The second time will be the charm! On Thursday 11 November, MEPs will be asked to vote again on the draft regulation on cross-border health threats - the flagship regulation of the Health Union package (see EUROPE 12600/24).
Indeed, the day after their first vote, the European Commission announced the launch of HERA: the European Health Emergency Response and Preparedness Authority (see EUROPE 12792/24). As this authority was presented as “the missing piece” in the configuration of the European Health Union, MEPs quickly indicated that they would do their utmost to ensure that references to HERA were included in the draft regulation on cross-border threats.
It is indeed to this regulation that the European authorities will have to refer in the future to “coordinate European legislation, agencies and health instruments” in the event of a crisis, recalls MEP Véronique Trillet-Lenoir (Renew Europe, France) in her report on the subject.
To set things right, the Parliament will vote on Thursday on some 30 amendments drafted by Ms Trillet-Lenoir and supported by the shadow rapporteurs of the EPP, S&D, Greens/EFA, ECR and The Left. The adopted amendments will then be incorporated into the position originally adopted by the Parliament (see EUROPE 12792/12).
One of these amendments specifies, for example, that in the event of a health emergency, the EU27 will be able to jointly develop, stockpile and purchase medical countermeasures “under the auspices of HERA”. Another states that the provision of information on the availability of these countermeasures and on European stocks of medicines should be “managed and coordinated by HERA”.
Addressing HERA’s shortcomings
MEPs also intend to use this opportunity to try to correct the few points they consider problematic in the configuration of the new health authority, starting with the role they have been given.
HERA, as it was conceived, only offers parliamentarians an observatory role on its board of directors (see EUROPE 12799/11). In one of the amendments to be voted on Thursday, MEPs suggest that the European Commission should also invite a representative of the Parliament to become an “active member” of HERA’s future health crisis management board.
Several amendments also aim to strengthen the involvement of organisations of health professionals and, in particular, patients’ associations in the authority. The Parliament believes that the latter were not involved enough in the initiative, unlike the pharmaceutical industry.
MEPs are also expected to demand that the European Commission carry out a thorough review of HERA’s structure, governance and funding by 2023 and every two years thereafter. These reviews could include “in particular the need to modify the structure of HERA, including the possibility of making it an autonomous agency”, the amendment suggests.
Finally, the Parliament will seek guarantees on the transparency of the European Commission’s expenditure on the joint procurement of medical countermeasures. In particular, it will try to obtain the publication of purchase contracts signed with pharmaceutical companies, which has so far been rejected (see EUROPE 12824/9).
First ‘trilogue’ on 18 November
In the various internal debates, discussions, and meetings on HERA since mid-September, the political groups have always been very united and almost unanimous.
The amendments put to the vote on Thursday should therefore be easily adopted and thus incorporated into MEPs’ negotiating position on the draft regulation on cross-border threats.
It will then be up to the rapporteurs to defend these demands when negotiating the draft regulation with the EU Council. Interinstitutional negotiations (‘trilogues’) on the subject, which have been somewhat delayed by the MEPs’ manoeuvre, are expected to start on 18 November, according to our information.
To see the draft report and the amendments to be voted on Thursday: https://bit.ly/2YtlUE2 (Original version in French by Agathe Cherki)