21 Amendments of Danilo Oscar LANCINI related to 2020/0322(COD)
Amendment 126 #
Proposal for a regulation
Recital 6
Recital 6
(6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, as well as in close dialogue with industry and supply chain actors, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 142 #
Proposal for a regulation
Recital 8
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical long-term healthcare and sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 159 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Joint procurement should be limited to serious cross-border treats to health and should not impact pre-existing contractual agreements with suppliers of medical countermeasures and should be carried in accordance with the Directive 2014/24/EU in a transparent manner, while respecting the following conditions: the procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; a preliminary consultation phase involving potential participating manufacturers must take place; clear volume commitments irrespective of the selected supply modality must be ensured; participating countries need to commit not to procure the same medicines via other means; joint procurement lead times must be aligned with manufacturing processes lead times; national authorities should apply certain regulatory flexibilities; award criteria beyond price should be defined. Any joint procurement endeavour shall prevent market disruptions both in participating countries and other Member States not participating.
Amendment 202 #
Proposal for a regulation
Recital 18
Recital 18
(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers with close involvement of the relevant industry stakeholders. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
Amendment 262 #
Proposal for a regulation
Article 4 – paragraph 2 – point d a (new)
Article 4 – paragraph 2 – point d a (new)
Amendment 305 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
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 specific provisions to address the situation of those citizens with higher risks, and targeted provisions to ensure the continuity of essential long-term healthcare services for chronic, degenerative, life-threatening diseases and other time sensitive conditions, with appropriate safety and quality standards.
Amendment 320 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national preparedness and response plans each Member State shall coordinate 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. Coordination, dialogue and exchange of information with industry and supply chain stakeholders shall also be ensured.
Amendment 343 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
(i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; continuity of critical long-term care; coordination mechanisms;
Amendment 349 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; details on the exiting national stockpile of medical countermeasures held by supply chain distributors; access to diagnostic services during emergencies; basic and safe gender- sensitive health and emergency services; continuity of critical long-term care; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 361 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated, trained and equipped human resources for emergencies and continuity of critical long-term care; and
Amendment 423 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools, and to ensure the continuity of healthcare services for chronic, degenerative, and life-threatening diseases.
Amendment 431 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health during extraordinary emergencies such as future pandemics, where purchase and supply of products cannot be ensured as efficiently by other means. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 439 #
Proposal for a regulation
Article 12 – paragraph 2 – point b a (new)
Article 12 – paragraph 2 – point b a (new)
(b a) the joint procurement shall be carried in accordance with the Directive 2014/24/EU in a transparent manner;and should respect the following: 1.The procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; 2.A preliminary consultation phase involving potential participating manufacturers must take place; 3.Ensure clear volume commitments irrespective of the selected supply modality; 4.Participating countries need to commit not to procure the same medicines via other means and must honour pre- existing supply contracts with manufacturers; 5.Joint procurement lead times must be aligned with manufacturing processes lead times; 6.National authorities should apply certain regulatory flexibilities; 7. Award criteria other than price should be defined.
Amendment 443 #
Proposal for a regulation
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product, and this shall not impact pre-existing contractual agreements with suppliers of medical countermeasures;
Amendment 450 #
Proposal for a regulation
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
(d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition, nor replace exiting procurement procedures implemented by participating countries;
Amendment 460 #
Proposal for a regulation
Article 12 – paragraph 2 – point e a (new)
Article 12 – paragraph 2 – point e a (new)
(e a) the joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, jeopardise product choice, or create market distortion or any concentration of demand, and shall therefore be time-limited to the emergency situation;
Amendment 464 #
Proposal for a regulation
Article 12 – paragraph 3 – introductory part
Article 12 – paragraph 3 – introductory part
3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing any actiond participating in any action during extraordinary emergencies such as future pandemics, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 511 #
Proposal for a regulation
Article 14 – paragraph 2 – point b a (new)
Article 14 – paragraph 2 – point b a (new)
(b a) be used as a mechanism through which relevant third-party stakeholders, including marketing authorisation holders, are made aware, in a timely fashion, of epidemiological data, modelling and response scenarios developed by EU authorities.
Amendment 557 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
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, as well as to any directly involved third party stakeholders (such as manufacturers of relevant medical countermeasures), provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
Amendment 587 #
Proposal for a regulation
Article 21 – paragraph 1 – point c a (new)
Article 21 – paragraph 1 – point c a (new)
(c a) coordination with relevant third- party stakeholders (such as manufacturers of relevant medical countermeasures), to explore and anticipate appropriate responses in order to rapidly address the alert.
Amendment 621 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, manufacturing, research, development, 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 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.