HERA

Dear colleagues,

It is a great pleasure to be here today, and I am delighted for this opportunity to share our views on HERA and its future.

Please allow me to take a step backwards, before going to the gist of today’s question.

In light of SARS and MERS, experts in the field had long anticipated a public health crisis caused by a coronavirus. Despite these predictions, national and European stakeholders were unprepared for serious health crises. The pandemic has had a significant impact on both society and the global economy. As of August 2023, COVID-19 has resulted in over 275 million infections and over 2 million reported deaths in Europe alone. Some of this could have been avoided if we had been better prepared.

HERA was created to assist us in solving this long-standing issue of underpreparedness. Given the ongoing climate crisis and the ensuing expected health emergencies, I believe that one of the core tasks that should be integrated in its reviewed mandate, should be to develop and coordinate the European Union's health crisis preparedness strategies. The future is unpredictable. However, we do have a sense of the crises that are waiting for us, and what we would need to prepare for such eventualities. The crux now is to keep the work going. Europeans will not forgive us if we are not adequately prepared next time.

A second task that should accompany this role, is ensuring the security of supply of critical medicines and crisis-relevant medical countermeasures. This is about joint procurement and stockpiling, surely, but it is also about research & development and industrial policy. In scenarios of extreme demand shocks, producing countries have earlier access to medical countermeasures. This was true during COVID-19 where several studies found a strong correlation between having domestic production capacity and access to medical countermeasures. One study indicated that 60% of the early advance purchase agreements went to just 13 countries – all vaccines producers. It is therefore pivotal that Europe has the capacity to quickly develop and produce medical countermeasures at scale to protect Europeans.

I believe that HERA, together with the Belgian Presidency, has already made two major steps in this direction. First by yesterday’s launch of a Critical Medicines Alliance, which will develop a pipeline of projects that should help stabilise our supply of critical medicines.

I don’t know if anyone has read The Guardian this week, but they are dedicating a whole series to medicines shortages in the UK. In the US too, medicine shortages and high-risk foreign dependencies are a hot topic in Congress. These topics keep governments awake all over the world. I am therefore really proud about the leadership Europe is showing in this field. We are taking matters into our own hands. Thanks to HERA, I believe we can now say that we are one step ahead. That is no small feat.

Secondly, HERA is a major player in our endeavour to set up an EU-wide clinical trial platform. It will provide the secretariat to the coordination committee and identify the right partners, funding, etc. You are all health experts, so I need not emphasise how important it is that Europe disposes of a multicountry infrastructure to enable clinical trials at scale. This is certainly true in the context of a pandemic, when we are racing against the clock to develop new vaccines and therapeutics.

For the future, I believe that HERA must further develop itself into a health security actor. This means that it must further build out the pillars of joint procurement, stockpiling, research & development and industrial deployment. It should also try to maximise international cooperation, and avoid zero sum games where each government just fends for itself.

I have thus far defined the future of HERA as a forward-looking actor in the field of crisis preparedness and as a security actor dealing with medical countermeasures. I will now put forward two open questions.

The first one is: what role does HERA play in the bigger ecosystem of health crisis governance? We don’t have a straightforward answer to this question. Ultimately, it will have to be the Commission who decides on the workflow. However, yesterday you discussed a paper from CEPS that was ordered by the Belgian Presidency to help with the problem analysis, and put forward some avenues for improvement. I firmly believe that the next Commission should take this reflection further, and try to make the EU’s crisis governance as rational, comprehensible and efficient as possible. If not, the different actors will lose precious energy to turf wars and conflicts, rather than to actual policy making.

The second question is related to this, namely: who will provide scientific guidance to the EU in times of crisis?

The challenges we face today cannot be addressed by focussing on medical countermeasures alone. We also need scientific expertise to guide us through crises, including by developing guidelines on how and when to use medical countermeasures. The best example of why we need to develop this expertise at the European level is the AstraZeneca vaccine roll-out, during which several countries limited the vaccine's use to different age groups, ultimately undermining collective trust in vaccination.

When I was a researcher at the University of Amsterdam, I analysed public opinion on joint procurement. The data show that even before COVID there was great support among Europeans for joint procurement. However, most citizens also agreed that if we buy collectively, we should also collectively agree on the rules on how to use these products.

To me, this is one of the most important lessons learned from the COVID-19 vaccines, as well as the antivirals purchased without an HTA and the current joint procurement efforts for antibiotics and RSV vaccines. Now, I am certainly not saying that HERA itself should become the EU’s scientific authority. Rather I am saying that its work should be based on the authority of science. In this sense, the future of HERA cannot be viewed separately from the future of ECDC or the role of the Chief Medical Officers at the EU level.

It is an undeniable fact that the world we live in today is more volatile, insecure, and dangerous than it was in the past few decades.

This changing world should seriously challenge our vision around preparedness and security. Are we ready to deal with the health implications of the triple environmental crisis, and what does this imply? Are we ready to deal with the consequences of e.g. a nuclear attack? How will we deal with floodings and forest fires?

It is in this context that HERA should develop its mandate. By becoming a forward-looking actor who sets out preparedness strategies. By becoming a health security actor ensuring that Europeans have access to critical medicines and crisis-related countermeasures. Always backed by science, always operating in a larger ecosystem.

Thank you.