30 Amendments of Pietro FIOCCHI related to 2020/0321(COD)
Amendment 137 #
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 or veterinary use or a medical device does not meet demand for that medicinal product or medical device for patient need, no matter the cause;
Amendment 181 #
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 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 211 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the use of the European Medicines Verification System (set up in the context of the Falsified Medicines FMD) data for mapping consumption for human medicines and preventing medicines shortages, and of the Substance, product, organisation and referential (SPOR) master management for human medicines and the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data.
Amendment 229 #
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 233 #
Proposal for a regulation
Recital 31 b (new)
Recital 31 b (new)
(31b) In order to facilitate the reliable exchange of information on medicinal products in a robust and consistent manner, identification of human medicinal products should be based on the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).
Amendment 238 #
Proposal for a regulation
Recital 31 c (new)
Recital 31 c (new)
(31c) It is important to acknowledge the role of the pharmaceutical industry during the Covid-19 crisis and the fact that industry demonstrated resilience, through continued manufacturing, avoiding any major supply disruption for patients during the whole Covid-19 crisis.
Amendment 239 #
Proposal for a regulation
Recital 31 d (new)
Recital 31 d (new)
(31d) 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. A better understanding of the root causes and drivers of shortages should include identification of bottlenecks in the supply chain via the European Medicines Verification System (setup in the context of the Falsified Medicines Directive) could readily be used for this purpose.
Amendment 240 #
Proposal for a regulation
Recital 31 e (new)
Recital 31 e (new)
(31e) During Covid-19 the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities, such as electronic product information (e- leaflet), should also be feasible outside of a crisis to help manufacturers to prevent shortages.
Amendment 257 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) ‘public health emergency’ means a public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […] and the Agency will define upfront the actual criteria to capture the drivers of such an emergency in Article 3.
Amendment 262 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) '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 265 #
Proposal for a regulation
Article 2 – paragraph 1 – point c b (new)
Article 2 – paragraph 1 – point c b (new)
(cb) '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 268 #
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 338 #
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 394 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. The Medicines Steering Group together with the industry (via the industry single points of contacts - iSPOCs) will determine the list of critical products and any future actions taken for the molecules included on the critical product list.
Amendment 403 #
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 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 to in footnote 4][insert reference to adopted text referred
Amendment 409 #
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 454 #
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). 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 460 #
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);
Amendment 462 #
Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)
Article 9 – paragraph 1 – point f a (new)
(fa) 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);
Amendment 465 #
Proposal for a regulation
Article 9 – paragraph 1 – point f b (new)
Article 9 – paragraph 1 – point f b (new)
(fb) Include the use of including use of the European Medicines Verification System data for shortages in an epidemiological crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market;
Amendment 471 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. The information referred to in point (b) of paragraph 2 (as determined in Article 9(1) (c) and Article 11 (a) shall not include at least:ny information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each Member State. The system at the Agency shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via Industry Single Points of Contact (iSPOC).
Amendment 494 #
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 499 #
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 shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the information through, if the information is not available via the points of contact designated in accordance with Article 9(2) and using the reporting methods anderoperable system connected with the national shortages reporting systems established pursuant toin Article 9 (1). They shall provide updates where necessary (c).
Amendment 501 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Marketing authorisation holders of medicinal products authorised in the Union shall, within 612-24 months from the date of application of this Regulation, provide the information required pursuant to Article 9(1)(e) in the form of an electronic submission in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Those marketing authorisation holders shall update their submission wherever necessary.
Amendment 507 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency after consultation and agreement with industry on a case by case scenario.
Amendment 509 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. TIt should be determined upfront what information is commercially confident, based on this the Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.
Amendment 520 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. 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 537 #
Proposal for a regulation
Article 12 – paragraph 1 – point a a (new)
Article 12 – paragraph 1 – point a a (new)
(aa) The European Commission shall facilitate the coordination between manufacturers and other relevant stakeholders to address demand surges adapting with relevant European legislation including competition, internal market and pharmaceutical regulation.
Amendment 548 #
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) inform the Medicines Steering Group and industry (via the trade associations) of any measures taken and report on the results;
Amendment 623 #
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.