39 Amendments of Pietro FIOCCHI related to 2023/0132(COD)
Amendment 181 #
Proposal for a directive
Recital 18
Recital 18
(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally 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 product custom-made product forto meet the special needs of an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The use of hospital exemption should apply only where there is neither a centrally authorised medicinal product nor a relevant clinical trial or compassionate use program for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union. The manufacturing of such products should not result in any one of the following conditions over the course a year: (i) standardised process; (ii) repetitive process; (iii) process involving pre-planning other than that which is required for an urgent ad-hoc situation. 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 exemptionall stakeholders. 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 183 #
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 product custom-made product for an individual patientto meet the special needs of an individual patient where there is neither an authorised medicinal product available, a compassionate use programme nor a relevant clinical trial for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). 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 exemptionall stakeholders. 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 278 #
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, without this being considered patent or Supplementary Protection Certificate ( SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of th infringement. The application of this limited exemption is however fragmented across the Union and the 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 limited exemption is however fragmented across the Union and iportant in order to increase competition, reduce pr ices, 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, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC 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, for the reference medicinal product, there can be no commercial uslevant 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 281 #
Proposal for a directive
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(c a) very persistent and very mobile (vPvM);
Amendment 283 #
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1
Article 22 – paragraph 2 – subparagraph 1
or d) are endocrine active agents.
Amendment 290 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. TWhen the ERA indicate a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 294 #
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobialbiotics shall include an evaluation of the risk for antimicrobialbiotic resistance selection in the environment due to the entire manufacturing supply chain inside and outside theof the active substance or medicinal product within the European Union, use and disposal of the antimicrobial antibiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 304 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.
Amendment 313 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified asto potentially harmfulcause a risk to the environment by risk-based prioritisation in accordance with paragraph 2. This programme shall be made publicly available by the Agency.
Amendment 320 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products asthat potentially harmfulcause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.
Amendment 324 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.
Amendment 326 #
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.
Amendment 328 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.
Amendment 334 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobialbiotics to the environmental from manufacturing sites may lead to antimicrobialbiotic resistance (“AMR”‘’ABR’’), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturingantibiotic resistance selection during manufacturing of the antibiotics.
Amendment 339 #
(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 producmedicinal product available to patients and the prescribing doctors who requested it in the same markets within two years of the date of approval of the indication.
Amendment 413 #
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 basisincidentally and exceptionally on a non-routine basis as defined in this paragraph and 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 product custom-made product forto meet the special need of an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). For the purpose of this article “non-routine basis” means advanced therapy medicinal products, prepared on an incidental and exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product nor a relevant clinical trial or compassionate use program for the same indication with an advanced therapy medicinal product for which the patient is eligible [in the Union] and which shall not result in any one of the following conditions over the course a year: (a) standardised process; (b) repetitive process and (c) process involving pre- planning other than that which is required for an urgent ad-hoc situation.
Amendment 416 #
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 exceptionally 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 product custom-made product for an individual patientto meet the special needs of an individual patient in cases of medical need when there is no suitable advanced therapy medicinal product available in the relevant indication, either as an authorised medicinal product, under a compassionate use programme referred to in Article 26 of [revised Regulation 726/2004] or under a clinical trial for which the patient is eligible [in the Union] (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 425 #
Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2
Article 2 – paragraph 2 – subparagraph 2
The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The approval shall be based on a risk- benefit assessment and be compliant with the conditions and definitions under this Article. The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product or no adequate clinical trial option or compassionate use program has been made available in the Union since the grant of the hospital exemption approval, and if the manufacturing of such product does not result in any one of the conditions highlighted in the definition of non- routine basis in paragraph 1, over the course of the year. The Commission, by means of implementing acts, may supplement the details of the application for the approval or renewal of hospital exemption referred to in this Article
Amendment 427 #
Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2
Article 2 – paragraph 2 – subparagraph 2
The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product, compassionate use programme as referred to in referred to in Article 26 of [revised Regulation 726/2004] or no adequate clinical trial option has been made available [in the Union] since the grant of the hospital exemption approval
Amendment 429 #
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 only made available electronically, it shall not preclude the marketing authorisation holder from providing the package leaflet in paper format in addition to the electronic format 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 436 #
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices, long-term follow up and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).
Amendment 438 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, quality, 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 shall 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 439 #
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 442 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, quality, 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 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 446 #
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. Where the hospital exemption approval holder has not complied with the requirements referred to in paragraphs 1, 2, 3 and 4, the hospital exemption approval shall be revoked by the competent authority of the Member State. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.
Amendment 448 #
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 449 #
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.
Amendment 452 #
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, quality, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, in the form of a mandatory publicly accessible and available registry, which shall be regularly updated.
Amendment 457 #
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 459 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a
Article 2 – paragraph 7 – subparagraph 1 – point a
Amendment 460 #
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. After consultation with Member States and relevant stakeholders, the Agency shall implement a system providing public access to the electronic version of the package leaflet, the summary of product characteristics and the labelling on the database provided in Article 138 of [revised Regulation (EC) No 726/2004] The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 462 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point c
Article 2 – paragraph 7 – subparagraph 1 – point c
Amendment 464 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
Amendment 470 #
Proposal for a directive
Article 2 – paragraph 8
Article 2 – paragraph 8
8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter. These reports and the data contained therein shall be made publicly available and shall be considered in any subsequent legislative decision or amendment, following stakeholders' consultation.
Amendment 499 #
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, and during the duration period of the compulsory licencefor the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date such suspension takes effect.
Amendment 605 #
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 611 #
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 616 #
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 618 #
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 shall be designated as a value added medicinal product.