Today, the Council has adopted its position on the November 2020
Commission proposal to give the European Medicines Agency (EMA) a
stronger role in crisis preparedness and management.
This proposal would allow the EMA to facilitate activities such
as monitoring and mitigating the risk of medicines shortages,
providing scientific advice on medicines to treat disease caused
by a crisis, and coordinating clinical trials. Welcoming the
adoption of the Council position, Commissioner in charge of
Health & Food Safety Stella Kyriakides made
the following statement:
“The European Medicines Agency has been an essential partner
in our response to the COVID-19 pandemic. But the crisis has
shown that we cannot take for granted the availability of
medicines and medical equipment to treat patients. A reinforced
agency will allow us to react quickly, efficiently, and
in a coordinated manner to any future emergency.
I am pleased that the Council has endorsed our ambitious
proposal so swiftly, and progress needs to follow equally quickly
on our proposals to strengthen the mandate of the European Centre
for Disease Prevention and Control and closer cooperation on
cross-border health threats.
Strong EU Agencies are crucial for our collective response to
health threats or crises and they need to be fully equipped to
play the role we expect and need from them.
I want to thank the Portuguese presidency for the work
achieved in the past six months and I look forward to continue
working with the European Parliament and Council on turning our
vision for a strong European Health Union into a reality.”
Next steps
Following the adoption of the Council's position, known as
‘general approach' on the Commission's proposal, the European
Parliament is due to adopt its position at its July plenary. The
Council, Parliament and European Commission will then negotiate
the text of the Commission proposal, known as “trilogue”, to
reach an agreement under the Slovenian Presidency.
Negotiations on the other two proposed regulations, for a
reinforced European Centre for Disease Prevention and Control and
a revised Regulation on cross-border health threats are also
moving forward. The Commission will continue to work closely with
the European Parliament and Council on all three proposals
towards a swift adoption. As announced in the European Health Union
package, the Commission will also propose a new European
Health Emergency Preparedness and Response Authority (HERA) in
the autumn. This will strengthen the European Health Union with
better EU preparedness and response to serious cross-border
health threats, by enabling rapid availability, access and
distribution of needed countermeasures.
Background
On 11 November 2020, the Commission proposed a European Health
Union package to strengthen crisis preparedness and response in
Europe. The package includes three draft regulations to improve
health crisis management in the Union. They intend to strengthen
the mandates of the European Medicines Agency and the European
Centre for Disease Prevention and Control and set up stronger
coordination for cross-border health threats, including being
able to declare an EU-level public health emergency.
Under the new regulation, the European Medicines Agency will be
able to facilitate a coordinated Union-level response to health
crises by:
- monitoring and mitigating the risk of shortages of critical
medicines and medical devices
- providing scientific advice on medicines which may have the
potential to treat, prevent or diagnose the diseases causing
those crises
- coordinating studies to monitor the effectiveness and safety
of vaccines
- coordinating clinical trials.
For More Information
Health Union
Proposal to extend the
mandate of the European Medicines Agency
EU Coronavirus
response
