outline some of the European Medicines Agency 's new tasks and how they will help address public health needs in an emergency.

COVID-19 posed unprecedented challenges for EMA on many fronts. There was an urgent public health need for vaccines and treatments for an entirely new disease. We needed to urgently support developers and conduct rapid regulatory reviews of potentially promising new vaccines and medicines. Country lock-downs, export bans, logistical challenges as well as increased demand, in particular for ICU medicines, meant that, in the early stages of the pandemic, we were faced with a sudden disruption of supply chains for many medicines in the EU. These challenges led us to set up a special group with our member state partners to monitor and mitigate shortages of medicines – even though this was not part of our formal mandate.

Our Health Threats Plan in place, which we activated in February 2020, allowed us to respond promptly. We could immediately provide advice to developers of medicines for COVID-19 and review emerging evidence. We also put in place free scientific advice for COVID-19 product developments. We set up the EMA Pandemic Task force (ETF) to bring together the best expertise to provide advice and facilitate fast decision-making by our scientific committees.

What we did in practice during the early days of the pandemic led to a realisation that there was a need to have more formal mechanisms in future crisis situations.

The Commission proposed new legislation to extend EMA’s mandate, which was supported by the European Parliament and the Council, and has now been implemented. This legislation not only recognises and?reinforces the role of the Agency in crisis preparedness and management, but also includes a certain amount of reimagining.

While it recognises the approach?the Agency has taken to respond to COVID-19 and strengthens or reinforces some of?our existing processes, the new mandate also enables us to re-imagine approaches to the collection and use of real world evidence. One of our main areas of focus is to expand our access to data for evidence-based decision making. In this regard we have some initiatives that will help us to generate the data needed to assess and monitor how medicines perform in real life, to understand the disease and the health status of our populations. With DARWIN EU?, a pan-European network that aims to provide timely and reliable evidence on medicines from healthcare databases across the EU, it will be easier for us to see how products perform once on the market and to better understand specific diseases. In addition, our joint EMA-ECDC vaccine monitoring platform will enable us to plan and coordinate independent studies on vaccine use, effectiveness and safety, which will increase our evidence base.

The extension of our mandate has particularly strengthened our ability to support Member States in dealing with shortages. The reporting obligations will enable better forecasting and allow to match supply and demand for critical products. We are working on building a new EU platform to manage and mitigate shortages of medicines in public health emergencies and major events across the EU.

EMA’s role for medical devices has also been fundamentally expanded. Next year we will start monitoring and mitigating shortages of critical medical devices during public health emergencies. The Agency is now running the secretariat of the Medical Device Expert Panels, which are responsible for the review of the assessments of certain high risk medical devices and in vitro diagnostics conducted by notified bodies.

The role, value and indeed the power of collaboration was?also a key learning. Working hand in hand with our European and international partners has been critical for the effective response to the pandemic. At EU level the adoption of the Agency’s extended mandate is complemented by other new legislation, in particular the new EU law on cross-border health threats, the creation of the European Health Emergency Preparedness and Response Authority (HERA) and the extension of the mandate of the European Centre for Disease Prevention and Control (ECDC) .

It has also become clear that a?pandemic comes with its share of mis- and disinformation. The best way to counter fake news is utmost transparency coupled with clear and timely communication. We have proactively made all the information on vaccines and therapeutic products?publicly available and worked on consistent health messaging across the EU institutions and with Member States to build public confidence. Vaccines can only protect us?all if people trust our recommendations and get vaccinated.

We will continue to further improve coordination and communication with EU partners and stakeholders. We look forward to our future collaboration in order to strengthen health security in the EU.