The Council has positioned itself - the trialogue can begin.   

UM – 08/2021

Following 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

The 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 threats). The EC thought it could regulate this by passing an implementing act.

Member states want the decision-making committee to be co-chaired

The 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

The ECDC 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

However, 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

The 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 14.

With the 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.