20.5.2022
EN
Official Journal of the European Union
C 205/85 Thursday 11 November 2021
Amendments 35 and 253 Proposal for a regulation Recital 18 Text proposed by the Commission (18)
The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened.
To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level.
In order to recognise such an emergency situation, the Commission should establish an independent ad­ visory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition.
The advisory committee should consist of independent experts, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers.
Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
Amendment (18)
The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened.
To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level.
In order to recognise such an emergency situation, the Commission should establish an independent ad­ visory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition.
The advisory committee should consist of independent experts, representatives of health and care workers, including nurses and medical doctors, and representa­ tives of civil society, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, of the HERA and of other Union bodies or agencies as observers.
All members of the Advisory Committee should provide declarations of interest.
The advisory committee should work in close cooperation with national advisory bodies.
Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, Union export control mechanisms, flexible mechanisms to develop, procure, manage and deploy medical counter­ measures through the HERA as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
The recognition of a public health emergency may trigger the activation of the framework set out in a Council Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.
That framework should remain operational for an initial period of 6 months, renewable as long as the public health emergency exists.