36 Amendments of Dacian CIOLOŞ related to 2023/0131(COD)
Amendment 401 #
Proposal for a regulation
Recital 92 b (new)
Recital 92 b (new)
(92 b) What constitutes significant benefit in a patient population can change over time, therefore, the concept should remain sufficiently flexible to ensure a future-proof regulatory framework while ensuring predictability through additional guidance developped in consultation with patient organisations.
Amendment 411 #
Proposal for a regulation
Recital 96 a (new)
Recital 96 a (new)
Amendment 433 #
Proposal for a regulation
Recital 105 a (new)
Recital 105 a (new)
(105 a)One of the overarching goals of this Regulation is to help meeting the medical needs of patients with rare diseases, to improve the affordability of orphan medicinal products and the patient access to orphan medicinal products across the Union, and to encourage innovation in areas of need. While other Union programmes and policies also contribute to these goals, people living with a rare disease continue to face common challenges that are many and multifactorial, including delayed diagnoses, lack of available transformative treatments, and difficulties to access treatments where they live, reflecting the fragmentation of the market across the Member States. The European added value to addressing the needs of people living with a rare disease being exceptionally high due to the rarity of patients, experts, data, and resources, it is appropriate for the Commission to develop, to complement this Regulation, a dedicated framework for rare diseases to bridge relevant legislation, policies and programmes, and support national strategies with a view to better meet the unmet needs of people living with rare diseases and their carers. This framework should be needs driven and goals based, and developped in consultation with the Member States and patient organisations as well as, where relevant, other interested parties.
Amendment 457 #
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected. Whenever possible, priority should be given to the use of non-animal approaches.
Amendment 477 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate 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, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against medicine shortages, in respect of the commitments taken in the framework of the "Voluntary Solidarity Mechanism for medicines". It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. 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 482 #
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, also based on notifications of marketing authorisation holders. 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 to ensure monitoring of the supply of those products. Health professional and patient organisations should be consulted before the adoption of the list. 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. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency minimum safety-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 484 #
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, also based on notifications of marketing authorisation holders. 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 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. 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. The MSSG should develop in coordination with the Agency a Voluntary Solidarity Mechanism to allow Member States where stocks of important medicines are critically low and where other available options have been exhausted to send out on a voluntary basis a notification, to which other Members States may respond on a voluntary basis to provide temporary relief. This mechanism should leverage existing structures, including the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and should invite manufacturers and wholesalers to participate where relevant. _________________ 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 488 #
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)In addition to existing and planned policy, legislative and regulatory measures, the Union need a strategic and coordinated industrial approach to ensure the security of supply of the most critical medicines. The Critical Medicines Alliance and the future Critical Medicines Act could allow national authorities, industry, civil society representatives, the Commission and the EU agencies to develop together coordinated actions at Union level against the shortages of medicines, in compliance with the competition rules and the Union’s international commitments. The future Critical Medicines Act could support the European green, digital manufacturing of critical medicines, APIs and intermediate ingredients, diversify the EU pharmaceutical supply chains and secure the strategic autonomy of critical medicines.
Amendment 489 #
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)To avoid that measures foreseen or taken by a Member State to prevent or mitigate a shortage at national level when responding to the legitimate needs of its citizen increase the risk of shortages in another Member State, the Agency should assess those measures with regards to their potential or actual impact on the availability and security of supply in other Member States and at European level, and inform of its assessment the Member States and the MSSG.
Amendment 490 #
Proposal for a regulation
Recital 138 b (new)
Recital 138 b (new)
(138 b)One of the aims of this Regulation is to set out a framework for the activities to be deployed by the Member States and the Agency to improve the Union's capacity to react efficiently and in a coordinated manner to support shortage management and security of supply of medicinal products, in particular critical medicinal products, to EU citizens, at all times. Those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades and the root causes are multifactorial. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently expand that framework to continue addressing the causes of shortages of medicinal products, and better prevent and mitigate their effects.
Amendment 491 #
Proposal for a regulation
Recital 138 c (new)
Recital 138 c (new)
(138 c) To complement this Regulation and as a first step to a more structural, long term approach to reduce Union dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries, the Commission should propose by (OP: 24 months after the date of entry into force of this Regulation) a legislative initiative for an EU Critical Medicines Act for supporting the European green, digital manufacturing of key medicines, active pharmaceutical ingredients, and intermediate pharmaceutical ingredients for which the Union is dependent on one country or a limited number of manufacturers.
Amendment 492 #
Proposal for a regulation
Recital 138 d (new)
Recital 138 d (new)
(138 d)It is appropriate for the Commission to build upon the Communication addressing medicine shortages in the European Union of 24 October 2023 and the many tools which can be used to promote a coordinated industrial approach, bringing together public and private actors from the European health and industrial ecosystem.
Amendment 599 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including with regard to the quality of life of a relevant patient population or subpopulation, of a life- threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 677 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and subsequent consultation of patient organisations.
Amendment 762 #
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.
Amendment 775 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated where appropriate by the Agency in a designated registry.
Amendment 977 #
Proposal for a regulation
Article 52 – paragraph 2 – subparagraph 1 – point a
Article 52 – paragraph 2 – subparagraph 1 – point a
(a) to lend its assistance by participating in a joint inspection with the supervisory authority of the site to assess the respect of the good manufacturing practice (GMP) including the practices relating to the environmental and social standards. In that case the supervisory authority leads the inspection and the follow up thereof. After completion of the inspection, the supervisory authority grants the relevant good manufacturing practice (GMP) certificate and enters the certificate in the Union database; or
Amendment 991 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, as applicable. To avoid any conflict of interest, the Agency shall ensure a separation between the experts responsible for providing scientific advice to a medicinal product developer and those subsequently involved in evaluating marketing authorisation for the same medicine. In the absence of a sufficient panel in the context of a rare disease, an exception may be granted.
Amendment 996 #
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. When granting scientific advice, the Agency shall ensure to the greatest extent possible that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a marketing authorisation application for the same medicinal product. The Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application should not have taken part in any pre- submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European Public Assessment Report.
Amendment 1282 #
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a European Framework for Rare Diseases By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers.
Amendment 1293 #
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients.
Amendment 1512 #
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Article 118 – paragraph 1 a (new)
Amendment 1522 #
Proposal for a regulation
Article 119 – paragraph 1 – point e a (new)
Article 119 – paragraph 1 – point e a (new)
(e a) issue forecast of demand to provide early-warning of potential critical shortages.
Amendment 1541 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on actualll notified shortages of medicinal products, in cases in whichas soon as thate competent authority has assessed the shortage, on a publicly available website;
Amendment 1543 #
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;
Amendment 1554 #
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Article 121 – paragraph 1 – point c b (new)
(c b) launch information campaign to discourage hoarding or to avoid waste, at any level of the supply chain, from wholesalers to patients.
Amendment 1559 #
Proposal for a regulation
Article 121 – paragraph 2 – point f
Article 121 – paragraph 2 – point f
(f) inform the Agency within one week of any actions foreseen or taken by that Member State to mitigate the shortage at national level.
Amendment 1560 #
Proposal for a regulation
Article 121 – paragraph 2 a (new)
Article 121 – paragraph 2 a (new)
2 a. After the expansion of the ESMP referred to in article 122 (6) and for the purpose of articles 118 (1), and 121 (2), point (a), competent authorities of the Member States shall set up national IT systems which are interoperable with the ESMP and allow for the automated exchange of information with the ESMP while avoiding duplication of reporting.
Amendment 1569 #
Proposal for a regulation
Article 122 – paragraph 1 a (new)
Article 122 – paragraph 1 a (new)
1 a. For the purpose of Article 118 (1a) (new) and based on the information provided pursuant to articles 121 (1), point (d), and 121 (2), the Agency shall assess the actions taken or foreseen by a Member State to mitigate a shortage at national level with regards to any potential or actual negative impacts of these actions on the availability and security of supply in another Member State and at European level. The Agency shall inform the Member State in question of its assessment in a timely manner and the MSSG and the Member States potentially or actually impacted through the single point of contact working party referred to in Article 3(6) of Regulation (EU) 2022/123. The Agency shall also inform the Commission of its assessment.
Amendment 1584 #
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. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and, where relevant, with other relevant IT systems and databases, without duplication of reporting. Data included in the ESMP shall contain information on the expected duration of the shortages and the mitigation measures to resolve it. The ESMP shall be fully digitalised and automated and shall use artifical intelligence to provide information about trends in demand and supply from existing data.
Amendment 1596 #
Proposal for a regulation
Article 123 – paragraph 2
Article 123 – paragraph 2
2. The MSSG shall review the status of the critical shortage whenever necessary and shall update the list when it considers that a medicinal product needs to be added or that the critical shortage has been resolved based on the report pursuant to Article 122(5). The MSSG may recommend monitoring forecasts of supply and demand for medicinal products for human use in the EU/EEA and monitoring of available stocks in the whole supply chain.
Amendment 1597 #
Proposal for a regulation
Article 123 – paragraph 2 – subparagraph 1 (new)
Article 123 – paragraph 2 – subparagraph 1 (new)
After adopting the list of critical shortages of medicinal products, the MSSG may analyse the vulnerabilities in the supply chain of those medicines.
Amendment 1606 #
Proposal for a regulation
Article 123 – paragraph 4 – subparagraph 1 (new)
Article 123 – paragraph 4 – subparagraph 1 (new)
Member States, within the MSSG, may decide to activate the “Voluntary Solidarity Mechanism for medicines” to (a) notify a critical shortage of a medicinal product at national level to other Member States and the Commisison, (b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States, (c) organise, with the support of the Agency, meetings with the issuing Member States, the donating part and other relevant parties to discuss operational requirements, (d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.
Amendment 1683 #
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 increase of manufacturing capacity, reorganisation of manufacturing capacity, diversification of suppliers and, inventory management, establishment of minimum safety stock and if necessary, redistribution of available stock among Member States to address urgent needs.
Amendment 1693 #
Proposal for a regulation
Article 132 – paragraph 1 b (new)
Article 132 – paragraph 1 b (new)
1 b. The MSSG shall set up a Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicine during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.
Amendment 1705 #
Proposal for a regulation
Article 134 – paragraph 1 a (new)
Article 134 – paragraph 1 a (new)
1 a. The Commission shall also work with the European Centre for Disease prevention and Control on building reliable forecasts of potentiel threats and potential shortages.