3 Amendments of Christel SCHALDEMOSE related to 2020/0322(COD)
Amendment 27 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) To ensure resilience of the single market during future health emergency situations and in order to reduce the dependence on third countries, this Regulation should foster the creation of minimum European stocks of medical countermeasures as strategic products.
Amendment 63 #
Proposal for a regulation
Recital 18
Recital 18
(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 through the creation of a new mechanism that increases the coordination and facilitates joint procurement procedures for the development, stockpiling and donation of medical countermeasures. In order to recognise such an emergency situation, the Commission should establish an independent advisory 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, and of the European Parliament. 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 125 #
Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(ca) the joint procurement shall be conducted in such a way so as to strengthen the purchasing power of participating countries, improve the security of supply and ensure fair, equitable and affordable, access to medical countermeasures against serious cross-border threats to health;