33 Amendments of Patrizia TOIA related to 2023/0132(COD)
Amendment 30 #
Proposal for a directive
Recital 8
Recital 8
(8) This revision should maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for children and patients affected by rare diseases in all therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.
Amendment 33 #
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially infor paediatric and orphan medicinal products and in other areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 66 #
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare andpaediatric, rare as well as chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 234 #
Proposal for a directive
Article 4 – paragraph 1 – point 38 a (new)
Article 4 – paragraph 1 – point 38 a (new)
(38 a) ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics
Amendment 269 #
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2
Article 18 – paragraph 1 – subparagraph 2
As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device. In case of combined products intended for paediatric use, a risk/benefit analysis should be taken into account following the opinion of the Paediatric Working Party of the Agency, established in accordance with Article 142 of the Regulation
Amendment 354 #
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 1820 days after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 354 #
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 1820 days after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 355 #
Proposal for a directive
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
Without prejudice to national provisions regarding the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, where a marketing authorisation has been granted in accordance with [revised Regulation (EC) No 726/2004], Member States shall ensure that the medicinal product is made available on the market within 90 days from the date of the issuing of the marketing authorisation as referred to in Article 16 of the [revised Regulation (EC) No 726/2004]
Amendment 355 #
Proposal for a directive
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
Without prejudice to national provisions regarding the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, where a marketing authorisation has been granted in accordance with [revised Regulation (EC) No 726/2004], Member States shall ensure that the medicinal product is made available on the market within 90 days from the date of the issuing of the marketing authorisation as referred to in Article 16 of the [revised Regulation (EC) No 726/2004]
Amendment 366 #
Proposal for a directive
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 630 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.
Amendment 366 #
Proposal for a directive
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 630 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.
Amendment 367 #
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. If within the 630-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.
Amendment 367 #
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. If within the 630-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.
Amendment 368 #
Proposal for a directive
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, including the harmonisation of the approved paediatric indications, dosages and ages for which the product is recommended, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.
Amendment 368 #
Proposal for a directive
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, including the harmonisation of the approved paediatric indications, dosages and ages for which the product is recommended, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.
Amendment 369 #
Proposal for a directive
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 630 days from the date when the matter was referred to it.
Amendment 369 #
Proposal for a directive
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 630 days from the date when the matter was referred to it.
Amendment 608 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, including studies covering the paediatric population conducted according to a PIP and
Amendment 608 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, including studies covering the paediatric population conducted according to a PIP and
Amendment 624 #
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 usstudies, trials and other activities are conducted for the purposes of:
Amendment 624 #
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 usstudies, trials and other activities are conducted for the purposes of:
Amendment 633 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, innovative, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 633 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, innovative, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 637 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 646 #
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 650 #
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 654 #
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;
Amendment 656 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)
Article 85 – paragraph 1 – point a – point iii c (new)
(iii c) ensuring the subsequent practical requirements associated with the abovementioned activities
Amendment 658 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
Amendment 664 #
Proposal for a directive
Article 85 – paragraph 1 a (new)
Article 85 – paragraph 1 a (new)
The activities falling within the first paragraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.
Amendment 666 #
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 activities.in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manifactured for the purposes set out in point a
Amendment 683 #
Proposal for a directive
Article 101 – paragraph 1
Article 101 – paragraph 1
1. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities of the Member States in order to guarantee their independence in the performance of those pharmacovigilance activities. The competent authorities should guarantee that not less than 10% of these activities and funds are focused on paediatric populations
Amendment 716 #
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriatethat medicinal products are released and continuedously supplies of that medicinal productd to pharmacies and persons authorised to supply medicinal products in a sufficient quantity so that the needs of patients in the Member State in question are covered.