BETA

18 Amendments of Alessandra MORETTI related to 2023/0131(COD)

Alessandra MORETTI

Proposal for a regulation
Article 12 – paragraph 4 – point h

(h) where appropriate, details of any recommended obligation to conduct ~~any other~~ post- authorisation treatment optimisation studies to improve the safe and effective use of the medicinal product; Such an obligation to conduct such studies shall take into account the scientific guidance referred to in Article 123 of [revised Directive 2001/83/EC];

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
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~~including information of a commercially confidential nature if their disclosure is in the public interest or relevant for public health reasons.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 17 – paragraph 1

1. ~~Without prejudice to paragraph 2, a~~A marketing authorisation for a medicinal product shall be valid for ~~an unlimited period~~five years and might be renewed on the basis of a re-evaluation of the risk-benefit balance by the Agency.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1

By way of derogation from paragraph 1, the Commission may decide when granting an authorisation, on the basis of a scientific opinion by the Agency concerning the safety of the medicinal product, to limit the validity of the marketing authorisation to five years.deleted

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 2

~~Where the validity of the marketing authorisation is limited to five years,~~ 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.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 3

Where a renewal application has been submitted ~~in accordance with the second subparagraph~~, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

2023/11/21
Committee: ENVI

Alessandra MORETTI

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~~in advance about the intention 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 the reasons for such action, and before any action is taken in this sense.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

(f a) commercial reasons;

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 29 – paragraph 1

Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. Marketing authorisation holders that benefit from regulatory protection shall disclose information on actual costs of research and development in accordance with Article 84a of the aforementioned Directive.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 40

Granting the right to a transferable data 1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency. 2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product. 3. An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics: (a) it represents a new class of antimicrobials; (b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union; (c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection. In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level. 4. To be granted the voucher by the Commission, the applicant shall: (a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market; (b) provide information on all direct financial support received for research related to the development of the priority antimicrobial. Within 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.Article 40 deleted exclusivity voucher

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
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, also throughspecific purpose-led R&D projects to be carried out along the entire life cycle, including research, development, production and distribution; in the elaboration of the strategic roadmap and its overall activities and initiatives, 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 and manufacturing 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 and manufacturing of medicinal products of health and strategic importance, 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 therapies; (iii) the development of medicinal products neglected by the private sector or for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable; c) ensuring mechanisms for comparative research and data collection, including if necessary independent clinical trials, on the clinical efficacy, benefit-risk profile, and cost-effectiveness of authorized biomedical products and drugs, in full coordination and respect with the EMA prerogatives and competences; 3. The European Commission implements the EMF initially as an autonomous body with own resources, ensures that its governance is mainly expressed by the scientific communities of the Member States , after a transparent selection process, and that the EMF legal framework is open to partnerships with non Member States, in the spirit of a European research infrastructure of global significance

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 41

1. A voucher may be used to extend the data protection for a period of 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder. A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection. A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn. 2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection. 3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further. 4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.Article 41 deleted Transfer and use of the voucher

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 42

1. A voucher shall cease to be valid in the following cases: (a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product; (b) where it is not used within 5 years from the date it was granted. 2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. 3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83]. _________________ 69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).Article 42 deleted Validity of the voucher

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 43

Duration of application of Chapter III This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.Article 43 deleted

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
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 any of the following conditions:

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
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 entities, such as for example the European Medicine Facility as established in article 40a, provided for in framework programmes for research and technological development.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 73 a (new)

Article73a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall: (a) upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product. (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency. (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

2023/11/21
Committee: ENVI

Alessandra MORETTI

Proposal for a regulation
Article 125 – paragraph 1 – point f a (new)

(f a) inform the Agency about the exact causes for the shortage and provide clear clarifications about the responsibilities for this shortage along the entire life cycle of the medicinal product;

2023/11/21
Committee: ENVI