97 Amendments of Margarita DE LA PISA CARRIÓN related to 2020/0321(COD)
Amendment 78 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) The COVID-19 pandemic has shown the need for increased cooperation of the European Medicines Agency with Member States and the pharmaceutical industry in order to improve the capacity of the EU and Member States to combat future health emergencies or serious events;
Amendment 108 #
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 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 servicuse of including 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 management1 for human medicines, and Copernicus earth observation datathe EUDAMED IT platform for medical devices.
Amendment 120 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29 a) In order to ensure that the democratic oversight on EMA is maintained, especially in times of crisis, the Commission commits to answer questions asked by Members of the European Parliament before the deadline expires;
Amendment 121 #
Proposal for a regulation
Recital 31 a (new)
Recital 31 a (new)
(31 a) To enable the Agency to be better prepared for the consequences of major events for human or veterinary medicinal products and public health emergencies, it is necessary to establish an European High Level Forum composed by health and pharmaceutical experts, Agency members and other interested parties with the purpose of sharing useful information, exchanging different points of view and finding appropriate solutions.
Amendment 124 #
Proposal for a regulation
Recital 31 b (new)
Recital 31 b (new)
Amendment 126 #
Proposal for a regulation
Recital 31 c (new)
Recital 31 c (new)
(31 c) In order to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, identification of human medicinal products will be based on the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP);
Amendment 127 #
Proposal for a regulation
Recital 31 d (new)
Recital 31 d (new)
(31 d) acknowledges 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 128 #
Proposal for a regulation
Recital 31 e (new)
Recital 31 e (new)
(31 e) 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 (set up in the context of the Falsified Medicines Directive) could readily be used for this purpose;
Amendment 129 #
Proposal for a regulation
Recital 31 f (new)
Recital 31 f (new)
(31 f) 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 130 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) monitor and report to prevent on shortages of medicinal products for human use and medical devices;
Amendment 133 #
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 ;and the Agency will define upfront the actual criteria to capture the drivers of such an emergency in Article 3. _________________ 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. […].
Amendment 135 #
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 demanpatient need for that medicinal product or medical device at national level no matter the cause;
Amendment 140 #
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 142 #
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 148 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1 a. The Medicines Steering Group will be established for a fixed term and will cease its activities when the health emergency or the imminent major event has been declared to end.
Amendment 151 #
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 mayshould invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. The chair shall ensure that a broad spectrum of opinions is taken into account. The chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various Member States concerned;
Amendment 151 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The Covid-19 pandemic has shown the need for increased cooperation of the European Medicines Agency with Member States and the pharmaceutical industry in order to improve the capacity of the Union and Member States to combat future health emergencies or serious events.
Amendment 156 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including the clarified mention of its competences, procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.
Amendment 158 #
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 159 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity.
Amendment 161 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency and it should be capable of establishing the necessary preventive mechanisms that are necessary-.
Amendment 166 #
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 event, includingpotential a shortage of a critical medicinal product in a given Member State, that is likely to lead toas in the case of 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 168 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Following the express recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety, quality, and efficacy of the medicinal products concerned. The information evaluated shall become public in due time.
Amendment 170 #
The Medicines Steering Group shall provide advice to the Commission and Member States on any appropriate action it believes should be taken at Union level on the medicinal products concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 726/2004.18This advice shall be made public, together with all the relevant information based on which the advice was compiled. If certain information can't be made available to the public, in order to respect confidentiality, the public health, commercial interests, grounds derived from Article 30 of this regulation, or the public order, it is mentioned. The Medicines Steering Group shall strive for the greatest transparency possible. _________________ 18 Regulation (EC) No 726/2004
Amendment 172 #
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 174 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party and the pharmaceutical operators concerned thereof.
Amendment 175 #
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 itshould 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 177 #
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 180 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
On the basis of the critical medicines lists 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 perArticle 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 183 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
The Medicines Steering Group shall monitor supply and demand of medicinal products included on those across the entire value-chain, from resources to patient;
Amendment 185 #
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, Member States and 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 188 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Medicines Steering Group may, on its own initiative or upon request from the Commission or Member states, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.
Amendment 189 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. Without prejudice to Article 30, reports and recommendations of the Medicines Steering Group will be made available to the public to their greatest extend.
Amendment 191 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
Amendment 198 #
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 EMA 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 201 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop a streamlined electronic monitoring and reporting systems; accessible by Member State authorities and marketing authorization holders;
Amendment 203 #
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 holders 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;s (iSPOC), this database should be digital, regularly updated, and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.
Amendment 206 #
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 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 209 #
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 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 will 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 217 #
Proposal for a regulation
Article 9 – paragraph 3 – point h a (new)
Article 9 – paragraph 3 – point h a (new)
(h a) 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)1a; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner
Amendment 218 #
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 221 #
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 the Article 9(1). They shall provide updates where necessary(c).
Amendment 223 #
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 6 months12-24 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)5. Those marketing authorisation holders shall update their submission wherever necessary.
Amendment 224 #
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 227 #
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 228 #
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;
Amendment 229 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(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 231 #
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 232 #
Proposal for a regulation
Recital 31 a (new)
Recital 31 a (new)
(31a) It is important to acknowledge the role of the pharmaceutical industry during the COVID-19 crisis and the fact that the industry demonstrated its resilience, through continuous manufacturing, avoiding any major disruption of supply to patients throughout the COVID-19 crisis.
Amendment 233 #
Proposal for a regulation
Article 12 – paragraph 1 – point f a (new)
Article 12 – paragraph 1 – point f a (new)
Amendment 235 #
Proposal for a regulation
Recital 31 b (new)
Recital 31 b (new)
(31b) The establishment of an interoperable electronic platform between Member States and the Union is necessary for the prevention, monitoring and reporting of shortages of medicines and medical devices.
Amendment 237 #
Proposal for a regulation
Recital 31 c (new)
Recital 31 c (new)
(31c) 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 bottle necks in the supply chain via the European Medicines Verification System (set up in the context of the Falsified Medicines Directive) could readily be used for this purpose.
Amendment 241 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened during the declared public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 249 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3 a. The Emergency Task Force will be empowered to coordinate and exchange information and best practices with the health authorities of the Member States and the pharmaceutical industry in order to generate new synergies.
Amendment 251 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) monitor and report to prevent on shortages of medicinal products for human use and medical devices;
Amendment 256 #
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 and the Agency will define upfront the actual criteria to capture the drivers of such and emergency in Article 3; _________________ 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. […].
Amendment 259 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Where a developer engages in an accelerated scientific advice process, the Emergency Task force shall provide such advice free of charge . The advice shall be endorsed by the Committee for Medicinal Products for Human Use at the latest 20 days following the submission to the Agency of a complete set of requested information and data by the developer. The advice shall be endorsed by the Committee for Medicinal Products for Human Use.
Amendment 260 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The Emergency Task Force shall establish and update procedures for the request and submission of the set of information and data required, including inform cooperation onwith the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with Article 4 of the Regulation 536/2014on clinical trials on medicinal products for human use. These procedures shall become public.
Amendment 269 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the re view, the Emergency Task Force mashall engage marketing authorisation holders and developers in preliminary discussions and may subsequently request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability.
Amendment 271 #
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 demanpatient need for that medicinal product or medical device at national level no matter the cause;
Amendment 273 #
Proposal for a regulation
Article 16 – paragraph 7 a (new)
Article 16 – paragraph 7 a (new)
7 a. Marketing Authorisation Holders or developers may suggest medicinal products which may have the potential to be used to address the public health emergency. The Emergency Taskforce shall take these suggestions into account and, given that the suggestion is accompanied with sufficient scientific data that the medicinal products have the potential to halt the public health emergency, give an appropriate reaction to the suggestion. The reaction shall be public.
Amendment 282 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(d a) 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.
Amendment 284 #
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 288 #
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. The Medical Devices Steering Group will establish the basis for strengthened cooperation with national health authorities and the pharmaceutical industry.
Amendment 290 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The Agency shall publish on an accessible way, the public health emergency critical devices list and any updates to that list on its web-portal.
Amendment 299 #
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) after consultation with all relevant stakeholders specify the procedures for establishing the public health emergency critical devices list;
Amendment 310 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1 a. The Medicines Steering Group will be established for a fixed term and will cease its activities when the health emergency or the imminent major event has been declared to end;
Amendment 312 #
Proposal for a regulation
Article 26 – paragraph 1 – point a a (new)
Article 26 – paragraph 1 – point a a (new)
(a a) The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline.
Amendment 317 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.
Amendment 318 #
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Article 30 – paragraph 1 – introductory part
1. Unless otherwise provided for in this Regulation and wWithout prejudice to Regulation (EC) No 1049/200124 and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43
Amendment 320 #
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 to attend its meetings. The Chair shall ensure that a broad spectrum of opinions is taken into account. The chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various Member States concerned;
Amendment 330 #
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 mayshall invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings.
Amendment 334 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda, minutes and recommendations of the Medicines Steering Group shall be made available to the public through the Agency's online portal.
Amendment 335 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including the clarified mention of its competences, procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.
Amendment 344 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity;
Amendment 347 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency and it shall be capable of establishing the necessary preventive mechanisms that are necessary.
Amendment 369 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Following the express recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety, quality, and efficacy of the medicinal products concerned.
Amendment 374 #
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 406 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
The Medicines Steering Group shall monitor supply and demand of medicinal products included on those across the entire value-chain, from resources to patient;
Amendment 411 #
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, Member States, 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 413 #
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 reportport on a systematic, structured, and timely basis the results of its monitoring to the Commission 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 420 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 430 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. Without prejudice to Article 30, reports and recommendations of the Medicines Steering Group will be made available to the public to their greatest extent.
Amendment 431 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinated measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 453 #
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 498 #
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 506 #
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 542 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals, in order to support their work and communication with patients;
Amendment 552 #
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline;
Amendment 577 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3 a. The Emergency Task Force shall be empowered to coordinate and exchange information and best practices with the health authorities of the Member States and the pharmaceutical industry in order to generate new synergies.
Amendment 586 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda and minutes of the Task Force shall be made public through the Agency's online portal.
Amendment 589 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The Emergency Task Force shall establish procedures for the request and submission of the set of information and data required, including inform cooperation onwith the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with Article 4 of the Regulation 536/2014 on clinical trials on medicinal products for human use.
Amendment 603 #
Proposal for a regulation
Article 16 – paragraph 7 a (new)
Article 16 – paragraph 7 a (new)
7 a. Marketing authorisation holders or developers may suggest medicinal products which may have the potential to be used to address the public health emergency. The Emergency Taskforce shall take these suggestions into account and, given that the suggestion is accompanied with sufficient scientific data that the medicinal products have the potential to halt the public health emergency, give an appropriate reaction to the suggestion. The reaction shall be public.
Amendment 646 #
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. The Medical Devices Steering Group will establish the basis for strengthened cooperation with national health authorities and the pharmaceutical industry.
Amendment 704 #
Proposal for a regulation
Article 26 – paragraph 1 – point d a (new)
Article 26 – paragraph 1 – point d a (new)
(da) work in conjunction with the European Centre for Disease Prevention and Control (ECDC) to categorise and establish different priority levels for the medicinal products identified as critical.
Amendment 714 #
1 a. The purpose of this Regulation is to increase cooperation between the European Medicines Agency, the European Commission, the Member States and stakeholders. Highlights that under no circumstances this Regulation should establish a sanctions regime.
Amendment 716 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.