How to build a European Health Union

By Nathalie Moll, Director General, EFPIA

Cast your mind back just over a year ago to the early weeks of the COVID-19 outbreak. It was a time of deep uncertainty when industry, policymakers and citizens had more questions than answers.

Faced with a new virus that spread swiftly without regard for borders, European and national agencies scrambled to understand the threat and draw up solutions at speed. Patients worried about the impact of travel restrictions and border closures on the supply of their medicines. Researchers in companies, hospitals and universities worked around the clock to test treatments, diagnostics and vaccines that would be key to any exit plan.

The resilience of systems, agencies and institutions designed to respond to emergencies was on the line. This was not a drill.

Today, while the pandemic is far from over, we are in a position to reflect on how Europe responded to the most severe cross-border health threat of our time.

This stress test highlighted some of our strengths while revealing a range of weaknesses.

Ad hoc solutions were eventually found to most of the acute challenges posed by the first phase of the pandemic. Our task now is to build on what worked and address systemic shortcomings: we must keep the best and fix the rest. This evaluation should be based on facts and evidence rather than on short term or self-serving political statements.


Fighting future crises

None of us can know when the next public health crisis will arise or what form it will take. However, we can be sure that it will come. To be better prepared, we must permanently strengthen the capacity of the EU and its agencies to ensure a more agile and robust response.

It is vital that we have learned the importance of keeping borders between Member States open, avoiding unilateral export restrictions, and discouraging stockpiling of medicines. To do this permanently, we must improve data on demand for medicines so that patients get the treatments they need. Europe also needs more effective tools for accelerating research and deployment of medical countermeasures. And we should agree ways to safeguard the continuity of clinical trials during any future crisis.

This cannot be achieved without partnership between all the key players. The pharmaceutical industry welcomes the European Commission’s commitment to build the foundations of a stronger European Health Union in which 27 countries work together to “detect, prepare and respond collectively”, as Ursula von der Leyen, European Commission President, has put it.

Central to this will be reinforcing the role of two existing agencies – the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) – and the creation of a new one: the Health Emergency Response Authority (HERA).


Strengthening the ECDC

Prior to the pandemic, the limited capacity of the ECDC was a common grumble among European policymakers and industry leaders alike. Now we must take practical steps to strengthen its mandate. This will help the agency perform its core tasks more efficiently, address some of the shortcomings in the EU response to COVID-19 and raise the profile of the institution. When citizens look to Europe for a trusted source of information on infectious disease and vaccination, they should find a strong, scientific body capable of moving swiftly at a moment of crisis while playing a valuable role in preventative health in normal times.

It is critically important that the ECDC can get full and immediate access to all relevant data from Member States. The agency needs the internal ability to provide robust monitoring, surveillance, risk assessment and forecasting on epidemiological trends, health system capacities, and demand for treatment in relation to serious cross-border health threats.

Surveillance networks and capabilities need to be strengthened to better assess the burden of infectious disease, evolving infectious disease epidemiology, vaccine safety, vaccine effectiveness, and vaccination coverage rates.

During the first wave of the pandemic, industry was deprived of up-to-date ECDC information on the likely progression of the pandemic in each country, as well as patient need and hospital capacity data. This information was crucial for manufacturers to adequately forecast demand and plan manufacturing and distribution arrangements, to supply those medicines to the right regions at the right time.

I sincerely hope that in renewing the ECDC we can create formal opportunities for regular interaction between the agency and pharmaceutical industry. We believe that the ECDC could draw on industry’s knowledge and state-of-the-art expertise in many key areas. Such structured stakeholder engagement is compatible with responsible governance, as the WHO and the US CDC have shown.

A modern European Medicines Agency

By holding press conferences and public engagement events, the EMA has seen its profile raised during the pandemic. Its rolling reviews of new vaccines, and publication of expert risk assessments, show how the agency can support Member State authorities while guiding the public.

We are convinced that the EMA can do even more. The executive steering group on shortages should embrace ongoing collaboration between the EMA, the European Commission and stakeholders.

A consistent and workable definition of shortages based on countries’ actual patient needs should be agreed and used across Europe.

It is what we were all in dire need of during the first wave of this pandemic to ensure treatments reached the patients who needed them, and it is something that we must resolve as soon as possible. The information contained in the national data repositories set up following the Falsified Medicines Directive could be used to monitor net stocks levels at aggregate level.

The work of the EMA in faster regulatory assessment of treatments and vaccines has been in the spotlight throughout the pandemic. The role of the Emergency Task Force should include the implementation of learnings from previous crises, regulatory support to HERA, and engagement with external stakeholders with the ambition of working on global preparedness plans.

Looking more broadly, I hope that the review of the EMA’s mandate is a first step to future-proofing the agency. We must think beyond today’s crisis to consider the role the agency can play in delivering on the objectives of the EU pharmaceutical strategy and in making Europe more competitive at a global level. We believe that a modernised EMA should have an executive steering group working on innovative products that blur the traditional lines between drugs, devices, diagnostics and digital. It is important to fight the next battle rather than refighting that last one.

Data-driven future

Whatever form the next crisis takes, having access to high-quality data can only help to inform the response. That is why integrating the EMA into the future European Health Data Space should be a priority.

Enabling the Agency to access or query real world data (RWD) to support decision-making throughout the product lifecycle will also address some of the longer-term aspirations to improve the use of RWD.

I was heartened to see the Commission’s proposal for a structure that would allow the EMA and ECDC to coordinate safety and effectiveness studies after vaccines are authorised and I would like to congratulate both agencies on the recent announcement that the EMA and ECDC are joining forces to strengthen post-marketing monitoring of the safety, effectiveness, and impact of COVID-19 vaccines in the EU. Vaccine developers would welcome the possibility to collaborate with EMA and ECDC on this new initiative.

A new HERA

Along with strengthening the institutions we had at the beginning of the pandemic, it has become clear that a new agency is needed. I welcome the ambition to create a HERA and look forward to seeing more detail on its scope and funding. HERA should have the flexibility, agility and collaborative instinct required to respond rapidly to emerging threats and to stimulate innovation. It should be embedded within the existing EU R&D ecosystem and establish strong ties with other agencies.

The biopreparedness framework should include appropriate liability protection for the parties involved in the development, manufacture, and deployment of therapeutics and vaccines, and compensation for people who suffer adverse events due to these products, in an effective and timely manner, via no-fault compensation systems, without needing to resort to litigation.

Crises tend to accelerate history.

As we dare to look beyond the COVID-19 pandemic, we do so in the knowledge that changes are on the horizon if we are serious about improving our preparedness for the next emergency.

This will mean rethinking our institutions and systems, and the overall EU mandate in the context of the coming Conference on the Future of Europe.

While the task is not to be underestimated, I know I am not alone in sensing an appetite for change. In building a European Health Union together, we must seize the opportunity to create a more resilient Europe.