7 Amendments of Aldo PATRICIELLO related to 2020/0322(COD)
Amendment 125 #
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 149 #
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. The Commission should ensure coordination and information exchange between the entities organizing and participating in any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . . During a health crisis situation, manufacturing is often needed rapidly and at short notice.It is therefore crucial that the joint procurement lead times are aligned and coherent with manufacturers’ lead times to ensure clarity and expectations from both organizing and participating entities.Regulatory flexibility should be considered and allowed to ensure faster supply to the markets, for example by accepting each other Marketing Authorizations in case of emergencies. Joint procurement implies shared responsibilities and a fair approach with rights and obligations for all parties involved, relevant authorities and manufacturers. In this respect, commitments should be defined since the beginning and respected, from them manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes. This is also important to avoid wasting medicinal products. _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 189 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 201 #
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 319 #
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 should also be considered.
Amendment 413 #
Proposal for a regulation
Article 10 – paragraph 1 – point 1 (new)
Article 10 – paragraph 1 – point 1 (new)
(1) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain shall also be ensured to start early discussions about expected potential serious cross- border threats to health in the market by way of sharing expected supply constraints, allowing better coordination, synergies and appropriate reaction when relevant;
Amendment 469 #
Proposal for a regulation
Article 12 – paragraph 3 – point f – point i (new)
Article 12 – paragraph 3 – point f – point i (new)
i) The purpose of joint procurement should be to guarantee stability in an unpredictable environment during a serious cross-border threat to health only.In other circumstances, other measures shall be privileged, such as procurement at national level; The joint procurement shall be carried in a transparent, timely and effective way defining clear steps since the beginning of the procedure in terms of process, scope, tender specifications, timelines and formalities;