What changed

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposalCouncil forposition at first reading with a view to the adoption of a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

(COM(2023)0193 –(07105/2/2026– C90144/2023C100243/2026 – 2023/0131(COD))

(Ordinary legislative procedure: firstsecond reading)

The European Parliament,

– having regard to the Commission proposalCouncil toposition Parliamentat andfirst thereading Council(07105/2/2026– (COM(2023)0193),C100243/2026),

– having regard to Article 294(2) and Article 114 and Article 168(4), point (c), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90144/2023),

– having regard to the opinion of the European Economic and Social Committee of 25 October 2023,

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– after consulting the Committee of the Regions,

– having regard to theits opinionposition ofat first reading on the EuropeanCommission Economicproposal andto SocialParliament Committeeand ofthe ...,Council (COM(2023)0193),

– having regard to theArticle opinion294(7) of the CommitteeTreaty ofon the RegionsFunctioning of ...,the European Union,

– having regard to the provisional agreement approved by the committee responsible under Rule 5975(4) of its Rules of Procedure,

– having regard to theRule opinion68 of the Committee on Industry,its ResearchRules andof Energy,Procedure,

– having regard to the letters from therecommendation Committeefor onsecond Budgetsreading andof the Committee on Agriculture andPublic RuralHealth Development,(A100000/2026),

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A90000/2023),

1. Approves the Council position at first reading;

1. Adopts its position at first reading hereinafter set out;

2. Notes that the act is adopted in accordance with the Council position;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union

4. Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;

5. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Recital 9: (9) As to the scope of this Regulation, the authorisation of antimicrobials is in the interest of patients' health at Union level and therefore it should be made possible to authorise them at Union level.

SHORT JUSTIFICATION

Recital 30: (30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product. Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as in particular substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies.

The Council position at first reading reflects the agreement reached between the European Parliament and the Council in interinstitutional negotiations at early second reading stage.

Recital 36: (36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, ad-hoc working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.

Recital 39: (39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients, healthcare professionals, industry, associations representing payers, academia or other stakeholders, as relevant.

Recital 43: (43) In the interest of public health, marketing authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations. However, Member States should be able, exceptionally, to prohibit the use in their territory of medicinal products for human use. Member States should provide due justification for such prohibition to the Agency.

Recital 60: (60) Regulatory decision-making on the development, authorisation and supervision of medicinal products may be supported by access and analysis of health data, including real world data, where appropriate, i.e. health data generated outside of clinical studies. The Agency should be able to use such data, including via the Data Analysis and Real World Interrogation Network (DARWIN) and the European Health Data Space interoperable infrastructure. Through these capabilities the Agency may take advantage of all the potential of supercomputing, artificial intelligence and big data science to fulfil its mandate, without compromising privacy rights. In this regard, the Agency should also engage in a systematic early and continuous dialogue on the collection of real-world-data with the Member State Coordination Group on Health Technology Assessment in accordance with Regulation (EU) 2021/2282, payers, healthcare professionals, patient and consumer organisations and developers. Where necessary the Agency may cooperate with the competent authorities of the Member States towards this objective.

Recital 67: (67) The Agency, in consultation with the Member States and the Commission, should set the scientific selection criteria for medicinal products that receive pre-authorisation support with priority to be given to the most promising developments in therapies. In the case of medicinal products for unmet medical needs, based on the scientific selection criteria set by the Agency, any interested developer can submit preliminary evidence to demonstrate that the medicinal product has the potential to provide a major therapeutic advancement with respect to the identified unmet medical need. Information on the advice given in relation to the enhanced scientific and regulatory support for priority medicinal products should be included in a dedicated specific section within the European public assessment report.

Recital 68: (68) Before a medicinal product for human use is authorised for placing on the market of one or more Member States, it generally has to undergo extensive studies to ensure that it is safe, of high quality and effective for use in the target population. However, in the case of certain categories of medicinal products for human use, in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant a conditional marketing authorisation on the basis of less complete data than is normally the case. Such marketing authorisation should be granted subject to specific obligations. The categories of medicinal products for human use concerned should be the medicinal products, including orphan medicinal products, that aim at the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, or that are intended to be used in emergency situations in response to public health threats.

Recital 76: (76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation or when the marketing authorisation holder has been granted a standard or conditional marketing authorisation for the relevant indication.

Recital 76 a (new): (76a) It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities in relation to medicinal products that receive a temporary emergency marketing authorisation. Those measures should include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The public information regarding clinical trials and marketing authorisation decisions should be in accordance with Regulation (EU) 2022/123 of the European Parliament and of the Council1a. / 1a Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).

Recital 77: (77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure whereby pharmaceutical companies neglect investment in research and development (R&D) concerning novel antibiotics due to profitability considerations; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area.

Recital 78 a (new): (78a) In addition to the growing threat of antimicrobial resistance, there are other market failures present in the pharmaceutical sector for which further action at Union level is required to meet the public health needs of Union citizens. In particular, there is a stark misalignment between the R&D priorities of the pharmaceutical industry and the public health needs of Union citizens. The market failures in the Union have, in certain instances, also resulted in excessive prices for medicinal products and have led to shortages of medicinal products. This Regulation should therefore address those market failures to better deliver on the objectives of affordability, accessibility and availability of medicinal products in the Union.

Recital 78 b (new): (78b) Member States, the Union, third countries, international organisations and agencies have identified the key areas of priority pharmaceutical research, including novel antibiotics and antivirals, improved diagnostics and treatments for emerging infectious diseases, affordable and efficacious medicinal products in the areas oncology, neurodegenerative diseases and other areas of unmet medical need for which the development of orphan medicinal products is needed. However, while Member States and the Union offer generous corporate R&D subsidies as well as R&D tax incentives to stimulate pharmaceutical research, there is little evidence to suggest, and no obligation to ensure, that the composition of R&D portfolios of pharmaceutical companies is determined by such direct or indirect subsidies. It is therefore increasingly evident that effective public health policy is undermined by shortcomings in transparency and accountability in public expenditure directed towards health.

Recital 78 c (new): (78c) Those market failures highlight the need for a paradigm shift in both the Member States’ and the Union’s approach to generating pharmaceutical R&D in key areas of priority and in public expenditure directed towards health. The establishment of a mission oriented R&D facility at Union level which acts in the public interest could alleviate those market failures. The European Medicines Facility (‘EMF’) should therefore be established as an independent agency under this Regulation. The EMF should be tasked with conducting research and developing novel antimicrobials as well as with regard to other areas of unmet medical need, to support the Union to overcome market failures.

Recital 79: deleted

Recital 80: deleted

Recital 81: deleted

Recital 82: deleted

Recital 83: deleted

Recital 84: deleted

Recital 90: (90) Objective criteria for the orphan designation based on the prevalence of the life-threatening or chronically debilitating condition for which diagnosis, prevention or treatment is sought and the existence of no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union should be maintained; a prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold. The orphan designation criterion on the basis of return on investment should be mandatory during the review and, where necessary, the marketing exclusivity should be reduced where it is shown on the basis of available evidence that the product is sufficiently profitable, and that therefore the maintenance of market exclusivity regarding the product is no longer justified.

Recital 102: (102) In order to incentivise research and development of orphan medicinal products addressing high unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest.

Recital 123: (123) The summary of the results of all the paediatric clinical trials included in the European clinical trial database created by Regulation (EU) No 536/2014 should be made publicly available within 6 months after the end of the clinical trials unless this is not possible for justified scientific reasons. Non-compliance with Regulation (EU) No 536/2014 should be subject to penalties.

Recital 129: (129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities to access evidence, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On this basis, the Agency should, after consulting with the affected marketing authorisation holder, take initiative to update the summary of product characteristics in case new efficacy or safety data has an impact on the benefit-risk balance of a medicinal product.

Recital 133: deleted

Recital 134: deleted

Recital 135: deleted

Recital 137: (137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. Member States should be able to introduce or maintain more robust measures to achieve security of supply for medicines than the safeguards provided for in this Regulation.

Recital 141: (141) To ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with this Regulation, the Commission should be able to impose financial penalties. When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties. The penalties imposed should be effective, proportionate and dissuasive, taking into consideration the economic power of the operator and having regard to the circumstances of the specific case. For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to set maximum amounts for penalties. Those maximum amounts should not be linked to the turnover of a particular medicinal product but the economic entity involved.

Article 2 – paragraph 2 – point 4: (4) ‘orphan medicinal products sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);

Article 2 – paragraph 2 – point 7: (7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product;

Article 2 – paragraph 2 – point 12: deleted

Article 2 – paragraph 2 – point 14 a (new): (14a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorisation holder or a manufacturer;

Article 2 – paragraph 2 – point 14 b (new): (14b) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients;

Article 5 – paragraph 2: 2. An applicant shall agree with the Agency the submission date of an application for a marketing authorisation. The applicant shall also inform the Agency of its intention of applying for a marketing authorisation under Article 18 or 19.

Article 6 – paragraph 2 – subparagraph 1: For medicinal products, during a public health emergency, that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening condition in the Union, the Agency may, after the Commission has recognised a public health emergency at Union level in accordance with Article 23(1) of Regulation (EU) 2022/2371 and following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.

Article 6 – paragraph 2 – subparagraph 2: The Agency may at any stage suspend or cancel the phased review, where the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient maturity or where it is considered that the medicinal product no longer fulfils an exceptional therapeutic advancement or where the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) of Regulation (EU) 2022/2371. The Agency shall inform the applicant accordingly.

Article 6 – paragraph 5 – subparagraph 2: The marketing authorisation applicant shall 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 shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.

Article 8 – paragraph 1 – point b: (b) identification and characterisation of hazards for the environment, animals and for human health; for the purpose of this point, ‘hazards for human health’ includes the risks to the health of human beings other than the treated patient as the risk to the treated patient shall be assessed as part of the benefit-risk assessment of the medicinal product;

Article 9 – paragraph 2: 2. In case of first-in-class medicinal products or when a novel question is raised during the assessment of the submitted environmental risk assessment, the Committee for Medicinal Products for Human Use, or the rapporteur, shall carry out necessary consultations with bodies Member States have set up in accordance with Directive 2001/18/EC. They shall also consult with relevant Union bodies, inter alia the European Environment Agency. Details on the consultation procedure shall be published by the Agency at the latest by [OJ:12 months after the date of entry into force of this Regulation].

Article 10 – paragraph 2: 2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a reasonable 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 Agency, the application shall be considered as refused.

Article 12 – paragraph 4 – point f: (f) where appropriate, details of any recommended obligation to conduct post-authorisation safety studies or to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Chapter VIII as well as possible penalties in case of non-compliance;

Article 12 – paragraph 4 – point g: (g) where appropriate, details of any recommended obligation to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 21 while taking into account the scientific guidance referred to in Article 123 of [revised Directive 2001/83/EC] and the consultation process in accordance with Article 162 of this Regulation;

Article 12 – paragraph 4 – point h: (h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies to improve the safe and effective use of the medicinal product as well as possible penalties in case of non-compliance;

Article 12 – paragraph 4 – point i: (i) in case of medicinal products for which there is a detailed justification as to the grounds of uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with specific attention given to new active substances and therapeutic indications, a post-authorisation obligation to substantiate the clinical benefit as well as possible penalties in case of non-compliance;

Article 12 – paragraph 4 – point j: (j) where appropriate, details of any recommended obligation to conduct additional post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed, as well as possible penalties in case of non-compliance;

Article 12 – paragraph 4 – point m a (new): (ma) a stewardship plan in accordance with Article 17 of [revised Directive 2001/83/EC] and special information requirements in accordance with Article 69 of that Directive for any antimicrobials, as well as any other obligations imposed on the marketing authorisation holder;

Article 12 – paragraph 4 – point m b (new): (mb) where applicable, a confirmation as to whether the medicinal product satisfies the criteria of Article 83 of [revised Directive 2001/83/EC] regarding medicinal products addressing an unmet medical need;

Article 13 – paragraph 1 – subparagraph 5: Where the draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences and make that information publicly available at the same time as the decision.

Article 13 – paragraph 1 – subparagraph 6: The Commission shall send the draft decision and the accompanying reasoning referred to in the fifth subparagraph to the Member States and the applicant.

Article 13 – paragraph 4: 4. The Agency shall disseminate the documents referred to in Article 12(4), points (a) to (e), and, where relevant, the documents referred to in Article 12(4), points (f) to (mb), together with any deadlines laid down pursuant to paragraph 1, first subparagraph.

Article 15 – 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 risk mitigation measures proposed by the applicant in accordance with Article 22(3) of [revised Directive 2001/83/EC];

Article 16 – paragraph 3 – subparagraph 1: The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and following a consultation of relevant patient organisations with regard to the readability, clarity and comprehensibility of European public assessment report summaries.

Article 16 – paragraph 3 – subparagraph 2 – indent 2: – the complete environmental risk assessment submitted to the Agency by the marketing authorisation applicant as well as a summary of environmental risk assessment studies and their results as submitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.

Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new): – for antimicrobials, all information referred to in Article 17 of and Annex I to [revised Directive 2001/83/EC] as well as any other obligations imposed on the marketing authorisation holder.

Article 17 – paragraph 1: 1. A marketing authorisation for a medicinal product shall be valid for five years.

Article 17 – paragraph 2 – subparagraph 1: deleted

Article 17 – paragraph 2 – subparagraph 2: The marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

Article 17 – paragraph 2 – subparagraph 3: Where a renewal application has been submitted, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

Article 17 – paragraph 2 – subparagraph 4: The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation and any subsequent marketing authorisations shall be valid for an additional period of 10 years.

Article 17 – paragraph 2 – subparagraph 4 a (new): Where post-authorisation studies to be performed in accordance with Article 20(1) justify it, the Commission may decide to withdraw a marketing authorisation for a medicinal product based on evidence pointing to a risk to public health.

Article 18 – paragraph 2 – subparagraph 2 a (new): Where specific conditions referred to in paragraph 1, point (c), are not fulfilled within the timeframe given by the Agency or the marketing authorisation holder does not provide duly justified reasons for not fulfilling the conditions, the Commission may suspend, revoke or vary the marketing authorisation by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Article 19 – paragraph 1 – subparagraph 2: In emergency situations, as referred to in Article 2(1) of Regulation (EU) 2022/2371, a conditional marketing authorisation or a new conditional therapeutic indication referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.

Article 19 – paragraph 3: 3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations, in particular for ongoing or new studies as referred to in paragraph 4 of this Article, the time limit for compliance and penalties in accordance with Article 172 in cases of non-compliance, shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Article 19 – paragraph 4: 4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies in accordance with Article 20, with a view to confirming the safety and efficacy of the medicinal product. The Agency shall make relevant deadlines and criteria for ongoing and new studies publicly available.

Article 19 – paragraph 6: 6. By way of derogation from Article 17(1), an initial conditional marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis for the first three years after granting the authorisation and every two years thereafter. However, where the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) of Regulation (EU) 2022/2371, the marketing authorisation holder shall pursue a marketing authorisation in accordance with Article 5 of this Regulation.

Article 19 – paragraph 7 – subparagraph 1 a (new): Where specific conditions referred to in paragraph 3 are not fulfilled within the timeframe given by the Agency or the marketing authorisation holder does not provide duly justified reasons for not fulfilling the conditions, the Commission may suspend, revoke or vary the marketing authorisation by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Article 19 a (new): Article 19a / Revocation of conditional marketing authorisation / The Commission may in justified cases revoke the conditional marketing authorisation that was granted in accordance with Article 19 where the benefit of the immediate availability of the medicinal product on the Union market no longer outweighs the risk due to missing confirming data or non-compliance with the obligations set out in Article 19.

Article 20 – paragraph 1 – subparagraph 1 – introductory part: After the granting of a marketing authorisation, the Agency may at any time consider that it is necessary that the marketing authorisation holder:

Article 20 – paragraph 1 – subparagraph 2: If this obligation would apply to several medicinal products, the Agency shall oblige the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study.

Article 21 – paragraph 1 a (new): Where a conditional marketing authorisation has been granted in accordance with Article 19, a post-authorisation efficacy study shall always be required in accordance with Article 19(4).

Article 23 – paragraph 1 a (new): A temporary emergency marketing authorisation granted in accordance with Article 30 shall leave the civil and criminal liability of the manufacturer and marketing authorisation holder unaffected.

Article 24 – paragraph 1 – subparagraph 1: In addition to the notification made pursuant to Article 116, the marketing authorisation holder shall notify the Agency without undue delay of any action they take to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with detailed reasoning for such action.

Article 24 – paragraph 1 – subparagraph 2 – 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; in such cases, the Agency shall immediately inform the Commission who is to be responsible for informing the relevant national and Union authorities.

Article 24 – paragraph 1 – subparagraph 2 – point f a (new): (fa) commercial considerations.

Article 24 – paragraph 1 – subparagraph 3: Where the action referred to in the first subparagraph is to withdraw a medicinal product from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated with the medicinal product, as well as indicate any potential alternative therapeutic equivalent.

Article 24 – paragraph 4: 4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on fair and reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC].

Article 24 – paragraph 4 a (new): 4a. The marketing authorisation holder from which the marketing authorisation has been transferred to a third party shall notify the Agency of the transfer as soon as possible. The information regarding the transfer provided shall be made publicly available.

Article 25 – paragraph 1 – subparagraph 3: As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall immediately withdraw the initial or duplicate marketing authorisation.

Article 26 – paragraph 10: 10. The Agency shall adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article.

Article 27 – paragraph 1 a (new): The Committee shall also draw up an opinion whenever there is disagreement concerning the evaluation of medicinal products through the mutual recognition procedure.

Article 30 – paragraph 3 a (new): Where a medicinal product receives a temporary emergency marketing authorisation in accordance with this Article, robust transparency measures and standards shall be put in place by the Agency. Those measures shall include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The public information regarding clinical trials and marketing authorisation decisions shall be published in accordance with Article 17 of Regulation (EU) 2022/123.

Article 31 – paragraph 1 – point b a (new): (ba) when recognition of the public health emergency has been terminated, the marketing authorisation holder shall be required to apply for a marketing authorisation in accordance with Article 34 without undue delay.

Article 32 – paragraph 2 – subparagraph 1: The Agency shall without undue delay review any new evidence provided by the developer, the Member States or the Commission, or any other evidence that comes to its attention, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.

Article 34 – paragraph 1: The temporary emergency marketing authorisation shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371 or when sufficient data have been collected in order to grant a conditional marketing authorisation in accordance with Article 19.

Article 35 – paragraph 1 – point d a (new): (da) a conditional marketing authorisation has been granted.

Article 37 – paragraph 1: When the temporary marketing authorisation of a medicinal product is suspended or revoked for reasons other than the safety of the medicinal product, or if that temporary emergency marketing authorisation ceases to be valid, Member States may, in exceptional circumstances, allow for a transitional period, the supply of the medicinal product to patients who are already being treated with it. Conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices shall continue to apply during that period.

Chapter III – title: ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF PRIORITY ANTIMICROBIALS

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Article 40 a (new): Article 40a / Establishment and role of the European Medicines Facility / 1. The European Medicines Facility ( ‘EMF’) is hereby established. / 2. The main missions and responsibilities of the EMF shall be: / (a) setting out a long-term vision of health priorities in the public interest at a Union level in the form of a strategic roadmap with a number of specific purpose-led R&D projects; in the elaboration of the strategic roadmap, the EMF shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level; / (b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas: / (i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level; / (ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therap…

Article 41: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Article 42: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Article 43: deleted / (deleted) / (deleted)

Article 45 – paragraph 4 a (new): 4a. Where specific conditions referred to in paragraph 1 to 4 are not fulfilled within the timeframe given by the Agency or the marketing authorisation holder does not provide duly justified reasons for not fulfilling the conditions, the Commission may vary the marketing authorisation of the affected medicinal product accordingly and update the summary of the product characteristics and package leaflets by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Article 47 – paragraph 1: 1. An application for variation of a centralised marketing authorisation by the marketing authorisation holder shall be made electronically in the formats made available by the Agency, unless the variation is an update by the marketing authorisation holder of their information held in a database. The electronic format shall include a baseline sequence in regards to the Common Technical Document (CTD).

Article 48 – paragraph 1 – subparagraph 1: An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non-clinical or clinical evidence for a new therapeutic indication.

Article 48 – paragraph 1 – subparagraph 2: The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication.

Article 48 – paragraph 2: 2. In cases where the opinion is favourable, marketing authorisation holders of the medicinal products concerned shall be notified and given the possibility to comment. After consultation with the marketing authorisation holder, the Agency may submit a variation to update the product information with the new therapeutic indication. The marketing authorisation holder shall inform relevant stakeholders, such as healthcare professionals, of the added indication.

Article 48 – paragraph 3: deleted

Article 52 – paragraph 6 – point c a (new): (ca) the inspectors are free of any conflicts of interest.

Article 54 – paragraph 4 – subparagraph 1: Under the joint audit programme, the auditors shall issue an audit report after each audit. The audit report shall include, where relevant, appropriate recommendations on measures that the Member State concerned shall consider to ensure that its relevant quality system and its enforcement activities are consistent with Union quality standards.

Article 54 – paragraph 6: 6. The compilation of Union procedures on inspections and exchange of information referred to in Article 3(1) of Directive 2017/1572 shall be updated, whenever needed, by the Agency to cover rules applicable to the functioning, structure, and tasks of the joint audit programme.

Article 55 – paragraph 5: 5. In cases referred to in paragraph 4, the Member State shall ensure by all means possible that healthcare professionals are rapidly informed of its action and the reasons for the action. Networks set up by professional associations may be used to this effect. The Member States shall inform the Commission and the Agency of actions taken for this purpose.

Article 58 – paragraph 4: 4. The Agency shall include in the European public assessment report the key areas of the scientific advice as well as a detailed log of the pre-submission activities of the medicinal product, including the names of the experts involved, once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.

Article 58 – paragraph 4 a (new): 4a. The Agency shall, to the greatest extent possible, ensure that there is a separation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product. / When appointing rapporteurs for the purpose of evaluating marketing authorisation applications, the Agency’s Committee on Medicinal Products for Human Use shall duly take into account any involvement of individuals as coordinators in providing scientific advice for the same medicinal product in the pre-submission stage of activities. / If, in exceptional cases, the Agency appoints as rapporteur an expert who had a prominent role in providing scientific advice on the same medicinal product during the pre-submission stage of activities, the Agency shall document and publish detailed information for the decision with the European public assessment report. The Agency shall nonetheless ensure that at least one of two rapporteurs had no prominent role in the pre-submission activities for that medicinal product. / Where a separation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product is not possible, it shall be recorded in the summary minutes of the meetings in accordance with Article 147(2)

Article 60 – paragraph 1 – introductory part: 1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil at least one of the following conditions:

Article 60 – paragraph 1 – point c: (c) are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, including advanced therapy medicinal products, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).

Article 60 – paragraph 4 a (new): 4a. Where a priority medicinal product benefits from enhanced scientific and regulatory support from the Agency, the European public assessment report shall include a specific section on the Agency’s pre-submission activities, and information on the key areas of the scientific advice and regulatory support provided and on the follow-up by the requester, including corresponding information and data which show that the conditions for the PRIME scheme have been fulfilled.

Article 63 – paragraph 1 – point a: (a) the condition affects not more than five in 10 000 persons in the Union when the application for an orphan designation is submitted or the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union and, without incentives, it is unlikely that the marketing of the medicinal product in the Union would generate a sufficient return to justify the necessary investment;

Article 65 – paragraph 2 – point c a (new): (ca) detailed reasons for the transferring of the orphan designation

Article 66 – paragraph 5: 5. At any time, an orphan designation may be withdrawn at the request of the orphan medicine sponsor. The orphan medicine sponsor shall provide a reasoned justification for the withdrawal request which shall be made publicly available.

Article 67 – paragraph 3 – point f a (new): (fa) where applicable, any request made in accordance with Article 66(2) and any decisions taken in that respect.

Article 68 – paragraph 2: 2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit organisations provided for in framework programmes for research and technological development.

Article 70 – paragraph 1 – introductory part: 1. An orphan medicinal product shall be considered as addressing a high unmet medical need where it fulfils the following two requirements:

Article 70 – paragraph 1 – point b: (b) the use of the orphan medicinal product results in a substantial reduction in disease morbidity or mortality for the relevant patient population.

Article 70 – paragraph 3: 3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission, the authorities or bodies and other relevant stakeholders referred to in Article 162.

Article 71 – paragraph 2 – point a: (a) eight years for orphan medicinal products other than those referred to in points (b), (ba) and (c);

Article 71 – paragraph 2 – point b a (new): (ba) five years for a new orphan therapeutic indication of medicinal products which have already received marketing authorisation in the Union ;

Article 71 – paragraph 2 – point c: (c) three years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].

Article 71 – paragraph 2 a (new): 2a. For the medicinal products referred to in paragraph 2, points (ba) and (c), the market exclusivity in respect of the orphan indication shall not prevent the entry of generic and biosimilar medicinal products on the market, provided that they are for other uses that are not subject to the market protection applicable in accordance with paragraph 2. / The periods set out in paragraph 2, points (a) and (b), of this Article may however be reduced to five years if, by the end of the fourth year in respect of the medicinal product concerned, it is established by the Agency that the criteria laid down in Article 63(1), point (a), are no longer met, inter alia, where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. To that end, a Member State shall inform the Agency that the criterion on the basis of which market exclusivity was granted may not be met and the Agency shall then initiate the procedure laid down in Article 67(2). The sponsor shall provide the Agency with the information necessary for that purpose.

Article 72 – paragraph 1: deleted / (deleted)

Article 72 – paragraph 2 – subparagraph 1: The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least three years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.

Article 72 – paragraph 4: 4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraph 1.

Article 74 – paragraph 2 – subparagraph 1 – point b: (b) following the acceptance by the Agency of a duly justified request from an applicant in accordance with paragraph 3.

Article 74 – paragraph 3: 3. When it is not possible, on the basis of scientifically justified reasons, to have a complete paediatric development plan in accordance with the timing given in Article 76(1) an applicant may submit a duly justified request to the Agency to utilise the procedure mentioned in paragraph 2. The Agency has 20 days to accept or refuse the request and shall immediately inform the applicant and state the reasons for refusal.

Article 75 – paragraph 1 – point a: (a) that the specific medicinal product or class of medicinal products is very likely to be ineffective or unsafe in part or all of the paediatric population;

Article 94 – paragraph 2 – subparagraph 3: If for justified scientific reasons it is not possible to submit the summary of the result of the trial within 6 months it shall be submitted to the EU database at the latest within twelve months after the trial has ended. The justification for the delay needs also to be submitted in the EU database. Non-compliance withRegulation (EU) No 536/2014 shall be subject to penalties.

Article 104 – paragraph 1 – subparagraph 1 – introductory part: The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal for the dissemination of information on medicinal products authorised or to be authorised in the Union. By means of that portal, the Agency shall make public the following. The dedicated webportal shall be set up in accordance with Directive (EU) 2016/2102 of the European Parliament and of the Council1a: / 1a Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).

Article 104 – paragraph 1 – subparagraph 1 – point c: (c) the risk management plans for medicinal products authorised in accordance with this Regulation and the accompanying summaries of the risk management plans;

Article 104 – paragraph 1 – subparagraph 2: The risk mitigation plans and summaries referred to in point (c) shall include a description of any additional risk minimisation measures.

Article 104 – paragraph 3 – subparagraph 2: Information in such register shall be publicly available and be easily accessible on the Agency’s website, unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].

Article 105 – paragraph 3: 3. The Agency shall, in consultation with the Commission, Member States and their relevant authorities, as well as other relevant parties, including experts from academia, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the Eudravigilance database.

Article 113: deleted

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Article 115: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Article 116 – paragraph 1 – point d: (d) a temporary disruption in supply of a medicinal product in a given Member State based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

Article 117 – paragraph 1: 1. By ... [12 months after the date of entry into force of this Regulation], the marketing authorisation holder as defined in Article 116(1) shall prepare a shortage prevention plan and send it to the competent authority as defined in Article 116(1), for any medicinal product placed on the market. The shortage prevention plan shall be kept up to date and ready to be sent to the public authority upon its request. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Article 117 – paragraph 2: 2. The Agency shall, in collaboration with the working party referred to in Article 121(1) and after consultation with healthcare professionals and patient and consumer organisations, draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

Article 117 – paragraph 3 a (new): 3a. The shortage prevention plans shall be made available to healthcare professionals and patient and consumer organisations on a dedicated website by the competent authority.

Article 118 – paragraph 1 – subparagraph 1: Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 of this Regulation, the information contained in the repositories system referred to in Article 67(2), second subparagraph, point (e), of [revised Directive 2001/83/EC], and the notification made pursuant to Article 116(1), points (a) to (d), of this Regulation, the competent authority concerned as referred to in Article 116(1) of this Regulation shall continuously monitor any potential or actual shortage of those medicinal products.

Article 118 – paragraph 2: 2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned shall set a deadline for the submission of the information requested.

Article 120 – paragraph 1 a (new): 1a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.

Article 120 – paragraph 2: 2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any relevant information requested in a timely manner.

Article 121 – paragraph 1 – point b: (b) publish information on all expected or actual shortages of medicinal products, the reason for the shortage, as well as measures taken to counter the expected or actual shortage, as soon as that competent authority has assessed the shortage and provided clear recommendations and possible alternatives to healthcare professionals and patients, on a publicly available and user-friendly website;

Article 121 – paragraph 2 – point f: (f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level without undue delay.

Article 121 – paragraph 5 – point a: (a) report to the Agency on any information received from the marketing authorisation holder as defined in Article 116(1) of the medicinal product concerned or from other actors pursuant to Article 120(1a) and (2);

Article 122 – paragraph 4 – introductory part: 4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c) and in consultation with relevant patient and consumer organisations:

Article 122 – paragraph 6: 6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure, that data is interoperable between the ESMP, Member States’ IT systems and where relevant, with other relevant IT systems and databases, without duplication of reporting. The Agency shall work towards making the ESMP fully digitalised.

Article 124 – paragraph 2 – subparagraph 2: For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Article 124 – paragraph 3: 3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available and user-friendly webpage that provides information on all actual critical shortages of medicinal products, including the reasons for the shortages. After assessing the shortages, the Agency shall provide recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b)

Article 125 – paragraph 1 – point c: (c) comply with the recommendations referred to in Article 123(4);

Article 125 – paragraph 1 – point f: (f) inform the Agency of the end date of the critical shortage without undue delay;

Article 125 – paragraph 1 – point f a (new): (fa) inform the Agency of the cause of the critical shortage no later than 14 working days after it has been resolved.

Article 127 – paragraph 1: 1. The competent authority of the Member State shall, after consultation with healthcare professionals and national patient and consumer organisations, identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).

Article 127 – paragraph 4: 4. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information from other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public. Those actors shall state whether the information provided to the competent authority of the Member States contains any commercially confidential information, provide a justification for that statement and indicate the information in question.

Article 129 – paragraph 1: For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information pro-actively where they deem it necessary or as requested in a timely manner.

Article 130 – paragraph 1 – subparagraph 1 – introductory part: The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and after consultation with patient organisations, ensure the following:

Article 130 – paragraph 1 – subparagraph 1 – point a: (a) develop a common methodology to identify critical medicinal products, including the evaluation of the therapeutic indication, vulnerabilities and the availability of appropriate alternatives with respect to the supply chain of those medicines, in consultation with patient and consumer organisations, as well as other relevant stakeholders;

Article 131 – paragraph 1: 1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and patient and consumer organisations, as well as other relevant stakeholders as set out in Article 162 of this Regulation. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Article 131 – paragraph 2: 2. The MSSG shall propose updates to the Union list of critical medicines to the Commission, where necessary.

Article 132 – paragraph 1: 1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers, inventory management and pricing mechanisms and cost-containment measures.

Article 133 – paragraph 1 – point c: (c) comply with the recommendations referred to in Article 132(1);

Article 134 – paragraph 1 – introductory part: 1. The Commission shall:

Article 134 – paragraph 2: 2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt an implementing act to improve security of supply and other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors and other relevant entities.

Article 134 a (new): Article 134a / General provisions / 1. Member States may introduce or maintain more robust provisions than those provided for in this Regulation with regard to the security of supply of and the availability of medicinal products. / 2. The implementation of this Regulation shall in no circumstances constitute grounds for a reduction of the level of safeguards already afforded by Member States with regard to the security and availability of supply of medicinal products. Where Member States detect infringements of measures in relation to Chapter X, penalties in accordance with Article 171(1) shall be imposed without undue delay.

Article 138 – paragraph 1 – subparagraph 2 – point a: (a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures; the Agency, after consulting with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 and the health technology coordination group established by Article 3 of Regulation (EU) 2021/2282, shall set out binding uniform standards for the design of scientific studies.

Article 138 – paragraph 1 – subparagraph 2 – point n: (n) creating a user-friendly database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

Article 138 – paragraph 1 – subparagraph 2 – point zl: (zl) drawing up scientific guidelines to facilitate the implementation of the definitions established in this Regulation and in [revised Directive 2001/83], and for the environmental risk assessment of medicinal products for human use, in consultation with the Commission and the Member States and relevant stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations.

Article 138 – paragraph 1 – subparagraph 2 – point zl a (new): (zla) where scientific guidelines are provided, the Agency shall ensure that such guidelines are always kept up-to-date and based on the latest scientific developments.

Article 138 – paragraph 2 – subparagraph 1: The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, the package leaflet and the information shown on the labelling, as well as Member States where the medicinal product is placed on the market. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 40(4), point (b), and Article 57 of [revised Directive 2001/83/EC].

Article 138 – paragraph 2 – subparagraph 3: The database shall also include references to clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 81 of Regulation (EU) No 536/2014.

Article 142 – paragraph 1 – point j a (new): (ja) an ad hoc working group on Advanced Therapy Medicinal Products ;

Article 142 – paragraph 1 – point j b (new): (jb) an ad hoc working group on Orphan Medicinal Products ;

Article 142 – paragraph 1 – point j c (new): (jc) an ad hoc working group on Paediatric Committee ;

Article 142 – paragraph 1 – point k a (new): (ka) create a pool of experts from Member States and relevant stakeholders to work in the ad hoc working groups; the members shall be selected based on relevant experience in relation to the different ad hoc working groups, so they can contribute to the regulatory support and scientific advice procedures, and they shall be free of any conflicts of interest.

Article 147 – title: Transparency and conflict of interest

Article 147 – paragraph 1 – subparagraph 1: Members of the Management Board, members of the committees, rapporteurs and experts shall carry out their activities in an independent, impartial and transparent manner. They shall not have financial or other interests in the pharmaceutical industry which could affect their independence or impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial and other interests and update it whenever necessary. They shall disclose any other facts of which they become aware that might in good faith reasonably be expected to involve, or give rise to, a conflict of interest.

Article 147 – paragraph 1 – subparagraph 2: deleted

Article 147 – paragraph 2: 2. Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda. These declarations shall be made available to the public. Where the Agency decides that a declared interest constitutes a conflict of interest, that representative shall not take part in any discussions or decision-making, or obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.

Article 147 – paragraph 2 a (new): 2a. Patients, clinical experts and other relevant experts shall declare any financial and other interests relevant to the joint work in which they are due to participate. Such declarations and any actions taken as a result shall be recorded in the summary minutes of the meeting and in the outcome documents of the joint work in question.

Article 147 – paragraph 2 b (new): 2b. All indirect interests which could relate to the pharmaceutical industry shall be entered in a register held by the Agency which is accessible to the public. / The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts.

Article 148 – paragraph 3 – point a a (new): (aa) four co-opted members chosen by the Committee among experts proposed by Member States or the Agency on the basis of their specific scientific competence and expertise, with a view to ensuring that the relevant expertise is available within the Committee for the purpose of working groups and ad-hoc working groups in the field of advanced therapy medicinal products, paediatric medicinal products, herbal medicinal products and orphan medicinal products.

Article 150 – title: Scientific working parties, ad-hoc working groups and scientific advisory groups

Article 150 – paragraph 3 – subparagraph 2: The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. Patient representatives shall also be included as members of the working parties. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

Article 153 – paragraph 1: At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. Guidelines for the determination of added therapeutic value shall be drawn up in collaboration with patient organisations.

Article 162 – paragraph 2: 2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders.

Article 166 – paragraph 1: 1. To support its public health tasks and in particular the evaluation and monitoring medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space, for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product.

Article 166 – paragraph 1 – subparagraph 1 a (new): Such data shall in particular include personal electronic health data as defined in Regulation (EU) .../... [draft EHDS Regulation 2022/0140(COD)] and where relevant, data from monitoring studies on the use, effectiveness and safety of medicinal products intended for treatment, prevention, or the diagnosis of disease, including health data provided by public authorities and data as referred to in Article 20, first paragraph, point (b), of Regulation (EU) 2022/123.

Article 166 – paragraph 2: 2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product. Such update shall only take place after the consultation with the marketing authorisation applicant or marketing authorisation holder concerned.

Article 169 – paragraph 1 – subparagraph 2 – point b: (b) as regards special categories of personal data, is strictly necessary and subject to appropriate safeguards, which may include anonymisation and pseudonymisation requirements and techniques, data minimisation and retention measures, specific organisational measures and access controls on a ‘need to know’ basis and other appropriate measures, confidentiality requirements, and fundamental rights of data subjects as set out in Regulations (EU) 2016/679 and (EU) 2018/1725.

Article 169 – paragraph 3: deleted

Article 171 – paragraph 1: 1. By ... [six months after the date of entry into force of this Regulation], Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Article 172 – paragraph 1: 1. The Commission shall impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations. The penalties imposed by the Commission shall be effective, proportionate and dissuasive.

Article 180 – paragraph 13: deleted

Annex I – point 3: 3. Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding herbal medicinal products, which shall in any case not be authorised by the Union.

Annex II – point 25 a (new): (25a) the obligation to notify the competent authority of the Member State and, where relevant, the Agency about cessation, withdrawal, temporary suspension or temporary disruption in accordance with the deadlines provided for in Article 116;

Annex II – point 25 b (new): (25b) the obligation to have in place and keep up to date a shortage prevention plan as provided for in Article 117;

Annex II – point 25 c (new): (25c) the obligation to comply with the recommendations and measures taken in case of a critical shortage as provided for in Article 125;

Annex II – point 25 d (new): (25d) the obligation to comply with the recommendations and measures taken in relation to critical medicinal products as provided for in Article 133.

Annex IV – Part V a (new): Part Va / For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: / 1. Product availability information: / Product availabilities shall be reported per wholesale warehouse and shall be indexed as yes/no. / 2. Service level information: / Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.

EXPLANATORY STATEMENT

The Rapporteur welcomes the long-awaited proposals on both the pharmaceutical Regulation and the Directive as a centrepiece of the European Health Union, which provide a much-needed revision for the crucial legislative framework providing the pharmaceutical rules in the Union. Given that the provisions set out in both the Regulation and Directive are intrinsically interconnected, the Rapporteur considers it essential that these legal texts are considered closely together.

This revision will help the Union to provide a high level of public health by ensuring quality, safety, and efficacy of medicinal products for European patients. Furthermore, it will be a step towards securing timely and equitable access for patients across all Member States. The Rapporteur is committed to delivering on the overarching objectives of ensuring greater accessibility, affordability, and availability of medicinal products for patients across the whole Union.

Furthermore, the Rapporteur welcomes the stepping away from the model of “one-size-fits-all" towards a stepwise approach of incentive models, where actual innovation is promoted and rewarded. The Rapporteur further builds on this principle in his approach to amendments on the modulation of incentives.

Increasingly in the past years the European Union has experienced occasions of shortages of critical and essential medicinal products, to the detriment of patients across the EU. The measures proposed by the European Commission are therefore very much welcomed, as we will be setting a framework to counter shortages, react efficiently and in a coordinated matter. Measures introduced include shortage management and security of supply of medicinal products and in particular critical medicinal products. Further developing the tasks and responsibilities of the EMA towards shortage prevention is another positive addition in the text.

In a similar vein, the Rapporteur is positive regarding the enhanced provisions on the Environmental Risk Assessment proposed by the Commission and the proposed restructuring of the European Medicines Agency that will facilitate streamlined procedures and accelerated marketing authorisations.

The Rapporteur is also dubious of Chapter IX of the proposal which introduces a regulatory sandbox for medicinal products. Firstly, the rapporteur considers the provisions in the Commission’s proposal vague in nature and has not been satisfied with explanations or examples of which types of products could be eligible for such a regulatory sandbox. The rapporteur also bases his decision of the deletion of this chapter after consultation with several stakeholders, and notably industry actors who expressed reluctance with the introduction of another parallel regulatory framework. The Rapporteur and several stakeholders consider that the frameworks within the pharmaceutical rules are broad and encompassing. There is concern that such a sandbox could provide a way of circumventing rules and obligations laid down in the other frameworks provided for in the Regulation. Additionally, the rapporteur would oppose derogations from the requirements set out in both the Regulation and the Directive, particularly with regards to the Environmental Risk Assessment.

Furthermore, the Rapporteur also perceives shortcomings within the Commission proposal, notably on incentives for the development of priority antimicrobials.

Antimicrobial resistance is a rapidly increasing public health threat, already responsible for 35,000 deaths annually in the EU alone and 1.3 million deaths globally. In this regard, the Rapporteur recognises the severity of this issue and the need for the creation of new priority microbials as envisaged in the Regulation. It is also the conviction of the rapporteur that the EU must take action to prevent excessive use of antimicrobials and pharmaceutical waste in the environment, which contribute to the proliferation of antimicrobial resistance. However, the Rapporteur expresses severe scepticism towards the proposed solution of the Transferable Exclusivity Voucher (TEV) which are an indirect and non-transparent form pricing which will cost national health budgets in an unpredictable manner and delay the entry of generic medicines to the market, to the detriment of patients. It is incomprehensible to the Rapporteur that the Commission would propose such a measure without even the accompanying requirement and conditionality to guarantee supply of the priority antimicrobial from which the voucher was awarded. Additionally, the Rapporteur feels that safeguards are missing for the continuous supply of the antimicrobial after the voucher has been sold to another company.

In the absence of the TEV, the Rapporteur proposes the establishment of the ‘European Medicines Facility’ (EMF) as a Union Agency. The EMF should set out specific purpose led R&D projects focusing on health priorities in the public interest at a Union level. These projects should follow a strategic roadmap addressing priority antimicrobials, as well as medicinal products addressing high unmet medical needs and unmet medical needs which have not been sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies. The Rapporteur introduces the overarching idea of the EMF in this draft report and will further supplement the proposal in later amendments.

Additionally, the Rapporteur considers it necessary and complementary to mandate the Commission to establish a Union push and pull incentives scheme as an additional measure to incentivise the development of novel antibiotics which could include the likes of market-entry rewards, ‘play or pay’ fees, or subscription payment mechanisms.

This report also includes several smaller tweaks and more adaptations of a technical nature. However, the Rapporteur would like to briefly highlight increased emphasis on the involvement of patients and consumer organisations and the strengthening of provisions on transparency and conflicts of interests throughout the text.

Given the time constraints in the preparation of this draft report, the Rapporteur reserves the right to further amend and supplement this draft report with additional measures, clarifications and to further develop ideas introduced in the text. The Rapporteur is looking forward to engaging constructively with all shadow rapporteurs on this Regulation and equally the rapporteur and shadows on the Directive where coordination is necessary.

The list in the Annex of entities or persons from whom the rapporteur has received input from contains all contributions received, even if not all of it has been used in order to draft the report. Additionally, all meetings in regard to the Regulation can be found on the dedicated profile of the Rapporteur on the website of the European Parliament.