Activities of Adam BIELAN related to 2020/0322(COD)
Plenary speeches (1)
European Centre for Disease Prevention and Control - Serious cross-border threats to health (debate)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on Regulation on serious cross-border threats to health repealing Decision No 1082/2013/EU
Amendments (13)
Amendment 16 #
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 29 #
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 EUnion. The exclusivity clause should entail countries participating in the joint procurement procedure being prevented from conducting and finalising parallel contracts concerning the same medical countermeasures and negotiating parties, thus avoiding the exclusion of those countries from the group of participating countries. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . __________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 36 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) The joint procurement procedure should first and foremost foster cooperation and solidarity between the Member States during a serious health crisis, strengthen their negotiating position and allow for a preferable purchasing conditions, concerning the quantity, price or availability of a procured medical countermeasure.
Amendment 38 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) The primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross-border health crisis only, ensuring equitable access for patients and increased visibility and predictability for actors involved.
Amendment 40 #
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) Since one of the primary responsibility of the Member States is to ensure the protection of their citizens, additional flexibility is needed when it comes to being able to adjust contractual provisions after the initial contract has been established, in order to increase, decrease or cancel the order for the medical countermeasures. In order to protect the contractors, directly engaged in activities that serve Union policies, such contractual adjustments should be duly justified by the national authorities participating in the joint procurement procedure, by explaining the seriousness or urgency of the circumstances in question and such adjustments should be enforced in close cooperation with contracted partners and taking due account of the commitments made up to date of contractual adjustment.
Amendment 42 #
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) The Joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure actors involved can fulfil their contractual responsibilities. In this respect, it is crucial to define clear and transparent steps since the beginning of the procedure in terms of process, scope, tender specifications, timelines and formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure.
Amendment 44 #
Proposal for a regulation
Recital 9 c (new)
Recital 9 c (new)
(9c) The COVID-19 pandemic has exposed the limited diversity of suppliers and an over-reliance on particular supply chains. Such vulnerabilities need to be addressed by encouraging broader participation of small and medium-sized enterprises (SMEs) in joint procurement procedures. Particular emphasis should be placed on providing technical assistance and reducing the administrative burdens in order to boost the involvement of SMEs in the process.
Amendment 56 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain should be encouraged to facilitate preliminary dialogue concerning foreseeable serious cross-border threats to health in the market by way of sharing information on the expected supply constraints, allowing better coordination, synergies and robust reaction if needed.
Amendment 64 #
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 123 #
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. In addition, joint procurement shall not exempt participating countries from honouring existing contractual agreements nor shall replace countries regular procurement processes;
Amendment 132 #
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(da) qualitative criteria beyond the lowest price shall be defined and be considered in the awarding process of the joint procurement bids;
Amendment 138 #
Proposal for a regulation
Article 12 – paragraph 2 – point e a (new)
Article 12 – paragraph 2 – point e a (new)
(ea) a Member State engaging in a joint procurement may make a change to the request set out earlier, including resignation from participation in the procurement, if there has been a significant change in the circumstances arising from a well-founded public interest.
Amendment 170 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
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, the added-value of the joint public procurement procedure, as well as the coordination of the response with the HSC.