Activities of Antoni COMÍN I OLIVERES related to 2020/0322(COD)
Plenary speeches (2)
European Centre for Disease Prevention and Control - Serious cross-border threats to health (debate)
European Centre for Disease Prevention and Control - Serious cross-border threats to health (debate)
Amendments (104)
Amendment 105 #
Proposal for a regulation
Recital 1
Recital 1
(1) A network for the epidemiological surveillance and control of communicable diseases was set up by Decision No 2119/98/EC of the European Parliament and of the Council.13 Its scope was extended by Decision No 1082/2013/EU of the European Parliament and of the Council14 to strengthen and provide for a further coordinated and wider approach to health security at Union level. The implementation of that legislation confirmed that coordinated Union action on monitoring, early warning of and combating those threats adds value to the protection and improvement of human health. The implementation of this legislation is another sign with which the Union is committed to the conclusions of the Global Conference on Primary Health Care of Astana of 25 and 26 October 2018. _________________ 13Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (OJ L 268, 3.10.1998, p.1). 14Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 106 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) Among the most dangerous pathogens are the respiratory viruses, including orthopoxviruses such as smallpox, or novel influenzas, and coronaviruses. The Union, through its capabilities and know-how, should counter all these potential threats.
Amendment 110 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.
Amendment 111 #
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2 b) Knowing that the SARS-CoV-2 virus has been uncannily good at disrupting cellular programming, the Union should prepare itself for all those serious cross-border threats that could have the same levels of cellular disruption, for which the sufficient and most reliable research and capabilities should be deployed.
Amendment 112 #
Proposal for a regulation
Recital 2 c (new)
Recital 2 c (new)
(2 c) In October, 2019, the first Global Health Security Index reported of a world largely unprepared to deal with a pandemic. Inter alia, it stated that there was a lack of political will for accelerating health security in a perpetual cycle of panic and neglect, and that no country was fully prepared. With the current legislation, which builds upon the lessons- learned during the management of the COVID–19 pandemic, the Union wishes to amend this situation and prepare itself for future serious cross-border threats that may originate in epidemics or pandemics.
Amendment 114 #
Proposal for a regulation
Recital 3
Recital 3
(3) An important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU. This Committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health. The European Parliament should nominate observers for the HSC.
Amendment 115 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for disease prevention and health promotion. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies.
Amendment 116 #
Proposal for a regulation
Recital 4 b (new)
Recital 4 b (new)
(4 b) It is necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, agro- environmental, educational, housing, cultural, social assistance, etc. Health in all policies (HiAP) should be a non- negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology in all the programmes managed by the Union.
Amendment 119 #
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 and foodstuffs, in vitro diagnostic medical devices and applications, substances of human origin (blood, plasma, tissues and cells, organs), and exposure to ionising radiation.
Amendment 121 #
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, 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. All actions should be consistent with the WHO’s One Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.
Amendment 128 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, a shift is needed towards a healthcare model in which chronic diseases gain more weight and pandemics’ risk is significantly reduced. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices exchanging mechanisms.
Amendment 132 #
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. Where appropriate, regional authorities should participate in the drawing of these plans. 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, facilitating the sharing of best practices. To ensure the putting into operation and the running of these plans, the Commission should 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 136 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7 a) Preparedness and response planning are also essential elements in order to prevent a “doom loop” situation, namely a cycle of negative economic feedback. When the COVID–19 pandemic hit, the world suffered a supply shock, where trade was disrupted,factories and stores closed, then salaries where in danger, the supply shock could turn into a demand shock, and that would further weaken supply, which would increase unemployment and further diminish demand. In order to prevent a subsequent doom loop, the Union should make high- quality preparedness and response planning.
Amendment 137 #
Proposal for a regulation
Recital 7 b (new)
Recital 7 b (new)
(7 b) Ensuring supply chain resilience across the Union is not a primordial mission of the Centre, yet the ECDC can provide data, knowledge, and skills, to the Commission and the EMA in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID– 19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 138 #
Proposal for a regulation
Recital 7 c (new)
Recital 7 c (new)
(7 c) It is therefore necessary that the European Medicines Agency (EMA) assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of this authority, yet the EMA should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 141 #
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, and regional level where applicable. 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 and regional 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 155 #
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 entail that the Member States participating in the joint procurement procedure will not be allowed to negotiate and sign parallel contracts with producers. In case these Member States negotiate and sign parallel contracts, they should be excluded from the group of participating countries. 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 174 #
Proposal for a regulation
Recital 10
Recital 10
(10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross- border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. The ECDC should also monitor the impact of communicable diseases on diseases that are not communicable(such as mental diseases), taking into account existing datasets, tools and registers.
Amendment 179 #
Proposal for a regulation
Recital 11
Recital 11
(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance, cancer, and mental health.
Amendment 183 #
Proposal for a regulation
Recital 12
Recital 12
(12) In case of cross-border health threats due to a communicable disease, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin, from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national bloodand regional blood, plasma and transplant services and their authorities to serve this dual purpose.
Amendment 185 #
Proposal for a regulation
Recital 13
Recital 13
(13) A system enabling the notification at Union level of alerts related to serious cross-border threats to health has been put in place by Decision No 2119/98/EC in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level. To avoid duplication and ensure coordination across Union alert systems, the Commission and ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all-hazard alerts from a single coordinated source. The notification system of the EWRS should be an electronic, digital, interoperable platform which may also be built upon distributed ledger technology (DLT) and include data from national and regional competent authorities. Finally, this platform should also be linked to the Health dataspace.
Amendment 190 #
Proposal for a regulation
Recital 14
Recital 14
(14) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency. The involvement of Union agencies and Commission bodies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach, via a permanent network of agencies and relevant Commission services to support the preparation of risk assessments. In order to achieve a sufficient degree of increased expertise and competences, there should also be an increase of the respective financial and human resources of Union agencies and bodies.
Amendment 193 #
Proposal for a regulation
Recital 15
Recital 15
(15) The Member States have a responsibility to manage public health crises at national and regional level. However, measures taken by individual Member States could affect the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. The aim to coordinate the response at Union level should, therefore, seek to ensure, inter alia, that measures taken at national and regional level are proportionate and limited to public health risks related to serious cross-border threats to health, and do not conflict with obligations and rights laid down in the Treaty on the Functioning of the European Union such as those related to free movement of persons, goods and services.
Amendment 194 #
Proposal for a regulation
Recital 16
Recital 16
(16) To this effect, the HSC responsible for the coordination of response at Union level, should assume additional responsibility for the adoption of opinions and guidance for Member States related to the prevention and control of a serious cross border threats to health. Furthermore, should the coordination of national and regional public health measures prove insufficient to ensure an adequate Union response, the Commission should further support Member States via the adoption of recommendations on temporary public health measures.
Amendment 196 #
Proposal for a regulation
Recital 17
Recital 17
(17) Inconsistent communication with the public and stakeholders such as healthcare professionals as well as those dedicated to research, development and innovation, can have a negative impact on the effectiveness of the response from a public health perspective as well as on 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 and regional needs and circumstances. In those Member States with regions having health competences, the information should also come from these regions towards their Member State and the Commission. 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 198 #
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, taking into account the urgency of the situation where the Commission may have to recognise the public health emergency 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, therefore without any type of decision-making competence in order to guarantee that the Commission can act accordingly to the urgent need of recognising the public health emergency at Union level. 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 205 #
Proposal for a regulation
Recital 19
Recital 19
(19) Before recognising a situation of public health emergency at Union level, the Commission should liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision. Where such a recognition is adopted, the Commission should also inform the WHO thereof. The liaison with the WHO should not question the Union’s strategic autonomy in countering the serious cross-border threats or outbreaks within its borders.
Amendment 211 #
Proposal for a regulation
Recital 22
Recital 22
(22) The processing of personal data for the purpose of implementing this Regulation should comply with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council19 . In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national and regional level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing measures. _________________ 19Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 213 #
Proposal for a regulation
Recital 24
Recital 24
(24) As responsibility for public health is not an exclusively national matter in certain Member States, but is substantially decentralised, national and regional authorities should, where appropriate, involve the relevant competent authorities in the implementation of this Regulation.
Amendment 216 #
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 to: 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 and regional 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.
Amendment 219 #
Proposal for a regulation
Recital 28
Recital 28
(28) In order to ascertain the state of implementation of the national and regional 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 Commission in respect of procedures, standards and criteria for the audits aimed at the assessment of preparedness and response planning at national and regional 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 delegated 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 delegated acts. _________________ 21 OJ L 123, 12.5.2016, p. 1.
Amendment 221 #
Proposal for a regulation
Article 1 – paragraph 1 – point b – point i
Article 1 – paragraph 1 – point b – point i
(i) preparedness plans at Union and national and regional levels;
Amendment 224 #
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. TIn order to honour the One Health approach and the Health in all policies principle, the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The European Health Union, with its regulation on a reinforced mandate for the European Medicines Agency, and its regulation amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control, strengthen the Union health framework in order to address serious cross-border health threats, and shall be funded by the EU4Health programme. It shall be complementary to other Union policies and funds, namely, but not exclusively, actions implemented under the Horizon Europe, the Digital Europe Programme, ESIF. rescEU, ESI, ESF+, Next Generation EU, and SMP.
Amendment 231 #
Proposal for a regulation
Article 2 – paragraph 1 – point a – point iii a (new)
Article 2 – paragraph 1 – point a – point iii a (new)
(iii a) rare diseases of biological origin;
Amendment 236 #
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues, such as non- communicable diseases, or health consequences such as mental health conditions.
Amendment 240 #
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 and regional 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.
Amendment 243 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a communicable or infectious disease, through manual or other technological means;
Amendment 245 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues as well as their impact on non- communicable diseases or health consequences such as mental health conditions;
Amendment 252 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]
Amendment 253 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]
Amendment 263 #
Proposal for a regulation
Article 4 – paragraph 2 – point d a (new)
Article 4 – paragraph 2 – point d a (new)
(d a) support policies that guarantee the health in all policies principle and the One Health approach;
Amendment 265 #
Proposal for a regulation
Article 4 – paragraph 2 – point d b (new)
Article 4 – paragraph 2 – point d b (new)
(d b) exchange good practices in order to make it easier for Member States to make the transition towards a healthcare model where aging and chronicity have gained relevance;
Amendment 266 #
Proposal for a regulation
Article 4 – paragraph 2 – point d c (new)
Article 4 – paragraph 2 – point d c (new)
(d c) strengthen public sector participation in health research strategies, in coherence with the Horizon Europe programme, in order to reinforce the necessary resources so that all strategic health research that cannot be done without public support may be carried out;
Amendment 269 #
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. The secretariat shall be provided by the Commission and shall be instituted within the competent directorate general of the Commission.
Amendment 273 #
Proposal for a regulation
Article 4 – paragraph 7 – introductory part
Article 4 – paragraph 7 – introductory part
7. Member States shall designate one representative and not more than two alternate members of the HSC in each working formation referred to in paragraph 1. Member States shall designate their representatives and alternate members within 30 days after the entry into force of this Regulation. In case a representative or an alternate representative cedes her or his responsibilities within the HSC, the Member State shall designate a substitute or substitutes within 30 days.
Amendment 274 #
Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 a (new)
Article 4 – paragraph 7 – subparagraph 1 a (new)
In case the Member State has not designated any substitute within 30 days after the termination of the previous representative or alternate member, the HSC shall nevertheless continue its undertakings after an official letter sent to the Member State by the Chair of the HSC.
Amendment 276 #
Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 b (new)
Article 4 – paragraph 7 – subparagraph 1 b (new)
The European Parliament shall nominate two observers, elected by its Committee on Environment, Public Health and Food Safety. These observers shall be elected during the European Parliament’s mandate. Each observer shall be elected for a maximum of five years.
Amendment 287 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. The Union preparedness and response plan shall complement the national and regional preparedness and response plans established in accordance with Article 6.
Amendment 291 #
Proposal for a regulation
Article 5 – paragraph 3 – point a
Article 5 – paragraph 3 – point a
(a) the timely cooperation between the Commission, the Member States, regions with health competences, and the Union agencies;
Amendment 292 #
Proposal for a regulation
Article 5 – paragraph 3 – point b
Article 5 – paragraph 3 – point b
(b) the secure exchange of information between the Commission, Union agencies, regions with health competences, and the Member States;
Amendment 294 #
Proposal for a regulation
Article 5 – paragraph 3 – point c
Article 5 – paragraph 3 – point c
(c) the epidemiological surveillance and monitoring, as well as the impact of communicable diseases on non- communicable diseases;
Amendment 316 #
Proposal for a regulation
Article 6 – title
Article 6 – title
National and regional preparedness and response plans
Amendment 324 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national and regional preparedness and response plans each Member State and region with health competences shall coordinate with the Commission in order to reach consistency with the Union preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national and regional plan.
Amendment 333 #
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their preparedness and response planning and implementation at national and regional level.
Amendment 338 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) identification of, and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national and regional level for the health sector, as provided to the WHO in accordance with the IHR;
Amendment 365 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c
Article 7 – paragraph 1 – subparagraph 1 – point c
(c) implementation of national and regional response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health, and other specific issues.
Amendment 371 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
The report shall include, whenever relevant, interregional preparedness and response elements in line with the Union and national and regional plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions.
Amendment 375 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
The report shall include country profiles for monitoring progress and developing action plans to address identified gaps at national and regional level.
Amendment 377 #
Proposal for a regulation
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5 a. The notification platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the Health data space.
Amendment 384 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national and regional plans and their coherence with the Union plan. Such audits shall be implemented with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1).
Amendment 407 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point b
Article 10 – paragraph 1 – subparagraph 1 – point b
(b) promoting the interoperability of national and regional preparedness planning and the intersectoral dimension of preparedness and response planning at Union level;
Amendment 412 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point e
Article 10 – paragraph 1 – subparagraph 1 – point e
(e) monitoring progress, identifying gaps and actions to strengthen preparedness and response planning, including in the field of research, at national, regional and at Union levels.
Amendment 426 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national and regional preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools.
Amendment 441 #
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 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. Member States that run parallel negotiation processes, having reached the signature or not of such processes, shall be excluded from the group of participating countries;
Amendment 476 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, the EMA and the competent authorities responsible at national, and where applicable regional, level for epidemiological surveillance.
Amendment 477 #
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) detect and monitor any multinational communicable disease outbreaks with respect to source, time, population and place in order to provide a rationale for public health action, as well as its impact on non-communicable diseases or health consequences like mental health conditions;
Amendment 480 #
Proposal for a regulation
Article 13 – paragraph 2 – point c
Article 13 – paragraph 2 – point c
(c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national , regional and Union level;
Amendment 485 #
Proposal for a regulation
Article 13 – paragraph 2 – point h
Article 13 – paragraph 2 – point h
(h) identify research priorities and needs, and implement relevant research activities with the aim of anticipating future health hazards;
Amendment 487 #
Proposal for a regulation
Article 13 – paragraph 2 – point h a (new)
Article 13 – paragraph 2 – point h a (new)
(h a) make mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
Amendment 490 #
Proposal for a regulation
Article 13 – paragraph 3 – introductory part
Article 13 – paragraph 3 – introductory part
3. The national and regional competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network:
Amendment 493 #
Proposal for a regulation
Article 13 – paragraph 3 – point f
Article 13 – paragraph 3 – point f
(f) information about contract tracing monitoring systems developed at national and regional level.
Amendment 496 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. When reporting information on epidemiological surveillance, the national and regional competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.
Amendment 518 #
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6 a. The surveillance platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the health data space where possible.
Amendment 519 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national and regional plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national and regional reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.
Amendment 521 #
Proposal for a regulation
Article 15 – paragraph 2 – introductory part
Article 15 – paragraph 2 – introductory part
2. The EU reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national and regional reference laboratories, in particular, in the following areas:
Amendment 523 #
Proposal for a regulation
Article 15 – paragraph 2 – point g
Article 15 – paragraph 2 – point g
(g) training in current and innovative research procedures and skills.
Amendment 524 #
Proposal for a regulation
Article 15 – paragraph 2 – point g a (new)
Article 15 – paragraph 2 – point g a (new)
(g a) obtaining, recording and sharing information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma- derived products;
Amendment 525 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC., with a governance structure where national and regional reference laboratories and networks shall cooperate;
Amendment 529 #
Proposal for a regulation
Article 15 – paragraph 4 – introductory part
Article 15 – paragraph 4 – introductory part
4. The designations provided for in paragraph 1 shall follow a public selection process, be limited in time, with a minimum period of 5 years, and be reviewed regularly. Designations shall establish the responsibilities and tasks of the designated laboratories. Groups or coalitions of laboratories shall also be eligible for such designation.
Amendment 533 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1 a. The network shall share information on developments that are still not harmonised throughout the Union, such as plasma-derived products.
Amendment 540 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Following an alert notified pursuant to Article 19 concerning a serious cross- border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1), Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the ‘Early Warning and Response System’ (‘EWRS’) and, if the urgency of the situation so requires, through the HSC about developments with regard to the threat concerned at national and regional level.
Amendment 543 #
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 and regional level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 551 #
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. The EWRS shall establish interoperable databases with Member States, and regions where applicable. The ECDC shall coordinate the data exchange processes, from assessing the data requirement, transmission and collection, up to data updates and processing. The EWRS shall assess the implementation of distributed ledger technology (DLT).
Amendment 554 #
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. Each Member State shall designate the competent authority or authorities responsible at national and regional level for notifying alerts and determining the measures required to protect public health, for the purposes of early warning and response.
Amendment 556 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. National and regional competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria:
Amendment 559 #
2. Where the national and regional competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
Amendment 562 #
Proposal for a regulation
Article 19 – paragraph 3 – introductory part
Article 19 – paragraph 3 – introductory part
3. When notifying an alert, the national and regional competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:
Amendment 564 #
Proposal for a regulation
Article 19 – paragraph 3 – point g
Article 19 – paragraph 3 – point g
(g) public health measures implemented or intended to be taken at national and regional level;
Amendment 567 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The Commission shall make available to the national and regional competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 21, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health already transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.
Amendment 571 #
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national, and regional where appropriate, competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out by:
Amendment 576 #
Proposal for a regulation
Article 20 – paragraph 3 – subparagraph 1
Article 20 – paragraph 3 – subparagraph 1
The Commission shall make the risk assessment available to the national, and regional where appropriate, competent authorities promptly through the EWRS, and, if appropriate, through linked alerts systems. Where the risk assessment is to be made public, the national, and regional where appropriate, competent authorities shall receive it prior to its publication.
Amendment 578 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national, and regional where appropriate, competent authorities through the EWRS and to the HSC.
Amendment 579 #
Proposal for a regulation
Article 21 – paragraph 1 – point a
Article 21 – paragraph 1 – point a
(a) national and regional responses, including research needs, to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Regulation;
Amendment 592 #
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions, who shall also be accordingly informed.
Amendment 595 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3 a. Where the public health measures that a Member State adopts to counter a serious cross-border threat to health lasts or is extended for more than 14 days, it shall inform the other Member States and the Commission about the scientific evidence that justify the necessity, suitability and proportionality of the continuity of such measures to attain the purpose stated in the communications referred to in paragraphs 2and 3.
Amendment 598 #
Proposal for a regulation
Article 22 – paragraph 2 – point b
Article 22 – paragraph 2 – point b
(b) respect the responsibilities of the Member States, and the regions where appropriate, for the definition of their health policy and for the organisation and delivery of health services and medical care;
Amendment 599 #
Proposal for a regulation
Article 22 – paragraph 2 – point c
Article 22 – paragraph 2 – point c
(c) be necessary, suitable and proportionate to the public health risks related to the threat in question, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services, and to the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union.
Amendment 602 #
Proposal for a regulation
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(c a) assess the overall strategic implications of the public health measures proposed in the recommendation, with special regard for their economic, political, social and psychological consequences.
Amendment 616 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The Commission shall make public the selected experts and the professional and/or scientific backgrounds that support their nomination. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.
Amendment 631 #
6 a. The minutes of the Advisory Committee shall be public.
Amendment 632 #
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) mechanisms to monitor shortages of, develop, procure, managufacture, produce, manage, store, distribute and deploy medical countermeasures;
Amendment 635 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to national and regional competent authorities involved in the contact tracing measures concerned. That selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at Union level.
Amendment 636 #
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
5. Personal data may also be exchanged in the context of automated contact tracing, with the user’s consent, and using contact tracing applications. In order to ensure a sufficient degree of data privacy, the Commission shall assess the use of technologies such as blockchain.
Amendment 639 #
(b) procedures for the interlinking of the EWRS with contact tracing systems at Union and international level;