28 Amendments of Danilo Oscar LANCINI related to 2020/0321(COD)
Amendment 230 #
Proposal for a regulation
Recital 31 a (new)
Recital 31 a (new)
(31a) National Competent Authorities (NCAs) should establish a reliable and harmonised pan-European interoperable and digital reporting system for shortages and preventing duplication of shortages reporting. The standardized reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact. For this the NCAs should establish a uniform harmonized pan-European interoperable and digital NCAs reporting system consisting of harmonised and common data fields and interoperable with other systems like Substance, product, organisation and referential (SPOR) master management, EMA systems and Industry Single Point of Contact (iSPOC) and operating in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages.
Amendment 234 #
Proposal for a regulation
Recital 31 b (new)
Recital 31 b (new)
(31b) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes.
Amendment 267 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device for patient and healthcare actors' needs;
Amendment 280 #
Proposal for a regulation
Article 2 – paragraph 1 – point d a (new)
Article 2 – paragraph 1 – point d a (new)
(da) 'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder, a manufacturer, a distributors, or any other actor in the distribution chain respectively;
Amendment 281 #
Proposal for a regulation
Article 2 – paragraph 1 – point d b (new)
Article 2 – paragraph 1 – point d b (new)
(db) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to treatments need;
Amendment 282 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product and who, as part of that product’s development, is seeking to generate scientific data with regard to the product’s quality, safety and efficacy of a medicinal product as part of that product’s development;
Amendment 285 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand and / or supply, or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 329 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders, and other stakeholders in the medicines supply chain, to attend its meetings.
Amendment 337 #
Proposal for a regulation
Article 3 – paragraph 5 a (new)
Article 3 – paragraph 5 a (new)
5 a. The Medicines Steering Group shall be supported in its work by a working party comprised of industry single points of contact related to shortages (iSPOC) and a two way communication line need to be established between the Medicines Steering Group and the iSPOC.
Amendment 341 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The Medicines Steering Group together with the industry (via the industry single points of contacts - iSPOCs) shall determine the list of critical products and any future actions taken for the molecules included on the critical product list.
Amendment 357 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any potential event, including a shortage of a critical medicinal product in a given Member State, that is likely to lead to following a major event or a public health emergency. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).
Amendment 376 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, in consultation with marketing authorisation holders, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.
Amendment 386 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Agency shall immediately publishAccess to the critical medicines lists and any updates to those lists on itshall be granted to Member State representatives and the European Commission on a confidential basis, via the Agency’s web- portal referred to in Article 26 of Regulation (EC) No 726/2004.
Amendment 401 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
On the basis of the critical medicines lists , the establishment of a two way communication line with industry via the industry single point of contacts (iSPOC) and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand, with demand being based on actual patient need at the Member State level, as per Article 2(f), of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]
Amendment 414 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, the pharmaceutical industry and the sub- network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.
Amendment 439 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. The measures recommended by the Steering Group to the Commission, Member States, marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.
Amendment 441 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8 and after having consulted representatives from national competent authorities and from marketing authorisation holder representatives, as well as other stakeholders in the medicines supply chain, the Agency shall:
Amendment 442 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:
Amendment 452 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronic monitoring and reporting systems; by implementing and building on existing regulatory infrastructure (EU telematics[1]). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the national competent authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the Agency from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States.
Amendment 459 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) establish and maintain a list ofupdate the Article 57(1)(l) of Regulation 726/2004 Data base by including the industry single points of contact from marketing authorisation s (iSPOC), this database shoulders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004 be digital, regularly updated, and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)2;
Amendment 467 #
Proposal for a regulation
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders who can be different from the contacts established under Article 9(1) point (e), and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based on the medicinal products included on the critical medicines lists;
Amendment 488 #
Proposal for a regulation
Article 9 – paragraph 3 – point g a (new)
Article 9 – paragraph 3 – point g a (new)
(ga) update the format and content of the Article 57 database to include the industry Single Point of contact (iSPOC) names as reported by industry. Industry should be able to digitally update the iSPOC names in the Article 57 database if needed and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)3;
Amendment 491 #
Proposal for a regulation
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
(h) information on stock levels from the wholesale distributors and legal person entitled to supply the medicinal product to the public, via their representatives who are part of the sub-network referred to in point (a) of paragraph 2.
Amendment 493 #
Proposal for a regulation
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3 a. The information referred to in point (c) of paragraph 2 shall include at least details of (a) available alternative medicinal products; (b) information from the wholesale distributors and legal person entitled to supply the medicinal product to the public.
Amendment 500 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists, and all distributors legally authorised to supply medicines to the public, shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the information through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where necessary.
Amendment 523 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States shall, by the deadline set by the Agency, where relevant, following the creation of a harmonized pan- European interoperable and digital National Competent Authorities (NCAs) shortages reporting system based on common data fields (a) submit the set of information requested by the Agency in Chapter 2 Article 9 (4) including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);
Amendment 560 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as a permanent structure as part of the Agency. It shall be convened during public health emergencies, either in person or remotely. The Agency shall provide its secretariat. The Emergency Task Force shall work with scientific committees, working parties and scientific advisory groups of the Agency in the area of pandemic preparedness and response. It shall cooperate with Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues related to pandemic preparedness. The Agency, in collaboration with the Member States, shall, in parallel, proactively foster expertise building to avoid a shortage of expertise due to a public health emergency, in areas which are unrelated to the public health emergency.
Amendment 622 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management.