Activities of Kateřina KONEČNÁ related to 2023/0132(COD)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (35)
Amendment 235 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underservedfor which no or only suboptimal treatments are available and to encourage pharmaceutical research and development that truly addresses the needs of patients. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will or subpopulation’, ‘burden of disease’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency shall involve patient representatives in its decision- making, seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interestAs chronic diseases represent 86% of all deaths in the EU, the burden of diseases cannot solely be assessed by measuring mortality and morbidity, but should include relevant patient experience data, including quality of life.
Amendment 345 #
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, including radionuclides and their salts for radionuclide radiopharmaceuticals, and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use of a certification scheme also for additional master files, including quality master files, i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursorchemical precursors for complex radiopharmaceuticals, radionuclides for radiolabelling purposes and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance, as well as for raw materials and starting materials used for manufacturing of cell therapy and gene therapy.
Amendment 398 #
6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days.a given period of time in duly justified cases, including medicine shortages as described in [revised Regulation (EC) No 726/2004] and supply disruptions caused by market withdrawals for commercial reasons. By way of derogation from points (a) and (b) in paragraph 5, pharmacies may prepare medicinal products dispensed outside the hospital pharmacy on a routine basis in the situations described in the first subparagraph
Amendment 533 #
Proposal for a directive
Article 4 – paragraph 1 – point 53 a (new)
Article 4 – paragraph 1 – point 53 a (new)
(53 a) ‘patients’ organisations’ means not-for-profit organisations which are patient focused, and where patients and/or carers, when patients are unable to represent themselves, represent a majority of members in governing bodies;
Amendment 585 #
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior vetting by the competent authority.
Amendment 588 #
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 599 #
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2
Article 18 – paragraph 1 – subparagraph 2
As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device, especially by paediatric patients, including storage, assemblage, hygiene and application/intake technique required.
Amendment 602 #
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
As part of the assessment, in accordance with Article 29, of the medicinal product referred to in the first subparagraph, the competent authorities shall assess the benefit-risk balance of the medicinal product taking into account the use of the medicinal product together with the medical device, especially by paediatric patients, including storage, assemblage, hygiene and application/intake technique required.
Amendment 651 #
Proposal for a directive
Article 22 a (new)
Article 22 a (new)
Amendment 719 #
Proposal for a directive
Article 37 – paragraph 2 – subparagraph 1
Article 37 – paragraph 2 – subparagraph 1
The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States and patients may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.
Amendment 726 #
Proposal for a directive
Article 43 – paragraph 3
Article 43 – paragraph 3
3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet as well as, the information referred to in Article 17 (1) for antimicrobials, and any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.
Amendment 732 #
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 any information of a commercially confidential nature unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 739 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which there is substantial, on duly justified grounds described in the assessment report, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 1244 #
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/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their 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 1249 #
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 usstudies, trials and other activities are conducted for the purposes of:
Amendment 1259 #
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 conductedapplying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variation facilitating health technology assessment as defined in Regulation (EU) 2021/2282; filing for pricing and reimbursement; participating in a tender to generate data for an application, for: able market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.
Amendment 1269 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
Amendment 1280 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
Amendment 1290 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 1327 #
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 1382 #
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or healthcare professionals.
Amendment 1385 #
Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1
Article 106 – paragraph 1 – subparagraph 1
Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e) and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.
Amendment 1473 #
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 1492 #
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 medicinal products othe cost of which may be reimbursedr than those referred to in paragraph 1.
Amendment 1507 #
Proposal for a directive
Article 178 – paragraph 2 a (new)
Article 178 – paragraph 2 a (new)
2 a. The Commission shall adopt delegated 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.
Amendment 1519 #
Proposal for a directive
Article 186 – paragraph 1
Article 186 – paragraph 1
1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which mayshall be based on a system of prior vetting at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.
Amendment 1570 #
Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1
Article 206 – paragraph 1 – subparagraph 1
Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.
Amendment 1580 #
Proposal for a directive
Article 206 – paragraph 3 a (new)
Article 206 – paragraph 3 a (new)
3 a. 4. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive
Amendment 1591 #
Proposal for a directive
Article 208 – paragraph 1
Article 208 – paragraph 1
1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests which shall be made publicly available.
Amendment 1604 #
Proposal for a directive
Annex I – point 13 a (new)
Annex I – point 13 a (new)
(13 a) Patient experience data in accordance with article 22a (new).
Amendment 1615 #
Proposal for a directive
Annex I – point 23 a (new)
Annex I – point 23 a (new)
(23 a) A summary of the applicant’s expected market launch plans in the EU.
Amendment 1616 #
Proposal for a directive
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part
In general, clinical trials shall include patients who are representative of the population to be treated with the new medicinal product, use clinically meaningful endpoints, and be done as ‘controlled clinical trials’ if possible, randomised and as appropriaversus the best proven inte rversusntion; placebo and versuscontrol may be used in addition if necessary and established medicinal product of proven therapeutic value; any other design shall be justified. The treatment of the control groups will vary from case to case and also will depenthical. The Agency shall adopt scientific guidelines on criteria for identifying the best proven intervention(s) taking into account the outcome of the consultation with the Commission, and with the stakeholders involved oin ethicale considerultations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo mechanism referred to in Article 162 of [revised Regulation (EC) 726/2004]. Any study design other than that referred to in the first subparagraph shall be duly justified; the grounds for any exceptions and conditions shall be laid down in a guideline developed by the Agency following the same consultation process described in the second subparagraph. The scientific guidelines adopted by the Agency shall observe the principles of the Declaration of Helsinki.
Amendment 1623 #
Proposal for a directive
Annex IV – paragraph 1 – point j
Annex IV – paragraph 1 – point j
(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;
Amendment 1629 #
Proposal for a directive
Annex VI – paragraph 1 – point 2
Annex VI – paragraph 1 – point 2
(2) the therapeutic indications and efficacy-related information;
Amendment 1630 #
Proposal for a directive
Annex VI – paragraph 1 – point 2 a (new)
Annex VI – paragraph 1 – point 2 a (new)
(2 a) a key information section reflecting the results of consultations with target patients’ organisations to ensure that it is legible, clear and easy to use;