9 Amendments of Alessandra BASSO related to 2020/0322(COD)
Amendment 8 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Public health falls, as a matter of principle under the responsibility of the Member States, which are free to organise and deliver their health-care services in whatever manner they wish, as well as to procure medical devices, medicines, vaccines and health products, and to devise policies for cooperation and sharing of best practice, information and medical equipment, however they see fit.
Amendment 9 #
Proposal for a regulation
Recital 2
Recital 2
(2) In light of the lessons learnt during the ongoing COVID-19 pandemic, such as systemic weaknesses in the supply chain of certain medical devices and medicines in Europe, in particular dependence on China and India, and in order to facilitate adequate Union-wide preparedness and response to all cross- border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation by Member States with the European Centre for Disease Prevention and Control (ECDC). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies.
Amendment 17 #
Proposal for a regulation
Recital 6
Recital 6
(6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States and in full compliance with the principle of subsidiarity, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 24 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) This regulation should draw on lessons learned from the COVID-19 pandemic to assess whether an EU coordination mandate is needed, particularly in view of the difficulties encountered in the European Commission’s negotiation of contracts for centralised procurement of vaccines as when as during their delivery. Such lessons should lead to the incorporation into negotiating mandates of provisions on negotiators’ qualifications, terms and conditions and deadlines for delivery, as well as the benefits or sanctions applicable in the event of diligence or default.
Amendment 65 #
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. 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. 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’. In accordance with the limits set by the Treaties, none of these mechanisms should be binding on Member States, but they should make it easier for the Union and the Member States to coordinate and adopt measures at the European level.
Amendment 105 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 157 #
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) enable the automated collection of surveillance and laboratory data, make use of information from electronic health records, with the consent of the patients concerned and in strict compliance with personal data protection rules, as well as media monitoring, media monitoring, and apply artificial intelligence for data validation, analysis and automated reporting;
Amendment 160 #
Proposal for a regulation
Article 14 – paragraph 6 – point d
Article 14 – paragraph 6 – point d
Amendment 168 #
Proposal for a regulation
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
1a. It shall have no effect on the activation and functioning of health emergency arrangements under Member States’ legislation, where they exist.