(1)

The COVID-19 pandemic demonstrated the need for coordinated action at Union level to respond to health emergencies, including monitoring the needs, swift development, manufacturing, procurement and equitable distribution of medical countermeasures.

(2)

The European Parliament, the European Council and the Council have called for proactive Union action and for ensuring preparedness and the ability to act jointly to respond to health crises.

(3)

In light of the experience with the first months of the COVID-19 pandemic, the President of the Commission called in the 2020 State of the Union address to draw lessons from the current crisis and to build a European Health Union, including a dedicated European structure for biomedical advanced research and development to support capacity and readiness to respond to cross-border health threats and emergencies – whether of natural, accidental or deliberate origin.

(4)

As set out in the Communication ‘Building a European Health Union: Reinforcing the Union’s resilience for cross-border health threats’ (1) adopted in November 2020, the Health Emergency Preparedness and Response Authority (‘HERA’) will be a key element for the establishment of a stronger European Health Union, together with a strengthened cross-border health threats legal framework, and with extended and improved crisis related mandates for the European Centre for Disease Prevention and Control, the European Medicines Agency and the Pharmaceutical Strategy for Europe.

(5)

The bio-defence preparedness plan ‘HERA Incubator’ (2), established to tackle the threats posed by the emerging SARS-CoV-2 variants as the vanguard for HERA, is successfully facilitating contacts and cooperation between regulatory authorities of the Member States, other public authorities and the industry, and between the industry players involved in the supply chain. This work is synergetic with the Structured Dialogue on security of medicines supply by providing insight into the functioning of the pharmaceutical value chains and will help identify their bottlenecks.

(6)

Nevertheless the task of ensuring supply and access in the area of medical countermeasures, such as vaccines, medicines, medical equipment and diagnostics, has until now been shattered between different policy frameworks and funding programmes of the Union. The need to increase the effectiveness of preparedness and response to health emergencies requires the establishment of a dedicated central structure, HERA as a Commission service, complementary to and in synergy with the existing Union structures and mechanisms, including the Union’s crisis preparedness and management system.

(7)

HERA should extensively coordinate and cooperate with Member States. For that purpose, Member States should be represented in the HERA Board, to contribute to the identification of Union priorities, mutualise efforts and leverage existing resources. To enable information exchange, knowledge generation and cooperation, HERA should bring together Member States experts from the area of health research at the technical level and industrial sectors within the HERA Advisory Forum.

(8)

As set out in the Communication on the Health Emergency Preparedness and Response Authority, HERA will be tasked with two functional ‘modes’: preparedness and crisis response following a recognition of a public health emergency at Union level,

(a)

the Head of HERA;

(b)

the Coordination Committee;

(c)

the HERA Board;

(d)

the HERA Advisory Forum.

(a)

prepare a multiannual strategic plan for HERA and an annual draft work programme for HERA’s various fields of activity, taking into account the programming cycle calendar of contributing Union programmes;

(b)

negotiate and conclude procurement and other contracts related to medical countermeasures with third parties;

(c)

be responsible for the implementation of HERA’s activities and for the financial administration. HERA’s activities shall respect the governance of contributing Union programmes, in particular EU4Health, Horizon Europe and Union Civil Protection Mechanism;

(d)

determine the internal organisation of HERA, within the constraints of the budget allocated to it by the budgetary authority;

(e)

report to the Member of the Commission in charge of Health.

1.

The Coordination Committee shall be composed of:

2.

The Coordination Committee shall be co-chaired by the Vice-President and the Member of the Commission in charge of Health.

3.

The Head of HERA and the Director General in charge of Health and Food Safety shall attend meetings ex officio.

4.

The Coordination Committee shall meet regularly and at least four times a year.