Mandate of the EMA to be strengthened

The European Commission has taken various measures during the Coronavirus pandemic to support its member states in ensuring the availability of medicines and medical devices. These measures were responsive in nature and could only be agreed upon to a limited extent between member states, the EMA and the manufacturers of medicines and medical devices. The coronavirus pandemic has shown that the European Commission's powers to coordinate this task are inadequate for structurally implementing comprehensive public health protection measures.

The present proposed regulation now provides for the extending the EMA’s mandate to ensure the availability of medicines and medical devices in the event of health emergencies of European significance (e.g. a pandemic) or special incidents.

Prevention, monitoring and management

In the future, the EMA should actively contribute to the preservation of public health by monitoring and mitigating potential or actual bottlenecks relating to medicines or medical devices.

To this end, an executive steering committee for pharmaceutical bottlenecks and safety of medicines will be set up. This steering committee will be composed of representatives from the EMA, one representative from the European Commission and one high-level representative from each member state. Similarly, an executive steering committee will be set up for medical devices and this committee will only be activated in the event of health emergencies of European significance.

In essence, the steering committees will be entrusted with the following tasks:
- drawing up lists of essential medicines or medical devices that are essential for dealing with a health emergency or special incidents
- monitoring the demand and supply of available devices with the intention of early identification of potential or actual bottlenecks and reporting to the European Commission
- supplementing the surveys and predictions about the supply situation with epidemiological data from the ECDC in order to substantiate the expected demand for essential devices
- the steering committee will be able to make proposals to the European Commission, the member states, manufacturers and other bodies to prevent and mitigate bottlenecks as part of its reporting process

Roles of manufacturers, member states and the European Commission

Manufacturers should assist by providing information on potential and actual bottlenecks. This includes information about the expected period of a potential or actual bottleneck, alternative devices and production capacities for essential devices.

Member states should provide information about the expected demand through designated contact points. With the support from the EMA, information about stock levels, e.g. at wholesalers, and, where available, information about the prescribing procedure will also be provided.

The European Commission should use the available information to propose necessary measures to alleviate potential or actual bottlenecks for devices on the essential list.

Another "Emergency Task Force" expert panel from the EMA is to provide scientific support to help overcome the health emergency, e.g. by coordinating studies and monitoring the efficacy and safety of vaccines or consultancy on accelerated clinical drug trials. 

Background information

The regulation is intended to assign specific tasks to the EMA to overcome health emergencies of European significance or special incidents, in particular by providing transparency regarding the supply and demand for medicines and medical devices. Thus, it represents a solution approach in response to the experience of the coronavirus pandemic by contributing to the protection of public health in emergency situations and it is also intended to complement the expected pharmaceutical strategy.

The proposal is part of the package of measures to create a Health Union in response to the coronavirus pandemic. The measures of the present proposal are intended to act in accordance and synergy with the parallel proposals for regulations on the extension of the mandate of the ECDC (see News 11/2020) and on serious cross-border health threats (see News 11/2020).