54 Amendments of Fulvio MARTUSCIELLO related to 2023/0131(COD)
Amendment 455 #
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly importsignificant in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especialparticularly in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.
Amendment 460 #
Proposal for a regulation
Recital 134
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existingcurrent levels of protection need to be respected.
Amendment 464 #
Proposal for a regulation
Recital 135
Recital 135
(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the particularspecificities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where appropriatsuitable, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.
Amendment 524 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product 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);
Amendment 527 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7
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 if such an advantage or contribution benefits a substantial part of the target population;
Amendment 544 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which are likely to fall in the scope of this Regulation,might be regulated as medicinal products or other categories of products pursuant to a specific plan and for a limited time under regulatory supervision.
Amendment 664 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the envirconmtental 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 applicant; or timelines of post- authorisation studies to further clarify environmental risk assessment, as required in article 20(c), cannot be agreed.
Amendment 834 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for afor a marketing authorisation , made before that 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 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency or alternatively incentives already introduced in other areas such as rare diseases.
Amendment 847 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – introductory part
Article 40 – paragraph 3 – subparagraph 1 – introductory part
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:.
Amendment 849 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 855 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 862 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 869 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 2
Article 40 – paragraph 3 – subparagraph 2
In theits 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.
Amendment 874 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b
Article 40 – paragraph 4 – subparagraph 1 – point b
(b) provide information on all direct financial support received from any public authority of publicly funded body based in the European Union, for research related to the development of the priority antimicrobial.
Amendment 913 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
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 fourhas at least two years of regulatory data protection remaining.
Amendment 935 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if ain normal circumstances, a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is consistent with the expected needs of the Union market and the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder.
Amendment 948 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date of from the entry into force of this Regulation. [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 , the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 1056 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 1062 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. The orphan medicineal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.
Amendment 1063 #
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part
Article 64 – paragraph 2 – subparagraph 1 – introductory part
The application for the designation of the orphan medicine sponsoral product shall be accompanied by the following particulars and documentation:
Amendment 1066 #
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The Agency shall verify the validity of the application and share its draft scientific conclusions with the applicant. The applicant shall be invited to provide their observations on the draft conclusions.The Agency shall, in consultation with the Member States, the Commission and interested parties, draw up detailed guidelines on the required procedure, format and content of applications for designation and for the transfer of the orphan designation pursuant to Article 65.
Amendment 1068 #
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordancewithin 90 days of the receipt of a valid application. Within the timelines for adoption of a decision foreseen in subparagraph 1, the Agency shall transmit its scientific conclusions to the applicant. Within 30 days of receipt of the scientific conclusions, the sponsor may submit to the Agency a writh Article 63(2) wten request, citing detailed grounds, for a re-examination. Within 930 days of the receipt of a valid application.following receipt of a request for re-examination, the Agency shall confirm or revise its previous scientific conclusions.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. If, within the 30-day period referred to in subparagraph 3, the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1073 #
The decision together with the Annexes referred to Agency shall adopt a decision within a period not exceeding 10 days following this paragraph shall be notified to the applicante date on which the scientific conclusions have become definitive.
Amendment 1076 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 1086 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 1091 #
Amendment 1092 #
Proposal for a regulation
Article 66 – paragraph 4
Article 66 – paragraph 4
4. An orphan designation ceases to be valid once an orphan medicine sponsor has obtained a marketing authorisation for the relevant medicinal product in accordance with Article 13(2). An orphan designation shall however remain valid in case the indication of the initial marketing authorisation addresses only a subset of the population affected by the designated orphan condition or where the orphan medicinal product sponsor can provide evidence that studies supporting the use of the designated orphan medicinal product are planned or ongoing with respect to additional indications within the scope of the designated condition / orphan designation.
Amendment 1128 #
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
Amendment 1146 #
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
Amendment 1148 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
Amendment 1164 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1179 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) thirteen years for orphan medicinal products addressing a high unmetwhich fulfil one of the following requirements: i. there is no medicinal product authorised in the Union for such condition or where ii. despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal need as referred to in Article 70; product, in addition to having a significant benefit, will bring exceptional therapeutic advancement or iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted.
Amendment 1202 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 1228 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1235 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1245 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two 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. If the newly approved therapeutic indication meets one of the requirements listed in Article 71(2) point (b), and where the first orphan marketing authorisation was not granted a period of market exclusivity as referred in Article 71(2) point (b), the period of market exclusivity shall be prolonged by 36 months in total.
Amendment 1253 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1401 #
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1411 #
Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1
Article 113 – paragraph 2 – subparagraph 1
The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or, Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114.
Amendment 1416 #
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and mayshall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162.
Amendment 1420 #
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commissionproducts which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in- vitro diagnostics, substances of human origin, , it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1432 #
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and, Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1436 #
Proposal for a regulation
Article 113 – paragraph 7 – point c
Article 113 – paragraph 7 – point c
(c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.
Amendment 1444 #
Proposal for a regulation
Article 113 – paragraph 9
Article 113 – paragraph 9
9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoaption of supplementary conditionsng the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).
Amendment 1451 #
Proposal for a regulation
Article 114 – paragraph 3
Article 114 – paragraph 3
3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.
Amendment 1459 #
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1
Article 115 – paragraph 1 – subparagraph 1
The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspendtop or restrict their use and inform the Commission in accordance with Article 113(2).
Amendment 1462 #
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 2
Article 115 – paragraph 1 – subparagraph 2
Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place.
Amendment 1480 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo 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).
Amendment 1496 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketUnion list of critical medicinal products referred to in Article 131. 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.
Amendment 1585 #
Proposal for a regulation
Article 122 – paragraph 6
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, where relevant, data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, without duplication of reporting including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive 2023/0132 (COD) , without duplication of reporting for Marketing Authorisation Holders and National Competent Authorities.
Amendment 1651 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
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 marketing authorisation holders, ensure the following:
Amendment 1660 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 1676 #
Proposal for a regulation
Article 131 – paragraph 1
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), in addition to marketing authorisation holders and other relevant stakeholders. 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”).
Amendment 1685 #
Proposal for a regulation
Article 132 – paragraph 1
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) in addition to marketing authorisation holders and other relevant stakeholders, 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. SuchAny measures may includeor recommendations on diversification of suppliers and inventory managemenshould be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact.