25 Amendments of Romana TOMC related to 2020/0322(COD)
Amendment 7 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Health provisions of the Treaties are still largely under-used in terms of the purposes they could be used to achieve. The aim is therefore to ensure that this Regulation makes the best possible use of the legal bases on health set out in the Treaty, in order to manifest the European Union’s strong health policy while preserving the normal functioning of the single market during serious cross-border threats to health.
Amendment 13 #
Proposal for a regulation
Recital 2
Recital 2
(2) In light of the lessons learnt during the ongoing COVID-19 pandemic 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 without prejudice to the protection of personal data.
Amendment 14 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices, personal protective equipment (PPE) and foodstuffs, substances of human origin (blood, tissues and cells, organs), and exposure to ionising radiation.
Amendment 22 #
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 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. __________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 33 #
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. 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 . The European Commission shall pay special attention to ensure that joint procurement of medical countermeasures within the meaning of Article 12, also includes procurement of orphan drugs. __________________ 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 37 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to achieve transparency, the Commission shall provide to the European Parliament complete, timely and accurate information on the ongoing negotiations and give an access to the tender documents for the purposes of carrying out the procedure referred to in Article 12 of this Regulation.
Amendment 57 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) This Regulation ensures coordinated action at European Union’s level, in order to avoid the closure of internal borders and the paralysis of the internal market, which could threaten the circulation of basic supplies, including medicines, medical products and personal protective equipment (PPE). It is therefore necessary to ensure the correct implementation of European law in the field of export restrictions through a permanent notification mechanism.
Amendment 59 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The European Commission shall ensure that, at the time of the declaration of a state of emergency, the number of accommodation facilities in hospitals in the Member States as well as the number of available accommodation units in intensive care units in the Member States are known, for the purpose of cross- border movement of patients.
Amendment 61 #
Proposal for a regulation
Recital 17
Recital 17
(17) Inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on, encourage the dissemination of false information but also negatively affect economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national needs and circumstances. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross-sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council17 . __________________ 17Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1).
Amendment 66 #
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 require 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. The Commission shall ensure the secure processing of such data and shall ensure that they are treated in accordance with the personal data protection. 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 81 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘medical countermeasure’ means medicinal products for human use and medical devices as defined in Directive 2001/83/EC of the European Parliament and of the Council23 and in Regulation (EU) 2017/745 of the European Parliament and of the Council24 or other goods or services for the for the purpose of preparedness and response to a serious cross-border threat to health among which especially drugs for the treatment of orphan diseases. __________________ 23 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 24Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 82 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8a) ‘green lines’ means passable and safe passage transit corridors that in case of declared public health emergency at Union level allows Member States to preserve the free circulation of essential goods and medical countermeasures.
Amendment 83 #
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. The Health Security Committee (‘HSC’) is hereby established. It shall be composed of representatives of all the Member States, in two working formations:
Amendment 84 #
Proposal for a regulation
Article 4 – paragraph 2 – point d
Article 4 – paragraph 2 – point d
(d) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health while taking into account the proper functioning of the single market.
Amendment 86 #
Proposal for a regulation
Article 4 – paragraph 6 – point c a (new)
Article 4 – paragraph 6 – point c a (new)
(ca) remote digital working in situations when the HSC cannot physically meet for justified reasons.
Amendment 95 #
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. The Union preparedness and response plan also provides for measures to ensure the normal functioning of the single market during serious cross-border threat to health.
Amendment 100 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic services during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 145 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. In accordance with the principle of transparency, the Commission shall regularly inform the European Parliament on the negotiations and other details of the joint procurement of medical countermeasures.
Amendment 147 #
Proposal for a regulation
Article 12 – paragraph 3 b (new)
Article 12 – paragraph 3 b (new)
3b. The European Parliament reserves at all times the right to inspect the uncensored content of all contracts concluded in proceedings under this Article.
Amendment 159 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and, complete and accurate information, data and documents transmitted and exchanged through the digital platform.
Amendment 165 #
Proposal for a regulation
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(ca) take into account the need for the normal functioning of the single market, in particular the existence of green lines for free circulation of food and other medical countermeasures.
Amendment 166 #
Proposal for a regulation
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
(c) activation of support from the ECDC as referred to in Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/12527]] to mobilise and deploy the EU Health Task Force. and in particular the establishment of a list of accommodation facilities in intensive care units in the Member States for the purpose of potential cross-border relocation of patients;
Amendment 167 #
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(ca) green lines under Article 25a of this Regulation.
Amendment 169 #
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Article 25a Free movement of goods and services 1. After recognising a public health emergency under Article 23 of this Regulation, green lines shall be set up to allow the free movement of food and medical countermeasures within the internal market. The Commission is empowered to adopt delegated acts to supplement this Regulation with provisions on the establishment of the green lines referred to in the first subparagraph of paragraph 1. 2. Only on condition that the Commission grants prior authorisation Member States may, in accordance with Article 36 of TFEU, impose export restrictions on medical countermeasures concerning another Member State or Member States during a public health emergency at Union level. Upon receiving a request for prior authorisation referred to in the first subparagraph of paragraph 2 from a Member State, the Commission shall decide whether to grant it without delay. If within five days the Commission has not granted the prior authorisation in question, it shall be deemed granted.
Amendment 171 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
By 2025 and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response with the HSC and the impact of the Regulation on the proper functioning of the single market during serious cross-border threats to health.