the agreement based on the dossier that extends the mandate to the EMA
(European Medicines Agency) on June 16 this year (Negotiating EMA mandate), the Council’s mandates for a regulation
covering serious cross-border health threats and extending the tasks of the
ECDC (European Centre for Disease Control and Prevention) have also been
available since the end of July.
Declaration of a pandemic only with a qualified majority
objective of the proposed regulation covering serious cross-border health
threats is to ensure a coordinated response to threats from communicable
diseases, those with chemical or biological origins as well as any
environmental threats. The heart of the proposal empowers the EU to declare a
pandemic on its own. However, according to the will of the member states, the
decision to do this should be taken by a legal act with a 2/3 majority (see Negotiating a mandate on cross-border health
EC thought it could regulate this by passing an implementing act.
Member states want the decision-making committee to be co-chaired
Council also put the brakes on the crisis coordination arrangements. The member
states want to play a more prominent role in the coordinating committee, i.e.
the HSC (Health Security Committee) than that proposed by the EC. If they have
their way, the presidency of the HSC will be shared between the EC and the
Council. The decisions will also be taken by a qualified majority rather than
simple majority. Difficult issues, such as joint procurement, will be further
discussed at a later time, possibly during the process for a new HERA (Health
Emergency Preparedness and Response) authority.
Data protection has been tightened up
will be mandated to assist member states in assessing their preparedness
capacities and developing their own contingency plans, and to bring them
together at European level in an EU preparedness and response plan. The ECDC
should become a medical emergency centre through its digital epidemiological
surveillance system. The ECDC should also be able to make recommendations in
the future. So far, it has been limited to scientific expertise. Even though
the recommendations are not legally binding, they will create a need for
apolitical explanation in a case of doubt. The Council's amendments (see ECDC negotiating mandate) to the original proposals include specifying the
responsibilities as well as stricter provisions for handling personal data.
The ECDC should only "study" national crisis arrangements
under the impact of the pandemic, Council members went beyond the EC's proposal
for an ECDC task force to assist member states in the event of a crisis and in
preparing for a public health crisis. Member states sympathise with not
limiting the use of the task force to times of crisis, but making it permanent
to assist member states upon request in preparedness and response planning and
in responding to outbreaks of communicable diseases. On the other hand, member
states have put the brakes on the ECDC's right to review national pandemic
policies. A "less stringent" wording has now been agreed upon here.
National pandemic plans and emergency capacities are not to be evaluated by the
ECDC, but merely studied.
Next stage: HERA
Council's consolidated negotiating positions are an important milestone towards
improving coordination and preventing public health emergencies in Europe. On
the one hand, the Council's amendments make it clear that the member states are
self-confident in demanding the power to shape health protection. On the other,
the shock of the coronavirus pandemic is being felt throughout the organisations
in the member states. Strengthening European institutions and competencies to
the extent envisaged here would otherwise be difficult to imagine in a core
area of health policy. HERA’s authority will also be established In a
subsequent step. The EC intends to present its proposed regulation on September
present Council mandates, the entire first legislative package on the European
Health Union can now be negotiated in the trialogue. They are expected to start
in September. The EU Parliament will use the legislative process to present its
own legislative preferences.