37 Amendments of Pilar del CASTILLO VERA related to 2023/0132(COD)
Amendment 36 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.
Amendment 38 #
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) This Directive recognizes that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.
Amendment 81 #
Proposal for a directive
Recital 52 a (new)
Recital 52 a (new)
(52 a) (51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;
Amendment 97 #
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU shall be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.
Amendment 108 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal productfter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of the reference medicinal product, there can be no commercial usrelevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 116 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 123 #
Proposal for a directive
Recital 65
Recital 65
(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States and Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine
Amendment 146 #
Proposal for a directive
Recital 76
Recital 76
(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to placmake the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.
Amendment 225 #
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
(30 a) ‘platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles. The Commission should promote the development of Platform Technologies that should be part of an open platform, available for the different developers (academic, small biotech and big pharma) generating knowledge and data that once available can accelerate the process of development and evaluation of new therapies. In this context, the supported Platform Technology will appear in the status of PRE-COMPETITION and if it is having advantage of as an existing patent, it will be available under reasonable fee. These Platform Technologies once open to all the stakeholders can be easily updated while having regulatory support in benefit of EU patients. Or. {EN}en
Amendment 231 #
Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)
Article 4 – paragraph 1 – point 36 a (new)
(36 a) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.
Amendment 357 #
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 358 #
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawnrefused.
Amendment 362 #
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 364 #
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 389 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.
Amendment 396 #
Proposal for a directive
Article 56 – paragraph 9
Article 56 – paragraph 9
9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the EU or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product , and any data in its possession relating to the volume of prescriptions.
Amendment 426 #
Proposal for a directive
Article 59 – paragraph 1
Article 59 – paragraph 1
Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those medicinal products have already been marketed with other therapeutic indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the medicinal product on the Union market taking into account the paediatric indication, and make the medicinal product available to patients and the prescribing doctors who requested it in all Member States where the medicinal product is already placed on the market.
Amendment 431 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a package leaflet in paper format in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 441 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.
Amendment 450 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 456 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 462 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the Revised Regulation … after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 480 #
Proposal for a directive
Article 67 – paragraph 6
Article 67 – paragraph 6
6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology, shortage monitoring or prevention, for implementation of Article 56(3), for compliance with enforcement of distributor public service obligations, making product information available electronically, or for data protection prolongation for market launch use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).
Amendment 495 #
Proposal for a directive
Article 74 – paragraph 4 a (new)
Article 74 – paragraph 4 a (new)
4 a. The official language obligation as mentioned in Article 74.1 shall not apply when the product is not intended to be delivered to the patient for self- administration. In this case a single appropriate language can be used.
Amendment 575 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or, severely debilitating or chronic disease and the following conditions are met:
Amendment 584 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, mortality or impact on quality of life;
Amendment 586 #
Proposal for a directive
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of the medicinal product results in: (i) a meaningful reduction in disease morbidity or, mortality, severity or side effects for the relevant patient population; or (ii) a meaningful positive impact on quality of life; or (iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.
Amendment 599 #
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.
Amendment 604 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 612 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 615 #
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 619 #
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product should be designated as a value added medicinal product.
Amendment 625 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, for:the purpose of: (i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining pricing and reimbursement approval; (iv) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 659 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), may cover include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers. This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.
Amendment 670 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 714 #
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.
Amendment 750 #
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.