45 Amendments of Nathalie COLIN-OESTERLÉ related to 2023/0131(COD)
Amendment 207 #
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creating a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while strengthening the fight against shortages of medicinal products, in particular by ensuring security of supply and addressing environmental concerns.
Amendment 208 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) Addressing the issue of shortages of medicinal products has been a long- standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament such as the European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem1 a, as well as by discussions within the Council of the European Union. However, that issue has remained, to date, unaddressed. _________________ 1 a OJ C 385, 22.9.2021, p. 83.
Amendment 209 #
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
Amendment 210 #
Proposal for a regulation
Recital 2 c (new)
Recital 2 c (new)
(2 c) The implementation of the 'Strategic Technologies for Europe Platform' (STEP) should contribute to reducing the Union's dependencies on third countries in the field of biotechnologies and turn into a fully- fledged sovereignty fund for the pharmaceutical industry in the future1 aa. The European pharmaceutical industry must be protected from international competition, and fiscal and financial incentives should be permitted in order to encourage manufacturers to relocate to Europe the production of active ingredients and medicines of strategic importance for healthcare. _________________ 1 aa Regulation of the European Parliament and of the Council establishing the Strategic Technologies for Europe Platform (‘STEP’) and amending Directive 2003/87/EC, Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241.
Amendment 469 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a grow, which have increased twentyfold over the past 20 years ing threat to public healthe European Union, are a genuine health scourge, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components, while 45% of medicinal products marketed in the EU are not produced in the EU and 80 to 85% of the active ingredients are imported from China and India. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages of medicinal products included on the Union list of critical medicinal products, and in particular medicines of health and strategic interest (MHSI). The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 476 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achievecombat shortages of medicinal products, a better security of supply for medicinal products in the internal market and tois a key element contribute therebying to a high level of public health protection,; it is appropriate, therefore, to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe, in particular by making security of supply a criterion as important as the price in public pharmacy contracts and in medicine-related procurement. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.
Amendment 483 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure continuously and in real time, also based on notifications of marketing authorisation holders. To this end, the Agency should set up a European platform on stocks of medicinal products which is continuously updated in real time with data transmitted by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56, should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation, prioritising medicines of health and strategic interest (MHSI), to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. These recommendations may relate to national stockpiling initiatives to ensure that they are proportionate to needs and do not have undesirable consequences, such as supply tensions in other Member States. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 493 #
Proposal for a regulation
Recital 139 a (new)
Recital 139 a (new)
(139a) The list of critical medicinal products drawn up at Union level should harmonise existing national lists and should not create confusion for the different actors in the pharmaceutical sector.
Amendment 494 #
Proposal for a regulation
Recital 139 b (new)
Recital 139 b (new)
(139b) The creation of one of more non- profit pharmaceutical undertakings capable of producing certain medicines of health and strategic interest (MHSI) whose situation is critical or which are no longer profitable for pharmaceutical firms should complement and guarantee security of supply and prevent possible shortages of critical medicinal products.
Amendment 495 #
Proposal for a regulation
Recital 139 c (new)
Recital 139 c (new)
(139c) Policies on the pricing of pharmaceutical products which only contain expenditure have a negative effect on the reliability of supply. The competent authorities of the Member States should be able to recommend an increase in the prices of products for which a risk of shortages or market consolidation has been identified.
Amendment 496 #
Proposal for a regulation
Recital 139 d (new)
Recital 139 d (new)
(139d) The Covid-19 pandemic showed that introducing temporary regulatory flexibility measures in the event of a public health emergency can help tackle shortages of medicinal products.
Amendment 497 #
Proposal for a regulation
Recital 139 e (new)
Recital 139 e (new)
Amendment 498 #
Proposal for a regulation
Recital 139 f (new)
Recital 139 f (new)
(139f) Public procurement procedures can be an effective tool for tackling shortages of medicinal products. At Member State level, invitations to tender based solely on price and where there is only one bidder increase the risk of shortages of medicinal products by strongly eroding prices, reducing the number of suppliers on the market. At Union level, joint procurement should be recognised as a tool to tackle critical shortages, in particular during a health crisis, as demonstrated by the Covid-19 pandemic.
Amendment 519 #
Proposal for a regulation
Article premier – paragraph 1
Article premier – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to tackling shortages and to the security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.
Amendment 547 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11
Article 2 – paragraph 2 – point 11
(11) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients andin the short or medium term and which has been identified using the methodology pursuant to Article 130(1), point (a).
Amendment 548 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11a) ‘medicine of health and strategic interest’ (MHSI) means a medicinal product for which an interruption in treatment poses an immediate danger to the life of the patient.
Amendment 558 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply, as defined by Regulation 2022/1231 b, of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand, as defined by Regulation 2022/123, for that medicinal product in that Member State, whatever the cause. _________________ 1 b Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 750 #
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
1 a. Following the receipt of a notification of the suspension of a medicinal product's marketing issued pursuant to Article 116, the competent authority of the Member State where the medicinal product was marketed can recommend increasing the prices of products for which a risk of shortages or market consolidation has been identified.
Amendment 1395 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 1476 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply, four months if the medicinal product is on the Union list of critical medicinal products established by Article 131 or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1495 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placincluded on the marketUnion list of critical medicinal products established by Article 131. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1503 #
Proposal for a regulation
Article 117 – paragraph 1 a (new)
Article 117 – paragraph 1 a (new)
1a. Pursuant to Article 173(2), the Commission may adopt implementing acts listing medicinal products not included on the Union list of critical medicinal products for which a shortage prevention plan is required due to a lack of therapeutic alternatives.
Amendment 1510 #
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products and send the information to the Agency without undue delay.
Amendment 1513 #
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Article 118 – paragraph 1 a (new)
1a. To carry out that monitoring, the Agency shall establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors.
Amendment 1521 #
Proposal for a regulation
Article 119 – paragraph 1 – point b a (new)
Article 119 – paragraph 1 – point b a (new)
(ba) promptly provide information on the stock available and any supply shortages in accordance with Article 130(2), point (da), establishing a European medicine stock platform.
Amendment 1551 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
Amendment 1555 #
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Article 121 – paragraph 1 – point c b (new)
(cb) examine the options for regulatory flexibility to alleviate shortages of medicinal products in the event of a health crisis.
Amendment 1576 #
Proposal for a regulation
Article 122 – paragraph 4 – point d
Article 122 – paragraph 4 – point d
(d) specify the methods for the provision of recommendations referred to in Article 123(4), including the introduction of regulatory flexibility;
Amendment 1577 #
Proposal for a regulation
Article 122 – paragraph 4 – point d a (new)
Article 122 – paragraph 4 – point d a (new)
(da) define the tools, working methods and guidelines for the solidarity mechanism referred to in Article 123(3a), in particular any necessary regulatory flexibility allowing for the quick movement of medicinal products between Member States and backed up by appropriate funding.
Amendment 1586 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP to make it a genuine prevention tool by transforming it into a European medicine stock platform that is continuously updated in real time, as provided for in Article 130. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.
Amendment 1598 #
Proposal for a regulation
Article 123 – paragraph 2 a (new)
Article 123 – paragraph 2 a (new)
2a. In accordance with the methods established in Article 122(4), point d, the MSSG may decide to activate the solidarity mechanism to allow available national surplus stocks to be shared to alleviate critical shortages.
Amendment 1641 #
Proposal for a regulation
Article 128 – paragraph 1 – point e a (new)
Article 128 – paragraph 1 – point e a (new)
(ea) manage and replenish the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).
Amendment 1657 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, prioritising medicines of health and strategic importance (MISSs) and in consultation, where appropriate, with relevant stakeholders;
Amendment 1663 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d a (new)
Article 130 – paragraph 1 – subparagraph 1 – point d a (new)
(da) establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, industrial actors and wholesale distributors.
Amendment 1664 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d b (new)
Article 130 – paragraph 1 – subparagraph 1 – point d b (new)
(db) develop, with the Member States, innovative and coordinated strategies and step up exchanges of good practice in the area of stock management.
Amendment 1665 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point d c (new)
Article 130 – paragraph 1 – subparagraph 1 – point d c (new)
(dc) coordinate, with marketing authorisation holders, the management of the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).
Amendment 1672 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC], prioritising medicines of health and strategic importance (MISSs) and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”). The Union list of critical medicinal products shall be drawn up in coordination with the lists established and communicated by the Member States.
Amendment 1689 #
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and inventory management, pricing mechanisms, tender procedures and the use of regulatory flexibility.
Amendment 1697 #
Proposal for a regulation
Article 133 a (new)
Article 133 a (new)
Amendment 1698 #
Proposal for a regulation
Article 134 – paragraph 1 – introductory part
Article 134 – paragraph 1 – introductory part
1. The Commission may, where it considers it appropriate and necessaryshall:
Amendment 1700 #
Proposal for a regulation
Article 134 – paragraph 1 – point a
Article 134 – paragraph 1 – point a
(a) take into account the MSSG recommendations and implement the relevant measures;Does not affect the English version.)
Amendment 1701 #
Proposal for a regulation
Article 134 – paragraph 1 – point b
Article 134 – paragraph 1 – point b
(b) inform the MSSG and the Member State authorities of those measures taken by the Commission.
Amendment 1702 #
Proposal for a regulation
Article 134 – paragraph 1 – point c
Article 134 – paragraph 1 – point c
(c) request the MSSG to provide information or an opinion or further recommendations referred to in Article 132(1).Does not affect the English version.)
Amendment 1703 #
Proposal for a regulation
Article 134 – paragraph 1 – point c a (new)
Article 134 – paragraph 1 – point c a (new)
Amendment 1704 #
Proposal for a regulation
Article 134 – paragraph 1 – point c b (new)
Article 134 – paragraph 1 – point c b (new)
(cb) develop, within the framework of the Public Procurement Directive 2014/24/EU1 c, guidelines to support sustainable public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the most economically advantageous tender (MEAT) criteria in order to establish remedies against single-winner, price- only tenders. _________________ 1 c Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94 28.3.2014, p. 65).