20.5.2022 |
EN |
Official Journal of the European Union |
C 205/64 |
P9_TA(2021)0449
Serious cross-border threats to health ***I
Amendments adopted by the European Parliament on 14 September and 11 November 2021 on the proposal for a regulation of the European Parliament and of the Council on serious cross-border threats to health repealing Decision No 1082/2013/EU (COM(2020)0727 — C9-0367/2020 — 2020/0322(COD)) (1)
(Ordinary legislative procedure: first reading)
(2022/C 205/12)
Amendment 1
Proposal for a regulation
Recital 1 a (new)
Text proposed by the Commission |
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Amendments 2 and 244
Proposal for a regulation
Recital 2
Text proposed by the Commission |
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Amendment 245
Proposal for a regulation
Recital 2 a (new)
Text proposed by the Commission |
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Amendment 246
Proposal for a regulation
Recital 2 b (new)
Text proposed by the Commission |
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Amendment 3
Proposal for a regulation
Recital 3
Text proposed by the Commission |
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Amendment 247
Proposal for a regulation
Recital 3 a (new)
Text proposed by the Commission |
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Amendment 4
Proposal for a regulation
Recital 4 a (new)
Text proposed by the Commission |
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Amendment 5
Proposal for a regulation
Recital 5
Text proposed by the Commission |
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Amendment 242
Proposal for a regulation
Recital 5 a (new)
Text proposed by the Commission |
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Amendment 6
Proposal for a regulation
Recital 6
Text proposed by the Commission |
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Amendment 7
Proposal for a regulation
Recital 7
Text proposed by the Commission |
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Amendment 8
Proposal for a regulation
Recital 8
Text proposed by the Commission |
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Amendment 9
Proposal for a regulation
Recital 8 a (new)
Text proposed by the Commission |
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Amendment 10
Proposal for a regulation
Recital 8 b (new)
Text proposed by the Commission |
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Amendment 11
Proposal for a regulation
Recital 8 c (new)
Text proposed by the Commission |
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Amendments 12 and 248
Proposal for a regulation
Recital 8 d (new)
Text proposed by the Commission |
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Amendment 13
Proposal for a regulation
Recital 8 e (new)
Text proposed by the Commission |
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Amendment 14
Proposal for a regulation
Recital 8 f (new)
Text proposed by the Commission |
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Amendments 15 and 249
Proposal for a regulation
Recital 9
Text proposed by the Commission |
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Amendment 16
Proposal for a regulation
Recital 9 a (new)
Text proposed by the Commission |
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Amendment 17
Proposal for a regulation
Recital 9 b (new)
Text proposed by the Commission |
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Amendment 18
Proposal for a regulation
Recital 9 c (new)
Text proposed by the Commission |
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Amendment 19
Proposal for a regulation
Recital 9 d (new)
Text proposed by the Commission |
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Amendment 20
Proposal for a regulation
Recital 9 e (new)
Text proposed by the Commission |
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Amendment 21
Proposal for a regulation
Recital 9 f (new)
Text proposed by the Commission |
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Amendment 22
Proposal for a regulation
Recital 9 g (new)
Text proposed by the Commission |
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Amendment 23
Proposal for a regulation
Recital 9 h (new)
Text proposed by the Commission |
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Amendment 24
Proposal for a regulation
Recital 10
Text proposed by the Commission |
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Amendments 25 and 250
Proposal for a regulation
Recital 11
Text proposed by the Commission |
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Amendment 26
Proposal for a regulation
Recital 12
Text proposed by the Commission |
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Amendments 27 and 251
Proposal for a regulation
Recital 12 a (new)
Text proposed by the Commission |
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Amendment 28
Proposal for a regulation
Recital 13
Text proposed by the Commission |
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Amendment 29
Proposal for a regulation
Recital 14
Text proposed by the Commission |
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Amendments 30 and 252
Proposal for a regulation
Recital 14 a (new)
Text proposed by the Commission |
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Amendment 31
Proposal for a regulation
Recital 14 b (new)
Text proposed by the Commission |
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Amendment 32
Proposal for a regulation
Recital 15 a (new)
Text proposed by the Commission |
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Amendment 33
Proposal for a regulation
Recital 16 a (new)
Text proposed by the Commission |
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Amendment 34
Proposal for a regulation
Recital 17
Text proposed by the Commission |
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Amendments 35 and 253
Proposal for a regulation
Recital 18
Text proposed by the Commission |
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Amendment 36
Proposal for a regulation
Recital 20
Text proposed by the Commission |
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Amendment 37
Proposal for a regulation
Recital 21
Text proposed by the Commission |
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Amendment 38
Proposal for a regulation
Recital 22
Text proposed by the Commission |
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Amendment 39
Proposal for a regulation
Recital 25
Text proposed by the Commission |
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Amendment 40
Proposal for a regulation
Recital 28
Text proposed by the Commission |
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Amendment 41
Proposal for a regulation
Recital 28 a (new)
Text proposed by the Commission |
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Amendment 42
Proposal for a regulation
Article 1 — paragraph 1 — point c
Text proposed by the Commission |
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Amendment 254
Proposal for a regulation
Article 1 — paragraph 1 — point c a (new)
Text proposed by the Commission |
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Amendment 43
Proposal for a regulation
Article 1 — paragraph 2 — point b a (new)
Text proposed by the Commission |
Amendment |
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Amendment 44
Proposal for a regulation
Article 1 — paragraph 3
Text proposed by the Commission |
Amendment |
3. The implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. |
3. In keeping with the ‘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 EU4Health programme, the European Structural and Investment Funds (ESIF), Horizon Europe, the Digital Europe Programme, rescEU reserve, the European Social Fund Plus (ESF+), the Emergency Support Instrument (ESI) and the Single Market Programme (SMP). |
Amendment 45
Proposal for a regulation
Article 1 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
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3a. This Regulation shall ensure that in future health emergencies, the detection of, health interventions concerning and treatment of other serious diseases are not halted. |
Amendment 46
Proposal for a regulation
Article 1 — paragraph 3 b (new)
Text proposed by the Commission |
Amendment |
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3b. This Regulation shall be implemented with full respect for the dignity and fundamental rights and freedoms of persons. |
Amendment 243
Proposal for a regulation
Article 2 — paragraph 1 — point a — point i
Text proposed by the Commission |
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Amendment 47
Proposal for a regulation
Article 2 — paragraph 2
Text proposed by the Commission |
Amendment |
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues. |
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases , the monitoring of the impact of such diseases on major non-communicable diseases and on related special health issues , such as mental health, and the impact on deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions . |
Amendment 48
Proposal for a regulation
Article 2 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
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3a. This Regulation shall promote the implementation of the International Health Regulations, reduce administrative burden and duplication of resources, and strengthen the gaps exposed during the COVID-19 pandemic in the prevention of, preparedness for and response to public health threats. |
Amendment 49
Proposal for a regulation
Article 2 — paragraph 4
Text proposed by the Commission |
Amendment |
4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health. |
4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), especially in relation to major non-communicable diseases, if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health. |
Amendment 50
Proposal for a regulation
Article 2 — paragraph 5
Text proposed by the Commission |
Amendment |
5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. |
5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. |
Amendment 51
Proposal for a regulation
Article 2 — paragraph 6
Text proposed by the Commission |
Amendment |
6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation. |
6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation. The Union shall call for the establishment of a WHO framework convention on pandemic preparedness and response. That convention shall be such as to facilitate the implementation of the International Health Regulation (2005) (1a) and resolve the weaknesses of that Regulation, identified during the COVID-19 crisis. |
Amendment 52
Proposal for a regulation
Article 2 — paragraph 6 a (new)
Text proposed by the Commission |
Amendment |
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6a. This Regulation shall also apply, where appropriate, to regional competent authorities, systems and programmes in the fields covered by this Regulation. |
Amendment 255
Proposal for a regulation
Article 3 — paragraph 1 — point - 1 (new)
Text proposed by the Commission |
Amendment |
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Amendment 53
Proposal for a regulation
Article 3 — paragraph 1 — point 3
Text proposed by the Commission |
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Amendment 54
Proposal for a regulation
Article 3 — paragraph 1 — point 4
Text proposed by the Commission |
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Amendment 55
Proposal for a regulation
Article 3 — paragraph 1 — point 5 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 56
Proposal for a regulation
Article 3 — paragraph 1 — point 5 b (new)
Text proposed by the Commission |
Amendment |
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Amendment 57
Proposal for a regulation
Article 3 — paragraph 1 — point 7 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 58
Proposal for a regulation
Article 3 — paragraph 1 — point 8
Text proposed by the Commission |
Amendment |
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Amendment 59
Proposal for a regulation
Article 3 — paragraph 1 — point 8 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 60
Proposal for a regulation
Article 3 — paragraph 1 — point 8 b (new)
Text proposed by the Commission |
Amendment |
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Amendment 61
Proposal for a regulation
Article 3 — paragraph 1 — point 8 c (new)
Text proposed by the Commission |
Amendment |
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Amendment 62
Proposal for a regulation
Article 4 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. Representatives of relevant Union agencies shall participate in HSC meetings as observers. |
Amendment 63
Proposal for a regulation
Article 4 — paragraph 2 — point b
Text proposed by the Commission |
Amendment |
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Amendment 64
Proposal for a regulation
Article 4 — paragraph 2 — point c
Text proposed by the Commission |
Amendment |
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Amendment 65
Proposal for a regulation
Article 4 — paragraph 2 — point d a (new)
Text proposed by the Commission |
Amendment |
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Amendment 66
Proposal for a regulation
Article 4 — paragraph 4
Text proposed by the Commission |
Amendment |
4. The HSC shall be chaired by a representative of the Commission. The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State. |
4. The HSC shall be chaired by a representative of the Commission without the right to vote . The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State. |
Amendment 67
Proposal for a regulation
Article 4 — paragraph 5 a (new)
Text proposed by the Commission |
Amendment |
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5a. Members of the HSC and the Commission shall ensure thorough consultation with relevant Union agencies, public health experts, international organisations and stakeholders, including healthcare professionals. |
Amendment 68
Proposal for a regulation
Article 4 — paragraph 7 a (new)
Text proposed by the Commission |
Amendment |
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7a. The European Parliament shall designate representatives to participate in the Health Security Committee (‘HSC’) as observers. |
Amendment 69
Proposal for a regulation
Article 4 — paragraph 7 b (new)
Text proposed by the Commission |
Amendment |
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7b. The list of members of the HSC at both the political and technical levels shall be made public on the Commission and Council websites. Members of the Committee shall have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All direct interests which could relate to the medical or another relevant sector shall be entered in a register held by the Commission and be accessible to the public, upon request. |
Amendment 70
Proposal for a regulation
Article 4 — paragraph 7 c (new)
Text proposed by the Commission |
Amendment |
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7c. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission’s web-portal. |
Amendment 256
Proposal for a regulation
Article 4 — paragraph 7 d (new)
Text proposed by the Commission |
Amendment |
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7d. The HSC shall act in cooperation with the board of HERA established under the Commission decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority, and the Health Crisis Board (HCB) to be established under a Council regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. The coordination between those bodies shall ensure the participation of all relevant stakeholders, including healthcare professionals’ organisations, patients’ associations, and industry and supply chain actors with recognised experience in disciplines related to the HSC, HCB and to the work of the HERA. The provisions related to conflict of interests and transparency, as provided for in paragraphs 7b and 7c, shall apply in relation to this paragraph also. The Commission shall invite a representative of the European Parliament to serve as an active member of the HCB. |
Amendment 71
Proposal for a regulation
Chapter II — title
Text proposed by the Commission |
Amendment |
Amendment 72
Proposal for a regulation
Article 5 — title
Text proposed by the Commission |
Amendment |
Union preparedness and response plan |
Union prevention, preparedness and response plan |
Amendment 73
Proposal for a regulation
Article 5 — paragraph 1
Text proposed by the Commission |
Amendment |
1. The Commission, in cooperation with Member States and the relevant Union agencies, shall establish a Union health crisis and pandemic plan (‘the Union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level. |
1. The Commission, in cooperation with Member States and the relevant Union agencies and taking into account the WHO framework , shall establish a Union health crisis and pandemic plan (‘the Union prevention , preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level. |
Amendment 74
Proposal for a regulation
Article 5 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The Union preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6. |
2. The Union prevention, preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6. |
Amendment 75
Proposal for a regulation
Article 5 — paragraph 3 — introductory part
Text proposed by the Commission |
Amendment |
3. The Union preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for: |
3. The Union prevention, preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for: |
Amendment 257
Proposal for a regulation
Article 5 — paragraph 3 — point a
Text proposed by the Commission |
Amendment |
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Amendment 258
Proposal for a regulation
Article 5 — paragraph 3 — point b
Text proposed by the Commission |
Amendment |
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Amendment 76
Proposal for a regulation
Article 5 — paragraph 3 — point c
Text proposed by the Commission |
Amendment |
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Amendment 77
Proposal for a regulation
Article 5 — paragraph 3 — point e
Text proposed by the Commission |
Amendment |
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Amendment 78
Proposal for a regulation
Article 5 — paragraph 3 — point f a (new)
Text proposed by the Commission |
Amendment |
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Amendment 79
Proposal for a regulation
Article 5 — paragraph 3 — point f b (new)
Text proposed by the Commission |
Amendment |
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Amendment 259
Proposal for a regulation
Article 5 — paragraph 3 — point f c (new)
Text proposed by the Commission |
Amendment |
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Amendment 80
Proposal for a regulation
Article 5 — paragraph 3 — point g a (new)
Text proposed by the Commission |
Amendment |
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Amendment 81
Proposal for a regulation
Article 5 — paragraph 3 — point g b (new)
Text proposed by the Commission |
Amendment |
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Amendment 82
Proposal for a regulation
Article 5 — paragraph 3 — point g c (new)
Text proposed by the Commission |
Amendment |
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Amendment 83
Proposal for a regulation
Article 5 — paragraph 3 — point g d (new)
Text proposed by the Commission |
Amendment |
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Amendment 84
Proposal for a regulation
Article 5 — paragraph 3 — point g e (new)
Text proposed by the Commission |
Amendment |
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Amendment 85
Proposal for a regulation
Article 5 — paragraph 4
Text proposed by the Commission |
Amendment |
4. The Union preparedness and response plan shall include interregional preparedness elements to establish coherent, multi-sectoral, cross-border public health measures, in particular considering capacities for testing, contact tracing, laboratories, 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. |
4. The Union prevention, preparedness and response plan shall include cross-border and interregional preparedness plans 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 86
Proposal for a regulation
Article 5 — paragraph 4 a (new)
Text proposed by the Commission |
Amendment |
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4a. The Union preparedness and response plan shall also provide for measures to ensure that the single market functions normally in the event serious cross-border threats to health arise. |
Amendment 87
Proposal for a regulation
Article 5 — paragraph 5
Text proposed by the Commission |
Amendment |
5. In order to ensure the operation of the Union preparedness and response plan, the Commission shall conduct stress tests, exercises and in-action and after-action reviews with Member States, and update the plan as necessary. |
5. In order to ensure the operation of the Union prevention, preparedness and response plan, the Commission shall conduct stress tests, exercises and in-action and after-action reviews with Member States, and update the plan as necessary. The prevention, preparedness and response plan shall take into account health systems data and relevant data to be collected at national or regional level. |
Amendment 88
Proposal for a regulation
Article 5 — paragraph 5 a (new)
Text proposed by the Commission |
Amendment |
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5a. In order to respond to public health emergencies, the European Commission may issue recommendations, based on Union health systems data, on the minimum resources needed, in relation, among other things, to each Member State’s population, for the provision of baseline universal health coverage of adequate quality, including on the option of pooling resources at Union level. |
Amendment 89
Proposal for a regulation
Article 5 — paragraph 5 b (new)
Text proposed by the Commission |
Amendment |
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5b. The reviews and any subsequent adjustments to the plan shall be published to increase the transparency of the process of prevention, preparedness and response planning. |
Amendment 90
Proposal for a regulation
Article 6 — title
Text proposed by the Commission |
Amendment |
National preparedness and response plans |
National prevention, preparedness and response plans |
Amendments 91 and 260
Proposal for a regulation
Article 6 — paragraph 1
Text proposed by the Commission |
Amendment |
1. When preparing national preparedness and response plans each Member State 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 plan. |
1. When preparing national prevention, preparedness and response plans each Member State shall consult patients’ organisations, healthcare professionals’ organisations, industry and supply chain stakeholders, and national social partners, coordinate with the Commission , in particular with the HERA, in order to reach consistency with the Union prevention, preparedness and response plan, which shall be in accordance with arrangements for governance, capacities and resources referred to in Article 5(3), including with regard to national stockpiling requirements and the management of Union strategic reserves, and inform without delay the Commission , the HCB and the HSC of any substantial revision of the national plan. |
Amendment 92
Proposal for a regulation
Article 6 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. National prevention, preparedness and response plans shall include arrangements for governance and information on capacities and resources referred to in Article 5(3). |
Amendment 93
Proposal for a regulation
Article 7 — title
Text proposed by the Commission |
Amendment |
Reporting on preparedness and response planning |
Reporting on prevention, preparedness and response planning |
Amendments 94 and 261
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 1
Text proposed by the Commission |
Amendment |
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 level. |
1. Member States shall within 6 months of the entry into force of this regulation and every 2 years thereafter provide the Commission and relevant Union agencies and bodies with an updated report on their prevention, preparedness and response planning and implementation at national level and, where appropriate, regional and cross-border levels . |
Amendment 95
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — introductory part
Text proposed by the Commission |
Amendment |
That report shall cover the following: |
That report shall be succinct, based on common indicators, give an overview of the actions implemented in the Member States, and shall cover the following: |
Amendment 96
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point a
Text proposed by the Commission |
Amendment |
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Amendment 97
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point a a (new)
Text proposed by the Commission |
Amendment |
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Amendment 98
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point a b (new)
Text proposed by the Commission |
Amendment |
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Amendment 99
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point b
Text proposed by the Commission |
Amendment |
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Amendment 100
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point b — point i
Text proposed by the Commission |
Amendment |
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Amendment 101
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point b — point ii
Text proposed by the Commission |
Amendment |
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Amendment 102
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point b — point iii
Text proposed by the Commission |
Amendment |
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Amendment 103
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point b — point iii a (new)
Text proposed by the Commission |
Amendment |
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Amendment 104
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point c a (new)
Text proposed by the Commission |
Amendment |
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Amendment 105
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 2 — point c b (new)
Text proposed by the Commission |
Amendment |
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Amendment 106
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 3
Text proposed by the Commission |
Amendment |
The report shall include , whenever relevant , interregional preparedness and response elements in line with the Union and national plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions . |
For Member States sharing a land border with at least one other Member State, the report shall include cross-border , interregional and intersectoral prevention, preparedness and response plans with neighbouring regions including coordination mechanisms for all elements listed in points (a), (b) and (c), cross-border training and sharing of best practices for healthcare staff and public health staff and coordination mechanisms for the medical transfer of patients . Union or national entities that are engaged in stockpiling of medical products shall engage with the Commission and Member States in reporting of stocks that are available and taken into account in both Union and national preparedness and response planning. |
Amendment 107
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 3 a (new)
Text proposed by the Commission |
Amendment |
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The report shall also include, as far as feasible, information on the impact of communicable diseases on major non-communicable diseases. |
Amendment 108
Proposal for a regulation
Article 7 — paragraph 1 — subparagraph 3 b (new)
Text proposed by the Commission |
Amendment |
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The latest available version of the prevention, preparedness and response plans shall be attached to the report. |
Amendment 262
Proposal for a regulation
Article 7 — paragraph 2 — subparagraph 1
Text proposed by the Commission |
Amendment |
2. The Commission shall make the information received in accordance with paragraph 1 available to the HSC in a report prepared in cooperation with the ECDC and other relevant Union agencies and bodies every 2 years. |
2. The Commission shall make the information received in accordance with paragraph 1 available to the HSC in a report prepared in cooperation with the ECDC and other relevant Union agencies and bodies every 2 years. For the purpose of drawing up the report, the HERA shall assess the availability of crisis-relevant medical countermeasures, the production capacity for and the existing stockpiles of such countermeasures and the risk of disruption in supply chains in the framework of the national preparedness and response planning, taking into account information obtained pursuant to Regulation (EU) …/… [OJ: Please insert the number of the Regulation on EMA [ISC/2020/12532]] and in particular Articles XX [Article numbers to be confirmed after adoption] thereof, concerning the monitoring and mitigation of shortages of critical medicinal products, medical devices and in vitro diagnostic medical devices. |
Amendment 109
Proposal for a regulation
Article 7 — paragraph 2 — subparagraph 4
Text proposed by the Commission |
Amendment |
The recommendations of the report shall be published on at the website of the Commission. |
The recommendations of the report shall be published on the websites of the Commission and the ECDC . |
Amendment 110
Proposal for a regulation
Article 8 — title
Text proposed by the Commission |
Amendment |
Auditing on preparedness and response planning |
Auditing on prevention, preparedness and response planning |
Amendment 111
Proposal for a regulation
Article 8 — paragraph 1
Text proposed by the Commission |
Amendment |
1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national 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). |
1. Every 2 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence with the Union plan. Such audits shall be based on a set of indicators and implemented in cooperation with the relevant Union agencies, aiming at the assessment of prevention, preparedness and response planning at national level with regard to the information referred to in Article 7(1).. |
Amendment 112
Proposal for a regulation
Article 8 — paragraph 2 — subparagraph 1
Text proposed by the Commission |
Amendment |
2. Member States shall present an action plan addressing the proposed recommendations of the audit and the corresponding corrective actions and milestones. |
2. In the event the audit identifies deficiencies, the Member State shall , within six months of receipt of its conclusions, present an action plan addressing the proposed recommendations of the audit and setting out the corresponding corrective actions and milestones. |
Amendment 113
Proposal for a regulation
Article 8 — paragraph 2 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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If a Member State decides not to follow a recommendation, it shall state its reasons for doing so. |
Amendment 114
Proposal for a regulation
Article 9 — title
Text proposed by the Commission |
Amendment |
Commission report on preparedness planning |
Commission report on prevention, preparedness planning |
Amendment 115
Proposal for a regulation
Article 9 — paragraph 1
Text proposed by the Commission |
Amendment |
1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the audits referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on preparedness and response planning at Union level. |
1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the audits referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on prevention, preparedness and response planning at Union level. |
Amendment 116
Proposal for a regulation
Article 9 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions. |
Amendment 117
Proposal for a regulation
Article 9 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The Commission may adopt recommendations on preparedness and response planning addressed to Member States based on the report referred to in paragraph 1. |
2. The Commission may adopt recommendations on prevention, preparedness and response planning addressed to Member States based on the report referred to in paragraph 1. Those recommendations may cover, inter alia, the minimum resources needed to respond to public health emergencies in relation to, among other things, population size, and they shall be developed on the basis of good practice and policy assessments. |
Amendment 118
Proposal for a regulation
Article 10 — title
Text proposed by the Commission |
Amendment |
Coordination of preparedness and response planning in the HSC |
Coordination of prevention, preparedness and response planning in the HSC |
Amendments 119 and 263
Proposal for a regulation
Article 10 — paragraph 1 — subparagraph 1
Text proposed by the Commission |
Amendment |
1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health. |
1. The Commission , relevant Union agencies and bodies, including the HERA, and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, prevention, early warning and assessment of, and response to serious cross-border threats to health. |
Amendment 120
Proposal for a regulation
Article 10 — paragraph 1 — subparagraph 2 — point a
Text proposed by the Commission |
Amendment |
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Amendment 121
Proposal for a regulation
Article 10 — paragraph 1 — subparagraph 2 — point b
Text proposed by the Commission |
Amendment |
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Amendment 122
Proposal for a regulation
Article 10 — paragraph 1 — subparagraph 2 — point e
Text proposed by the Commission |
Amendment |
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Amendment 123
Proposal for a regulation
Article 10 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. The Commission and the Member States shall, where appropriate, conduct a dialogue with stakeholders, including health and care workers’ organisations, industry and supply chain stakeholders, and patient and consumer organisations. That dialogue shall include regular exchanges of information between authorities, industry and relevant actors in the pharmaceutical supply chain to identify expected supply constraints so as to allow better coordination, development of synergies and appropriate responses. |
Amendment 124
Proposal for a regulation
Article 11 — paragraph 1 — subparagraph 1
Text proposed by the Commission |
Amendment |
1. The Commission may organise training activities for healthcare staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations. |
1. The Commission may organise training activities , supported by the relevant Union agencies, in close cooperation with medical associations and patient organisations, for healthcare staff, social service staff and public health staff in the Member States in particular interdisciplinary One Health training , including preparedness capacities under the International Health Regulations. |
Amendment 125
Proposal for a regulation
Article 11 — paragraph 1 — subparagraph 2
Text proposed by the Commission |
Amendment |
The Commission shall organise those activities in cooperation with the Member States concerned. |
The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned, and in coordination, where possible, with the WHO to avoid duplication of activities, including preparedness capacities under the International Health Regulations . |
Amendment 126
Proposal for a regulation
Article 11 — paragraph 1 — subparagraph 2 a (new)
Text proposed by the Commission |
Amendment |
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In cross-border regions, joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be promoted and familiarity with public health systems shall be mandatory. |
Amendment 127
Proposal for a regulation
Article 11 — paragraph 1 — subparagraph 2 b (new)
Text proposed by the Commission |
Amendment |
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The Commission shall use the fullest potential of distance learning to broaden the number of trainees. |
Amendment 128
Proposal for a regulation
Article 11 — paragraph 2
Text proposed by the Commission |
Amendment |
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 preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools. |
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 preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools , ensure the continuity of critical long-term healthcare services and be consistent with the One Health approach . |
Amendment 129
Proposal for a regulation
Article 11 — paragraph 3
Text proposed by the Commission |
Amendment |
3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union. |
3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union in coordination, where possible, with ECDC activities in this area . |
Amendment 130
Proposal for a regulation
Article 11 — paragraph 5
Text proposed by the Commission |
Amendment |
5. The Commission may support organising programmes, in cooperation with the Member States, for the exchange of healthcare staff and public health staff between two or more Member States and for the temporary secondment of staff from one Member State to the other. |
5. The Commission may support organising programmes, in cooperation with the Member States, for the exchange of healthcare staff and public health staff between two or more Member States and for the temporary secondment of staff from one Member State to the other. In organising those programmes, account shall be taken of the contribution made by professional health organisations in each of the Member States. |
Amendments 131 and 264
Proposal for a regulation
Article 12 — paragraph 1
Text proposed by the Commission |
Amendment |
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 Council (29) with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. |
1. The Commission , in particular with the HERA, and any Member States may engage in a joint procurement procedure as contracting parties conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (29) with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame . |
Amendment 132
Proposal for a regulation
Article 12 — paragraph 2 — point a
Text proposed by the Commission |
Amendment |
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Amendment 133
Proposal for a regulation
Article 12 — paragraph 2 — point c
Text proposed by the Commission |
Amendment |
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Amendment 134
Proposal for a regulation
Article 12 — paragraph 2 — point c a (new)
Text proposed by the Commission |
Amendment |
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Amendment 135
Proposal for a regulation
Article 12 — paragraph 2 — point c b (new)
Text proposed by the Commission |
Amendment |
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Amendment 136
Proposal for a regulation
Article 12 — paragraph 2 — point c c (new)
Text proposed by the Commission |
Amendment |
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Amendment 137
Proposal for a regulation
Article 12 — paragraph 2 — point c d (new)
Text proposed by the Commission |
Amendment |
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Amendment 265
Proposal for a regulation
Article 12 — paragraph 2 — point e a (new)
Text proposed by the Commission |
Amendment |
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Amendment 266
Proposal for a regulation
Article 12 — paragraph 2 — point e b (new)
Text proposed by the Commission |
Amendment |
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Amendment 138
Proposal for a regulation
Article 12 — paragraph 3 — introductory part
Text proposed by the Commission |
Amendment |
3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing any action, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under: |
3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing and participating in any action, including, but not limited to joint procurement procedures, development, stockpiling in facilities that meet the specific legal requirements for the storage of medical countermeasures and having the greatest proximity to and accessibility for the greatest number of population centres, without compromising the accessibility of those products for people in remote, rural and outermost regions, distribution and donation of medical countermeasures , which shall be of benefit to low- and middle-income countries, under different mechanisms established at Union level, in particular under: |
Amendment 139
Proposal for a regulation
Article 12 — paragraph 3 — point a
Text proposed by the Commission |
Amendment |
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Amendments 140 and 267
Proposal for a regulation
Article 12 — paragraph 3 — point f
Text proposed by the Commission |
Amendment |
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Amendment 141
Proposal for a regulation
Article 12 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
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3a. Participating countries shall ensure that there is adequate stockpiling and distribution of procured medical countermeasures. The main details and characteristics of that stockpiling and distribution shall be set out in national plans. |
Amendment 142
Proposal for a regulation
Article 12 — paragraph 3 b (new)
Text proposed by the Commission |
Amendment |
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3b. In accordance with the principle of transparency, the Commission shall regularly inform the European Parliament about negotiations concerning the joint procurement of medical countermeasures. |
Amendment 143
Proposal for a regulation
Article 12 — paragraph 3 c (new)
Text proposed by the Commission |
Amendment |
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3c. The European Parliament reserves at all times the right to scrutinize, under existing confidentiality rules, the uncensored content of all contracts concluded in proceedings under this Article. |
Amendment 144
Proposal for a regulation
Article 12 — paragraph 3 d (new)
Text proposed by the Commission |
Amendment |
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3d. The Commission and Member States shall provide up-to-date, accessible and clear information to consumers on their rights and duties regarding jointly procured medical countermeasures, including details on liability for damages, and access to legal protection and to consumer representation. |
Amendment 145
Proposal for a regulation
Article 12 — paragraph 3 e (new)
Text proposed by the Commission |
Amendment |
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3e. Where the joint procurement procedure for medical countermeasures to cross-border threats to health is not applied, the Commission shall encourage Member States to exchange information on pricing and delivery dates for medical countermeasures. |
Amendments 146 and 268
Proposal for a regulation
Article 13 — paragraph 1
Text proposed by the Commission |
Amendment |
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, and the competent authorities responsible at national level for epidemiological surveillance. |
1. The network for the epidemiological surveillance of the communicable diseases , including communicable diseases of zoonotic origin, 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, in particular the HERA, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance. |
Amendment 147
Proposal for a regulation
Article 13 — paragraph 2 — point b a (new)
Text proposed by the Commission |
Amendment |
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Amendment 148
Proposal for a regulation
Article 13 — paragraph 2 — point b b (new)
Text proposed by the Commission |
Amendment |
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Amendment 149
Proposal for a regulation
Article 13 — paragraph 2 — point d
Text proposed by the Commission |
Amendment |
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Amendment 150
Proposal for a regulation
Article 13 — paragraph 2 — point e
Text proposed by the Commission |
Amendment |
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Amendment 151
Proposal for a regulation
Article 13 — paragraph 2 — point h a (new)
Text proposed by the Commission |
Amendment |
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Amendment 152
Proposal for a regulation
Article 13 — paragraph 3 — point f a (new)
Text proposed by the Commission |
Amendment |
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Amendment 153
Proposal for a regulation
Article 13 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
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3a. The information communicated by Member States referred to in point (a) of paragraph 3 shall be reported at least at NUTS II level to the European Surveillance System (TESSy) or another platform, on a timely basis determined in accordance with Article 7. |
Amendment 154
Proposal for a regulation
Article 13 — paragraph 6 — subparagraph 2 a (new)
Text proposed by the Commission |
Amendment |
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The ECDC shall support the Member States to ensure the collection and sharing of data in times of health crisis and the integrated operation of the network for the epidemiological surveillance of communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1). The ECDC shall, where appropriate, also make available its expertise in that domain to third countries. |
Amendment 155
Proposal for a regulation
Article 13 — paragraph 9 — subparagraph 1 — introductory part
Text proposed by the Commission |
Amendment |
9. The Commission shall , by means of implementing acts, establish and update: |
9. The Commission shall adopt delegated acts in accordance with Article 28 concerning the establishment and update of : |
Amendment 156
Proposal for a regulation
Article 13 — paragraph 9 — subparagraph 1 — point c
Text proposed by the Commission |
Amendment |
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deleted |
Amendment 157
Proposal for a regulation
Article 13 — paragraph 9 a (new)
Text proposed by the Commission |
Amendment |
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9a. Where duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between Member States so require, the procedure provided for in Article 28a shall apply to delegated acts adopted pursuant to this Article. |
Amendment 158
Proposal for a regulation
Article 13 — paragraph 9 b (new)
Text proposed by the Commission |
Amendment |
|
9b. The Commission shall, by means of implementing acts, establish and update procedures for the operation of the epidemiological surveillance network developed pursuant to Article 5 of Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/12527]]. |
Amendment 159
Proposal for a regulation
Article 13 — paragraph 10
Text proposed by the Commission |
Amendment |
10. On duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread among the Member States, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 27(3) for the adoption of case definitions, procedures and indicators for surveillance in Member States in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1). The indicators mentioned above shall also support the assessment of capacity for diagnosis, prevention and treatment. |
10. On duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread among the Member States, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 27(3) for the adoption procedures for surveillance in Member States in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1). |
Amendment 160
Proposal for a regulation
Article 14 — paragraph 1
Text proposed by the Commission |
Amendment |
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. |
1. The ECDC shall ensure the continued development of the digital platform after having conducted a data protection impact assessment and having mitigated any risks to the rights and freedoms of the data subjects, 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. It shall ensure there is human oversight of the digital platform and include specific measures for minimising risks that may emerge from the transfer of biases or incomplete data from multiple sources, as well as establish procedures for data quality review. Digital platforms and applications supporting epidemiological surveillance at Union and Member State level shall be implemented in compliance with the principle of data protection by design pursuant to Article 27(1) of Regulation (EU) 2018/1725. |
Amendment 161
Proposal for a regulation
Article 14 — paragraph 2 — point a
Text proposed by the Commission |
Amendment |
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Amendment 162
Proposal for a regulation
Article 14 — paragraph 2 — point b
Text proposed by the Commission |
Amendment |
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Amendment 163
Proposal for a regulation
Article 14 — paragraph 2 — point b a (new)
Text proposed by the Commission |
Amendment |
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Amendment 164
Proposal for a regulation
Article 14 — paragraph 3
Text proposed by the Commission |
Amendment |
3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and complete information, data and documents transmitted and exchanged through the digital platform. |
3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely, complete and accurate information, data and documents transmitted and exchanged through the digital platform. The Member States shall promote the automation of this process between the national and the Union surveillance system. |
Amendment 165
Proposal for a regulation
Article 14 — paragraph 5
Text proposed by the Commission |
Amendment |
5. For epidemiological purposes, ECDC shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research, policy making and regulatory purposes. |
5. For epidemiological surveillance purposes, ECDC shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research, policy making and regulatory purposes. The access to the health data shall be proportionate to specific and concrete purposes that shall have been defined previously by ECDC. |
Amendment 166
Proposal for a regulation
Article 14 — paragraph 6 — introductory part
Text proposed by the Commission |
Amendment |
6. The Commission shall adopt implementing acts for the functioning of the surveillance platform which lay down: |
6. The Commission, following the carrying out of a consultation procedure as set out in Article 42(2) of Regulation (EU) 2018/1725, shall adopt delegated acts in accordance with Article 28 concerning the functioning of the surveillance platform laying down: |
Amendment 167
Proposal for a regulation
Article 14 — paragraph 6 — point a
Text proposed by the Commission |
Amendment |
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Amendment 168
Proposal for a regulation
Article 14 — paragraph 6 — point c
Text proposed by the Commission |
Amendment |
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Amendment 169
Proposal for a regulation
Article 14 — paragraph 6 — point d
Text proposed by the Commission |
Amendment |
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Amendment 170
Proposal for a regulation
Article 14 — paragraph 6 — point f a (new)
Text proposed by the Commission |
Amendment |
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Amendment 171
Proposal for a regulation
Article 14 — paragraph 6 a (new)
Text proposed by the Commission |
Amendment |
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6a. Digital platforms and applications supporting epidemiological surveillance at Union and Member State level shall be implemented in compliance with the principle of data protection by design pursuant to Article 27(1) of Regulation (EU) 2018/1725. |
Amendment 172
Proposal for a regulation
Article 15 — paragraph 1
Text proposed by the Commission |
Amendment |
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 plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national 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. |
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 plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national reference laboratories to promote good practice and alignment by Member States on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States. |
Amendment 173
Proposal for a regulation
Article 15 — paragraph 2 — point f
Text proposed by the Commission |
Amendment |
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Amendment 174
Proposal for a regulation
Article 15 — paragraph 3
Text proposed by the Commission |
Amendment |
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC. |
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC, in cooperation with WHO network laboratories to avoid duplication of activities. The governance structure of the network shall cover cooperation and coordination with existing national and regional reference laboratories and networks . |
Amendment 175
Proposal for a regulation
Article 15 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
|
3a. The laboratories referred to in paragraph 1 shall contribute to sharing good practices and to improving the epidemiological surveillance referred to in Article 13. |
Amendment 176
Proposal for a regulation
Article 15 — paragraph 4
Text proposed by the Commission |
Amendment |
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. |
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. The Commission shall consult the Member States and the ECDC to elaborate the terms of reference and the criteria of the designation process. Designations shall establish the responsibilities and tasks of the designated laboratories. Laboratory consortia shall be eligible for designation. |
Amendment 177
Proposal for a regulation
Article 15 — paragraph 5 — point a
Text proposed by the Commission |
Amendment |
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Amendment 178
Proposal for a regulation
Article 17 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. The European Surveillance System (TESSy) shall be used for ad hoc monitoring of a serious cross-border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) and (d) of Article 2(1). |
Amendment 179
Proposal for a regulation
Article 17 — paragraph 3 — subparagraph 1
Text proposed by the Commission |
Amendment |
The Commission shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data. |
The Commission shall adopt, where necessary, delegated acts in accordance with Article 28 concerning the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data. |
Amendment 180
Proposal for a regulation
Article 17 — paragraph 3 — subparagraph 2
Text proposed by the Commission |
Amendment |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). |
deleted |
Amendment 181
Proposal for a regulation
Article 17 — paragraph 3 — subparagraph 3
Text proposed by the Commission |
Amendment |
On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may adopt or update the case definitions referred to in the first subparagraph through immediately applicable implementing acts in accordance with the procedure referred to in Article 27(3). |
Where duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States so require, the procedure provided for in Article 28a shall apply to delegated acts adopted pursuant to this Article. |
Amendment 182
Proposal for a regulation
Article 18 — paragraph 1
Text proposed by the Commission |
Amendment |
1. The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health. |
1. The EWRS shall enable the Commission , the ECDC, and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health. |
Amendment 183
Proposal for a regulation
Article 18 — paragraph 2 — subparagraph 1 — introductory part
Text proposed by the Commission |
Amendment |
The management and use of the EWRS involve the exchange of personal data in specific cases where the relevant legal instruments so provide. This includes: |
The management and operational use of the EWRS involve the exchange of personal data in specific cases where the relevant legal instruments so provide. This includes: |
Amendment 184
Proposal for a regulation
Article 18 — paragraph 2 — subparagraph 2
Text proposed by the Commission |
Amendment |
The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications, artificial intelligence models, space enabled applications, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States. |
The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications, artificial intelligence models, space enabled applications, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States or by the Union, used for the sole purpose of fighting the pandemic and proven to be adequate, necessary and proportionate, and in full compliance with Regulation (EU) 2016/679 and Directive 2002/58/EC. |
Amendment 185
Proposal for a regulation
Article 18 — paragraph 2 — subparagraph 2 a (new)
Text proposed by the Commission |
Amendment |
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To ensure data quality and consistency, the EWRS shall implement robust, accurate and interoperable data processes with Member States. The ECDC shall coordinate with Member States throughout such data exchange processes, from assessing the data requirements, transmission and collection, to up to date actualisation and interpretation, ensuring strong collaboration between the Commission, the ECDC and national and regional competent bodies. |
Amendment 186
Proposal for a regulation
Article 18 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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2a. The ECDC shall develop and improve the EWRS, to augment the automation of information collection and analysis, upgrade the categorisation of notifications, reduce open text communication, reduce the administrative burden and improve the standardisation of the notifications. |
Amendment 187
Proposal for a regulation
Article 18 — paragraph 2 b (new)
Text proposed by the Commission |
Amendment |
|
2b. The EWRS shall be improved to reduce the burden of bureaucracy and duplications of notification. The EWRS shall allow the national competent authorities to notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, and shall integrate this information in the EWRS system, in order to automatically notify an alert in the EWRS. |
Amendment 188
Proposal for a regulation
Article 18 — paragraph 4
Text proposed by the Commission |
Amendment |
4. The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange with other rapid alert systems at Union level, including exchange of personal data, in order to ensure the proper functioning of the EWRS and to avoid overlap of activities or conflicting actions with existing structures and mechanisms for preparedness, monitoring, early warning and combating serious cross-border threats to health. |
4. The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange with other rapid alert systems at Union and international level, including exchange of personal data, in order to ensure the proper functioning of the EWRS and to avoid overlap of activities or conflicting actions with existing structures and mechanisms for preparedness, monitoring, early warning and combating serious cross-border threats to health. |
Amendment 189
Proposal for a regulation
Article 18 — paragraph 4 a (new)
Text proposed by the Commission |
Amendment |
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4a. The EWRS shall be able to automatically collect information from other important databases, such as those comprising environmental data, climate data, water irrigation data and other data relevant to serious cross-border threats to health, that could facilitate understanding and mitigate the risk of potential health threats. |
Amendment 190
Proposal for a regulation
Article 19 — paragraph 2
Text proposed by the Commission |
Amendment |
2. Where the national 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. |
2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, as referred to in Article 18(2b), an alert shall be simultaneously notified in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation. |
Amendment 191
Proposal for a regulation
Article 19 — paragraph 3 — point f
Text proposed by the Commission |
Amendment |
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Amendment 192
Proposal for a regulation
Article 19 — paragraph 3 — point h
Text proposed by the Commission |
Amendment |
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Amendment 193
Proposal for a regulation
Article 19 — paragraph 3 — point i a (new)
Text proposed by the Commission |
Amendment |
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Amendment 194
Proposal for a regulation
Article 19 — paragraph 3 — point j
Text proposed by the Commission |
Amendment |
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Amendment 195
Proposal for a regulation
Article 19 — paragraph 4 a (new)
Text proposed by the Commission |
Amendment |
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4a. The Member State shall update the information referred to in paragraph 3 as new data become available. |
Amendment 196
Proposal for a regulation
Article 20 — paragraph 1 — introductory part
Text proposed by the Commission |
Amendment |
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 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: |
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 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 , including a risk assessment of the mental health of the affected population . That risk assessment shall be carried out by: |
Amendment 269
Proposal for a regulation
Article 20 — paragraph 1 — point -a (new)
Text proposed by the Commission |
Amendment |
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Amendment 197
Proposal for a regulation
Article 20 — paragraph 1 — point a
Text proposed by the Commission |
Amendment |
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Amendment 198
Proposal for a regulation
Article 20 — paragraph 1 — point a a (new)
Text proposed by the Commission |
Amendment |
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Amendment 199
Proposal for a regulation
Article 20 — paragraph 1 — point f a (new)
Text proposed by the Commission |
Amendment |
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Amendment 200
Proposal for a regulation
Article 20 — paragraph 2
Text proposed by the Commission |
Amendment |
2. At the request of the agency or body carrying out the risk assessment within its mandate, the agencies and bodies referred to in paragraph 1 shall, without undue delay, provide any relevant information data at their disposal. |
2. At the request of the agency or body carrying out the risk assessment within its mandate, the agencies and bodies referred to in paragraph 1 shall, without undue delay, provide any relevant information data and expertise at their disposal. When delivering its risk assessment, the agency or body shall be designated as the ‘lead’ agency in accordance with paragraph 3 . The agency or body shall ensure that it takes note of any information or expertise obtained from other agencies or bodies referred to in paragraph 1. |
Amendment 201
Proposal for a regulation
Article 20 — paragraph 3 — subparagraph 1
Text proposed by the Commission |
Amendment |
Where the risk assessment needed is totally or partially outside the mandates of the agencies referred to in paragraph 1, and it is considered necessary for the coordination of the response at Union level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment. |
Where the risk assessment needed is totally or partially outside the mandates of the agencies referred to in paragraph 1, and it is considered necessary for the coordination of the response at Union level, the Commission shall, upon request of the HSC or its own initiative, provide an ad hoc risk assessment. Where the risk assessment needed falls under the mandate of several of the agencies referred to in paragraph 1, the Commission shall designate a lead agency to be in charge of carrying out the risk assessment, in collaboration with the other agencies concerned, and set a deadline for the submission of the assessment by that agency. |
Amendment 202
Proposal for a regulation
Article 20 — paragraph 3 — subparagraph 2
Text proposed by the Commission |
Amendment |
The Commission shall make the risk assessment available to the national competent authorities promptly through the EWRS, and, if appropriate, through linked alerts systems. Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication. |
The Commission shall make the risk assessment available to the national competent authorities promptly through the EWRS, and, if appropriate, through linked alerts systems. Where the risk assessment is to be made public, the national competent authorities shall receive it prior to its publication through the EWRS and the HSC . |
Amendment 203
Proposal for a regulation
Article 20 — paragraph 3 — subparagraph 3
Text proposed by the Commission |
Amendment |
The risk assessment shall take into account, if available, relevant information provided by other entities, in particular by the WHO in the case of a public health emergency of international concern. |
The risk assessment shall take into account, if available, relevant information provided by public health experts and other entities, in particular by the WHO in the case of a public health emergency of international concern. |
Amendment 270
Proposal for a regulation
Article 21 — paragraph 1 — introductory part
Text proposed by the Commission |
Amendment |
1. Following an alert notification pursuant to Article 19, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 19 and the risk assessments referred to in Article 20, Member States shall coordinate within the HSC and in liaison with the Commission: |
1. Following an alert notification pursuant to Article 19, on a request from the Commission or a Member State and on the basis of the available information, including the information referred to in Article 19 and the risk assessments referred to in Article 20, Member States shall coordinate within the HSC and in liaison with the Commission in particular with the HERA : |
Amendment 204
Proposal for a regulation
Article 21 — paragraph 1 — point b
Text proposed by the Commission |
Amendment |
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Amendment 205
Proposal for a regulation
Article 21 — paragraph 1 — point c
Text proposed by the Commission |
Amendment |
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Amendment 206
Proposal for a regulation
Article 21 — paragraph 1 — point c a (new)
Text proposed by the Commission |
Amendment |
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Amendments 207 and 271
Proposal for a regulation
Article 21 — paragraph 2
Text proposed by the Commission |
Amendment |
2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. |
2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting or ceasing those measures, inform, consult and coordinate with the other Member States , in particular neighbouring Member States, the Commission , in particular the HERA, the HCB and the Health Security Committee on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. |
Amendments 208 and 272
Proposal for a regulation
Article 21 — paragraph 3
Text proposed by the Commission |
Amendment |
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. |
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 , relevant regional authorities, the Commission , in particular the HERA, the HCB and the Health Security Committee on the nature, purpose and scope of those measures especially in cross-border regions . |
Amendment 209
Proposal for a regulation
Article 21 — paragraph 3 a (new)
Text proposed by the Commission |
Amendment |
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3a. In the event of a serious cross-border threat to health overwhelming national response capacities in a Member State, that Member State may also request assistance from other Member States through the ERCC provided for in Decision No 1313/2013/EU of the European Parliament and of the Council (1a) . |
Amendment 273
Proposal for a regulation
Article 22 — paragraph 2 — point a
Text proposed by the Commission |
Amendment |
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Amendment 210
Proposal for a regulation
Article 22 — paragraph 2 — point c
Text proposed by the Commission |
Amendment |
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Amendment 211
Proposal for a regulation
Article 22 — paragraph 2 — point c a (new)
Text proposed by the Commission |
Amendment |
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Amendment 212
Proposal for a regulation
Article 22 — paragraph 2 — point c b (new)
Text proposed by the Commission |
Amendment |
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Amendment 213
Proposal for a regulation
Article 23 — paragraph 3
Text proposed by the Commission |
Amendment |
3. 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. |
3. Before recognising a situation of public health emergency at Union level, the Commission shall 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. |
Amendment 214
Proposal for a regulation
Article 23 — paragraph 4 — subparagraph 2
Text proposed by the Commission |
Amendment |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2) . |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(3) . |
Amendment 274
Proposal for a regulation
Article 23 — paragraph 4 a (new)
Text proposed by the Commission |
Amendment |
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4a. Following the recognition of public health emergency, the Council, upon the proposal of the Commission, may adopt a regulation activating the emergency framework where that is appropriate to the economic situation, pursuant to Article 3 of a Council Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. Where the emergency framework is activated, the HCB shall be set up to coordinate action by the Council, the Commission, the relevant Union agencies and bodies, and Member States to ensure the supply and access of medical countermeasures. In such situations, pursuant to the Joint Declaration on budgetary scrutiny of new proposals based on Article 122 TFEU, a Joint Committee consisting of representatives of the European Parliament and of the Council shall be established. |
Amendment 215
Proposal for a regulation
Article 24 — paragraph 1 — introductory part
Text proposed by the Commission |
Amendment |
1. For the purpose of the formal recognition of a public health emergency at Union level, the Commission shall establish an Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission, shall advise the Commission by providing its views on: |
1. For the purpose of the formal recognition of a public health emergency at Union level, the Commission , with the consultation of the Health Security Committee shall establish an Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission or the Health Security Committee , shall advise the Commission and the Health Security Committee by providing its views on: |
Amendment 216
Proposal for a regulation
Article 24 — paragraph 1 — point c — point ii
Text proposed by the Commission |
Amendment |
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Amendment 217
Proposal for a regulation
Article 24 — paragraph 1 — point c — point ii a (new)
Text proposed by the Commission |
Amendment |
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Amendment 218
Proposal for a regulation
Article 24 — paragraph 2
Text proposed by the Commission |
Amendment |
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 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. |
2. The Advisory Committee shall be composed of independent experts , representatives of health and care workers and civil society representatives , 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, research, development, manufacturing, cultural , transport and international aspects. The representatives of the ECDC and of the EMA shall take an active part 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 or the Health Security Committee may invite experts and stakeholders 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. The Commission shall publish the names of the experts selected to form part of the Advisory Committee and details of the professional and/or scientific backgrounds that justify their appointment. |
Amendment 219
Proposal for a regulation
Article 24 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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2a. The Commission shall publish on its website the list of members of the Advisory Committee and the qualifications supporting their appointment. A geographical balance of the membership shall be ensured whenever possible. The members shall act in the public interest and in an independent manner. They shall make declarations of interest and of commitments. Such declarations shall include any activity, position, circumstances or other facts potentially involving a direct or indirect interest, in order to make it possible to identify interests which might be considered prejudicial to those experts’ independence. |
Amendment 275
Proposal for a regulation
Article 24 — paragraph 2 b (new)
Text proposed by the Commission |
Amendment |
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2b. The Advisory Committee shall act in cooperation with the HCB and the HERA Advisory Forum established under the Commission Decision of 16 September 2021. Representatives of the HERA Advisory Forum shall participate as observers on the Advisory Committee. The coordination between those bodies shall ensure that there is participation by all relevant stakeholders, including healthcare professionals’ organisations, patients’ associations, and industry and supply chain actors with recognised experience in disciplines related to providing advice on response to health emergencies and to the work of the HERA. |
Amendment 220
Proposal for a regulation
Article 24 — paragraph 3
Text proposed by the Commission |
Amendment |
3. The Advisory Committee shall meet whenever the situation requires, on a request from the Commission or a Member State. |
3. The Advisory Committee shall meet whenever the situation requires, on a request from the Commission , the Health Security Committee or a Member State. |
Amendment 221
Proposal for a regulation
Article 24 — paragraph 6
Text proposed by the Commission |
Amendment |
6. The Advisory Committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation, and adoption of recommendations and voting. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission. |
6. The Advisory Committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation, and adoption of recommendations and voting. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Health Security Committee . |
Amendment 222
Proposal for a regulation
Article 24 — paragraph 6 a (new)
Text proposed by the Commission |
Amendment |
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6a. The minutes of the Advisory Committee shall be public. |
Amendment 223
Proposal for a regulation
Article 24 — paragraph 6 b (new)
Text proposed by the Commission |
Amendment |
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6b. The advisory committee shall work in close cooperation with national advisory bodies. |
Amendments 224 and 276
Proposal for a regulation
Article 25 — paragraph 1 — point b
Text proposed by the Commission |
Amendment |
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Amendment 225
Proposal for a regulation
Article 25 — paragraph 1 — point c
Text proposed by the Commission |
Amendment |
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Amendment 226
Proposal for a regulation
Article 25 — paragraph 1 — point c a (new)
Text proposed by the Commission |
Amendment |
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Amendment 227
Proposal for a regulation
Article 25 — paragraph 1 — point c b (new)
Text proposed by the Commission |
Amendment |
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Amendment 228
Proposal for a regulation
Article 25 a (new)
Text proposed by the Commission |
Amendment |
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Article 25a Green lanes 1. After recognising a public health emergency for a pandemic situation under Article 23(1), the Commission shall, in the case of border restrictions, establish green lanes to ensure that essential goods, medical countermeasures and cross border workers can move freely within the internal market. 2. The Commission is empowered to adopt delegated acts to supplement this Regulation with provisions on the establishment of the green lanes referred to in paragraph 1. 3. A Member State may only prohibit or restrict exports of medical countermeasures in cases defined in Article 36 TFEU during a public health emergency at Union level, on condition that it obtains prior authorisation from the Commission. 4. The Commission shall decide on the request for prior authorisation within five days of the request. If the Commission takes no decision within this period, the authorisation shall be deemed granted. |
Amendment 229
Proposal for a regulation
Article 26 — paragraph 1
Text proposed by the Commission |
Amendment |
1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to national 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. |
1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to national competent authorities involved in the contact tracing measures concerned. That selective messaging functionality shall be designed with respect for the principle of data minimisation and data protection by design and by default, and shall be operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at Union level. |
Amendment 230
Proposal for a regulation
Article 26 — paragraph 5
Text proposed by the Commission |
Amendment |
5. Personal data may also be exchanged in the context of automated contact tracing, using contact tracing applications. |
5. Personal data may also be exchanged in the context of automated contact tracing, using contact tracing applications , in full compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council (‘GDPR’) (1a) |
Amendment 231
Proposal for a regulation
Article 26 — paragraph 6 — subparagraph 1 — introductory part
Text proposed by the Commission |
Amendment |
6. The Commission shall , by means of implementing acts, adopt: |
6. Following a prior consultation procedure as set out in Article 42(2) of Regulation (EU) 2018/1725, the Commission shall adopt delegated acts in accordance with Article 28 concerning : |
Amendment 232
Proposal for a regulation
Article 26 — paragraph 6 — subparagraph 1 — point b
Text proposed by the Commission |
Amendment |
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Amendment 233
Proposal for a regulation
Article 26 — paragraph 6 — subparagraph 1 — point d
Text proposed by the Commission |
Amendment |
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Amendment 234
Proposal for a regulation
Article 26 — paragraph 6 — subparagraph 1 — point d a (new)
Text proposed by the Commission |
Amendment |
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Amendment 235
Proposal for a regulation
Article 26 — paragraph 6 — subparagraph 2
Text proposed by the Commission |
Amendment |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). |
deleted |
Amendment 236
Proposal for a regulation
Article 28 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The power to adopt delegated acts referred to in Article 8(3) shall be conferred on the Commission for an indeterminate period of time from … [date of entry into force of the basic legislative act or any other date set by the co-legislators]. |
2. The power to adopt delegated acts referred to in Articles 8(3), 13(9), 14(6), 17(3), 25a(2), and 26(6) shall be conferred on the Commission for a for a period of five years from … [date of entry into force of the basic legislative act or any other date set by the co-legislators]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period . |
Amendment 237
Proposal for a regulation
Article 28 — paragraph 3
Text proposed by the Commission |
Amendment |
3. The delegation of power referred to in Article 8(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |
3. The delegation of power referred to in Articles 8(3), 13(9), 14(6), 17(3), 25a(2) and 26(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |
Amendment 238
Proposal for a regulation
Article 28 — paragraph 6
Text proposed by the Commission |
Amendment |
6. A delegated act adopted pursuant to Article 8(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
6. A delegated act adopted pursuant to Articles 8(3), 13(9), 14(6), 17(3), 25a(2) and 26(6) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Amendment 239
Proposal for a regulation
Article 28 a (new)
Text proposed by the Commission |
Amendment |
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Article 28a Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 28(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council. |
Amendments 240 and 277
Proposal for a regulation
Article 29 — paragraph 1
Text proposed by the Commission |
Amendment |
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. |
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 , the HERA and the impact of the Regulation on the proper functioning of the single market when serious cross-border threats to health arise . By 2023 and every 2 years thereafter, the Commission shall carry out an in-depth review of the implementation of the operations of HERA, including its structure, governance, funding and human resources. Those reviews shall address, in particular, any need to modify HERA’s structure, including but not limited to the possibility of upgrading HERA to a standalone agency, the mandate of HERA and the financial implications of any such modification. The Commission shall report to the European Parliament and to the Council on the findings of the reviews. Those findings shall be made public. The reviews shall be accompanied, where appropriate, by a legislative proposal to address the issues referred to in this paragraph, in full respect of the role of the European Parliament as co-legislator. |
Amendment 241
Proposal for a regulation
Article 29 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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Based on the evaluation referred to in the previous paragraph, the Commission shall, where appropriate, submit a legislative proposal to amend this Regulation. |
(1) The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0247/2021).
(1a) Regulation (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).
(15) World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/publications/i/item/9789241580496
(15) World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/publications/i/item/9789241580496
(1a) 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).
(1b) Regulation (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).
(16) Decision 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).
(16) Decision 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).
(17) Decision (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 77 I, 20.3.2019, p. 1).
(17) Decision (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 77 I, 20.3.2019, p. 1).
(18) Regulation (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).
(18) Regulation (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).
(1a) World Health Organisation International Health Regulations (2005) Third Edition available at https://www.who.int/publications/i/item/9789241580496
(19) Regulation (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).
(19) Regulation (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).
(21) OJ L 123, 12.5.2016, p. 1.
(21) OJ L 123, 12.5.2016, p. 1
(1a) World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789241596664/en/
(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).
(24) Regulation (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).
(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).
(24) Regulation (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).
(1b) Regulation (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).
(29) Regulation (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).
(29) Regulation (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).
(1a) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism.
(1a) Regulation (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).