HERA in EU: the new agency to anticipate the next health emergencies

Like many regions in the world, the EU struggled in its response to Covid-19, particularly in 2020 during the first stage of the pandemic outbreak. To make cross-border strategic decisions and be able to better address future health emergiencies, the EU created HERA, the European Health Emergency Preparedness and Response Authority, an equivalent to the US BARDA (Biomedical Advanced Research and Development Authority). Alcimed revisits the creation of the HERA EU agency and its future challenges compared with its US twin, BARDA.

The genesis of EU HERA: a worrying observation in the face of the Covid-19 crisis

In 2019, the Global Health Security Index ranked several EU countries – France, Germany, Spain and Sweden – among the countries with the highest health security capabilities to respond to infectious disease outbreaks. However, the EU struggled in its response to Covid-19, particularly in 2020 during the first stage of the pandemic outbreak. This index dropped just a few months later in 2020. The lack of a central organization, coordination capabilities to with adequate means, became obvious.

From the beginning of the COVID19 pandemic, the EU faced difficulties to coordinated its actions and  gather quickly significant funds to support the health sector. Compared to the 14,5 billion USD funded by BARDA between February and October to support the health sector, the EU was not able to provide any major fund until June, when 4.9 billion euros was allocated to the Coronavirus Global Response which was not even dedicated for Europe.

In the first 6 months of the outbreak, Europe was not only left behind in the amount of public investment in medical countermeasures such as vaccines, masks, diagnostics, etc. but also exposed its tardiness to allocate funds across all the member countries. On top of that, the early stage of European response toward the pandemic was significantly weakened by nationalistic decisions taken by member states to secure scarce resources for their own population, rather than distributing these around Europe based on need.

The example of BARDA, the US organization prepared for a long time to respond to potential health emergencies

During the Covid-19 crisis the early funding of 14,5 billion USD funneled to pharmaceutical companies was indeed coherent to BARDA’s philosophy to provide necessary supports and market incentives for the private sector to accelerate the development and distribution of medical solutions.

If the US was able to respond promptly and effectively to the Covid-19 pandemic, the significant amount of investment in medical countermeasure funded by BARDA at the early stage surely played a critical role.

As a matter of fact, the US has been preparing for emergent threats like a global pandemic for a long time. After the 9/11 attacks and the subsequent anthrax attacks in 2001, the United States perceived the difficulty of effectively implementing medical solutions like vaccines, therapeutics, and diagnostics to protect US citizens from chemical, biological, radiological, and nuclear (CBRN) threats. BARDA was therefore established in 2006 to address the lack of market incentives for companies pursuing the development of countermeasures of these emergent threats.

BARDA was precisely created to bridge the “valley of death” faced by potential drug candidates between research phases and FDA approval. This authority provides funding, technical support, and services necessary to advance candidate products through the development pipeline. During the Covid-19 crisis the early funding of 14,5 billion USD funneled to pharmaceutical companies was indeed coherent to BARDA’s philosophy to provide necessary supports and market incentives for the private sector to accelerate the development and distribution of medical solutions. The almost immediate availability of funds made a real difference in the ability to respond quickly to the crisis.

Struggling to match the efficiency of the US model, the EU established HERA

The objective of HERA is to strengthen Europe’s ability to prevent, detect, and respond rapidly to cross-border health emergencies by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures when a health emergency hits.

After coming under criticism for falling short in matching US support for COVID-19 vaccines and therapeutics development, the European Commission, in September 2021, launched the HERA, European Health Emergency Preparedness, and Response Authority.

In terms of organization, HERA  in EU will not be a standalone agency but rather housed in the Commission, run by a board with representatives from each EU country, similar to the EU’s vaccination steering committee.

HERA will also work closely with the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) and complement their work both in preparedness and crisis times.

The EU HERA work plan: 1.3 billion euros to empower EU for its preparedness and response to current and future health emergencies

Founded less than a year ago, EU HERA was not fully functional until 2022. In February, HERA has set out a number of ambitious deliverables for 2022, both in the context of the ongoing COVID-19 response and in preparation for potential future health threats. Three pillars of this work plan include:

Prevent and prepare for future cross border health emergencies:

• Procuring and stockpiling medical countermeasures (580 M €)
• Research and development of medical countermeasures and innovative technologies against emerging threats (300M €)

Detect future health threats:

• Putting in place a state of the art real-time health threat detection and intelligence system
• Creating a dedicated IT platform for threat assessment and threat prioritization

Respond to health threats:

• Ensuring the timely provision of COVID-19 vaccines to the EU Member States, including variant-adapted vaccines if needed
• Procurement of COVID-19 therapeutics for the EU Member States

HERA facing multiple challenges in EU in the future

To address adequately the current and future health emergencies, HERA will face some significant challenges in achieving these objectives.

First, HERA will need to work in collaboration with the EMA and ECDC, which could create potential overlapping responsibilities. For instance, HERA is currently working in Europe on the ‘Vaccelerate’ program which aims to accelerate the recruitment, design, and regulation process of cross border Covid-19 vaccines in phase 2 & 3 clinical trials, whereas EMA has also been working on a Special Task Force to support the Covid vaccine including scientific advice on clinical trial design.

During the pandemic, the majority of the EU’s funding was spent on the procurement of vaccine batches rather than the early development of the vaccine as BARDA did in the early stage. In other words, the EU has chosen to believe that committing to the purchase of vaccines not yet on the market would provide pharmaceutical companies with enough market incentive to invest in the vaccine development, and thus adopted a more fiscally conservative approach focusing more on securing doses once the vaccines were developed. Washington, on the other hand, considered it necessary to fully support all stakeholders with abundant funding from the early development to the FDA approval.

If providing necessary market incentives and regulatory support to the private sector, as BARDA did in 2020, is the key to fighting future pandemics, HERA will have to develop a strong capacity to provide the necessary support to stakeholders such as pharmaceutical companies, research institutions, laboratories, from the very first steps of research and development phases.

The second challenge is whether EU HERA will be able to allocate sufficient resources to support and accelerate R&D in a future health emergency. The current budget of HERA in 2022 is 1.3 billion euro. While this is about a twenty-fold increase from the €65 million of EU annual spent on health priorities, it’s still uncertain, at this stage, that it would be enough compared to the 14.5 billion USD funded by BARDA during 2021.

Lastly, the ability of HERA to stimulate innovation is still unknown. For now, EU as been able thanks to its purchasing model to encourage investment in manufacturing capacity for vaccine candidates already in clinical trial stages. This pull strategy should be complemented by push incentives which favors the innovation and HERA might want to opt for a combination of both.

The inherent complexity and asymmetry of the EU health system accentuated the challenges of managing the COVID-19 crisis in the first year. EU HERA must learn from the past experiences and play an increasingly central role in efforts to deal with cross-border health threats. If you want to better understand the role of the European health authorities, Alcimed team can support you by running regulatory framework analysis and search for funding opportunities!

About the author, 

Shih Chuan, Consultant in Alcimed’s Life Science team in France