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From · opinion parliamentary committee · 2024-02-22 ITRE-AD-754773 on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

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To · opinion parliamentary committee draft · 2023-11-07 ITRE-PA-754773 on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

+124 added · −343 removed · 9 modified paragraphs hide unchanged text

Proposal for a directive

~~Recital 3~~

Article 47 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for 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.

(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;

(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 administrative burden as well as 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.

(d) The content or timelines of post-authorisation studies to further clarify environmental risk assessment, as required under Article 44 (h), cannot be agreed.

Or. en

Justification

Rejecting initial marketing authorization solely on the basis of environmental risk assessment is not appropriate, especially in cases where the necessary data can only be gathered post-marketing or when there's no established scientific consensus (e.g., antimicrobial resistance) or overly conservative assumptions are utilized. A more suitable approach would involve promoting the collection of high-quality post-approval data, accompanied by binding and time-constrained commitments as outlined in Article 44 and 87.

Amendment 2

Proposal for a directive

~~Recital~~Article 458 a (new)

Text proposed by the Commission

Amendment

(4 a) The pharmaceutical framework should be consistent with overarching EU industrial policy, including the Council Conclusions from 23 March 2023 which stressed the importance of strengthening incentives for investment in innovation and the 2016 Council Conclusions which stress any revision, including to the incentive framework, should not discourage the development of medicinal products needed for the treatment of rare diseases; increased innovation will further support patient outcomes and public health.

Article 58a

Obligation to submit an application for pricing and reimbursement in all Member States

1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith an application for pricing and reimbursement no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities:

(i) SMEs;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

(iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b.

2. For the purposes of paragraph 1 of this Article, Member States shall make their request within two years of the granting of a marketing authorisation. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the timelines laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State.

3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product directly available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement only in the Member States where the relevant patient population has been identified.

4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall cease.

5. The Commission shall, after consultation of the Agency, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. Inclusion of a medicinal product in that list may be based on criteria such as the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.

7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the submission of applications for pricing and reimbursement and Directive 89/105/EEC. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency.

Or. en

Amendment 3

Proposal for a directive

~~Recital~~Article 458 b (new)

Text proposed by the Commission

Amendment

(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.

Article 58b

EU Access to Medicines Notification System

1. The Commission shall, in collaboration with the Member States, set up and maintain an electronic notification system (the “EU Access to Medicines Notification System”) as a single-entry point for the notification of compliance with the obligations set out in Article 58a. The EU Access to Medicines Notification System shall be interoperable with the other Union-wide data repositories for medicinal products.

2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a.

3. By ... [3 years following the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements, including on security aspects and data governance, which are necessary for the practical implementation of the EU Access to Medicines Notification System. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

4. By ... [5 years after the date of entry into force of this Directive] and every 3 years thereafter, the Commission shall present a report to the European Parliament and the Council on the use and functioning of the EU Access to Medicines Notification System.

5. By ... [5 years after the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2)

Or. en

Amendment 4

Proposal for a directive

~~Recital 11~~

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need 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.

1. The regulatory data protection period shall be six 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.

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

1. The regulatory data protection period shall be 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.

Or. en

Justification

To compete effectively on a global scale, it's essential, among other measures, to extend EU Regulatory Data Protection (RDP) to at least 9 years to maintain attractiveness for investments.

Amendment 5

Proposal for a directive

~~Recital 11 a (new)~~

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.

(a) 24 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 years from that date for any of the following entities:

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.

Or. en

Justification

Tying the recovery of the 2-year lost RDP period to the release and continuous supply of a medicinal product fails to account for factors outside the control of marketing authorization holders. This proposal inadequately considers the intricacies of the regulatory landscape, national market access schemes, and healthcare expenditure choices. As a result, it disproportionately penalizes the industry for factors largely beyond its control, without improving patient access to innovative medicines.

Amendment 6

Proposal for a directive

~~Recital 11 b (new)~~

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive prolonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.

(b) six 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;

(b) one year, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application or subsequent variation that the medicinal product addresses an unmet medical need at least in one of its indications as referred to in Article 83;

Or. en

Justification

Recognizing and appropriately rewarding substantial efforts in conducting comparative trials, when warranted, is important. Increasing the length of RDP by one year serves this purpose.

Amendment 7

Proposal for a directive

~~Recital 26~~

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(26) In order to reward the compliance with all the measures included in the agreed paediatric investigation plan, for products covered by a supplementary protection certificate, if relevant information on the results of the studies conducted is included in the product information, a reward should be granted in the form of a six month extension of the supplementary protection certificate created by [Regulation (EC) No 469/2009 of the European Parliament and of the Council42 - OP please replace reference by new instrument when adopted].

(c) six 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;

(26) In order to reward the compliance with all the measures included in the agreed paediatric investigation plan, for products covered by a supplementary protection certificate, if relevant information on the results of the studies conducted is included in the product information, a reward should be granted in the form of an extension of the supplementary protection certificate created by [Regulation (EC) No 469/2009 of the European Parliament and of the Council42 - OP please replace reference by new instrument when adopted].

(c) one year, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application or subsequent variation use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;

~~_________________~~

Or. en

~~_________________~~

Justification

~~42 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 10).~~

Recognizing and appropriately rewarding substantial efforts in conducting comparative trials, when warranted, is important. Increasing the length of RDP by one year serves this purpose.

~~42 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 10).~~

Amendment 8

Proposal for a directive

~~Recital 31~~

Article 81 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

(31) Directive 2010/63/EU of the European Parliament and of the Council43 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models.

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within four years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

(31) Directive 2010/63/EU of the European Parliament and of the Council43 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models.

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, during the regulatory data protection period the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004. The prolongations referred to in the first subparagraph, points (b), (c) and (d), may each only be granted once and may only be granted during the period of regulatory data protection referred to in paragraph (1).

~~_________________~~

Or. en

~~_________________~~

~~43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).~~

Amendment 9

Proposal for a directive

~~Recital 39~~

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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 or severely debilitating disease and the following conditions are met:

(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initial application for the decentralised procedure within 30 days of the submission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immediately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

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

Or. en

Justification

An overly restrictive definition of unmet medical need poses the risk of excluding vital therapeutic developments for patients. This approach inadvertently discourages companies from investing in R&D that could have addressed significant unmet medical needs, reducing overall predictability. Additionally, patients often assign different values to the impact of new treatments compared to society. Society may prioritize incremental improvements for diseases with substantial societal burdens or those that aid in preventing future pandemics.

Amendment 10

Proposal for a directive

~~Recital 49 a (new)~~

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains.

(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;

Or. en

Justification

Amendment 11

Proposal for a directive

~~Recital 53~~

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(53) A marketing authorisation holder should 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.

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

(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.

(b) the use of the medicinal product results in

(i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

(ii) a meaningful positive impact on quality of life; or

(iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Justification

Amendment 12

Proposal for a directive

~~Recital 59 a (new)~~

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

(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.

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.

Or. en

Justification

It is of critical importance that the appropriate stakeholders are involved in identifying unmet medical needs from different perspectives. Collaborations need to be established to get an aligned understanding of UMN.

Amendment 13

Proposal for a directive

Article 1885 – paragraph 1 – ~~subparagraph~~introductory 1part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:

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.

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a medicinal product is used for the exclusive purpose of:

Or. en

Justification

A well-defined Bolar exemption that streamlines the regulatory approval process is crucial. It should cover strictly necessary activities, even when conducted by third parties in a reactive manner, while maintaining a precise scope to prevent misuse. Yet, extending the Bolar exemption to cover commercial or pre-commercial actions at the national level, such as pricing and reimbursement applications, is unwarranted. Such an extension would only facilitate risk-driven launches, jeopardizing patent rights' effectiveness in Europe and undermining their reliability.

Amendment 14

Proposal for a directive

Article 1885 – paragraph 1 – ~~subparagraph 2~~point a ~~(new)~~– introductory part

Text proposed by the Commission

Amendment

In case of combined products intended for paediatric use, a risk/benefit analysis should be taken into account following the opinion of the Paediatric Working Party of the Agency, established in accordance with Article 142 of the Regulation.

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) Necessary studies and trials conducted to generate data for an application for a marketing authorisation.

Or. en

Justification

Amendment 15

Proposal for a directive

Article 1885 – paragraph 31 – point a – point i

Text proposed by the Commission

Amendment

3. The application for a marketing authorisation for an integral combination of a medicinal product with a medical device shall include the documentation supporting the compliance of the medical device part with the general safety and performance requirements as referred to in paragraph 2 in accordance with Annex II, including, where relevant, the conformity assessment report by a notified body.

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

3. The application for a marketing authorisation for an integral combination of a medicinal product with a medical device shall include the evidence supporting the compliance of the medical device part with the general safety and performance requirements as referred to in paragraph 2 in accordance with Annex II, including, where relevant, the conformity assessment report by a notified body.

deleted

Or. en

Justification

Amendment 16

Proposal for a directive

Article 2485 – paragraph 21 – point a – point ii

Text proposed by the Commission

Amendment

~~2. The setting-up of the system of ERA monographs shall be based on a risk-based prioritisation of active substances.~~

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

~~2. The setting-up of the system of ERA monographs shall be based on a risk-based prioritisation of active substances and data requested.~~

deleted

Or. en

Justification

Amendment 17

Proposal for a directive

Article 2485 – paragraph 41 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years after entering into force of this Directive while taking into account outcomes from relevant Union initiatives, such as with regard to animal testing.

(b) any necessary activity set out in point (a), which may include the manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Or. en

Justification

Amendment 18

Proposal for a directive

Article 2485 – paragraph ~~5 – point e a (new)~~2

Text proposed by the Commission

Amendment

~~(e a) the risk-based prioritisation of data requirements for active substances, including to avoid unnecessary animal testing.~~

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

This exception shall cover the submission of the application for marketing authorisation. It shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Justification

Amendment 19

Proposal for a directive

~~Article 34 – paragraph 3~~

~~Text proposed by the Commission~~

~~Amendment~~

3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State shall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

~~Amendment 20~~

~~Proposal for a directive~~

~~Article 34 – paragraph 4 – subparagraph 2~~

~~Text proposed by the Commission~~

~~Amendment~~

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.

~~Amendment 21~~

~~Proposal for a directive~~

~~Article 34 – paragraph 5~~

~~Text proposed by the Commission~~

~~Amendment~~

5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

~~Amendment 22~~

~~Proposal for a directive~~

~~Article 36 – paragraph 4~~

~~Text proposed by the Commission~~

~~Amendment~~

4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State shall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

~~Amendment 23~~

~~Proposal for a directive~~

~~Article 36 – paragraph 4 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorization set out in Articles 43 to 45 are complied with.

~~Amendment 24~~

~~Proposal for a directive~~

~~Article 43 – paragraph 3~~

~~Text proposed by the Commission~~

~~Amendment~~

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1) and Annex I as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

~~Amendment 25~~

~~Proposal for a directive~~

~~Article 81 – paragraph 1~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Amendment 26~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part~~

~~Text proposed by the Commission~~

~~Amendment~~

(a) 24 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 four years from that date for any of the following entities:

~~Amendment 27~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point a a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~(a a) 12 months, where the marketing authorisation holder demonstrates that significant preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;~~

~~Amendment 28~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point b~~

~~Text proposed by the Commission~~

~~Amendment~~

(b) 12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application or subsequent variation that the medicinal product addresses an unmet medical need at least in one of its indications as referred to in Article 83;

~~Amendment 29~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point c~~

~~Text proposed by the Commission~~

~~Amendment~~

(c) 12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application or subsequent variation 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 accordance with article 215;

~~Amendment 30~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point d a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~(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;~~

~~Amendment 31~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point d b (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

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

~~Amendment 32~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 1 – point d c (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~(d c) 12 months, for medicinal products containing a majority, as defined by the Agency, of critical active pharmaceutical ingredients produced within the EU.~~

~~Amendment 33~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 2~~

~~Text proposed by the Commission~~

~~Amendment~~

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, during the regulatory data protection period the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004. The prolongations referred to in the first subparagraph, points (b), (c) and (d), may each only be granted once and may only be granted during the period of regulatory data protection referred to in paragraph (1).

~~Amendment 34~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 3~~

~~Text proposed by the Commission~~

~~Amendment~~

~~The prolongation referred to in the first subparagraph, point (d), may only be granted once.~~

~~deleted~~

~~Amendment 35~~

~~Proposal for a directive~~

~~Article 81 – paragraph 2 – subparagraph 3 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~The above incentives may be combined up to a maximum of 13 years.~~

~~Amendment 36~~

~~Proposal for a directive~~

~~Article 82 – paragraph 1 – subparagraph 1~~

~~Text proposed by the Commission~~

~~Amendment~~

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 in the Member States in which the marketing authorisation is valid.

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 made available to patients or prescribing doctors who requested the medicinal product, in the Member States in which the marketing authorisation is valid.

~~Amendment 37~~

~~Proposal for a directive~~

~~Article 82 – paragraph 2 – subparagraph 3 – introductory part~~

~~Text proposed by the Commission~~

~~Amendment~~

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

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

~~Amendment 38~~

~~Proposal for a directive~~

~~Article 82 – paragraph 2 – subparagraph 4 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

Where the conditions set out in paragraph 1 have not been fully satisfied within the time set out in Article 81(2), first subparagraph, point (a), due to duly justified circumstances out of the control of the marketing authorisation holder, the Member State shall confirm the conditions in paragraph 1 have been satisfied in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State. Where the conditions set out in paragraph 1 cannot be fully satisfied due to circumstances fully within the control of the Member State, the Member State shall confirm the conditions in paragraph 1 have been satisfied in their territory.

~~Amendment 39~~

~~Proposal for a directive~~

~~Article 82 – paragraph 3~~

~~Text proposed by the Commission~~

~~Amendment~~

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. Within 60 days from the request of the marketing authorisation holder, the Member State shall issue a confirmation of compliance or, a reasoned statement of non-compliance or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article.

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 competent authority shall issue a confirmation of compliance or, a reasoned statement of non-compliance based on objective and verifiable 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 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.

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.

~~Amendment 40~~

~~Proposal for a directive~~

~~Article 82 – paragraph 4 – subparagraph 1~~

~~Text proposed by the Commission~~

~~Amendment~~

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.

~~Amendment 41~~

~~Proposal for a directive~~

~~Article 82 – paragraph 4 – subparagraph 1 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Time limits other than those set out in paragraphs 1 to 3 may apply if a Member State and a marketing authorization holder reach an agreement to that effect.~~

~~Amendment 42~~

~~Proposal for a directive~~

~~Article 82 – paragraph 4 – subparagraph 2 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control.~~

~~Amendment 43~~

~~Proposal for a directive~~

~~Article 82 – paragraph 4 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

4a. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control.

~~Amendment 44~~

~~Proposal for a directive~~

~~Article 82 – paragraph 4 b (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

4b. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period after deletion of information of a commercially confidential nature.

~~Amendment 45~~

~~Proposal for a directive~~

~~Article 82 – paragraph 6~~

~~Text proposed by the Commission~~

~~Amendment~~

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).

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215.

~~Amendment 46~~

~~Proposal for a directive~~

~~Article 82 – paragraph 6 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

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 specificities, 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).

~~Amendment 47~~

~~Proposal for a directive~~

~~Article 82 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Article 82a~~

~~Prolongation of the data protection period for medicinal products developed primarily within the Union~~

1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that the majority of its preclinical development was performed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it.

2. By [OP please insert the date =12 months after the date of entering into force of this Directive] the Commission shall adopt a delegated act setting out the procedural aspects regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. Before the adoption of the delegated act, the Commission shall publish a study on the most adequate indicators to evaluate that the provision in paragraph 1 is met. with a particular focus on those indicators that could most effectively promote research and development within the Union, particularly for SMEs.

3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.

~~Amendment 48~~

~~Proposal for a directive~~

~~Article 83 – paragraph 1 – point b~~

~~Text proposed by the Commission~~

~~Amendment~~

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

~~(b) the use of the medicinal product results:~~

~~(i) in a meaningful reduction in disease morbidity or mortality, for the relevant patient population or~~

~~(ii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.~~

~~Amendment 49~~

~~Proposal for a directive~~

~~Article 83 – paragraph 3~~

~~Text proposed by the Commission~~

~~Amendment~~

~~Amendment 50~~

~~Proposal for a directive~~

~~Article 86 – paragraph 1 – subparagraph 1~~

~~Text proposed by the Commission~~

~~Amendment~~

Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted]. Where the agreed paediatric investigation plan is conducted in relation to a disease that is different from the one for which the medicinal product is intended in the adult population, the holder of the patent or supplementary protection certificate shall be entitled to a 12-month extension of the period.

~~Amendment 51~~

~~Proposal for a directive~~

~~Article 147 – paragraph 1 – subparagraph 1 – point a a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

~~(a a) maintain the market adequately supplied with the registered products, in an adequate and continuous manner, so that the needs of patients are covered;~~

~~Amendment 52~~

~~Proposal for a directive~~

~~Article 147 – paragraph 1 – subparagraph 1 – point g~~

~~Text proposed by the Commission~~

~~Amendment~~

(g) use only active substances that have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances, which include reliable, constant and timely delivery of the active substances to the manufacturing authorization holders;

~~Amendment 53~~

~~Proposal for a directive~~

~~Article 147 – paragraph 1 – subparagraph 1 – point j a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.

~~Amendment 54~~

~~Proposal for a directive~~

~~Article 147 – paragraph 1 – subparagraph 3 a (new)~~

~~Text proposed by the Commission~~

~~Amendment~~

Manufacturing authorisation holders may diversify their contracts with manufacturer or distributors of active substances if needed to ensure an adequate, constant and timely provision to comply with their public service obligations for supply.

~~Amendment 55~~

~~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.

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend or vary a marketing authorisation if a serious risk to the ~~environment,~~environment ~~including~~or public ~~health,~~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 notholder ~~adequately~~via ~~reducible,~~conditions ~~the~~laid ~~relevant~~out ~~Member~~in ~~State~~Articles ~~authorities~~44(h) or ~~the Commission may revoke the marketing authorization of the holder.~~87(c).

~~Amendment 56~~

Or. en

Justification

The significance of conducting an ERA as part of the marketing authorization process for medicinal products is undisputed. However, the idea of suspending, revoking or altering a marketing authorization for environmental reasons seems unwarranted and could affect patient access to medicines if not associated with the conditions of marketing authorization. A more suitable approach involves implementing binding, time-limited post-authorization commitments to grant market authorization holders the chance to address data indicating potential serious environmental risks.

Amendment 20

Proposal for a directive

(f) a serious risk to the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).

~~Amendment 57~~

Or. en

~~Proposal for a directive~~

Justification

~~Article 208 a (new)~~

The prospect of restricting the supply or withdrawing a medicinal product based on environmental concerns may be unwarranted and could adversely affect patient access to essential medications. A more suitable approach entails the utilization of binding, time-limited post-authorization commitments or similar measures, providing market authorization holders with the opportunity to address data that indicate potential serious environmental risks.

~~Text proposed by the Commission~~

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

~~Amendment~~

The following list is drawn up under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the draft opinion:

~~Article 208a~~

~~Fostering research, innovation and production of medicinal products in the Union~~

1. The Commission shall establish a strategy on research, innovation and production of medicinal products in the Union, based on the results published in the report defined in paragraph 2. Member States shall be encouraged to participate in this strategy.

2. By... [two years after the date of entry into force of this Directive] the Commission shall present an impact assessment evaluating potential measures to be implemented at Union level, and at a Member State level to foster research, innovation and production of critical medicinal products in the Union. This report shall evaluate the effect of measures such as:

~~(a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation;~~

~~(b) public-private partnerships in research and innovation;~~

~~(c) regulatory support for public research and innovation entities;~~

~~(d) incentives for production of critical medicinal products inside the Union. Proposed measures shall be in line with developing a strategic autonomy for the Union regarding medicinal products.~~

~~ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR for the OPINION HAS RECEIVED INPUT~~

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for the opinion declares that she has received input from the following entities or persons in the preparation of the opinion, until the adoption thereof in committee:

Entity and/or person

Boehringer Ingelheim

~~Johnson & Johnson~~

~~The list above is drawn up under the exclusive responsibility of the rapporteur for the opinion.~~

~~PROCEDURE – COMMITTEE ASKED FOR OPINION~~

~~Title~~

~~Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC~~

~~References~~

~~COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)~~

~~Committee responsible~~

~~Date announced in plenary~~

~~ENVI~~

~~14.9.2023~~

~~Opinion by~~

~~Date announced in plenary~~

~~ITRE~~

~~14.9.2023~~

~~Rapporteur for the opinion~~

~~Date appointed~~

~~Henna Virkkunen~~

~~5.10.2023~~

~~Discussed in committee~~

~~28.11.2023~~

~~Date adopted~~

~~22.2.2024~~

~~Result of final vote~~

–:

~~Members present for the final vote~~

Hildegard Bentele, Michael Bloss, Marc Botenga, Martin Buschmann, Cristian-Silviu Buşoi, Jerzy Buzek, Maria da Graça Carvalho, Ignazio Corrao, Beatrice Covassi, Josianne Cutajar, Nicola Danti, Marie Dauchy, Christian Ehler, Nicolás González Casares, Christophe Grudler, Henrike Hahn, Robert Hajšel, Ivo Hristov, Ivars Ijabs, Romana Jerković, Seán Kelly, Łukasz Kohut, Zdzisław Krasnodębski, Marisa Matias, Eva Maydell, Marina Mesure, Angelika Niebler, Ville Niinistö, Johan Nissinen, Mauri Pekkarinen, Tsvetelina Penkova, Morten Petersen, Manuela Ripa, Sara Skyttedal, Maria Spyraki, Riho Terras, Grzegorz Tobiszowski, Henna Virkkunen, Pernille Weiss

~~Substitutes present for the final vote~~

~~Pascal Arimont, Laura Ballarín Cereza, Jakop G. Dalunde, Margarita de la Pisa Carrión, Francesca Donato, Alicia Homs Ginel, Alin Mituța, Luděk Niedermayer, Susana Solís Pérez~~

~~Substitutes under Rule 209(7) present for the final vote~~

Alexander Bernhuber, Sara Cerdas, Ibán García Del Blanco, Mircea-Gheorghe Hava, Radan Kanev, Guy Lavocat, Javi López, Karen Melchior, Jessica Polfjärd, Bergur Løkke Rasmussen, Caroline Roose, Birgit Sippel, Dragoş Tudorache, Axel Voss

~~FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION~~

~~Key to symbols:~~