Changes from report parliamentary committee draft to plenary report

RemovedArticle 74 – paragraph 4 a (new): 4a. Where a competent authority grants a full or partial exemption to the language requirements in accordance with paragraph 4, patients' right to a copy of the document in the official language of the Member State shall be guaranteed upon request and free of charge.

AddedArticle 69 – paragraph 2 – subparagraph 2: Member States shall ensure that the awareness card is made available in paper format or both in paper format and electronically in the packaging of an antimicrobial.

RemovedArticle 80 – paragraph 4: 4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended for the indication that is relevant to the public health emergency with regard to that party insofar as the compulsory licence requires, in the relevant Member States and during the duration period of the compulsory licence.

AddedArticle 69 – paragraph 3 – subparagraph 1 a (new): Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial.

AddedArticle 69 – paragraph 3 a (new): 3a. The Commission may adopt implementing acts laying down further standards for the awareness card after consulting the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

AddedArticle 73 – paragraph 1: The outer packaging, the immediate packaging and the package leaflet may include symbols or pictograms designed to clarify certain information set out in Articles 64(1), 65 and 69 and other information compatible with the summary of product characteristics that is useful for the patient, to the exclusion of any element of a promotional nature.

AddedArticle 74 – paragraph 4: 4. The competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. Where a competent authority grants a full or partial exemption to the language requirements that apply to the label or package leaflet, the patients’ right to a printed copy in the official language or official languages of the Member State shall be guaranteed upon request and free of charge. / For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed.

AddedArticle 77 – paragraph 1 – point a a (new): (aa) the wording on prudent use and safe disposal of antimicrobials;

AddedArticle 80 – paragraph 2 a (new): 2a. The period referred in paragraph 2 of this Article shall be extended by an additional period of one year, where the marketing authorisation holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication, provided that significant clinical benefit in comparison with existing therapies has been demonstrated by the marketing authorisation holder with supporting data. That extension may only be granted once.

AddedArticle 80 – paragraph 4: 4. By way of derogation from paragraphs 1 and 2, when a compulsory licence has been granted by a relevant Member State authority in the Union under conditions laid down in Union law and in compliance with international agreements to a party, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence in the Member State(s) where the compulsory license has been granted.

Article 80 – paragraph 4 a (new): 4a. The marketing authorisation holder for the medicinal product for which a compulsory licence has been granted shall be informed of the decision without delay.

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ChangedArticle 81 – paragraph 1: 1. The regulatory data protection period shall be nineseven years and six months 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.

Article 81 – paragraph 2 – subparagraph 1 – point a: deleted / (deleted) / (deleted) / (deleted)

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RemovedSee amendments to new Article 58a.

Article 81 – paragraph 2 – subparagraph 1 – point b: (b) 12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

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ChangedArticle 81 – paragraph 2 – subparagraph 1 – point c:c (c)a (new): (ca) six months, forwhere medicinalthe productsmarketing whereauthorisation theholder clinicaldemonstrates trialsthat supportinga significant share of research and development, including preclinical and clinical, related to the marketingmedicinal authorisationproduct applicationhas usebeen adone relevantwithin the Union and evidence-basedat comparatorleast in accordancepart in collaboration with scientificpublic adviceentities, providedincluding byuniversity hospital institutes, centres of excellence or bioclusters located in the Agency;Union.

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AddedArticle 81 – paragraph 2 – subparagraph 1 – point d: deleted

AddedArticle 81 – paragraph 2 – subparagraph 3: deleted

AddedArticle 81 – paragraph 2 – subparagraph 3 a (new): By ... [12 months from the date of entry into force of this Directive], the Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by setting out the procedural aspects and criteria related to the first subparagraph, point (ca), of this paragraph.

AddedArticle 81 – paragraph 3 a (new): 3a. The regulatory protection referred to in paragraphs 1 and 2 shall not exceed eight years and six months.

Article 82: deleted

Change 37

RemovedSee amendments to new Article 58a.

AddedArticle 83 – paragraph 3: 3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies and the stakeholders referred to in Article 162(1) and (2), respectively, of [revised Regulation (EC) No 726/2004].

RemovedArticle 83 – paragraph 1 – introductory part: 1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating disease and the following conditions are met:

AddedArticle 85 – paragraph 1 – introductory part: 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 necessary studies, trials and other activities are conducted for the purpose of:

RemovedArticle 83 – paragraph 1 – point a: (a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity, high mortality or significant negative impact on quality of life;

AddedArticle 85 – paragraph 1 – point a – introductory part: deleted

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ChangedArticle 8385 – paragraph 1 – point b:a (b)– thepoint usei: of(i) theobtaining medicinala productmarketing resultsauthorisation in:and subsequent variations;

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RemovedArticle 83 – paragraph 1 – point b – point i (new): (i) a meaningful reduction in disease morbidity, mortality, severity or long term side effects for the relevant patient population; or

AddedArticle 85 – paragraph 1 – point a – point ii: (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

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ChangedArticle 8385 – paragraph 1 – point ba – point ii (new): (ii) a meaningfuliii: positive(iii) impactobtaining onpricing qualityand ofreimbursement life;approval; orand

Change 41

ChangedArticle 8385 – paragraph 1 – point ba – point iii (new): (iii) a meaningful delay(new): of(iiia) the onsetsubsequent ofpractical therequirements diseaseassociated orwith itssuch complications.activities.

Change 42

RemovedArticle 83 – paragraph 3: 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.

AddedArticle 85 – paragraph 1 – point b: The activities conducted exclusively for the purposes set out in the first paragraph, shall cover as relevant 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.

RemovedArticle 85 – paragraph 1 – point a – introductory part: (a) studies, trials and other necessary activities conducted to generate data for an application, for:

AddedArticle 85 a (new): Article 85a / Non-interference of intellectual property rights / 1. Member States shall consider the procedures and decisions referred to in Article 85 as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. / 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions referred to in Article 85. / 3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

RemovedArticle 85 – paragraph 1 – point a – point i: (i) a marketing authorisation;

AddedArticle 86 a (new): Article 86a / Reporting on access to medicinal products / The Commission, in collaboration with the Member States, shall develop indicators to measure access to medicinal products within the Union. Those indicators shall be evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the Union. / The Commission shall publish a report assessing access to medicinal products and barriers to improving such access in each Member State and at aggregated Union level. The report shall be publically available. / Based on the report, the Commission shall create a dedicated website with easily accessible information on the access indicators and access to medicinal products in the Union, intended for the general public and relevant stakeholders. / The report shall be drawn up for the first time by [the date of the end of the second year from the date of entry into force of this Directive] and every five years thereafter.

RemovedArticle 85 – paragraph 1 – point a – point iii: deleted

AddedArticle 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1: (c) to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product, or related active substance; where the post-authorisation environmental risk assessment study concerns an antimicrobial, it shall include relevant and comparable data on the volume of sales and the use per types of antimicrobial medicinal products; the Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report; the Agency shall take into account those data when adopting any relevant guidelines and recommendations.

RemovedArticle 85 – paragraph 1 – point b: (b) the activities conducted exclusively for the purposes set out in point (a), may cover the manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

AddedArticle 87 – paragraph 1 – subparagraph 2: The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study. Information on imposed post-authorisation studies shall be noted in the product’s European Public Assessment Report and a database of the competent authority.

RemovedArticle 86 – paragraph 1 – subparagraph 1: 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.

AddedArticle 92 – paragraph 3: 3. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority. Such procedures may also include updates by the marketing authorisation holder of their information held in a database. Where deemed justified by the Agency, accelerated assessment procedures shall also be envisaged for variations which are of major interest from the point of view of public health.

Article 94 – paragraph 1: 1. On the basis of relevant paediatric clinical studies received in accordance with Article 45(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council76 , the competent authorities of the Member States may, following a consultation of the marketing authorisation holder, vary the marketing authorisation of the medicinal product concerned accordingly and update the summary of product characteristics and package leaflet of the medicinal product concerned. The competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.

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AddedArticle 96 – paragraph 1 – subparagraph 1: Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance of the post-authorisation safety and efficacy long-term studies in children, including where relevant data from the off-label use of the product.

AddedArticle 97 – paragraph 1 – point e a (new): (ea) facilitate the protection of patients in relation to adverse events through the development and implementation of plans for safe administration and handling of medicinal products, which may include the use of digital medication safety systems in hospitals and ambulatory care settings.

AddedArticle 102 – paragraph 1 – point b a (new): (ba) the outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, in accordance with Article 22(7a) and Article 29(4a);

AddedArticle 102 – paragraph 1 – point d a (new): (da) where relevant, information related to antimicrobials, in accordance with Article 17(2) and Article 29(4a);

AddedArticle 102 – paragraph 1 – point d b (new): (db) where relevant, the awareness card with information on antimicrobial resistance and the appropriate use and disposal of antimicrobials;

AddedArticle 102 – paragraph 1 – point d c (new): (dc) periodic safety update reports;

AddedArticle 102 – paragraph 1 – point d d (new): (dd) information on the shortage status of medicinal products as referred to in Article 121(1), point (b), of [revised Regulation (EC) No 726/2004];

Article 105 – paragraph 2: 2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members, or healthcare professionals.

Change 44

RemovedArticle 147 – paragraph 1 – subparagraph 1 – point j a (new): (ja) use an appropriate wastewater treatment system.

AddedArticle 106 – paragraph 1 – subparagraph 1: Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow-up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.

AddedArticle 106 – paragraph 5: 5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004]

AddedArticle 106 – paragraph 5 a (new): 5a. Reports of adverse reactions arising from incorrect administration or dispensation of a medicinal product shall be available in the Eudravigilance database and shall be included in periodic safety update reports. Where relevant, Member States shall take corrective action to achieve high standards of medication safety in healthcare settings after consultation of healthcare professionals and other relevant stakeholders.

AddedArticle 107 – paragraph 3 a (new): 3a. The Agency or the national competent authorities, as appropriate, shall make publicly available the reports referred to in paragraph 1, points (a) and (b).

AddedArticle 123 – paragraph 1 – introductory part: The Agency shall, in cooperation with competent authorities of the Member States and other interested parties, including those referred to in Article 162 of [revised Regulation (EC) No 726/2004], draw up:

AddedArticle 123 – paragraph 1 – point a a (new): (aa) guidance for national competent authorities on the effective inclusion of patients and healthcare professionals in the data collection and communication of the risks of medicinal products within the pharmacovigilance activities;