23 Amendments of Cyrus ENGERER related to 2023/0131(COD)
Amendment 234 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20 a) Given that poor physical and mental health has a profound impact on societies and communities, high unmet medical needs shall be evaluated also within the broader context of public health and societal challenges.
Amendment 235 #
Proposal for a regulation
Recital 20 b (new)
Recital 20 b (new)
(20 b) Next to unmet medical needs already recognized in the antimicrobial, oncological, rare, and neurodegenerative diseases, particular attention should be given to unmet medical needs related to mental health sector and thus supporting novel mental health treatments which are showing promising potential.
Amendment 236 #
Proposal for a regulation
Recital 20 c (new)
Recital 20 c (new)
(20 c) The revision shall aim to support innovative mental health care treatments that combine pharmacological, and psychological aspects. Moreover, generation of empirical evidence for the quality and safety of novel mental health treatments should be further explored and supported. This includes understanding the interactions between the pharmacological substances and the psychotherapy as well as assistive technologies that can assist to patient preparation, monitoring or treatment integration.
Amendment 301 #
Proposal for a regulation
Recital 57 a (new)
Recital 57 a (new)
(57 a) Given the unmet needs in the area of mental health, the revision shall support early access to novel treatments for patients who need them most through means like compassionate use programmes and conditional marketing authorisation. These programs shall play a pivotal role in providing treatment experience for providers and generating valuable real-world data to inform safety policies and future product labelling.
Amendment 302 #
Proposal for a regulation
Recital 57 b (new)
Recital 57 b (new)
(57 b) Use of early access pilot programs to treat a diverse set of patients with complex comorbidities who are often excluded from clinical trials focused on novel mental health treatments should be supported. Allowing this would support gathering critical additional data on the safety and efficacy of these treatments in a broader population. Furthermore, these programs shall explore different treatment protocols, such as group therapy and peer support specialists, to find the optimal balance of safety, efficacy, affordability, and equitable access.
Amendment 303 #
Proposal for a regulation
Recital 57 c (new)
Recital 57 c (new)
(57 c) If an applicant for compassionate use is an SME, research institute, or not- for-profit entity, the administrative burden associated with making available for compassionate use a medicinal product for human use shall be reduced. This might include procedural and administrative assistance by the national competent authorities of the Member States and the Agency.
Amendment 516 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the monitoring and managamenet of shortages and critical shortages and security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.
Amendment 552 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) 'demand' means the request for a medicinal product by a healthcare or patient in response to clinical need; the demand is satisfactorily met when the medicinal products is acequired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients. Wholesalers are usually a key supply link between market authorization holders and the users of medicines, and in those cases, in order to estimate demand, the quantity requested in wholesale orders should be considered;
Amendment 570 #
(13) ‘critical shortage in the Member State’ means a shortage of a medicinal product, for which there is no appropriatetherapeutical alternative medicinal product available on the market in that Member State, and that shortage cannot be resolved.
Amendment 575 #
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) 'unavailability’ means a situation a product has not been launched, has been permanently withdrawn or marketing has been ceased or suspended.
Amendment 740 #
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Article22a Obligations and liability of the marketing authorisation holder The marketing authorisation holder of a centralised medicinal product shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products, so that the needs of patients in those Member States in which it is prescribed are covered.
Amendment 759 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose physical or mental health disease is considered to be life-threatening, treatment resistant, or causing psychological distress in palliative care, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.
Amendment 1384 #
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 2
Article 104 – paragraph 3 – subparagraph 2
Information in such register shall be publicly available and includes as a minimum the information reported in Annex II - Section 1.6 of [revised Directive 2001/83/EC], unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].
Amendment 1530 #
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers designated under article 166(1)(a) of [revised Directive 2001/83/EC] shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.
Amendment 1532 #
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any relevant information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1537 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;the reason for the shortage, as well as measures taken to counter the actual shortage, as soon as that competent authority has assessed the shortage and provided clear recommendations and possible alternatives to healthcare professionals and patients, on a publicly available and user-friendly website. The Member State shall, within one week, inform the Agency of any measure foreseen or taken at national level to mitigate the shortage or expected shortage.
Amendment 1563 #
Proposal for a regulation
Article 121 – paragraph 5 – point d
Article 121 – paragraph 5 – point d
(d) within one week, inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions, within one month.
Amendment 1582 #
Proposal for a regulation
Article 122 – paragraph 5 a (new)
Article 122 – paragraph 5 a (new)
Amendment 1604 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG may provide without any undue delay recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1621 #
Proposal for a regulation
Article 124 – paragraph 3 a (new)
Article 124 – paragraph 3 a (new)
3 a. Marketing authorisation holders as defined in Article 116(1) and other actors listed in Article 120(2) that are directly affected by the measures notified under Articles 121(1), point (b); 121(2), point (f); and 121(5), point (d) shall be granted access to documents, while protecting commercially confidential information. The Agency may set a deadline within which marketing authorisation holders and other actors may submit their comments.
Amendment 1629 #
Proposal for a regulation
Article 126 – paragraph 1 – introductory part
Article 126 – paragraph 1 – introductory part
1. The Commission shall, where it considers it appropriate and necessary to manage shortages and critical shortages:
Amendment 1632 #
Proposal for a regulation
Article 126 – paragraph 2 a (new)
Article 126 – paragraph 2 a (new)
2 a. The Commission shall take the appropriate steps to address any concerns raised by the report of the Agency in Article 122(6).
Amendment 1646 #
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely mannerpro-actively where they deem it necessary or as requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.