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
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
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.
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
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