Activities of Catherine AMALRIC 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 (75)
Amendment 144 #
Proposal for a directive
Recital 2
Recital 2
(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal treatments, inappropriate or highly burdensome treatments or treatments addressing subpopulations of a disease only. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.
Amendment 147 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and establishes a conducive environment for the research, development, and manufacturing of pharmaceuticals within the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 150 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 151 #
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public- private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.
Amendment 153 #
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.
Amendment 155 #
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4 a) This revision should align with the EU's ambitions in industry, digitalization, and trade, acknowledging the critical role of the European life sciences sector, especially the pharmaceutical industry, in upholding the EU's competitive edge. Bolstering robust European research and development is crucial for European sovereignty within the ambit of a globally competitive geopolitical landscape. The pharmaceutical legislative framework should be attuned to the broader EU industrial strategy, echoing the Council's emphasis from 23 March 2023 on amplifying incentives for investment in innovation and the 2016 Council's guidance that any amendments, including those affecting the incentive system, should not hinder the creation of drugs for rare disease treatment. Advancements in innovation are pivotal for enhancing patient health outcomes and the wider public health sector.
Amendment 156 #
Proposal for a directive
Recital 4 b (new)
Recital 4 b (new)
(4 b) This Directive should acknowledge that fostering a competitive pharmaceutical industry within the EU, bolstering EU-based clinical trials, and localizing the manufacture of active pharmaceutical ingredients are complementary objectives that enhance the Union's strategic health autonomy while increasing the affordability, accessibility, and availability of medicinal products, thereby supporting a more resilient and sustainable European health ecosystem.
Amendment 164 #
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the UnionEU's pharmaceutical industry, in particular of SMEs. Furthermore, it should aim to prioritize the expansion of EU-based clinical trials and the local production of active pharmaceutical ingredients, thereby reinforcing the strategic autonomy of the European health ecosystem. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, EU-based innovation and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 188 #
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) The Agency should create a program aimed at assisting academic institutions and non-profit organizations in navigating the centralized marketing authorization process. This initiative should be informed by insights from the EMA's pilot program that began in September 2022, which provided specialized support to academic and non- profit developers of advanced therapy medicinal products.
Amendment 220 #
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 222 #
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, tcooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 225 #
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases, antibiotics and generic and biosimilar medicinal products. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 251 #
Proposal for a directive
Recital 53 a (new)
Recital 53 a (new)
(53 a) During negotiations, developers and Member States should imperatively respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.
Amendment 262 #
Proposal for a directive
Recital 58
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. In addition, the timelines set by Directive 89/105/EEC should be respected during the negotiations between Member States and marketing authoriation holder to ensure a fast and timely patient's access to medicines.
Amendment 266 #
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Supply assurance can also be achieved through national strategies that facilitate patient access, such as programs for named patients, tailored individual patient initiatives, and the uptake and optimization of cross-border healthcare options, as stipulated in Directive 2011/24/EU. It is crucial to bolster cross- border healthcare, especially for treatments that require specialized infrastructure or technical expertise that may be lacking in certain Member States.
Amendment 308 #
Proposal for a directive
Recital 67
Recital 67
(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who. Member States should ensure appropriate collection system for all medicinal products.
Amendment 316 #
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.
Amendment 324 #
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 should be refused. The ERA should be updated when new data or knowledge about relevant risks become available. The Commission may explore creating an ecolabeling of medicinal products which respect the ERA's guidelines during their entire life cycle.
Amendment 346 #
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 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 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, radiopharmaceutical precursors 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 the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.
Amendment 357 #
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. Member States should also impose certain obligations of public services to wholesalers within the limits of their responsibilities to ensure that medicinal products made available on one market are not placed on another market to avoid creating a shortage for patients.
Amendment 359 #
Proposal for a directive
Recital 123 a (new)
Recital 123 a (new)
(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.
Amendment 363 #
Proposal for a directive
Recital 128
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.
Amendment 367 #
Proposal for a directive
Recital 130
Recital 130
(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.
Amendment 387 #
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Amendment 395 #
Proposal for a directive
Article 1 – paragraph 5 – point c a (new)
Article 1 – paragraph 5 – point c a (new)
(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.
Amendment 396 #
Proposal for a directive
Article 1 – paragraph 5 – point c b (new)
Article 1 – paragraph 5 – point c b (new)
(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.
Amendment 400 #
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 daysaccording to appropriate stability.
Amendment 408 #
Proposal for a directive
Article 1 – paragraph 10 – point a
Article 1 – paragraph 10 – point a
Amendment 419 #
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 and a hospital pharmacist, 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’).
Amendment 430 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
Amendment 434 #
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 thegood pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices 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 443 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety, quality 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 447 #
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. If a hospital exemption approval is revoked due to safety, quality, 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 456 #
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, safety, quality 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 publicly accessible repository of that data in the form of an EU-wide registry.
Amendment 465 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 466 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 497 #
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antiparasitics and antifungals;
Amendment 514 #
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
(30 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, and which is prepared in a separate document by the owner of the platform technology. 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 522 #
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, including global warming, or risks to public health, posed by the release of the medicinal productmanufacture, use and disposal of the medicine, as well as its release into the environment from the use and disposal of the medicinal product and. The assessment includes the identifictermination of riskmeasures to prevention, limitation and mitigation measuree these risks. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 550 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1 (new)
Article 6 – paragraph 2 – subparagraph 1 (new)
The marketing authorisation application shall include the results of controlled clinical trials randomised versus an established medicinal product of proven therapeutic value with clinical endpoints or versus placebo in case of lack of established medicinal product of proven therapeutic value. Any other design shall be duly justified and accepted only for exceptional situations.
Amendment 551 #
Proposal for a directive
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. The marketing authorisation application shall include the particulars and documentation listed in Annex I, submitted in accordance with Annex II. Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product for which an active substance master file, an additional quality master file and/or a platform technology master file exists and is referred to in the application.
Amendment 593 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
Amendment 596 #
Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)
Article 17 – paragraph 3 – subparagraph 1 (new)
Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.
Amendment 598 #
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, particularly for paediatric patients, encompassing aspects such as storage, assembly, cleanliness, and the technique required for application or intake.
Amendment 607 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, and guidelines relating to the assessment of the greenhouse gas emissions footprint of a medicine, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 618 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. 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. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.
Amendment 622 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. 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 during the manufacture and use of the medicine. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 630 #
Proposal for a directive
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3 a. The applicant also includes in the ERA an assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product. It specifies risk mitigation measures aimed at limiting greenhouse gas emissions during the production and use of the medicine. The applicant explains in detail that the proposed mitigation measures are appropriate and sufficient to limit these emissions in line with the European Union's climate objectives of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework required to achieve climate neutrality.
Amendment 632 #
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 648 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The results of the ERA assessment, including data provided by the marketing authorisation holder, shall be made publicly available by the Agency or, where appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.
Amendment 650 #
Proposal for a directive
Article 22 – paragraph 7 b (new)
Article 22 – paragraph 7 b (new)
7 b. With regard to medicinal products referred to in Articles 9 to 12, the applicant may take into account the ERAs carried out for the reference medicinal product when carrying out the ERA.The Commission is empowered to adopt delegated acts in accordance with Article 215, in order to supplement this Directive by specifying: a) reference methodologies for assessing the greenhouse gas emissions footprint of the production and use of the medicinal product; (b) the minimum data on which to base the assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product; (c) reference methodologies for the assessment of environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product; d) the minimum data on which to base the assessment of the environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product.
Amendment 652 #
Proposal for a directive
Article 22 a (new)
Article 22 a (new)
Article 22a In accordance with Article 6(2), applicants for marketing authorization are required to incorporate data on patient experiences within their application dossiers. If inclusion of such data is not feasible, applicants must present a comprehensive explanation to the Agency. The Agency shall cooperate with patient organizations, Member State authorities, and other pertinent entities to develop guidance on the creation, execution, analysis, and reporting of studies that integrate substantial and significant patient experience data for regulatory purposes.
Amendment 668 #
Proposal for a directive
Article 23 – paragraph 4 a (new)
Article 23 – paragraph 4 a (new)
4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.
Amendment 678 #
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 including cell and gene therapies;
Amendment 690 #
Proposal for a directive
Article 28 – paragraph 1 – point b a (new)
Article 28 – paragraph 1 – point b a (new)
(b a) the creation of the product occurred within a regulatory sandbox as outlined by Article 114 (2) of [revised Regulation (EC) No 726/2004], unless exceptions are warranted by scientific and technical reasoning.
Amendment 693 #
Proposal for a directive
Article 28 – paragraph 6 a (new)
Article 28 – paragraph 6 a (new)
6 a. When enacting delegated acts under this Article, the Commission shall engage in dialogue with the Agency, national competent authorities, the Pharmaceutical Committee, and pertinent interested parties.
Amendment 694 #
Proposal for a directive
Article 28 – paragraph 6 b (new)
Article 28 – paragraph 6 b (new)
6 b. The Commission shall submit a report on the acquired experience with adapted frameworks to the European Parliament and the Council of the European Union. The first report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Based on the report's findings, the Commission may propose legislative changes to the overarching pharmaceutical laws, reflecting the practical insights gained from employing adapted frameworks. d frameworks.
Amendment 763 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;
Amendment 771 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial of systemic administration; or
Amendment 789 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may setdecide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 1383 #
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 1384 #
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 1397 #
Proposal for a directive
Article 112 a (new)
Article 112 a (new)
Amendment 1445 #
Proposal for a directive
Article 160 – paragraph 2 a (new)
Article 160 – paragraph 2 a (new)
2. The Commission is empowered to adopt delegated acts in order to supplement this Directive by establishing, within good manufacturing practices for medicinal products and active substances, principles, guidelines and detailed guidelines to ensure that water pollution , soil and air linked to their manufacture are reduced as much as possible, in accordance with the state of scientific knowledge. The obligations created by the delegated acts will first have been the subject of a feasibility study including at least an assessment of their impacts in terms of environmental risk management and security of supply for the European market.
Amendment 1457 #
Proposal for a directive
Article 167 – paragraph 3 a (new)
Article 167 – paragraph 3 a (new)
Amendment 1474 #
Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)
Article 177 – paragraph 1 – subparagraph 1 (new)
Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.
Amendment 1545 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
Amendment 1555 #
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.
Amendment 1565 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.
Amendment 1567 #
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 oversee the examination and results of inquiries and disclose pertinent information, ensuring any commercially sensitive data is removed prior to publication.
Amendment 1582 #
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 medicinal products gathered are managed appropriately, preventing any technically preventable environmental leakage.
Amendment 1588 #
Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)
Article 207 – paragraph 1 – subparagraph 1 (new)
Member States shall promote awareness- raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.
Amendment 1590 #
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 and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.
Amendment 1594 #
Proposal for a directive
Article 208 – paragraph 2 a (new)
Article 208 – paragraph 2 a (new)
2 a. 3. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.
Amendment 1598 #
Proposal for a directive
Article 216 – paragraph 1
Article 216 – paragraph 1
By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, in particular regarding the prolongation of data protection period to take into account the evolution of scientific knowledge and innovation.