What changed between the plenary report and the adopted text

Added:3a. The regulatory protection referred to in paragraphs 1 and 2 shall not exceed eight years and six months. [Am. 206]

Added:Article 82 Prolongation of the data protection period for medicinal products supplied in Member States

Added:1. The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid.

Added:The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, as referred to in Chapter III, Section 3.

Added:2. To receive a prolongation referred to in Article 81(2), first subparagraph, point (a), the marketing authorisation holder shall apply for a variation of the relevant marketing authorisation.

Added:The application for a variation shall be submitted between 34 and 36 months after the date when the initial marketing authorisation was granted, or for entities referred to in Article 81(2), first subparagraph, point (a), between 46 and 48 months, after that date.

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

Added:(a) confirm that the conditions set out in paragraph 1 have been satisfied in their territory; or

Added:(b) waive the conditions set out in paragraph 1 in their territory for the purpose of the prolongation.

Added:Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a).

Added:3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State. Within 60 days from the request of the marketing authorisation holder, the Member State shall issue a confirmation of compliance or, a reasoned statement of non-compliance or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article.

Added:4. In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non-objection has been provided.

Added:For medicinal products granted a centralised marketing authorisation the Commission shall vary the marketing authorisation pursuant to Article 47 of [revised Regulation (EC) No 726/2004] to prolong the data protection period. For medicinal products granted a marketing authorisation in accordance with the decentralised procedure, the competent authorities of the Member States shall vary the marketing authorisation pursuant to Article 92 to prolong the data protection period.

Added:5. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Added:6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2). [Am. 207]

Added:Article 83 Medicinal products addressing an unmet medical need

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

Added:(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality;

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

Added:2. Designated orphan medicinal products referred to in Article 67 of [revised Regulation (EC) No 726/2004] shall be considered as addressing an unmet medical need.

Added: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 162162(1) and (2), respectively, of [revised Regulation (EC) No 726/2004]. [Am. 208]

Added:Article 84 Data protection for repurposed medicinal products

Added:1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Added:(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

Added:(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has not previously benefitted from data protection, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Added:2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product.

Added:3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indication.

Added:Article 85 Exemption to the protection of intellectual property rights

Added:Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usednecessary studies, trials and other activities are conducted for the purposespurpose of: [Am. 209]

Added:(a) studies, trials and other activities conducted to generate data for an application, for: [Am. 210]

Added:(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; [Am. 211]

Added:(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; [Am. 212]

Added:(iii) obtaining pricing and reimbursement. approval; and [Am. 213]

Added:(iiia) the subsequent practical requirements associated with such activities. [Am. 214]

Added:The activities conducted exclusively for the purposes set out in point (a), maythe 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. [Am. 215]

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

Added:Article 85a Non-interference of intellectual property rights

Added: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.

Added: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.

Added:3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property. [Am. 216]

Added:Article 86 Rewards for paediatric medicinal products

Added: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].

Added:The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

Added:2. The inclusion in a marketing authorisation of the statement referred to in Article 49(2) of this Directive or in Article 90(2) of [revised Regulation (EC) No 726/2004] shall be used for the purposes of applying paragraph 1.

Added:3. Where the procedures laid down in Chapter III, Sections 3 and 4, have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.

Added:4. In the case of an application for new therapeutic indications, including paediatric indications, new pharmaceutical forms, new strengths and new routes of administration of authorised medicinal products which are protected either by a supplementary protection certificate under [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted], or by a patent which qualifies for the granting of the supplementary protection certificate which leads to the authorisation of a new paediatric indication, paragraphs 1, 2 and 3 shall not apply if the applicant applies for, and obtains, a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies, in accordance with Article 81(2), first subparagraph, point (d).

Added:Article 86a Reporting on access to medicinal products

Added: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.

Added: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.

Added: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.

Added: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. [Am. 217]

Added:Chapter VIII Post-marketing authorisation measures

Added:Article 87 Imposed post-authorisation studies

Added:1. After the granting of a marketing authorisation, the competent authority of the Member State may impose an obligation on the marketing authorisation holder:

Added:(a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the competent authority of the Member State shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

Added:(b) to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly. The obligation to conduct the post-authorisation efficacy study shall be based on the delegated acts adopted pursuant to Article 88 while taking into account the scientific guidance referred to in Article 123.

Added:(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. [Am. 218]

Added:If the same concerns apply to more than one medicinal product, the competent authority of Member State shall, following consultation with the Agency, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation environmental risk assessment study.

Added: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. [Am. 219]

Added:2. The competent authority of the Member State shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.