33 Amendments of Pietro FIOCCHI related to 2020/0322(COD)
Amendment 32 #
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 . __________________ 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 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 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 46 #
Proposal for a regulation
Recital 9 c (new)
Recital 9 c (new)
(9c) During a health crisis 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 48 #
Proposal for a regulation
Recital 9 d (new)
Recital 9 d (new)
(9d) 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.
Amendment 49 #
Proposal for a regulation
Recital 9 e (new)
Recital 9 e (new)
(9e) 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. This is also important to avoid waste of medicinal products.
Amendment 52 #
Proposal for a regulation
Recital 9 f (new)
Recital 9 f (new)
(9f) If used, in order for joint procurement to be sustainable, it is crucial to define criteria beyond the price/cost only to be considered in the awarding process. Such criteria should take into consideration for instance the ability of the bidder to ensure security of supply in a health crisis situation.
Amendment 117 #
Proposal for a regulation
Article 12 – paragraph 2 – point a a (new)
Article 12 – paragraph 2 – point a a (new)
(aa) 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;
Amendment 119 #
Proposal for a regulation
Article 12 – paragraph 2 – point b a (new)
Article 12 – paragraph 2 – point b a (new)
(ba) 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, timeline sand formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure;
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 126 #
Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(ca) the joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 127 #
Proposal for a regulation
Article 12 – paragraph 2 – point c b (new)
Article 12 – paragraph 2 – point c b (new)
(cb) commitments should be defined and respected by all parties involved from manufacturers, supply chain stakeholders and authorities;
Amendment 130 #
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 existing procurement procedures implemented by participating countries;
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 141 #
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 and participating in any action, 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 150 #
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 countries participating in the joint procurement procedure are not allowed to negotiate and sign parallel contracts with producers, and define clear consequences for those that do. 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 . _________________ 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). “National stockpiles should be coordinated and discouraged in view of the creation of an EU strategic reserve of medical countermeasure and to prevent imbalances in the internal market. The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, including in relation to the disclosure of the exact amount ordered and provided to each participating country, and delivery of procured products, and details of the liability of participating countries.
Amendment 157 #
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 . _________________ 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 164 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) 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 166 #
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
Amendment 169 #
Proposal for a regulation
Recital 9 c (new)
Recital 9 c (new)
(9 c) 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;
Amendment 170 #
Proposal for a regulation
Recital 9 d (new)
Recital 9 d (new)
(9 d) 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;
Amendment 171 #
Proposal for a regulation
Recital 9 e (new)
Recital 9 e (new)
(9 e) 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 from the beginning and respected, by the manufacturers to deliver on the production, and by the authorities to purchase their agreed reserved volumes. This is also important to avoid waste of medicinal products;
Amendment 172 #
Proposal for a regulation
Recital 9 f (new)
Recital 9 f (new)
(9 f) If used, in order for joint procurement to be sustainable, it is crucial to define criteria beyond the price/cost only to be considering in the awarding process. Such criteria should take into consideration for instance the ability of the bidder to ensure security of supply in a health crisis situation;
Amendment 175 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10 a) An increasing number of Member States are seeking to establish national stockpiles of medical countermeasures, that generates a stark increase in demand as a result that far exceeds patient demand forecasts based on epidemiological need and create sudden large spikes in demand that can place considerable strain on suppliers and, as a result, lead to challenges in meeting demand in other countries and create imbalances in the internal market particularly affecting the smaller countries;
Amendment 350 #
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; and access to diagnostic services during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 438 #
Proposal for a regulation
Article 12 – paragraph 2 – point a a (new)
Article 12 – paragraph 2 – point a a (new)
(a a) The purpose of joint procurement should be to guarantee stability inan 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;
Amendment 440 #
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 ina transparent, timely and effective way defining clear steps since the beginning of the procedure in terms of process, scope, tender specifications, timeline sand formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure;
Amendment 442 #
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 447 #
Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(c a) The joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 449 #
Proposal for a regulation
Article 12 – paragraph 2 – point c b (new)
Article 12 – paragraph 2 – point c b (new)
(c b) Commitments should be defined and respected by all parties involved from manufacturers, supply chain stakeholders and authorities;
Amendment 451 #
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 existing procurement procedures implemented by participating countries;
Amendment 455 #
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(d a) qualitative criteria shall be defined and be considered in the awarding process of the joint procurement bids, in addition to the lowest price;
Amendment 465 #
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 and participating in any action, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under: