39 Amendments of Markus BUCHHEIT 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 18 #
Proposal for a regulation
Recital 7
Recital 7
(7) Preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies. To ensure the putting into operation and the running of these plans, the Commission should be able to ask Member States to conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 21 #
Proposal for a regulation
Recital 8
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15. In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that there is consistency between national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. __________________ International Health Regulation (IHR, 2005), https://www.who.int/ihr/publications/9789 241596664/en/
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 31 #
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. This exclusivity clause should nevertheless ensure that Member States who wish to be able to negotiate other contracts with different suppliers are free to do, so to be insulated from the eventuality of lateness or other failure affecting the joint procedure. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16. __________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
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 67 #
Proposal for a regulation
Recital 20
Recital 20
(20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should requireallow the Member States concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of the disease, between those Member States directly involved in the contact-tracing measures. The exchange of personal data concerning health by the Member States has to comply with Article 9(2)(i) of Regulation (EU) 2016/679 of the European Parliament and of the Council18. __________________ 18Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 68 #
Proposal for a regulation
Recital 23
Recital 23
(23) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States due to the cross-border dimension of serious threats to health but can be better achieved at Union level, the Union may adopt measures, itext apply only to voluntary cooperation by the Member States and to organisation at the level of the Union institutions, bodies and offices and agencies alone, issuing a regulation is not the right way to achieve them in a meaningful manner. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Artic, it is preferable, since the repeale,d this Regulation does not go beyond what is necessary in order to achieve those objext is a decision, to replace it with another decision or a directives.
Amendment 70 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation totext, the Commission should be able to propose decisions or recommendations establishing: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross- border threats to health subject to ad hoc monitoring; the procedures for the operation of the EWRS; the functioning of the surveillance platform; the designation of EU reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition and procedures necessary to ensure that the operation of the EWRS and the processing of data are in accordance with the data protection legislation. These definitions apply only within the above- mentioned European-level framework and shall not replace the national-level definitions used by the Member States.
Amendment 71 #
Proposal for a regulation
Recital 26
Recital 26
Amendment 74 #
Proposal for a regulation
Recital 27
Recital 27
Amendment 75 #
Proposal for a regulation
Recital 28
Recital 28
(28) In order to ascertain the state of implementation of the national preparedness plans and their coherence with the Union plan, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the CommissCommission should also be able to propose decisions or recommendations in respect of procedures, standards and criteria for the audits aimed at the assessment of preparedness and response planning at national level. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 201621. In particular, to ensure equal participation in the preparation of delegatedthese acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegatedthese acts. __________________ 21 OJ L 123, 12.5.2016, p. 1.
Amendment 77 #
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
Amendment 78 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
Amendment 79 #
Proposal for a regulation
Article 2 – paragraph 6
Article 2 – paragraph 6
6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation. They shall also have the right not to comply with the Commission’s decisions, recommendations and guidelines.
Amendment 85 #
Proposal for a regulation
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. As far as possible, the group shall adopt its guidance or opinions by consensus. These decisions shall not be binding.
Amendment 88 #
Proposal for a regulation
Article 5 – paragraph 3 – point e
Article 5 – paragraph 3 – point e
Amendment 89 #
Proposal for a regulation
Article 5 – paragraph 3 – point f
Article 5 – paragraph 3 – point f
Amendment 90 #
Proposal for a regulation
Article 5 – paragraph 3 – point g
Article 5 – paragraph 3 – point g
Amendment 96 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national preparedness and response plans each Member State shall coordinate withinform the Commission in order to reach consistency withand the HSC in order to ensure that the Union preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national plan is kept suitably up to date.
Amendment 98 #
Proposal for a regulation
Article 7
Article 7
Amendment 102 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms, means of national production and essential supplies for health; and dedicated, trained and equipped human resources for emergencies; and
Amendment 105 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 107 #
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The Commission and the Member States shallthat wish to do so may, in complement to HSC’s monitoring role, work together within ithe HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health.
Amendment 116 #
Proposal for a regulation
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) participation in the joint procurement procedure ishall be open to all Members States, European Free Trade Association (EFTA) States and Union candidate countries in accordance with Article 165(2) of Regulation (EU, Euratom) 2018/1046;
Amendment 118 #
Proposal for a regulation
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) the rights and obligations of Members States, EFTA States and Union candidate countri States not participating in the joint procedurement shall b are respected, in particular those relating to the protection and improvement of human health;
Amendment 121 #
Proposal for a regulation
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) Member States, EFTA States and Union candidate countries participating in a specific joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product;
Amendment 128 #
Proposal for a regulation
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
(d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition. It shall enable, among other things, the negotiation and procurement by Member States of medical countermeasures from suppliers other than the specific supplier chosen for the joint procedure in which they are participants;
Amendment 136 #
Proposal for a regulation
Article 12 – paragraph 2 – point e
Article 12 – paragraph 2 – point e
(e) the joint procurement shall not have any direct financial impact on the budget of Member States, EFTA States and Union candidate countries not participating in the joint procurement.
Amendment 143 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. Member States’ ability to hold strategic reserves shall be guaranteed, as well as their capacity to direct the use of these reserves solely for the benefit of their nationals and nationals of other Member States residing on their territory. Member States shall remain free to decide whether or not to share the use of these reserves.
Amendment 155 #
Proposal for a regulation
Article 13 – paragraph 10
Article 13 – paragraph 10
10. On duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread among the Member States, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 27(3)propose decisions or recommendations for the adoption of case definitions, procedures and indicators for surveillance in Member States in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1). The indicators mentioned above shall also support the assessment of capacity for diagnosis, prevention and treatment.
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 161 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. A network of Member States’ services supportenabling transfusion, transplantation and medically assisted reproduction, when authorised in national law, is established to allow for the continuous and rapid access to sero- epidemiological data, including assessment of donor population exposure and immunity, and to monitor, assess and help address disease outbreaks that are relevant to substances of human origin.
Amendment 162 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determinsuggesting the measures that may be required to protect public health.
Amendment 163 #
Proposal for a regulation
Article 21 – paragraph 1 – introductory part
Article 21 – paragraph 1 – introductory part
1. Following an alert notification pursuant to Article 19, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 19 and the risk assessments referred to in Article 20, Member States shall coordinate within the HSC and in liaison with the Commission:
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.