22 Amendments of Peter LIESE related to 2023/0131(COD)
Amendment 232 #
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products and medical devices that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 300 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56 a) The role of patient organisations is crucial in European Health Policy. Their finance, particularly their finance independent of individual pharmaceutical companies, is of particular importance. That is why the Commission should examine the situation and, if appropriate, make proposals to strengthen independent financing.
Amendment 314 #
Proposal for a regulation
Recital 68 a (new)
Recital 68 a (new)
(68 a) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of further measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials, and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.
Amendment 326 #
Proposal for a regulation
Recital 77
Recital 77
(77) The development of antimicrobial resistance is a growing concern and thealth problem in the Union and worldwide, thus involving a common responsibilty of all actors concerned. The pipeline of effective antimicrobials is obstructed due to a market failure; it is therefore necessary to considermaintain the efficacy of existing antimicrobials for as long as possible and to consider a number of new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area.
Amendment 486 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders and the information available in the European Medicines Verifications System (EMVS). The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 872 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point a
Article 40 – paragraph 4 – subparagraph 1 – point a
(a) demonstrate capacity and ensure to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;
Amendment 878 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 2
Article 40 – paragraph 4 – subparagraph 2
Within 3045 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.
Amendment 923 #
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 3045 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.
Amendment 938 #
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 a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. To protect the buyer from damage resulting from a possible revocation of a voucher after the transfer, seller and buyer shall make contractual liability arrangements.
Amendment 1008 #
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
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 or medical devices that, based on preliminary evidence submitted by the developer fulfil the following conditions:
Amendment 1027 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products or certain medical devices and are likely to address a high unmet medical need as referred to in Article 70(1);
Amendment 1035 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force, may offer enhanced scientific and regulatory support to developers of a certain medicinal product or medical device preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.
Amendment 1036 #
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
3. The Agency may stop the enhanced support if it is established that the medicinal product or the medical device will not address the identified unmet medical need to the anticipated extent.
Amendment 1403 #
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to effectively develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1410 #
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 1427 #
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, medical devices and in-vitro diagnostics, it shall provide a recommendation to the Commission. 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 1433 #
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 1439 #
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] and 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 1454 #
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] and 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 1498 #
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 markeUnion critical medicinal products list. 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 1502 #
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 critical medicinal product placed on the market. 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 1509 #
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through IT surveillance systems or data bases including the European Medicines Verifications System (EMVS).