Blog February 1, 2021

Pandemic Spurs Changes in EU Health Policy, Including Creation of EU “BARDA”

COVID-19 is posing significant healthcare challenges, and we have made our own recommendations for future pandemic preparedness and response based on the US experience so far in our recent whitepaper, “Building the firetruck after the fire: Analyzing the US COVID-19 response and its implications for the future.” 

In the European Union (EU), the COVID-19 pandemic has shown that the European Commission (EC) can play a critical role in healthcare, with member states cooperatively stepping up to meet the demands of the pandemic by receiving COVID-19 patients from neighboring countries and sending healthcare professionals and key medical equipment to where they were most needed. However, the pandemic also underscored a critical lack of stockpiles of medicines and equipment and the vulnerability of related supply chains within the EU. No coordinated, systematic approach has existed to support the development, production, and procurement of necessary vaccines and treatments within the EU. In contrast, the US Biomedical Advanced Research and Development Authority (BARDA) provided funding for the development of promising biomedical technology and made it possible for companies to work with a single agency to negotiate advanced purchase agreements of COVID-19 vaccines for the whole United States.

Health care issues within the EU are overseen by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). In the case of the COVID-19 pandemic, the ECDC has been providing member states with technical risk assessment and guidance based on the epidemiological spread of the virus, but not analysis of actual data from outbreaks. EMA streamlined assessment procedures to more efficiently review promising vaccines and therapeutics, and the EU signed three contracts with pharmaceutical companies for access to future vaccines. But these agreements came months after comparable ones in the United States were signed and access to potential new treatments remains limited.

Given the experience of the pandemic to date, the EU has recognized a critical need to improve preparedness and response for future disease outbreaks and to combat long-term threats arising from such issues as antimicrobial resistance, climate change, and the interactions between human and animal health and the environment. 

As a result, in September, the President of the EC called for key healthcare policy changes. These include the formation of a standalone health program to strengthen the framework for ongoing coordination between states on measures aimed at EU-level disease protection, prevention, preparedness, and response, as well as the creation of a new biomedical agency modeled after the US BARDA. 

The new initiative is intended to build on the experience gained during the COVID-19 pandemic by strengthening the authorities of both the ECDC and EMA. The ECDC will be able to issue stronger recommendations on measures aimed at disease control, mobilize the EU Health Task Force to assist with local response in member states, step up analysis and disease modeling to support member states in controlling outbreaks, and establish a new network of EU public health reference labs. The EMA’s ability to streamline product assessments and fast-track scientific advice and review of evidence from clinical trials and other studies would be strengthened, as would the EMA’s ability to monitor events that could lead to shortages of medicines in future pandemics. The EMA would also be able to activate a dedicated crisis management structure and play a key role in the development and faster approval of medicines to treat or prevent a disease causing a potential EU-wide public health crisis.

The new EU “BARDA,” to be established in 2021, would provide an additional forward-looking component of pandemic preparedness, identifying emerging technologies and products that might be scaled up for real-world use during health crises. As such, the new agency would be tasked to engage with industry, scientific organizations, academia, and networks of clinical research groups worldwide with the aim of creating successful public-private partnerships to foster the development of promising biomedical interventions. The job of the new agency would also be to build strategic stockpiles to protect against supply chain interruptions, especially for pharmaceuticals. No details of funding or governance for the new agency have yet been announced.