Activities of Susana SOLÍS PÉREZ related to 2023/0132(COD)

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 4 b (new)

(4 b) This Directive acknowledges 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the ~~Union~~EU's pharmaceutical industry, in particular of SMEs. Furthermore, it aims 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.

2023/12/01
Committee: ITRE

Proposal for a directive
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 custom-made product for 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’ ). Hospital exemptions are granted strictly when there is no certified medicinal alternative available, nor an appropriate clinical trial or compassionate use program that aligns with the therapeutic needs for an ATMP for which the patient is qualified within the European jurisdiction, provided that the production of such therapy is a singular event and not part of a standard manufacturing cycle. The system for granting marketing authorizations is underpinned by the evidence from clinical trials, which is essential for confirming product safety and effectiveness. Therefore, it's crucial to ensure that the hospital exemption does not deplete the pool of clinical trial participants or jeopardize the reliability of the marketing authorization process for Advanced Therapy Medicinal Products (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 exemption~~assist in the overall surveillance of the products’ quality, safety, and effectiveness.. 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 18 a (new)

(18 a) The Agency ought to 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 48

(48) ~~While pricing and reimbursement decisions are a Member State competence~~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.

2023/12/01
Committee: ITRE

Proposal for a directive
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. _________________ 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, antibiotics and generic and biosimilar medicinal products.

2023/12/01
Committee: ITRE

Proposal for a directive
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 lack effective treatments or where only less-than-ideal therapies exist, with the aim of spurring pharmaceutical research and development that genuinely meets patient requirements.that are currently underserved. 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~~ ’, ‘quality of life’, ‘burden of administration’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency shall include patient representatives in its decision-making processes, will 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 interest~~Given that chronic diseases account for 86% of all deaths in the EU, the assessment of disease burden should not be limited to mortality and morbidity metrics alone but ought to incorporate relevant data on patient experiences, including aspects related to quality of life. The inclusion of new therapeutic indications to an authorised medicinal products contributes to the access of patients to additional therapies and therefore should be incentivised.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 50 a (new)

(50 a) Advancing treatments in neglected therapeutic areas can significantly enhance patient lives, particularly by considering the management of side effects, daily functioning, pain, and co- existing illnesses. Enhancements in patient quality of life may lead to their re- engagement in work or education, benefiting both the individual and society by reducing economic burdens. Additionally, new treatments can lessen the load on caregivers, with wider social benefits. Defining these therapeutic areas and unmet needs should involve consultation with stakeholders like patients, healthcare providers, and industry experts.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 53

(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not..

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 53 a (new)

(53 a) It is imperative in negotiations between developers and Member States to respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 59 a (new)

(59 a) If negotiations between Member States and developers are conducted sincerely but fail to result in an agreement on the distribution and ongoing supply of a therapy, the introduction of a mediation process is warranted. This mechanism, overseen by the Commission, should safeguard developers from unfairly missing out on incentives due to factors beyond their influence.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures in instances where the ERA indicates that medicinal products may be hazardous to the environment. 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 and does not rectify deficiencies highlighted by the Agency or relevant authority, the marketing authorisation holder should be ~~refused~~subject to proportionate measures taken to ensure compliance while not hindering or postponing patient access to medications. The ERA should be updated when new data or knowledge about relevant risks become available.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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 its 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 digitalisation of package leaflets.

2023/12/01
Committee: ITRE

Proposal for a directive
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

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the ~~Union~~EU'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.

2023/11/21
Committee: ENVI

Proposal for a directive
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 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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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~~incidentally 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 custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). Within the context of this Article, 'non- routine basis' refers to the tailored preparation of an advanced therapy medicinal product under a hospital exemption, which occurs sporadically, under extraordinary circumstances, and is not part of a regular process, aimed at addressing the unique health requirements of a specific patient. This is applicable when no medicinal product with central authorization is accessible, nor is there a suitable clinical trial or program for compassionate use active for that particular medical need, for which the patient qualifies within the European Union. Indicators that an activity is conducted routinely include: (a) production of a product through processes that are standardized or repetitive; (b) engagement in planning processes that extend beyond the immediate clinical requirements of individual patients. The Agency is authorized to formulate guidelines for the practical application of what constitutes a 'non-routine basis'. In doing so, it must engage with national regulatory authorities and key stakeholders, including entities holding hospital exemption approvals, the pharmaceutical industry, and patient groups. Reflecting advancements in science and technology, the Commission has the authority to update the definition of 'non- routine' through implementing acts.

2023/12/01
Committee: ITRE

Proposal for a directive
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 custom-made product for 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’). Hospital exemptions should be granted strictly when there is neither a certified medicinal alternative available, nor an appropriate clinical trial or compassionate use program that aligns with the therapeutic needs for an Advanced Therapy Medicinal Product (ATMP) for which the patient is qualified within the European jurisdiction, provided that the production of such therapy is a singular event and not part of a standard manufacturing cycle. The system for granting marketing authorizations is underpinned by the evidence from clinical trials, which is essential for confirming product safety and effectiveness. Therefore, it is crucial to ensure that the hospital exemption does not deplete the pool of clinical trial participants or jeopardize the reliability of the marketing authorization process 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 exemption~~assist in the overall surveillance of the products’ quality, safety, and effectiveness.. 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.

2023/11/21
Committee: ENVI

Proposal for a directive
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. Approval will be contingent on an evaluation of the risks and benefits, adhering to the stipulations and interpretations provided in this Article. Such approval will not exceed a one-year term and can only be renewed after a thorough review to confirm the ongoing necessity of the hospital exemption for individual patient requirements. This includes verifying the continued absence of any centrally approved product, suitable clinical trial, compassionate use program, or other regulated options within the EU since the original approval was granted, and ensuring that the production of the product remains infrequent as specified in this article. The Commission is empowered to elaborate on the particulars of submitting and updating applications for hospital exemption approval as delineated in this Article, through implementing acts.

2023/12/01
Committee: ITRE

Proposal for a directive
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 collected data must encompass ongoing monitoring results for an adequate duration following the product's use. 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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 2 – paragraph 5

5. Should the holder of the hospital exemption approval fail to meet the conditions outlined in the preceding paragraphs, the authorization will be withdrawn by the national regulatory authority. 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 as well as inform the patient who has received the advanced therapy medicinal product produced under the hospital exemption. Additionally, there should be a notification to the patient who has been administered the advanced therapy medicinal product formulated under the hospital exemption.

2023/12/01
Committee: ITRE

Proposal for a directive
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 , such an EU-wide registry will be obligatory and open to the public, requiring regular updates to remain current and encompass a catalogue of the advanced therapy medicinal products formulated under hospital exemption currently employed in the Union, also specifying instances where such approval has been suspended or revoked.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 a (new)

the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.

2023/12/01
Committee: ITRE

Proposal for a directive
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. The contents of these reports, which detail the data, will be accessible to the public and will be taken into account during future legislative deliberations or amendments, subsequent to consultations with involved parties.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Dacian CIOLOŞ

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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;

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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 lack effective treatments or where only less-than-ideal therapies exist, with the aim of spurring pharmaceutical research and development that genuinely meets patient requirements.that are currently underserved. 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~~, ‘quality of life’, ‘burden of administration’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency should include patient representatives in its decision-making processes, will 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 interest.~~ Given that chronic diseases account for 86% of all deaths in the EU, the assessment of disease burden should not be limited to mortality and morbidity metrics alone but ought to incorporate relevant data on patient experiences, including aspects related to quality of life. The inclusion of new therapeutic indications to an authorised medicinal products should contribute to the access of patients to additional therapies and therefore should be incentivised.

2023/11/21
Committee: ENVI

Proposal for a directive
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 underserved. 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’ and 'quality of life' following scientific assessment by the Agency. The Agency will 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], consult relevant stakeholders including representatives from patient's organisations, healthcare professionals and industry 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 interest.

2023/11/21
Committee: ENVI

Proposal for a directive
Recital 50 a (new)

(50 a) Advancing treatments in neglected therapeutic areas can significantly enhance patient lives, particularly by considering the management of side effects, daily functioning, pain, and co- existing illnesses. Enhancements in patient quality of life should be able to lead to their re-engagement in work or education, benefiting both the individual and society by reducing economic burdens. Additionally, new treatments can lessen the load on caregivers, with wider social benefits. Defining these therapeutic areas and unmet needs should involve consultation with stakeholders like patients, healthcare providers, and industry experts.

2023/11/21
Committee: ENVI

Proposal for a directive
Recital 53

(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.

2023/11/21
Committee: ENVI

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 17 – paragraph 3

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 17 – paragraph 3 a (new)

3 a. 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Recital 59 a (new)

(59 a) If negotiations between Member States and developers are conducted sincerely but fail to result in an agreement on the distribution and ongoing supply of a therapy, the introduction of a mediation process should be warranted. This mechanism, overseen by the Commission, should safeguard developers from unfairly missing out on incentives due to factors beyond their influence.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1

For integral combinations of a medicinal product and a medical device the marketing authorisation applicant shall submit data establishing the safe and effective use of the integral combination of the medicinal product and the medical device, particularly for pediatric patients, encompassing aspects such as storage, assembly, cleanliness, and the technique required for application or intake .

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 22 a (new)

Article22a 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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures in instances where the ERA indicates that medicinal products may be hazardous to the environment. 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 and does not rectify deficiencies highlighted by the Agency or relevant authority, the marketing authorisation holder should be ~~refused~~subject to proportionate measures taken to ensure compliance while not hindering or postponing patient access to medications. The ERA should be updated when new data or knowledge about relevant risks become available.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
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;

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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 inaugural report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Depending 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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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 may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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;

2023/12/01
Committee: ITRE

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial~~biotic with an identified antimicrobial resistance risk; or

2023/12/01
Committee: ITRE

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

2023/12/01
Committee: ITRE

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~~incidentally 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 custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). For the purpose of this Article, 'non-routine basis' refers to the tailored preparation of an advanced therapy medicinal product under a hospital exemption, which occurs sporadically, under extraordinary circumstances, and is not part of a regular process, aimed at addressing the unique health requirements of a specific patient. This is applicable when no medicinal product with central authorization is accessible, nor is there a suitable clinical trial or program for compassionate use active for that particular medical need, for which the patient qualifies within the European Union. Indicators that an activity is conducted routinely include: (a) production of a product through processes that are standardized or repetitive; (b) engagement in planning processes that extend beyond the immediate clinical requirements of individual patients. The Agency is authorized to formulate guidelines for the practical application of what constitutes a 'non-routine basis'. In doing so, it shall engage with national regulatory authorities and key stakeholders, including entities holding hospital exemption approvals, the pharmaceutical industry, and patient groups. Reflecting advancements in science and technology, the Commission has the authority to update the definition of 'non-routine' through implementing acts.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared indicentally and exceptionally 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’).

2023/11/21
Committee: ENVI

Proposal for a directive
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. Approval will be contingent on an evaluation of the risks and benefits, in complicance with the requirements and interpretations provided in this Article.Such approval will not exceed a one-year term and can only be renewed after a thorough review to confirm the ongoing necessity of the hospital exemption for individual patient requirements.This includes verifying the continued absence of any centrally approved product, suitable clinical trial, compassionate use program, or other regulated options within the EU since the original approval was granted, and ensuring that the production of the product remains infrequent as specified in this article. The Commission is empowered to elaborate on the particulars of submitting and updating applications for hospital exemption approval as delineated in this Article, through implementing acts.

2023/11/21
Committee: ENVI

Proposal for a directive
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 productAfter carefully considering all relevant factors, including but not limited to the level of digitalisation of the country and the status of digital literacy of its citizens, Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. The electronic format should allow the reactive integration of new data on the drug including pharmacovigilance data. 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 made available electronically, a paper package leaflet in addition to the electronic format may always be made available 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.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 63 – paragraph 3 – subparagraph 1 (new)

By derogation from paragraph 3, when the medicinal products is not delivered directly to the patients, such as in hospital environment, the package leaflet may be available only in electronic format.

2023/12/01
Committee: ITRE

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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 collected data must encompass ongoing monitoring results for an adequate duration following the product's use. 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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 63 – paragraph 4 – subparagraph 1 (new)

A package leaflet shall include key information summarising benefit and harma data for each authorised indication.

2023/12/01
Committee: ITRE

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 5

5. Should the holder of the hospital exemption approval fail to meet the conditions outlined in the preceding paragraphs, the authorization will be withdrawn by the national regulatory authority. 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. as well as inform the patient who has received the advanced therapy medicinal product produced under the hospital exemption. Additionally, there should be a notification to the patient who has been administered the advanced therapy medicinal product formulated under the hospital exemption.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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, such an EU-wide registry will be obligatory and open to the public, requiring regular updates to remain current and encompass a catalogue of the advanced therapy medicinal products formulated under hospital exemption currently employed in the Union, also specifying instances where such approval has been suspended or revoked.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

(a a) the data to be collected by Member States, including a description of the use of hospital exemption, the number of patients treated, the clinical and quality of life outcomes used to measure efficacy and safety of the advance therapy medicinal products prepared under the hospital exemption;

2023/11/21
Committee: ENVI

Susana SOLÍS PÉREZ, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

(a a) the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.

2023/11/21
Committee: ENVI

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 63 – paragraph 7 – subparagraph 1 (new)

The progressive transition to the electronic version of the package leaflet shall be supported by pharmacists in their duties to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and, if needed, to design a personalised pharmaceutical plans, as prescription assistance software and dispensing assistance software evolve.

2023/12/01
Committee: ITRE

Proposal for a directive
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. The contents of these reports, which detail the data, will be accessible to the public and will be taken into account during future legislative deliberations or amendments, subsequent to consultations with involved parties.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 64 – paragraph 2 – subparagraph 1 (new)

In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [revised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in Article 112a and followed by a standardised explanatory sentence.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 66 – paragraph 2 – point a a (new)

(a a) the strength of the medicinal product;

2023/12/01
Committee: ITRE

Proposal for a directive
Article 66 a (new)

Article66a Labelling of blister packs in case of unit dose dispensing Wherever a Member State imposes dispensing of medicinal products by pharmacists, to fight against antibioresistance, or for any other reason, it ensures that the doses are packaged and labelled on unit dose pre-cut blisters. Each per-cut blister shall include the following labelling particulars : (a) the name of the medicinal product; (b) the strength of the medicinal product; (c) a data matrix barcode in which the following information is encoded: (i) the Global Trading Index Number (GTIN); (ii) the expiry date; (iii) the batch number. Member States shall promote the use of unit dose pre-cut blisters in hospital environment and, progressively, in dispensing pharmacies, when necessary.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 69 – paragraph 3 – subparagraph 1 (new)

Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 69 a (new)

Article69a The marketing authorization holder may add to the fixed-dose combination medicinal product's packaging an "awareness card" in digital or paper form. This card shall inform patients about the importance therapeutic adherence and available support for adherence in their Member State. The content of the awareness card should comply with Annex VI.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 74 – paragraph 4 – subparagraph 1 (new)

The offical language obligation as mentioned in paragraph 1 shall not apply when the medicinal product is not intended to be delivered to the patient for slef-administration.In this case a single appropriate language could be used.

2023/12/01
Committee: ITRE

Proposal for a directive
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;

2023/11/21
Committee: ENVI

Proposal for a directive
Article 81 – paragraph 1

1. The regulatory data protection period shall be ~~six~~nine years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

(a) 2436 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within ~~three~~four years from that date for any of the following entities:

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

(b) ~~six~~12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) ~~six~~12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accord with article 215;

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d a (new)

(d a) 12 months, where the marketing authorisation applicant has submitted a clinical trial application for a new medicinal product within the territory of the EU.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d b (new)

(d b) 12 months, for new medicinal products developed, produced, used and diposed in full respect of the scientific guidelines of the environmental risk assessment of medicinal products for human use.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)

(d c) 12 months, where the marketing authorisation applicant has committed to support the establishment of public- private partnerships, University Hospital Institutes, centres of excellence and bioclusters to accelerate research and development of a new medicinal product.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)

(d d) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced within the EU.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 1

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are ~~released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients~~made available to patients or prescribing doctors who requested the medicinal product, in the Member States in which the marketing authorisation is valid.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 – introductory part

The application for a variation shall contain documentation from the Member States competent authority in which the marketing authorisation is valid. Such documentation shall:

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 3

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State competent authority. Within 60 days from the request of the marketing authorisation holder, the ~~Member State~~competent authority shall issue a confirmation of compliance or, a reasoned statement of non-compliance based on objective and veriafable criteria, or alternatively provide a statement of non- objection to prolong the period of regulatory data protection pursuant to this Article. When a competent authority issues a justified statement of non-fulfilment, it must detail the requisite actions that would allow the conditions to be met and enable the resubmission of a request for confirmation of fulfilment within a reasonable e time frame. The authority shall subsequently provide a confirmation of fulfilment or a reasoned statement of non-fulfilment within two months from the date of the resubmission request.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 3 a (new)

3 a. The Commission is tasked with creating a mediation mechanism via implementing acts. This mechanism will support dialogue between developers and Member States to address disputes arising from a declaration of non-compliance by a Member State after earnest negotiations, or due to negotiation delays. Within this framework, there will be an option for a Commission decision that can supersede the documents referred to in paragraph 2.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 4 – subparagraph 1

In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non- objection has been provided. Should a Member State fail to adhere to the deadlines specified in Articles 2 and 6 of Directive 89/105/EEC, the conditions outlined in paragraph 1 will cease to be applicable within that Member State's jurisdiction with regard to the extension period.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 6

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. ~~Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).~~

2023/12/01
Committee: ITRE

Proposal for a directive
Article 82 – paragraph 6 a (new)

6 a. The Commission, via implementing acts, shall compile a list of products that, either due to their nature or other duly justified and accredited limiting factors or technical specificites, shall be exempt from the stipulations outlined in Article 81(2), point (a), and within this same Article 81, paragraphs 1 to 7. These specified products will be granted an automatic extension of the data protection period for 12 months, as detailed in Article 81(2), point (a). The adoption of these implementing acts shall proceed in line with the examination procedure described in Article 214(2) and (3).

2023/12/01
Committee: ITRE

Proposal for a directive
Article 83 – paragraph 1 – introductory part

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening, chronic, or severely debilitating disease and the following conditions are met:

2023/12/01
Committee: ITRE

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; the product lessens the complexity or frequency of treatment or administration, or the profile of adverse reactions; the product enhances patients' quality of life;

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population or specific subpopulation.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 83 – paragraph 3

3. ~~Where~~In close cooperation with HTA bodies, the Agency adopts scientific guidelines for the application of this Article it shall take into account the effect of the condition on life expectancy with the provision of standard care; the influence of the condition on patient experience, encompassing quality of life, after administering the current standard of care; and the suitability of the present standard of care for the patient. In formulating these guidelines, the Agency shall include members from patient organizations related to the pertinent disease areas, and consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004].

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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;

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 112 a (new)

Article112a Medicines under additional monitoring 1.The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the international non-proprietary names and active substances of: (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence. 5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 167 – paragraph 3 a (new)

3 a. To ensure continued supply to patients, the wholesale distributors shall not be authorised to supply medicinal products in another Member State should this, in any way, prevent them from covering the needs of the patients in the Member States concerned.

2023/12/01
Committee: ITRE

Proposal for a directive
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 may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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, including 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. Should the environmental risks, which also encompass public health dangers, surpass the therapeutic benefits for the intended patients and if these risks are not adequately reducible, the relevant Member State authorities or the Commission may revoke the marketing authorization of the holder.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Proposal for a directive
Article 208 – paragraph 2 a (new)

2 a. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.

2023/12/01
Committee: ITRE

Proposal for a directive
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.

2023/12/01
Committee: ITRE

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
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;

2023/11/21
Committee: ENVI

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial~~biotic with an identified antimicrobial resistance risk; or

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
Article 112 a (new)

Article112a Medicines under additional monitoring 1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the international non-proprietary names and active substances of: (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence. 5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 167 – paragraph 3 a (new)

3 a. To ensure continued supply to patients, the wholesale distributors shall not be authorised to supply medicinal products in another Member State should this, in any way, prevent them from covering the needs of the patients in the Member States concerned.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. Should the environmental risks, which also encompass public health dangers, surpass the therapeutic benefits for the intended patients and if these risks are not adequately reducible, the relevant Member State authorities or the Commission may revoke the marketing authorization of the holder.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
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.

2023/11/21
Committee: ENVI

Proposal for a directive
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.

2023/11/21
Committee: ENVI