Changes from plenary report to adopted text

Added4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency.

AddedArticle 34 Validity of a temporary emergency marketing authorisation

AddedThe 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.

AddedArticle 35 Variation, suspension or revocation of a temporary emergency marketing authorisation

AddedThe Commission may suspend, revoke or vary the temporary emergency marketing authorisation by means of implementing acts at any time in any of the following cases:

Added(a) the criteria laid down in Article 31 are no longer met;

Added(b) it is appropriate to protect public health;

Added(c) the marketing authorisation holder of a temporary emergency marketing authorisation has not complied with conditions and obligations set out in the temporary emergency marketing authorisation;

Added(d) the marketing authorisation holder of a temporary emergency marketing authorisation has not complied with the specific conditions set in accordance with Article 33.

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

AddedArticle 36 Granting of a marketing authorisation or conditional marketing authorisation after a temporary emergency marketing authorisation

AddedThe marketing authorisation holder of an authorisation in accordance with Article 33 may submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19 based on the pre-agreed deadlines established with the Agency. [Am. 145]

AddedFor the purpose of regulatory data protection, the temporary emergency marketing authorisation and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.

AddedArticle 37 Transitional period

AddedWhen 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. In such cases, the Member State shall inform the Agency about the application of the transitional period. Conditions for manufacturing, use, supply and safety monitoring and the compliance with the related good manufacturing and pharmacovigilance practices shall continue to apply during that period. [Am. 146]

AddedArticle 38 Relation with Article 18 of Regulation (EU) 2022/123

Added1. For medicinal products for which a temporary emergency marketing authorisation may be considered by the Agency, Article 18(1) and (2) of Regulation (EU) 2022/123 shall apply.

AddedThe Emergency Task Force shall provide a recommendation for a temporary emergency marketing authorisation to the Committee for Medicinal Products for Human Use for an opinion in accordance with Article 32. To this purpose, the Emergency Task Force set up pursuant to Article 15 of Regulation (EU) 2022/123 may, where appropriate, perform the activities referred to in Article 18(2) of that Regulation prior to the recognition of a public health emergency.

Added2. Where a request referred to in Article 18(3) of Regulation (EU) 2022/123 for a recommendation has been made and there is an application for a temporary emergency marketing authorisation for the medicinal product concerned, the procedure for a recommendation under Article 18(3) of Regulation (EU) 2022/123 shall be stopped and the procedure for a temporary emergency marketing authorisation shall prevail. Any available data shall be considered under the temporary emergency marketing authorisation application.

AddedArticle 39 Withdrawal of authorisations granted in accordance with Article 3(2) of [revised Directive 2001/83/EC]

AddedWhen the Commission has granted a temporary emergency marketing authorisation in accordance with Article 33, Member States shall withdraw any authorisation granted in accordance with Article 3(2) of [revised Directive 2001/83/EC] for the use of medicinal products containing the same active substance for any indications that are subject to the temporary marketing authorisation.

AddedArticle 39a Milestone payment reward scheme

Added1. An antimicrobial shall be considered a ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with regard to antimicrobial resistance and it has at least one of the following characteristics:

Added(a) it represents a new class of antimicrobials;

Added(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

Added(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.

AddedIn 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.

Added2. The Commission, in consultation with the Agency, shall award milestone payments and support to potential priority antimicrobials addressing the priority pathogens referred to in paragraph 1 of this Article. The milestone payments shall be financed through resource matching by the Commission, including within the framework of Article 12(2), point (b)(i), of Regulation (EU) 2021/695 of the European Parliament and of the Council and Regulation (EU) 2021/522 of the European Parliament and of the Council.

AddedThe Commission shall adopt delegated acts in accordance with Article 175 to supplement this Regulation by setting the criteria for the awarding of milestone payments, including payments for the completion of pre-specified development stages and criteria, taking into account the costs of the development of that stage and the anticipated costs of the next stage of development.

AddedThe awarding of milestone payments shall be contingent on legal commitments to use the payments:

Added(a) to further develop the priority antimicrobial;

Added(b) to apply for a marketing authorisation in accordance with this Regulation;

Added(c) to conduct antimicrobial stewardship and access plans as referred to in Article 17(1), point (a), of [revised Directive 2001/83/EC]; and

Added(d) where relevant, to apply for the joint procurement agreement referred to in Article 39b.

Added3. The priority antimicrobial shall also be subject to joint clinical assessment in accordance with Article 7(2), point (a), of Regulation (EU) 2021/2282.

Added4. A developer who benefits from milestone payments under this Article shall not be eligible to avail of a transferable exclusivity voucher in accordance with Article 40. [Am. 147]

AddedArticle 39b Subscription model for the joint procurement of antimicrobials

Added1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council with a view to the advance purchase of antimicrobials.

Added2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a joint procurement agreement between the parties determining the practical arrangements governing the subscription model system and other procedures, including the length of the subscription contract and the possibility of parallel procurement.

Added3. The joint procurement agreement shall take the form of a multi-year subscription and include the following conditions:

Added(a) delinkage or partial delinkage of funding from the volume of sales of the antimicrobial;

Added(b) commitment to continuous and sufficient supply in pre-agreed quantities;

Added(c) commitment to the antimicrobial stewardship and access plans as referred to in Article 17(1), point (a), of [revised Directive 2001/83/EC];

Added(d) commitment to the environmental risk assessment as referred to in Article 22 of [revised Directive 2001/83/EC];

Added(e) submission of a global access plan to supply third countries in critical need, including through development partners or voluntarily licensing.

Added4. Participation in the joint procurement procedure shall be open to all Member States and third countries, including the European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046.

Added5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of antimicrobials and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001. [Am. 148]

AddedCHAPTER III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’

AddedArticle 40 Granting the right to a transferable data exclusivity voucher

Added1. Following a request by the applicant when applying for a marketing authorisation, made before the marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3Article 39a(1), under the conditions referred to in paragraph 4 of this Article based on a scientific assessment by the Agency. [Am. 149]

Added2. The voucher referred to in paragraph 1 shall give the right to its holder to ana maximum of additional 12 months of data protection for one authorised medicinal product. [Am. 150]

Added2a. The Commission shall adopt delegated acts in in accordance with Article 175 to supplement this Regulation by setting up the eligibility of pathogens for the protection periods referred to in paragraph 2 of this Article in accordance with the WHO priority pathogens list or an equivalent established at Union level, with 12 months of data protection for an authorised product ranked ‘critical’, 9 months of data protection for those ranked ‘high’ and 6 months of data protection for those ranked ‘medium’. [Am. 151]

Added3. 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:

Added(a) it represents a new class of antimicrobials;

Added(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

Added(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.

AddedIn 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. [Am. 152]

Added4. To be granted the voucher by the Commission, the applicant shall:

Added(a) demonstrate capacity toand ensure the supply of the priority antimicrobial in sufficient quantities for the expected needs of the Union market, as defined in a contract with the Authority; [Am. 153]

Added(b) provide information on all direct financial support and indirect financial support in accordance with Article 57 of [revised Directive 2001/83/EC] received for research related to the development of the priority antimicrobial.; [Am. 154]