21 Amendments of Alessandra MORETTI related to 2023/0132(COD)
Amendment 369 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public support to then research and development costs of medicinal products, the reporting of all public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial suppos at any stage of the development, including but not limited to contracts, grants, tax breaks, and advance purchase agreements for the development, production and procurement of a particular medicinal product and its underlying technology and intellectual propert,y such as direct granthould be a requirement for all all market authorizations for contramedical products. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any directform of financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.
Amendment 589 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority mayshall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.
Amendment 731 #
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of anyincluding information of a commercially confidential nature if their disclosure is in the public interest or relevant for public health reasons. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 747 #
Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1
Article 46 – paragraph 1 – subparagraph 1
Amendment 753 #
Proposal for a directive
Article 46 – paragraph 2
Article 46 – paragraph 2
2. The marketing authorisation holder may submit an application for ao renewal of a national marketing authorisation granted under paragraph 1, second or third subparagraph. Such application shall be submitted, the marketing authorisation holder shall submit an application at least nine months before the national marketing authorisation ceases to be valid.
Amendment 1243 #
Proposal for a directive
Article 84 a (new)
Article 84 a (new)
Article84a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and the competent authorities of the Member States responsible for pricing and reimbursement a report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2.The Commission shall adopt implementing in acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 1254 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 1266 #
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, forfor the purpose of:
Amendment 1275 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) applying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 1283 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) facilitating health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1296 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) filing for pricing and reimbursement.
Amendment 1300 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in a tender to enable market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.
Amendment 1326 #
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 the submission of the application for a marketing authorisation andfalling under the first subparagraph include the submission of the relevant files to the competent authorities or bodies for their assessment, the offer, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1406 #
Proposal for a directive
Article 123 – paragraph 1 – point b a (new)
Article 123 – paragraph 1 – point b a (new)
(b a) scientific guidance on post- authorisation treatment optimisation studies.
Amendment 1467 #
Proposal for a directive
Article 176 – paragraph 3 – point b
Article 176 – paragraph 3 – point b
(b) shall be accurate, verifiable, based on strict scientific evidence and data and not be misleading.
Amendment 1471 #
Proposal for a directive
Article 176 – paragraph 4
Article 176 – paragraph 4
4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics.
Amendment 1478 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) contains substances that might generate addiction.
Amendment 1490 #
Proposal for a directive
Article 177 – paragraph 2 a (new)
Article 177 – paragraph 2 a (new)
2 a. products for which there is no scientifically based proof of efficacy, such as homeopatic or traditional medicinal products, shall not be advertised as valid alternatives to science based therapies and medicinal products, and their advertisement shall clearly inform the public regardig the lack of scientific base for their effects and therapeutic efficacy;
Amendment 1491 #
Proposal for a directive
Article 177 – paragraph 3
Article 177 – paragraph 3
3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of any medicinal products the cost of which may be reimbursed., particularly for public health reasons and to prevent overuse and misuse of such products;
Amendment 1500 #
Proposal for a directive
Article 178 – paragraph 1 – point a a (new)
Article 178 – paragraph 1 – point a a (new)
(a a) an explicit reminder of the potential risks associated to self medication together with the request to keep the family doctor informed about the use of any medicinal product;
Amendment 1505 #
Proposal for a directive
Article 178 – paragraph 2 a (new)
Article 178 – paragraph 2 a (new)
2 a. The European Commission shall adopt implementing acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.