BETA

7 Amendments of Marco CAMPOMENOSI related to 2020/0322(COD)

Amendment 8 #
Proposal for a regulation
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.
2021/04/21
Committee: IMCO
Amendment 9 #
Proposal for a regulation
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.
2021/04/21
Committee: IMCO
Amendment 17 #
Proposal for a regulation
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.
2021/04/21
Committee: IMCO
Amendment 24 #
Proposal for a regulation
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.
2021/04/21
Committee: IMCO
Amendment 105 #
Proposal for a regulation
Article 8 – paragraph 2
2. Member States shall present an action plan addressing the proposed recommendations of the audit and the corresponding corrective actions and milestones. These actions may, in particular, include: (a) legislation, if necessary; (b) (c) overview reports of audits series, which present cases of good practice.deleted review/adjustment of the training initiatives;
2021/04/21
Committee: IMCO
Amendment 157 #
Proposal for a regulation
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;
2021/04/21
Committee: IMCO
Amendment 160 #
Proposal for a regulation
Article 14 – paragraph 6 – point d
(d) the cases where, and the conditions under which the third countries and international organisations concerned may be granted partial access to the functionalities of the platform and the practical arrangements of such access;deleted
2021/04/21
Committee: IMCO