36 Amendments of Dolors MONTSERRAT related to 2023/0131(COD)
Amendment 468 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place for critical medicinal products, and especially those that do not have alternatives, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans. Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Veryfication System, which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.
Amendment 578 #
Proposal for a regulation
Article 4 – title
Article 4 – title
Member State authorisation of generics of centrally authorisedcertain categories of medicinal products
Amendment 581 #
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:
Amendment 584 #
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC] or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;
Amendment 586 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the generic medicinal product was marketed and where the applicant for the generic medicinal product has requested not to include this information in their marketing authorisation.
Amendment 749 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 3
Article 24 – paragraph 1 – subparagraph 3
Where the action referred to in the first subparagraph is to withdraw a medicinal product with no alternative therapeutic equivalent from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated.
Amendment 835 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for 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.
Amendment 844 #
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 848 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 857 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 860 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 867 #
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 875 #
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 949 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date offrom 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 1162 #
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 1177 #
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 1200 #
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 1232 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1237 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1240 #
Proposal for a regulation
Article 72 – paragraph 1 a (new)
Article 72 – paragraph 1 a (new)
1 a. The period of market exclusivity shall be prolonged by an additional 24 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 1242 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
Amendment 1263 #
Proposal for a regulation
Article 72 – paragraph 2 a (new)
Article 72 – paragraph 2 a (new)
2 a. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of [15] years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69.
Amendment 1265 #
Proposal for a regulation
Article 72 – paragraph 2 b (new)
Article 72 – paragraph 2 b (new)
2 b. As an alternative to the reward foreseen under Article 86 [of revised Directive] and upon request from the applicant, the period of market exclusivity for orphan medicinal products referred to in Article 71(2), points (a) and (b) shall be prolonged by an additional 24 months where an application for orphan marketing authorisation is submitted in respect of a designated orphan medicinal product pursuant to [Revised Regulation] and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan. The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned. The 24- month extension of the period of market exclusivity will be reflected in the marketing authorisation.
Amendment 1266 #
2 c. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 4, shall not benefit from the rewards referred to in Article 86 [of revised Directive].
Amendment 1267 #
Proposal for a regulation
Article 72 – paragraph 2 d (new)
Article 72 – paragraph 2 d (new)
2 d. The limitation referred to in paragraph 3 shall not apply where the period of orphan marketing exclusivity is extended in accordance with paragraph 4 in relation to such extension.
Amendment 1270 #
Proposal for a regulation
Article 72 – paragraph 3
Article 72 – paragraph 3
3. The orphan medicinal products which benefit from the prolongation of market exclusivity referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC].
Amendment 1392 #
Proposal for a regulation
Article 112 – paragraph 1 a (new)
Article 112 – paragraph 1 a (new)
Amendment 1465 #
(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1469 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1472 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than sixtwo months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1475 #
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. The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member State, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1492 #
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 anycritical medicinal product placed on the market. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for whicvh a shortage prevention plan shall be maintaned and kept up to date, including due to the lack of availability of alternatives. 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 1493 #
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 market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set outestablished in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product has been placed on the market.
Amendment 1516 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. 2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit aupdated versions of the shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may setestablish a deadline for the submission of the information requested.
Amendment 1547 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(ca) assess information on potential or actual shortages provided by marketing authorisation holders authorised to place on the market in a Member State in accordance with Article 5 of [revised Directive 2001/83/EC] as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers thereof, wholesale distributors, representative associations of interested parties or other legal persons or entities authorised or entitled to supply medicinal products to the public.
Amendment 1673 #
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). 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”). The Union list of critical m,edicinal products shall be coordinated with the list identified in the Member States by the competent authority of that Member State and shall supersede all national lists.