32 Amendments of Maria Angela DANZÌ related to 2023/0132(COD)
Amendment 152 #
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3 a) In the interest of public health and for the wellfunctioning EU regulatory framework, the innovative medicinal product should be understood as one that meets a previously unmet or inadequately met, substantive health need and offers enhanced effectiveness or other incremental benefit relative to existing therapeutic alternatives.
Amendment 277 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal product,fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stateof the patent or SPC of, for the reference medicinal product, there can be no commercial uslevant product or process, there can be placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 290 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursementto support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toaforementioned purposes, contributing to the timely market entry medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 301 #
Proposal for a directive
Recital 65
Recital 65
(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal productAvoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC
Amendment 356 #
Proposal for a directive
Recital 118
Recital 118
(118) It is therefore appropriate to harmonise the basic principles applicable to the prescription status of medicinal products in the Union or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonisation completed within the framework of the United Nations, concerning psychotropic or narcotic substances - the United Nations Single Convention of 1961 on narcotic drugs and Convention on Psychotropic Substances of 1971. Therefore, research on interactions between alcohol, painkillers and psychoactive substances, in particular the high- THC concentration cannabis, should be developed.
Amendment 415 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). A non-routine basis entails a treatment scale that does not exceed the treatment capacity of a hospital. Member States shall ensure that only hospitals are granted hospital exemption approvals. A transition period of 5 years is granted to holders of a hospital exemption (public and private) that exceed preparation on a nonroutine basis to obtain a centralised marketing authorisation. During the transition period, deviations from a non- routine basis guarantee patient access. Member States shall ensure that the scope for use is centred around targeting unmet medical need, in situations when similar treatment is not available and/or affordable.
Amendment 428 #
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet medical needs, if preparation on a non-routine basis is maintained. Competent authorities should share with each other information on hospital exemption approvals and the evidence used for such approvals upon request. In case of deviations between national laws, the authorities of the importing country should indicate that these deviations are acceptable. Requirements in Article 2(3-6) should be maintained.
Amendment 455 #
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.
Amendment 583 #
Proposal for a directive
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) an antimicrobial stewardshipresistance mitigation plan as referred to in Annex I;
Amendment 591 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardshipresistance mitigation plan unsatisfactory.
Amendment 594 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. If an antimicrobial can not be dispensed per unit, the marketing authorization holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.
Amendment 745 #
Proposal for a directive
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph, where necessary.
Amendment 770 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orbiotic or systemic antiviral or systemic antifungal;
Amendment 778 #
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antiparasitic; or
Amendment 786 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 792 #
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Wherever possible, Member States shall provide that prescriptions and dispensation shall be aligned with the number of units required for the treatment or therapy concerned.
Amendment 796 #
Proposal for a directive
Article 56 – paragraph 1 a (new)
Article 56 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall, in good faith, file for pricing and reimbursement in the Member States in which the marketing authorisation is valid within 4 months after the marketing authorisation was granted.The marketing authorisation holder shall be exempt from this obligation provided the competent authority of the Member State grants a product specific waiver. The obligation referred to in the first subparagraph shall exclude medicinal products defined in Article 4.1 (13), Article 10, Article 11, Article 12. Member States representatives may request the Commission to discuss issues related to this obligation in the Committee established by Council Decision 75/320/EEC (“Pharmaceutical Committee"). The Commission might invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.
Amendment 800 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State 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 the Member State in question are covered.
Amendment 804 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 2
Article 56 – paragraph 3 – subparagraph 2
The arrangements for implementing the first subparagraph should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of suc be based on the high level of human health protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.
Amendment 1253 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 1265 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, forfor the purpose of :
Amendment 1276 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) applying for a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand subsequent variations;
Amendment 1285 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1294 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 1301 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;
Amendment 1308 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1321 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) tThe activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation andfalling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1337 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activitiin a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.
Amendment 1341 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article 85a Ban of patent linkage 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1380 #
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members, or healthcare professionals.
Amendment 1605 #
Proposal for a directive
Annex I – point 21 – point a – introductory part
Annex I – point 21 – point a – introductory part
a) an antimicrobial stewardshipresistance mitigation plan which shall in particular outline:
Amendment 1617 #
Proposal for a directive
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part