45 Amendments of Alexander BERNHUBER related to 2020/0322(COD)
Amendment 120 #
Proposal for a regulation
Recital 6
Recital 6
(6) TIn line with the "One Health" and "Health in all policies" approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. The Union should urge Member States to implement the health-specific country-specific recommendations and support Member States to strengthen the resilience, responsiveness and readiness of healthcare systems in order to address future challenges, including pandemics. 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.
Amendment 133 #
Proposal for a regulation
Recital 7
Recital 7
(7) Prevention, 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’ prevention, 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 activitiParticular attention must be paid to cross- border regions. To support Member States in this endeavour, the Commission and Union agencies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff should be providedto improve their knowledge and ensure 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 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 152 #
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach in fighting against such threats. The joint procurement of medical countermeasures should, therefore, 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. In times of crisis, the Union should also aim to support access to medical countermeasures for Eastern Partnership and low- and middle-income 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 . The Member States should ensure a sufficient reserve of critical medical products at Member State level to counter the risk of shortages of critical products. _________________ 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 163 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Joint procurement should be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments should be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 167 #
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9 b) The joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure all actors involved shall fulfil their contractual responsibilities. Clear and transparent stages should be defined for the process, scope, specifications, timelines and formalities;
Amendment 173 #
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. Nevertheless, the ECDC should have the ability to monitor the impact of communicable diseases on non- communicable diseases, including the continuity of screening, diagnosis, monitoring, treatment and care in the healthcare system;
Amendment 176 #
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. In times of crisis, particular attention should also be paid to the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and to the mental health implications of the crisis and psychosocial needs of the population.
Amendment 188 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) Regular dialogue and exchange of information between authorities, industry, relevant entities of the pharmaceutical supply chain, healthcare professionals' and patients' organizations should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints or raising of specific clinical needs, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 199 #
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 and representatives of health and care workers, including nurses and medical doctors, 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. All members of the Advisory Committee should provide declarations of interest in line with the applicable rules in each case. The advisory committee should work in close cooperation with national advisory bodies. 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, Union export control mechanisms, 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 209 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) The Commission and the Member States should actively work towards a new global treaty for pandemic preparedness and response under the framework of the World Health Organization and with close involvement of other relevant organizations, building on and improving the existing global health instruments, especially the International Health Regulations (2005)1a to ensure a firm and tested foundation. Such a Treaty should support and focus on strengthening the international health framework and improving cooperation with regard to early detection, prevention, response and resilience to future pandemics. _________________ 1aWorld Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 225 #
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. TIn keeping with "One Health" and "Health in all policies approaches", the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The strengthened Union health framework addressing serious cross-border health threats shall work in synergy with and in a manner that is complementary to other Union policies and funds, such as actions implemented under the ESIF, Horizon Europe, the Digital Europe Programme, rescEU, ESI, ESF+ and SMP.
Amendment 235 #
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 issue, the surveillance of the impact of such diseases on non- communicable diseases and of related special health issues, such as mental health impacts of the crisis and the impact of deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions.
Amendment 281 #
Proposal for a regulation
Chapter II – title
Chapter II – title
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 293 #
Proposal for a regulation
Article 5 – paragraph 3 – point b a (new)
Article 5 – paragraph 3 – point b a (new)
(b a) the mapping of the strategic production capacities for the Union as a whole;
Amendment 295 #
Proposal for a regulation
Article 5 – paragraph 3 – point c a (new)
Article 5 – paragraph 3 – point c a (new)
(c a) the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during health emergencies;
Amendment 308 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Union preparedness and response plan shall include cross-border and interregional preparedness elementplans to establish coherent, multi-sectoral, cross- border public health measures, in particular considering capacities for testing, contact tracing, laboratories, training of healthcare staff and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks.
Amendment 330 #
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, where appropriate, regional and cross-border levels.
Amendment 341 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
(i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery at national and, where relevant, regional and cross-border levels; coordination mechanisms;
Amendment 348 #
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 serviceinformation relevant for the internal market and Union strategic reserves of medical products, including national stockpiles and capacities to contribute to the security of supply of critical medical products at Union level; equal access to diagnostic services and tools and medical products during emergencies; the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 359 #
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 and essential supplies for health; a reserve of critical medical products at Member State level; and dedicated, trained and equipped human resources for emergencies; and
Amendment 363 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
(iii a) pandemic stockpile/strategic stockpile: each State shall provide information on the number and availability of medical countermeasures and other essential medicines and medical devices for the control of the threats set out in Article2(1), as well as the capacity for their safekeeping and storage. In order to have a greater response capacity, storage shall be carried out in the premises and centres closest and most accessible to the population centres, which meet the necessary requirements to provide the service in accordance with the regulations applicable to medicinal products, medical devices and other medical countermeasures.
Amendment 364 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c
Article 7 – paragraph 1 – subparagraph 1 – point c
(c) implementation of national response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health impacts, the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and other specific issues.
Amendment 369 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
Amendment 396 #
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1 a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions.
Amendment 420 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned. In cross-border regions, mandatory joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be organised.
Amendment 433 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 452 #
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(d a) Joint procurement shall be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments shall be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 456 #
Proposal for a regulation
Article 12 – paragraph 2 – point d b (new)
Article 12 – paragraph 2 – point d b (new)
Amendment 472 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3 a. The Union shall strive to also support access to counter-measures for Eastern Partnership and low- and middle- income countries.
Amendment 478 #
Proposal for a regulation
Article 13 – paragraph 2 – point b a (new)
Article 13 – paragraph 2 – point b a (new)
(b a) monitor the impact of communicable diseases on the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 479 #
Proposal for a regulation
Article 13 – paragraph 2 – point b b (new)
Article 13 – paragraph 2 – point b b (new)
(b b) monitor the impact of communicable diseases on mental health;
Amendment 482 #
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, hospitalisation and mortality, the mental health impact and deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 486 #
Proposal for a regulation
Article 13 – paragraph 2 – point h a (new)
Article 13 – paragraph 2 – point h a (new)
(h a) identify any weakness in the global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of communicable diseases;
Amendment 494 #
Proposal for a regulation
Article 13 – paragraph 3 – point f a (new)
Article 13 – paragraph 3 – point f a (new)
(f a) information on the availability of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of the disease.
Amendment 504 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 565 #
Proposal for a regulation
Article 19 – paragraph 3 – point i a (new)
Article 19 – paragraph 3 – point i a (new)
(i a) the existing and potential production sites, with the sole aim of allowing the Union to map the strategic production capacities for the Union as a whole;
Amendment 566 #
Proposal for a regulation
Article 19 – paragraph 3 – point j
Article 19 – paragraph 3 – point j
(j) requests and offers for cross-border emergency assistance; , such as the medical transfer of patients or provision of healthcare staff by one Member State to another, in particular in cross-border areas in neighbouring regions;
Amendment 581 #
Proposal for a regulation
Article 21 – paragraph 1 – point b
Article 21 – paragraph 1 – point b
(b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals. In addition, the Commission shall broaden its communication activity to cover the general public by establishing and managing a portal to share verified information and fight against disinformation;
Amendment 593 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
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 relevant regional authorities and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions.
Amendment 613 #
(ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, non- pharmaceutical countermeasures, global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow-up of the disease concerned and public health research needs;
Amendment 619 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts and representatives of health and care workers, 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 sanitary, biomedical, behavioural, social, economic, cultural and international aspects. 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 625 #
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. All members of the Advisory Committee shall provide declarations of interest in line with the applicable rules in each case.
Amendment 633 #
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) mechanisms to monitor shortages of, develop, procure, ensure security of supply, manage and deploy medical countermeasures;
Amendment 634 #
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(c a) A Union export control mechanism with the aim of enabling the Union to guarantee timely and effective access to counter-measures.
Amendment 637 #
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, using contact tracing applications, in full compliance with the Regulation (EU) 20176/679 ('GDPR').