14 Amendments of Patrizia TOIA related to 2023/0131(COD)
Amendment 55 #
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. In addition, the Paediatric Committee’s competences and expertise with reference to the scientific assessment and agreement of paediatric investigation plans and other matters of paediatric interest not falling under the PRAC and CHMP responsibilities, will be retained into a Paediatric Working Party, composed of experts in different medical areas, which should provide scientific support and expertise to all Bodies of the Agency on matters related to paediatric medicinal products development and use. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 128 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, 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. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Verification System which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.
Amendment 133 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities and the Agency 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. in a centralised, digitalised and automated system.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 or the Agency. 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 strategic contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. In case of emergencies and on the basis of the notifications received, the Agency should be empowered to redirect medicinal products available in strategic contingency stocks for quick access and agile mobilization of medicines, medical supplies, and equipment in order to facilitate the response to health emergencies of any kind and to support the health network _________________ 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 148 #
Proposal for a regulation
Article 2 – paragraph 2 – point 8 a (new)
Article 2 – paragraph 2 – point 8 a (new)
(8 a) ‘paediatric population’ means that part of the population aged between birth and 18 years;
Amendment 149 #
Proposal for a regulation
Article 2 – paragraph 2 – point 9 a (new)
Article 2 – paragraph 2 – point 9 a (new)
(9 a) paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population
Amendment 397 #
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a Joint procurement of orphan medicinal products 1. Upon request by one or more Member States, the Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 with a view to the advance purchase of orphan medicinal products. 2. Provisions referred to in Directive 2014/24/UE, Article 12(2) and Article 12(3) of Regulation (EU) 2022/2371 shall apply for the joint procurement procedure as referred to in paragraph 1. 3. The Commission shall set up a coordination mechanism between the entities organising and participating in any action of the joint procurement, providing technical expertise and assistance at all stages of the procedure. 4. In order to provide incentives to encourage the uptake of the joint procurement procedure, a dedicated fund is made available. 5. The Commission shall, by means of implementing acts, set up the Fund as referred to in paragraph 4, where operating procedures and financial resources to be allocated are specified.
Amendment 402 #
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency, after receiving the opinion of its Paediatric Working Party, shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 404 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days and after receiving the opinion of its Paediatric Working Party, the Agency shall review these changes and adopt a decision on their refusal or acceptance.
Amendment 431 #
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 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 466 #
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 regulatory and shortages reporting systems and other relevant IT systems and databases, including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of the Directive without duplication of reporting.
Amendment 490 #
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 and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 504 #
Proposal for a regulation
Article 142 – paragraph 1 – point d a (new)
Article 142 – paragraph 1 – point d a (new)
(d a) the Paediatric Working Party
Amendment 513 #
Proposal for a regulation
Article 150 – paragraph 2 – subparagraph 1
Article 150 – paragraph 2 – subparagraph 1
The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations., rare diseases and paediatric medicines with mandatory involvement of patients representatives
Amendment 515 #
Proposal for a regulation
Article 150 – paragraph 3 – subparagraph 2
Article 150 – paragraph 3 – subparagraph 2
The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. and patient representatives.Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.