12 Amendments of Evelyne GEBHARDT related to 2020/0322(COD)
Amendment 23 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) In light of the lessons learnt during the ongoing COVID-19 pandemic, this Regulation should create a more robust framework for coordination at Union level. The shift for procurement of PPE, medical equipment and vaccines (under rescEU, the Joint Procurement Agreement (JPA) and the EU Emergency Support Initiative (ESI)) from national to European level has been effective and beneficial to citizens. It avoids competition between Member States and guarantees a secure, fair, equitable and affordable access to medical countermeasures. Therefore, joint procurement procedures should be applied by default for medical countermeasures to cross border threats to health.
Amendment 27 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) To ensure resilience of the single market during future health emergency situations and in order to reduce the dependence on third countries, this Regulation should foster the creation of minimum European stocks of medical countermeasures as strategic products.
Amendment 28 #
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 exclusivity clause should entail that participating countries may not negotiate and/or conclude parallel contracts with producers; otherwise they should be excluded 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 . Transparency measures must be improved in order to guarantee rapid, equal, fair and affordable access to critical medical countermeasures as fast as possible whilst avoiding price speculation between Member States. In case that joint procurement procedures are not applied, a high level of transparency regarding pricing, reimbursement of different treatments, medical products marketing and health technology assessment needs to be guaranteed, to allow Member States equal conditions when negotiating with pharmaceutical companies. __________________ 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 39 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to ensure a fair and equal procedure and access for all European citizens, the European Parliament shall scrutinize contracts concluded under the Joint Procurement Procedure.
Amendment 58 #
Proposal for a regulation
Recital 15
Recital 15
(15) The Member States have a responsibility to manage public health crises at national level. However, measures taken by individual Member States could affect the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. The aim to coordinate the response at Union level should, therefore, seek to ensure, inter alia, thatavoid competition between Member States seek to ensure, inter alia, fair, equitable and affordable access to medical countermeasures across Europe. The measures taken at national level arshall be proportionate and limited to public health risks related to serious cross- border threats to health, and do not conflict with obligations and rights laid down in the Treaty on the Functioning of the European Union such as those related to free movement of persons, goods and services.
Amendment 63 #
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 through the creation of a new mechanism that increases the coordination and facilitates joint procurement procedures for the development, stockpiling and donation of medical countermeasures. 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, and of the European Parliament. 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 76 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) joint procurement, management and deployment of medical countermeasures;
Amendment 80 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental, climate or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 111 #
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 aWith a view to the advance purchase of medical countermeasures for serious cross-border threats to health, joint procurement procedures 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 heashould be conducted by defaulth. __________________ 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 120 #
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 only through that procedure and not through other channels, and shall not run parallel negotiation processes for that product; running parallel negotiation processes shall lead to an exclusion from the group of participating countries.
Amendment 125 #
Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(ca) the joint procurement shall be conducted in such a way so as to strengthen the purchasing power of participating countries, improve the security of supply and ensure fair, equitable and affordable, access to medical countermeasures against serious cross-border threats to health;
Amendment 144 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. In case the joint procurement procedure for medical countermeasures is not applied, the European Commission as well as the Member States shall guarantee transparency of net pricing, delivery dates and reimbursement, to allow Member States equal conditions when negotiating with pharmaceutical companies.