28 Amendments of Vlad-Marius BOTOŞ related to 2020/0322(COD)
Amendment 25 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at Union level. The declaration by the WHO of a public health emergency, formally recognised at Union level, would bring about increased coordination and exceptionally allow for joint procurement procedures for the development, stockpiling, distribution and donation of medical countermeasures, to the most recommendable needs and where their purchase and supply cannot be ensured as efficiently by other means.
Amendment 26 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) The primary purpose of joint procurement should be to improve the preparedness and response to serious cross-border threats to health, and particularly to improve the security and capacity of supply of medical countermeasures in the participating countries throughout their existence, ensure equitable access to patients and provide increased visibility and predictability for actors involved.
Amendment 30 #
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 and for security and capacity of supply of the medical countermeasure in question. 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 and distribution 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 34 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) The Joint procurement should be carried in a transparent, timely and effective way to prevent market disruption and to ensure actors involved 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 should be guaranteed, as well as a clear and mutual communication throughout the whole procedure.
Amendment 41 #
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, provided it does not jeopardize the negotiation and compliance of purchase agreements, including in relation to the disclosure of the exact amount provided to each participating country, details regarding supply chains, production and delivery of procured products, and details of the liability of participating countries, as well as information on the existence of no-fault compensation systems in those participating countries.
Amendment 45 #
Proposal for a regulation
Recital 9 c (new)
Recital 9 c (new)
(9c) During the existence of a cross- border health threat situation, manufacturing is often needed rapidly and with 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.
Amendment 47 #
Proposal for a regulation
Recital 9 d (new)
Recital 9 d (new)
(9d) In order for this regulation to fulfil its main objectives, mainly to ensure a rapid response in the case of serious cross-border health threats, a priority conditionality binding the undertaking of the joint procurement procedures should be provided for, in order to ensure that the delivery and scheduled commitments to the participating countries are respected under all circumstances.
Amendment 50 #
Proposal for a regulation
Recital 9 e (new)
Recital 9 e (new)
(9e) In addition, suitable regulatory flexibilities should be considered and allowed by Member States’ authorities in the framework of joint procurement procedures and including, where relevant, for marketing authorisations, to ensure faster and timely supply in the European Single Market.
Amendment 51 #
Proposal for a regulation
Recital 9 f (new)
Recital 9 f (new)
(9f) 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 the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes.
Amendment 53 #
Proposal for a regulation
Recital 9 g (new)
Recital 9 g (new)
(9g) If used, in order for joint procurement to be sustainable, the Commission should ensure accessible, transparent, proportionate and non- discriminatory technical specifications, selection and award criteria by placing a significant and priority value and consideration on the highest safety and quality standards of the medical countermeasures, in accordance with the applicable legislation, and beyond the price and costs of those. Such criteria should also include the ability of the bidder to ensure security and capacity of supply in a cross-border health threat situation, as well as provide for adequate flexibility to allow for a wider selection of successful suppliers and the effective participation of small and medium-sized enterprises in the awarding process.
Amendment 54 #
Proposal for a regulation
Recital 9 h (new)
Recital 9 h (new)
(9h) To facilitate the negotiation of joint procurement procedures, Member States should establish no-fault compensation systems which should be used in the event of a cross-border health threat declared by the EU, allowing citizens who may suffer an adverse reaction to a particular medical countermeasure, subject to a joint procurement procedure, to receive fair compensation by proving solely the causal link between the medical countermeasure in question and the damages caused. These possible damages should not be borne individually by each injured person, but should be considered as a social burden shared by society as a whole. Therefore, equal access to fair compensation through no-fault compensation schemes should be provided.
Amendment 110 #
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 the purpose of preparedness and response to serious cross-border threats to health only. __________________ 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 113 #
Proposal for a regulation
Article 12 – paragraph 2 – point -a (new)
Article 12 – paragraph 2 – point -a (new)
(-a) the joint procurement shall be time-limited to the existence of a serious cross-border threat to health and be used for the purchase and supply of each medical countermeasure to the most recommendable needs, as long as it cannot be ensured as efficiently by other means;
Amendment 114 #
Proposal for a regulation
Article 12 – paragraph 2 – point -a a (new)
Article 12 – paragraph 2 – point -a a (new)
(-aa) the commitments and contractual obligations defined by the corresponding purchase agreement shall be respected by all parties involved;
Amendment 115 #
Proposal for a regulation
Article 12 – paragraph 2 – point -a b (new)
Article 12 – paragraph 2 – point -a b (new)
(-ab) a priority conditionality binding the undertaking of the joint procurement procedures should be provided for, in order to ensure that the delivery and scheduled commitments to the participating countries are respected;
Amendment 122 #
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; running parallel negotiation processes shall lead to being excluded from the group of participating countries, without prejudice to participating countries from honouring existing contractual agreements, nor existing procurement procedures implemented by participating countries;
Amendment 124 #
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 improve the security and capacity of supply of medical countermeasures against serious cross-border threats to health in the participating countries, ensure equitable access to the largest extent possible, and strengthen the purchasing power of participating countries;
Amendment 129 #
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 or concentration of demand; the joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU;
Amendment 131 #
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(da) the joint procurement shall be carried in a transparent, timely and effective way defining clear steps since the start of the procedure in terms of process, scope, tender specifications, timelines and formalities;
Amendment 133 #
Proposal for a regulation
Article 12 – paragraph 2 – point d b (new)
Article 12 – paragraph 2 – point d b (new)
(db) the joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 134 #
Proposal for a regulation
Article 12 – paragraph 2 – point d c (new)
Article 12 – paragraph 2 – point d c (new)
(dc) a preliminary consultation phase involving participating actors shall be guaranteed, as well as a clear mutual communication throughout the whole procedure;
Amendment 135 #
Proposal for a regulation
Article 12 – paragraph 2 – point d d (new)
Article 12 – paragraph 2 – point d d (new)
(dd) Member States’ authorities shall apply regulatory flexibilities, where relevant and with due regard to EMA’s guidance, to ensure the timely supply of medical countermeasures through joint procurement procedures during the existence of a cross-border health threat;
Amendment 137 #
Proposal for a regulation
Article 12 – paragraph 2 – point e a (new)
Article 12 – paragraph 2 – point e a (new)
(ea) the joint procurement shall be subject to high transparency standards, provided it does not jeopardize the negotiation and compliance of purchase agreements, including in relation to the disclosure of the exact amount provided to each participating country, details regarding supply chains, production and delivery of procured medical countermeasures, and details of the liability of participating countries, as well as information on the existence of no- fault compensation systems in those participating countries.
Amendment 139 #
Proposal for a regulation
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. Joint public procurement procedures shall include accessible, transparent, qualitative and non- discriminatory technical specifications and selection criteria, which shall be considered in the awarding process of the joint procurement bids and comply with the following conditions and order of priority: 1. They shall rely on the verification and compliance of the medical countermeasure forming the subject of the joint procurement procedure in question, with the highest safety and quality standards, as required by the relevant legislation; 2. They shall evaluate the ability of the bidder to ensure the security and capacity of supply of the medical countermeasure in question in a cross- border health threat situation; 3. They shall provide for sufficient and adequate flexibility of technical and economic solvency requirements, and lots shall accordingly be adjusted to those in the corresponding tender documents, thereby allowing the involvement and participation of small and medium-sized enterprises in joint procurement procedures and a wider selection of successful suppliers in the awarding process. 4. They shall evaluate lastly the price and costs of the medical countermeasure in question.
Amendment 140 #
Proposal for a regulation
Article 12 – paragraph 3 – introductory part
Article 12 – paragraph 3 – introductory part
Amendment 142 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. Participating Member states shall ensure an adequate stockpiling and distribution of procured medical countermeasures, whose main details and characteristics shall be set out in national plans. In addition, national plans shall address potential bottlenecks and capacity obstacles that may jeopardise the delivery of medical countermeasures acquired through joint procurement mechanisms to their final destination.
Amendment 146 #
Proposal for a regulation
Article 12 – paragraph 3 b (new)
Article 12 – paragraph 3 b (new)
3b. Member States shall establish no- fault compensation systems which shall be used in the event of a cross-border health threat declared by the EU, allowing citizens who may suffer an adverse reaction to a particular medical countermeasure subject to a joint procurement procedure, to receive fair compensation by proving solely the causal link between the medical countermeasure in question and the damages caused.
Amendment 148 #
Proposal for a regulation
Article 12 – paragraph 3 c (new)
Article 12 – paragraph 3 c (new)
3c. 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, access to legal protection and access to consumer representation.