31 Amendments of István UJHELYI related to 2023/0132(COD)
Amendment 182 #
Proposal for a directive
Recital 18
Recital 18
(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the general scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’)(‘hospital exemption’). This should remain incidental and exceptional to meet the special needs of an individual patient and under conditions that avoid that the marketing authorisation system and relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The marketing authorisation system also relies on the outcomes of clinical trials and provides the best guarantee for demonstrating the safety and efficacy of the products. In that light, it is important to avoid that hospital exemption may result in a shortage of patients for clinical trials or that it would undermine the predictability of securing a marketing authorisation for ATMPs. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemptionhelp a general monitoring of the quality, safety and efficacy of the products used. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.
Amendment 187 #
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) The Agency should also establish support programmes to help guiding academic and other not-for-profit entities through the centralised marketing authorisation procedure. This could build on the EMA pilot program for enhanced support to academic and non-profit developers of advanced therapy medicinal products, started in September 2022 and take into account experience with hospital exemption uses.
Amendment 265 #
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 should 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 326 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be refusedsubject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 347 #
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, 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 a certification scheme also for additional 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, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 358 #
Proposal for a directive
Recital 123
Recital 123
(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Proportionate restrictions should also be placed on wholesalers to ensure that products made available on one market are not placed on another market if it would create or exacerbate a shortage for patients.
Amendment 373 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of 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 support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.
Amendment 401 #
Proposal for a directive
Article 1 – paragraph 6
Article 1 – paragraph 6
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.
Amendment 414 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). Such use shall not be made in any one of the following situations: (a) there is a similar advanced therapy medicinal product that is covered by a marketing authorisation granted under [revised Regulation (EC) No 726/2004] and the use in the individual patient is not excluded by the terms of the summary of product characteristics of that product or ; (b) the individual patient is eligible for enrolment in an ongoing clinical trial or compassionate use programme for a similar advanced therapy medicinal product.
Amendment 422 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1 a. For the purpose of this Article, ‘non-routine basis’ means an advanced therapy medicinal product prepared under hospital exemption on an exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product available, nor an ongoing relevant clinical trial or compassionate use programme for the same indication with an advanced therapy medicinal product for which the patient is eligible. Standardised or repetitive processes, as well as major production planning in advance, which can be considered industrial and beyond what is needed to address the immediate clinical needs of individual patients, will be the indications that an activity occurs on a routine basis. The European Medicines Agency will be the deciding body to establish whether a process is on a routine or non-routine basis, and will do so in close consultation with the competent Member State authority and stakeholders, including representatives of hospital exemption approval holders, industry, and patients.
Amendment 424 #
Proposal for a directive
Article 2 – paragraph 2 – subparagraph 1
Article 2 – paragraph 2 – subparagraph 1
The manufacturing of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall notifyprovide a copy of any such approval, as well as subsequent changes, to the Agency. The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. An approval shall be subject to re-evaluation every year, taking into account the data submitted in accordance with paragraph 4, the completeness and reliability of these data, and other relevant information. An approval shall not be maintained when the conditions under paragraph 1 are not fulfilled any more.
Amendment 439 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data will include the results of patient follow-up for a sufficient period of time after the administration of the product. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.
Amendment 463 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point c
Article 2 – paragraph 7 – subparagraph 1 – point c
(c) the modalities for the exchange of knowledge between hospital exemption approval holders and holders of, or applicants for, marketing authorisations for advanced therapy medicinal products within the same Member State or different Member States;
Amendment 473 #
Proposal for a directive
Article 2 – paragraph 8 a (new)
Article 2 – paragraph 8 a (new)
8 a. In order to inform patients, healthcare professionals and other stakeholders, the EMA shall make the hospital exemption approvals, the repository mentioned in paragraph 6 and the reports mentioned in paragraph 8 publicly available, after deletion of personal data and commercially confidential information.
Amendment 475 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 506 #
Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a
Article 4 – paragraph 1 – point 29 – point a
(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or
Amendment 507 #
Proposal for a directive
Article 4 – paragraph 1 – point 29 – point b
Article 4 – paragraph 1 – point 29 – point b
Amendment 512 #
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.
Amendment 576 #
Proposal for a directive
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
Amendment 679 #
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product;
Amendment 784 #
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance in a concentration which are is persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 1209 #
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 as well as the stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].
Amendment 1216 #
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 1228 #
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 1231 #
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 1388 #
Proposal for a directive
Article 106 – paragraph 5
Article 106 – paragraph 5
5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004].
Amendment 1393 #
Proposal for a directive
Article 107 – paragraph 4 a (new)
Article 107 – paragraph 4 a (new)
4 a. The Agency and Member States shall cooperate to achieve high standards of safety in public health delivery, including in the prescribing, administration and monitoring of medicinal products, by supporting the digital transition of health systems in cooperation with healthcare professionals and service providers.
Amendment 1396 #
Proposal for a directive
Article 112 – paragraph 2 a (new)
Article 112 – paragraph 2 a (new)
2 a. Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.
Amendment 1566 #
Proposal for a directive
Article 201 – paragraph 1
Article 201 – paragraph 1
1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall coordinate the review and outcomes of the questions and will publish relevant details after deletion of any information of a commercially confidential nature.
Amendment 1584 #
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
Amendment 1601 #
Proposal for a directive
Article 218 – paragraph 1
Article 218 – paragraph 1
1. The procedures concerning the applications for marketing authorisations for medicinal products validated in accordance with Article 19 of Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] and that were pending on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive] shall be completed in accordance with Article 29Directive 2001/83/EC.