Next event: Indicative plenary sitting date, 1st reading/single reading 2021/07/05
Progress: Awaiting committee decision
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | GONZÁLEZ CASARES Nicolás ( S&D) | BUŞOI Cristian-Silviu ( EPP), RIES Frédérique ( Renew), METZ Tilly ( Verts/ALE), MÉLIN Joëlle ( ID), KOPCIŃSKA Joanna ( ECR), KONEČNÁ Kateřina ( GUE/NGL) |
Committee Opinion | IMCO | ||
Committee Opinion | ITRE | MÉLIN Joëlle ( ID) | Aldo PATRICIELLO ( PPE), Marc BOTENGA ( GUE/NGL), Jutta PAULUS ( Verts/ALE), Ivo HRISTOV ( S&D), Ivars IJABS ( RE), Margarita DE LA PISA CARRIÓN ( ECR) |
Committee Opinion | BUDG |
Lead committee dossier:
Legal Basis:
TFEU 114-p1, TFEU 168-p4
Legal Basis:
TFEU 114-p1, TFEU 168-p4Subjects
Events
PURPOSE: to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the unprecedented experience of the COVID-19 pandemic has demonstrated that the EU’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently limited.
The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the EU’s ability to rapidly and effectively react to such challenges during public health crises.
The proposal is part of a package of closely associated measures that aim to reinforce the crisis preparedness and response and enhance the role of the European Centre for Disease Prevention and Control (ECDC). Together, they form part of the EU’s overall health response to COVID-19 as well as an improved crisis management framework.
CONTENT: the proposed Regulation should develop the core tasks already given to the EMA to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies.
It would complement the measures directed at improving the overall EU crisis management framework by addressing the specific issues related to medicinal product and medical device sectors and the tasks of the Agency. It would thus introduce new rules for the Agency with the objective to provide mechanisms within the Agency to:
monitor and mitigate the risk of shortages of critical medicines and medical devices; provide scientific advice on medicines which may have the potential to treat, prevent or diagnose the diseases causing those crises; coordinate studies to monitor the effectiveness and safety of vaccines; coordinate clinical trials.
Budgetary implications
The financial impact of this proposal on the EU budget should be part of the next Multiannual Financial Framework 2021-2027. The budgetary implications should relate mainly to administrative, scientific and IT support.
Documents
- Reasoned opinion: PE691.143
- Committee draft report: PE680.818
- Legislative proposal published: COM(2020)0725
- Legislative proposal published: EUR-Lex
- Committee draft report: PE680.818
- Reasoned opinion: PE691.143
Activities
- Cristian-Silviu BUŞOI
Plenary Speeches (0)
- Dita CHARANZOVÁ
Plenary Speeches (0)
- Jytte GUTELAND
Plenary Speeches (0)
- Kateřina KONEČNÁ
Plenary Speeches (0)
- Peter LIESE
Plenary Speeches (0)
- Tilly METZ
Plenary Speeches (0)
- Roberta METSOLA
Plenary Speeches (0)
- Alessandra MORETTI
Plenary Speeches (0)
- Frédérique RIES
Plenary Speeches (0)
- Waldemar TOMASZEWSKI
Plenary Speeches (0)
- Nicolás GONZÁLEZ CASARES
Plenary Speeches (0)
- Mislav KOLAKUŠIĆ
Plenary Speeches (0)
- Lefteris NIKOLAOU-ALAVANOS
Plenary Speeches (0)
- Jutta PAULUS
Plenary Speeches (0)
- Ivan Vilibor SINČIĆ
Plenary Speeches (0)
- Bartosz ARŁUKOWICZ
Plenary Speeches (0)
- Nathalie COLIN-OESTERLÉ
Plenary Speeches (0)
- Joanna KOPCIŃSKA
Plenary Speeches (0)
- Lídia PEREIRA
Plenary Speeches (0)
- Edina TÓTH
Plenary Speeches (0)
- Sara CERDAS
Plenary Speeches (0)
- Heléne FRITZON
Plenary Speeches (0)
- Ivo HRISTOV
Plenary Speeches (0)
- Silvia SARDONE
Plenary Speeches (0)
- Véronique TRILLET-LENOIR
Plenary Speeches (0)
- Ivan DAVID
Plenary Speeches (0)
- Mikuláš PEKSA
Plenary Speeches (0)
- Margarita DE LA PISA CARRIÓN
Plenary Speeches (0)
- Romana JERKOVIĆ
Plenary Speeches (0)
Amendments | Dossier |
258 |
2020/0321(COD)
2021/03/26
ITRE
258 amendments...
Amendment 100 #
Proposal for a regulation Recital 20 (20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014 and coordinate the development of clinical trial protocols. Such an approach would strengthen the research environment in the Union, and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development,
Amendment 101 #
Proposal for a regulation Recital 20 a (new) (20 a) The Emergency Task Force should review clinical trial protocols and advice developers on clinical trials that are conducted in the Union. The Emergency Task Force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials, so that they can meet the criteria for effective public health interventions.
Amendment 102 #
Proposal for a regulation Recital 21 (21) With respect to medical devices, an executive steering group on medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand
Amendment 103 #
Proposal for a regulation Recital 22 (22) This Regulation also provides the Agency with a role to support the expert panels on medical devices designated under Commission Implementing Decision (EU) 2019/139612 to provide independent scientific and technical assistance to the Member States, the Commission, the Medical Device Coordination Group (MDCG), notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the EU regulatory system. _________________ 12Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. 23
Amendment 104 #
(23 a) Temporary exemption from the conformity assessment procedure for medical devices should only be considered in exceptional circumstances. Before allowing for such a derogation, the considerations should take into account both the safety of citizens using the device and the safety of the product. Only if both can be ensured even without a conformity assessment procedure, and the benefits for safeguarding supply outweigh the risks, a temporary exemption could be offered.
Amendment 105 #
Proposal for a regulation Recital 24 (24) Given the Agency’s long-standing and proven record of expertise in the field of medicinal products and considering the Agency’s experience from working with a multitude of groups of experts, it is appropriate to establish the appropriate structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the Agency with a mandate to host the expert panels on medical devices. In this regard, all national and, eventually, Union entities that are engaged in stockpiling of medical devices, should report their stocks to the Agency. This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. Those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the
Amendment 106 #
Proposal for a regulation Recital 25 (25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made through further implementing acts with a view to outlining the roles of the actors involved in the processing of personal data 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 and Data Analysis and Real World Interrogation Network - DARWIN. 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, while enabling data discoverability.
Amendment 107 #
Proposal for a regulation 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
Amendment 108 #
Proposal for a regulation 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
Amendment 109 #
Proposal for a regulation Recital 25 a (new) (25 a) Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The global pandemic has also shown how High Performance Computing, in combination with Big Data and AI, can be of critical importance in the global fight against COVID-19.
Amendment 110 #
Proposal for a regulation Recital 25 a (new) (25 a) Calling upon the NCAs to establish a reliable and harmonized pan- European interoperable and digital reporting system consisting of harmonized and common data fields and able to operate with other systems like SPOR, EMA systems and iSPOC and operate in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages and preventing duplication of shortages reporting.
Amendment 111 #
Proposal for a regulation Recital 26 (26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, such as electronic health records, insurance claims data and data from patient registries, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, while ensuring the applicability of the GDPR and EUDPR, and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4 EUDPR).
Amendment 112 #
Proposal for a regulation Recital 26 (26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure. It shall allow as well the definition of programs and data collection systems relating to outcomes, results, adverse and undesiderable events usable for all developers.
Amendment 113 #
Proposal for a regulation Recital 26 (26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies
Amendment 114 #
Proposal for a regulation Recital 26 (26) Rapid access and exchange of health data, including when generated with appropriate quality criteria, real world data i.e. health data generated outside of clinical studies,
Amendment 115 #
Proposal for a regulation Recital 26 a (new) (26 a) It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities on treatments, vaccines and medical devices falling under the scope of this Regulation. These measures should include timely publication of all relevant information on approved products and clinical data, having taken due regard to protection of personal data protection and commercially confidential information. The Agency should make public the recommendations, opinions and decisions from the steering groups. The membership of the steering groups and working parties should be made public. Members of the steering groups and experts should not have financial or other interests in the pharmaceutical industry which could affect their impartiality;
Amendment 116 #
Proposal for a regulation Recital 26 a (new) (26 a) The handling of sensitive health data requires a high level of protection against cyber-attacks. The Agency was the target of a cyber-attack that resulted in some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties. Highlights in this respect the need for a high level of security against cyber- attacks, and particularly cyber-espionage, at all times and especially during public health emergencies;
Amendment 117 #
Proposal for a regulation Recital 26 a (new) (26 a) Calls for the swift implementation of binding rules on security information and cybersecurity in line with the Security Union Strategy. Urges the Member States to accelerate the work towards completing the implementation of the main 5G Toolbox measures by the second quarter of 2021;
Amendment 118 #
Proposal for a regulation Recital 27 (27) During a public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention – which should provide forecasts in a timely manner to relevant actor of the pharmaceutical supply chain - and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. Regular two-way communication and exchange of information between regulators, industry and pertinent stakeholders of the pharmaceutical supply chain shall also be guaranteed to kick off prompt debates about estimated potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process, allowing better coordination, interactions and proper response when required;
Amendment 119 #
Proposal for a regulation Recital 28 (28)
Amendment 120 #
Proposal for a regulation 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) (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 122 #
(31 a) 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 should include identification of bottlenecks in the supply chain;
Amendment 123 #
Proposal for a regulation Recital 31 a (new) (31 a) Recalls the applicability of the GDPR and EUDPR and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4EUDPR);
Amendment 124 #
Proposal for a regulation Recital 31 b (new) Amendment 125 #
Proposal for a regulation Recital 31 b (new) (31 b) During COVID-19’s emergency, the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities should also be feasible outside of a crisis to help manufacturers to prevent shortages;
Amendment 126 #
Proposal for a regulation 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) (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) (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) (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 (b) monitor and report to prevent on shortages of medicinal products for human use and medical devices;
Amendment 131 #
Proposal for a regulation Article 1 – paragraph 1 a (new) This Regulation shall not prejudice the potential expansion of this framework by subsequent legislation in order to be applicable on a permanent basis beyond public health emergencies and major events.
Amendment 132 #
Proposal for a regulation 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 ;arising from a threat of human, animal, plant, food or environmental origin having a health dimension which requires urgent action by Authorities. _________________
Amendment 133 #
Proposal for a regulation 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
Amendment 134 #
Proposal for a regulation Article 2 – paragraph 1 – point d (d) ‘shortage’ means that supply of a
Amendment 135 #
Proposal for a regulation 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
Amendment 136 #
Proposal for a regulation 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 patient and healthcare actors’ needs for that medicinal product or medical device at national level;
Amendment 137 #
Proposal for a regulation 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 138 #
Proposal for a regulation 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
Amendment 139 #
Proposal for a regulation 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
Amendment 140 #
Proposal for a regulation 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
Amendment 141 #
Proposal for a regulation 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 142 #
Proposal for a regulation 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 143 #
Proposal for a regulation 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
Amendment 144 #
Proposal for a regulation 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 145 #
Proposal for a regulation 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 manufacturing, supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of 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 146 #
Proposal for a regulation 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 for, and/or supply or quality, safety, and efficacy of, medicinal products. Such an event may lead to shortages of 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 147 #
Proposal for a regulation Article 3 – paragraph 1 1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely
Amendment 148 #
Proposal for a regulation 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 149 #
Proposal for a regulation Article 3 – paragraph 2 2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The declarations of interests of all experts shall be made public and all necessary restrictions shall apply where conflicts of interest occur.
Amendment 150 #
Proposal for a regulation Article 3 – paragraph 2 a (new) 2 a. The membership of the Medicines Steering Group shall be made public. Members of the Medicines Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.
Amendment 151 #
Proposal for a regulation Article 3 – paragraph 3 3. The Medicines Steering Group shall be chaired by the Agency. The Chair
Amendment 152 #
Proposal for a regulation 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
Amendment 153 #
Proposal for a regulation 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, via the industry single point of contact (iSPOC), and other stakeholders in the medicines supply chain as well as interest groups representing patients and healthcare professionals, to attend its meetings.
Amendment 154 #
Proposal for a regulation Article 3 – paragraph 3 3. The Medicines Steering Group shall be chaired by the Agency. The Chair may
Amendment 155 #
Proposal for a regulation 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. After being established, these rules shall be made publicly available.
Amendment 156 #
Proposal for a regulation 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 157 #
Proposal for a regulation Article 3 – paragraph 5 5. The Medicines Steering Group shall be supported in its work by a working party comprised of single points of contact related to shortages from
Amendment 158 #
Proposal for a regulation 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) 6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity.
Amendment 160 #
Proposal for a regulation Article 4 – paragraph 1 1. The Agency shall continuously monitor any event that
Amendment 161 #
Proposal for a regulation 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 162 #
Proposal for a regulation Article 4 – paragraph 1 1. The Agency, in coordination with the ECDC, shall continuously monitor any event that is likely to lead to a major event or a public health emergency.
Amendment 163 #
Proposal for a regulation 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) pro-actively and with the shortest delay, report to the Agency on any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to 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
Amendment 164 #
Proposal for a regulation 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
Amendment 165 #
Proposal for a regulation 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, including a shortage of a medicinal product in a given Member State, that
Amendment 166 #
Proposal for a regulation 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
Amendment 167 #
Proposal for a regulation Article 4 – paragraph 5 – point a (a) where the major event or public health emergency may affect the manufacturing, safety, quality, and efficacy of medicinal products, Article 5 shall apply;
Amendment 168 #
Proposal for a regulation 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 169 #
Proposal for a regulation Article 5 – paragraph 1 Following the 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 manufacturing safety, quality, and efficacy of the medicinal products concerned.
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 171 #
Proposal for a regulation 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, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, 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 172 #
Proposal for a regulation 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 173 #
Proposal for a regulation 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
Amendment 174 #
Proposal for a regulation 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 4.
Amendment 176 #
Proposal for a regulation Article 6 – paragraph 4 4. The Agency shall
Amendment 177 #
Proposal for a regulation 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 178 #
Proposal for a regulation 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 of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. Monitoring shall be conducted during health crises as well as before, after and outside these crises in order to identify potential shortages before they can affect health and lives of EU citizens. 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 179 #
Proposal for a regulation Article 7 – paragraph 1 On the basis of the critical medicines lists, the establishment of two way communication line with industry and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor
Amendment 180 #
Proposal for a regulation 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.
Amendment 181 #
Proposal for a regulation 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
Amendment 182 #
Proposal for a regulation 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 of medicinal products, based on the actual and potential needs of patients, 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) 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 184 #
Proposal for a regulation 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, relevant other stake-holders of the pharmaceutical supply chain 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 185 #
Proposal for a regulation 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 186 #
Proposal for a regulation Article 8 – paragraph 2 2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device. It shall share its findings and conclusions with Union and national entities engaged with stockpiling of medicinal products and medical devices.
Amendment 187 #
Proposal for a regulation 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, 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 188 #
Proposal for a regulation 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) 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 190 #
Proposal for a regulation Article 8 – paragraph 5 5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 191 #
Proposal for a regulation Article 8 – paragraph 5 a (new) Amendment 192 #
Proposal for a regulation Article 8 – paragraph 5 a (new) 5a. The measures recommended by the Steering Committee to the Commission, the Member States, the marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.
Amendment 193 #
Proposal for a regulation 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 194 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8 and also consulting representatives from national competent authorities and from industries representatives, as well as other stakeholders in the medicines supply chain, the Agency shall:
Amendment 195 #
Proposal for a regulation Article 9 – paragraph 1 – point a (a) specify the procedures and criteria for establishing the critical medicines lists;
Amendment 196 #
Proposal for a regulation Article 9 – paragraph 1 – point a (a) specify the criteria and procedures for establishing the critical medicines lists;
Amendment 197 #
Proposal for a regulation Article 9 – paragraph 1 – point c (c) develop streamlined electronic monitoring and reporting systems
Amendment 198 #
Proposal for a regulation 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 199 #
Proposal for a regulation Article 9 – paragraph 1 – point c (c) develop streamlined electronic monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and National Competent Authorities and via iSPOC with Marketing Authorisation Holders;
Amendment 200 #
Proposal for a regulation Article 9 – paragraph 1 – point c (c) develop a streamlined and EU Harmonized electronic monitoring and reporting systems. The harmonised system prevent any duplication of the reporting process by industry;
Amendment 201 #
Proposal for a regulation 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 202 #
Proposal for a regulation Article 9 – paragraph 1 – point c (c) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 203 #
Proposal for a regulation Article 9 – paragraph 1 – point e (e)
Amendment 204 #
Proposal for a regulation Article 9 – paragraph 1 – point e (e) establish and maintain a list of 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 after updating it by including the industry single point of contacts (iSPOC) maintaining compliance with ISO IDMP;
Amendment 205 #
Proposal for a regulation Article 9 – paragraph 1 – point e (e)
Amendment 206 #
Proposal for a regulation 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 207 #
Proposal for a regulation 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 and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based
Amendment 208 #
Proposal for a regulation 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 and wholesalers based on the medicinal products included on the critical medicines lists;
Amendment 209 #
Proposal for a regulation 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 a
Amendment 210 #
Proposal for a regulation Article 9 – paragraph 3 – introductory part 3. The information referred to in point (b) of paragraph 2, without duplicating information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems, shall include at least:
Amendment 211 #
Proposal for a regulation Article 9 – paragraph 3 – point d (d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;
Amendment 212 #
Proposal for a regulation Article 9 – paragraph 3 – point d (d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause at each stage of the supply chain;
Amendment 213 #
Proposal for a regulation Article 9 – paragraph 3 – point d a (new) (d a) information on active substance manufacturing sites, where relevant;
Amendment 214 #
Proposal for a regulation Article 9 – paragraph 3 – point e (e) production, sales and market share data;
Amendment 215 #
Proposal for a regulation Article 9 – paragraph 3 – point g (g) mitigation plans including enhanced production
Amendment 216 #
Proposal for a regulation Article 9 – paragraph 3 – point g (g) mitigation plans including location- specific manufacturing, production and supply capacity;
Amendment 217 #
Proposal for a regulation 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) 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 219 #
Proposal for a regulation 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.
Amendment 220 #
Proposal for a regulation 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 221 #
Proposal for a regulation 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
Amendment 222 #
Proposal for a regulation 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 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 whenever
Amendment 223 #
Proposal for a regulation Article 10 – paragraph 2 2. Marketing authorisation holders of medicinal products authorised in the Union shall, within
Amendment 224 #
Proposal for a regulation 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 225 #
Proposal for a regulation Article 10 – paragraph 4 4. Where marketing authorisation
Amendment 226 #
Proposal for a regulation 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. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure, unless the information is in the public interest. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to sanctions to be determined by the Commission.
Amendment 227 #
Proposal for a regulation 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.
Amendment 228 #
Proposal for a regulation 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
Amendment 229 #
Proposal for a regulation 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 230 #
Proposal for a regulation 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;
Amendment 231 #
Proposal for a regulation 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 Article 12 – paragraph 1 – point f (f) liaise with third countries and relevant international organisations, as appropriate, to mitigate potential or actual shortages of medicinal products included on the critical medicines list or their active pharmaceutical ingredients, where those products or ingredients are imported into or exported from the Union and where such potential or actual shortages have international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.
Amendment 233 #
Proposal for a regulation Article 12 – paragraph 1 – point f a (new) Amendment 234 #
Proposal for a regulation Article 13 – paragraph -1 (new) -1 The Agency shall establish an early warning system to inform relevant stakeholders, including doctors and community and hospital pharmacists of any supply problems and potential or actual shortages of medicines included on the critical medicines lists.
Amendment 235 #
Proposal for a regulation Article 13 – paragraph 1 The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups with regard to the work
Amendment 236 #
Proposal for a regulation Article 13 – paragraph 1 The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups in a timely manner with regard to the work of the Medicines Steering Group, including the recommendations, opinions and decisions made by the Medicines Steering Group as well as agendas and minutes of the Group’s meetings.
Amendment 237 #
Proposal for a regulation Article 13 – paragraph 1 The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups with regard to the work, advices and findings of the Medicines Steering Group.
Amendment 238 #
Proposal for a regulation Article 14 – paragraph 1 1. The permanent Emergency Task Force is hereby established as part of the Agency. It shall be convened
Amendment 239 #
Proposal for a regulation Article 14 – paragraph 1 1. The Emergency Task Force is hereby established as a permanent structure as part of the Agency
Amendment 240 #
Proposal for a regulation Article 14 – paragraph 1 1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened in preparation for or during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 241 #
Proposal for a regulation 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 242 #
Proposal for a regulation Article 14 – paragraph 2 – point a a (new) (a a) The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to guide the trials towards meeting the criteria for effective public health interventions.
Amendment 243 #
Proposal for a regulation Article 14 – paragraph 2 – point b (b) reviewing clinical trial protocols and providing advice and guidance to developers on clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;
Amendment 244 #
Proposal for a regulation Article 14 – paragraph 2 – point c (c) providing scientific support to facilitate clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency. Such
Amendment 245 #
Proposal for a regulation Article 14 – paragraph 2 – point e (e) providing, by making publicly available, scientific recommendations with regard to the use of any medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;
Amendment 246 #
Proposal for a regulation Article 14 – paragraph 2 – point e (e) providing scientific recommendations with regard to the use of any human and veterinary medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16
Amendment 247 #
Proposal for a regulation Article 14 – paragraph 2 – point f (f) cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.
Amendment 248 #
Proposal for a regulation Article 14 – paragraph 3 3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. Members of the Emergency Task Force, including external experts, shall not have financial or other interests in the health industry which could affect their independence and impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be published. Members of the Emergency Task Force shall declare, at each meeting, any potential conflict of interest with respect to the items on the agenda. In the event of such a conflict of interest, the concerned member shall withdraw from the meeting. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1
Amendment 249 #
Proposal for a regulation 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 250 #
Proposal for a regulation Article 14 – paragraph 4 4. The composition of the Emergency Task Force shall be approved by the Management Board of the Agency and made publicly available. The Executive Director of the Agency or their representative and representatives of the Commission shall be entitled to attend all meetings.
Amendment 251 #
Proposal for a regulation Article 14 – paragraph 5 5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties
Amendment 252 #
Proposal for a regulation Article 14 – paragraph 5 5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 253 #
Proposal for a regulation Article 14 – paragraph 8 8. Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency Task Force as regards transparency and the independence of its members. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with conflicts of interest shall not participate in the process.
Amendment 254 #
Proposal for a regulation Article 14 – paragraph 9 9. The Agency shall publish information about the medicinal products that the Emergency Task Force considers may have the potential to address public health emergencies and any updates on its web-portal. The Agency shall also publish clinical trials data on medicines and vaccines reviewed by the Emergency Task Force and clinical trials protocols on which the Emergency Task Force provided advise to developers, in line with the provisions of the Regulation (EU) No 536/2014.
Amendment 255 #
Proposal for a regulation Article 14 – paragraph 9 9. The Agency shall rapidly publish all information about the medicinal products that the Emergency Task Force considers may have the potential to address public health emergencies and any updates on its web-portal.
Amendment 257 #
Proposal for a regulation Article 15 – paragraph -1 (new) -1. The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to ensure that these trials meet the criteria for effective public health interventions. These targets shall provide guidance for developers of medicinal products and underpin the scientific advice process outlined in this article.
Amendment 258 #
Proposal for a regulation Article 15 – paragraph 1 1. During a public health emergency, the Emergency Task Force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process based on targets referred to in Article 15.(-1). When providing scientific advice, a balance shall always be maintained between necessary facilitation in a crisis situation and patients’ safety.
Amendment 259 #
Proposal for a regulation 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.
Amendment 260 #
Proposal for a regulation 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, in
Amendment 261 #
Proposal for a regulation Article 15 – paragraph 6 6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16 and awaiting the launch of the Clinical Trials Information System (CTIS) in accordance with Art. 80 and 81 of Regulation (EU) No 536/2014.
Amendment 262 #
Proposal for a regulation Article 15 – paragraph 6 6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. In order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply, including encryption.
Amendment 263 #
Proposal for a regulation Article 15 – paragraph 6 6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. Due to the sensitive nature of this data, it shall be pseudonymised in line with the requirements of Article 89 of GDPR.
Amendment 264 #
Proposal for a regulation Article 15 – paragraph 6 6. Where a developer is the recipient of scientific advice, the developer shall subsequently and continuously submit all the data resulting from clinical trials to the Agency following a request made pursuant to Article 16.
Amendment 265 #
Proposal for a regulation Article 16 – paragraph 1 1. Following the recognition of a public health emergency, the Emergency Task Force shall undertake a review of the available scientific data on human and veterinary medicinal
Amendment 266 #
Proposal for a regulation Article 16 – paragraph 2 2. In preparation of the review, the Emergency Task Force may request all relevant information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force
Amendment 267 #
Proposal for a regulation Article 16 – paragraph 2 2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers
Amendment 268 #
Proposal for a regulation Article 16 – paragraph 2 2. In preparation of the review, the Emergency Task Force may 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, while applying state-of-the-art pseudonymisation, including encryption.
Amendment 269 #
Proposal for a regulation Article 16 – paragraph 2 2. In preparation of the
Amendment 270 #
Proposal for a regulation Article 16 – paragraph 2 2. In preparation of the review, the Emergency Task Force
Amendment 271 #
Proposal for a regulation Article 16 – paragraph 3 – introductory part 3. Based on a request from one or more Member States, or the Commission, the Emergency Task Force shall provide independent recommendations, driven only by public-health needs and not by other interests, to the Committee for Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on the following:
Amendment 272 #
Proposal for a regulation Article 16 – paragraph 6 6. In the preparation of its recommendations provided pursuant to paragraphs 3, the Emergency Task Force may consult the concerned Member State and request it to provide any information and data, which inf
Amendment 273 #
Proposal for a regulation 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 274 #
Proposal for a regulation Article 17 – paragraph 1 The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work and the data and sources used in the decision- making process of the Emergency Task Force.
Amendment 275 #
Proposal for a regulation Article 18 – paragraph 1 – point a (a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, while ensuring processing of patients' personal data is in compliance with the European data protection framework;
Amendment 276 #
Proposal for a regulation Article 18 – paragraph 1 – point a (a) develop and maintain highly secure and resilient electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies;
Amendment 277 #
Proposal for a regulation Article 18 – paragraph 1 – point b (b) coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities, while taking into consideration the priority recommendations of the HMA-EMA joint Big Data Task Force. Such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring
Amendment 278 #
Proposal for a regulation Article 18 – paragraph 1 – point c (c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (QCI), which would allow the transmission of sensitive information, using an ultra-secure form of encryption to shield against cyberattacks;
Amendment 279 #
Proposal for a regulation Article 18 – paragraph 1 – point c a (new) (c a) The Agency shall be equipped with a high level of security against cyber- attacks and cyber-espionage at all times, especially during major events and public health emergencies at Union level. Binding rules on security information and cybersecurity shall apply in line with the Security Union Strategy.
Amendment 280 #
Proposal for a regulation 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 and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.
Amendment 281 #
Proposal for a regulation Article 18 – paragraph 1 – point d a (new) (d a) take urgent and appropriate measures to ensure the protection of health data from cyber intrusions. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.
Amendment 282 #
Proposal for a regulation 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 283 #
Proposal for a regulation Article 19 – paragraph 1 1. The Executive Steering Group on Medical Devices (‘the Medical Devices Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely, in preparation for or during a public health emergency, or upon request of a Member State affected by a shortage. The Agency shall provide its secretariat.
Amendment 284 #
Proposal for a regulation Article 19 – paragraph 2 2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The declarations of interests of all experts must be made public and all necessary restrictions shall apply where conflicts of interest occur.
Amendment 285 #
Proposal for a regulation Article 19 – paragraph 2 a (new) 2 a. The membership of the Medical Devices Steering Group shall be made public. Members of the Medical Devices Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall vow to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.
Amendment 286 #
Proposal for a regulation Article 19 – paragraph 3 3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may
Amendment 287 #
Proposal for a regulation Article 19 – paragraph 3 3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups, healthcare professionals as well as representatives of patients and consumers to attend its meetings.
Amendment 288 #
Proposal for a regulation 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 289 #
Proposal for a regulation Article 20 – paragraph 1 1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 290 #
Proposal for a regulation Article 20 – paragraph 3 3. The Agency shall publish on an accessible way, the public
Amendment 291 #
Proposal for a regulation Article 20 – paragraph 3 3. The Agency shall publish the public health emergency critical devices list and any updates to that list in a timely manner on its web-portal.
Amendment 292 #
Proposal for a regulation Article 21 – paragraph 1 1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25, the Medical Devices Steering Group shall monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22 and the Advisory Committee on public health emergencies established
Amendment 293 #
Proposal for a regulation Article 22 – paragraph 2 2. Where requested by the Commission or the sub-network referred to in Article 23(2)(b), the Medical Devices Steering Group shall provide aggregated data and forecasts of demand to support its findings. In that regard, the Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medical device needs, and with the Medicines Steering Group referred to in Article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product as well as with Union and national entities engaged with stockpiling of medical devices.
Amendment 294 #
Proposal for a regulation Article 22 – paragraph 4 4. The Medical Devices Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures which may be taken by the Commission, Member States, medical device manufacturers, notified bodies and other entities, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies.
Amendment 295 #
Proposal for a regulation Article 22 – paragraph 5 5. The Medical Devices Steering Group may, upon request from the Commission coordinate measures, where relevant, between the national competent authorities, manufacturers of medical devices, notified bodies, and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a public health
Amendment 296 #
Proposal for a regulation Article 22 – paragraph 5 a (new) 5a. The measures recommended by the Steering Committee to the Commission, the Member States, the marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.
Amendment 297 #
Proposal for a regulation Article 22 – paragraph 5 a (new) 5 a. All the recommendations made by the Medical Devices Steering Group shall be made publicly available.
Amendment 298 #
Proposal for a regulation Article 23 – paragraph 1 – introductory part 1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21
Amendment 299 #
Proposal for a regulation 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 300 #
Proposal for a regulation Article 23 – paragraph 1 – point a (a) specify the procedures and criteria for establishing the public health emergency critical devices list;
Amendment 301 #
Proposal for a regulation Article 23 – paragraph 1 – point b (b) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 302 #
Proposal for a regulation Article 23 – paragraph 1 – point d Amendment 303 #
Proposal for a regulation Article 23 – paragraph 2 – point a (a) establish and maintain for the duration of the public health emergency, a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health emergency critical devices list based on single points of contact to be included for all medical device manufacturers in the database referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746;
Amendment 304 #
Proposal for a regulation Article 23 – paragraph 3 – point d (d) details of the potential or actual shortage such as actual or estimated start and end dates, and the known or suspected cause at each level of the supply chain;
Amendment 305 #
Proposal for a regulation Article 23 – paragraph 3 – point f (f) mitigation plans including enhanced production
Amendment 306 #
Proposal for a regulation Article 23 – paragraph 3 – point i (i) where conformity assessments are on-going, the status of the conformity assessment by the concerned notified bodies in relation to medical devices included in the public health emergency critical devices list and possible issues which need to be resolved in order to speedily complete the conformity assessment process.
Amendment 307 #
Proposal for a regulation Article 24 – paragraph 1 1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, medical device
Amendment 308 #
Proposal for a regulation Article 24 – paragraph 3 3. Where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies 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. The Agency shall assess the merits of each request and protect such commercially confidential information against unjustified disclosure unless the information is in the public interest.
Amendment 309 #
Proposal for a regulation Article 25 – paragraph 2 2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States shall gather information from manufacturers, importers, distributors, health care professionals and notified bodies on medical devices included on the public health emergency critical devices list.
Amendment 310 #
Proposal for a regulation Article 25 – paragraph 4 – point a (a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list while at the same time ensuring both patient and product safety;
Amendment 311 #
Proposal for a regulation Article 26 – paragraph 1 – point a (a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746 while at the same time ensuring both patient and product safety;
Amendment 312 #
Proposal for a regulation 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 313 #
Proposal for a regulation Article 26 – paragraph 1 – point b (b) consider the need for guidelines addressed to Member States, medical device manufacturers, notified bodies, health care professionals and other entities;
Amendment 314 #
Proposal for a regulation Article 26 – paragraph 1 – point e (e) liaise with third countries and relevant international organisations, as appropriate, to mitigate potential or actual shortages of medical devices included on the critical devices list or their component parts, where those devices or parts are imported into or exported from the Union, and where such potential or actual shortages have international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.
Amendment 315 #
Proposal for a regulation Article 27 – paragraph 1 The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, including the recommendations, opinions and decisions made by the Medical Devices Steering Group as well as agendas and minutes of the Group’s meetings.
Amendment 316 #
Proposal for a regulation Article 28 – paragraph 1 – point a (a) provide administrative, scientific and technical support to the expert panels for the provision of scientific opinions, views and advice;
Amendment 317 #
Proposal for a regulation 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 1.
Amendment 319 #
Proposal for a regulation Article 30 – paragraph 1 – point a (a) personal data in accordance with Article 32 and Article 4(1) of Regulation (EU) 2016/679 (‘GDPR’) and Article 3(1) EUDPR;
Amendment 320 #
Proposal for a regulation Article 30 – paragraph 1 – point a (a) personal data in accordance with
Amendment 321 #
Proposal for a regulation Article 30 – paragraph 5 5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Recalls that transfers of personal data to third countries or international organisations must comply with Chapter V of the EUDPR, relevant provisions of the GDPR, the LED and the Charter of Fundamental Rights and take into account the recommendations and guidelines of the EDPB.
Amendment 322 #
Proposal for a regulation Article 30 – paragraph 5 5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded legally binding and enforceable bilateral or multilateral confidentiality arrangements.
Amendment 65 #
Proposal for a regulation Recital 1 a (new) (1 a) According to Article 4(2) of the TFEU, common safety concerns in public health matters is amongst the shared competences of the EU;
Amendment 66 #
Proposal for a regulation Recital 2 (2) The unpreceden
Amendment 67 #
Proposal for a regulation Recital 2 (2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States. The pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with EMA in order to be better prepared for future health crisis and disruptions in the supply chain. COVID- 19 also underlined the need for more transparency on medicines pricing and EU marketing authorisation.
Amendment 68 #
Proposal for a regulation Recital 2 (2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective and transparent in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by austerity measures affecting public health services, insufficient public control on production, and by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 69 #
Proposal for a regulation Recital 2 (2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union
Amendment 70 #
Proposal for a regulation Recital 3 (3) The
Amendment 71 #
Proposal for a regulation Recital 3 a (new) (3a) The COVID-19 crisis has revealed the complexity of the supply of raw materials and highlighted a highly fragmented production chain and complex distribution networks, which are factors that the manufacturers and their management controllers are struggling to deal with and which require real collaboration between states, as well as a clear stance to be taken by the EMA;
Amendment 72 #
Proposal for a regulation Recital 3 b (new) (3b) the essential free movement of goods must be possible with a revised border management;
Amendment 73 #
Proposal for a regulation Recital 4 (4) Dealing with the issue of shortages of medicinal products has been a long- standing
Amendment 74 #
Proposal for a regulation Recital 4 a (new) (4 a) The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the EU to achieve better public health outcomes, since, as stated in the EU4Health Programme, human health is connected to animal health and the environment and actions to tackle threats to health should take into account those three dimensions.
Amendment 75 #
Proposal for a regulation Recital 5 (5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s and the Member States’ ability to rapidly and effectively react to such challenges during public health crises.
Amendment 76 #
Proposal for a regulation Recital 6 (6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for personal protective equipments and medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.
Amendment 77 #
Proposal for a regulation Recital 6 (6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact
Amendment 78 #
Proposal for a regulation 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 79 #
Proposal for a regulation Recital 7 (7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices
Amendment 80 #
Proposal for a regulation Recital 7 (7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the
Amendment 81 #
Proposal for a regulation Recital 8 (8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted
Amendment 82 #
Proposal for a regulation Recital 9 (9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers, other stakeholders of the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.
Amendment 83 #
Proposal for a regulation Recital 9 a (new) (9 a) The outbreak of COVID-19 and the subsequent health crisis revealed the need for a more coordinated European approach in crisis management. Although the emergency of the situation explains the lack of an impact assessment, sufficient allocation of resources in terms of staff and funding needs to be secured, taking into account the specificities of the health sector in the different Member States.
Amendment 84 #
Proposal for a regulation Recital 10 (10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. Highlights in this respect the necessity of developing analytics to predict emerging risks, including the use of alternative data sources.
Amendment 85 #
Proposal for a regulation Recital 11 (11) This Regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices, with a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously
Amendment 86 #
Proposal for a regulation Recital 11 a (new) (11 a) This Regulation establishes a framework to address the problem of shortages during public health emergencies and major events. However, shortages of medicinal products and medical devices is a persistent problem that affects health and lives of EU citizens between emergencies as well. Therefore, the Commission should subsequently propose the expansion of this framework to ensure that the problem of shortages is tackled on a permanent basis.
Amendment 87 #
Proposal for a regulation Recital 12 (12) In order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic and on experiences and examples in other countries.
Amendment 88 #
Proposal for a regulation Recital 13 (13) A harmonised system, based on common data fields, of monitoring of shortages of medicinal products, personal protective equipments and medical devices should be established, which will facilitate appropriate access
Amendment 89 #
Proposal for a regulation Recital 13 (13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with
Amendment 90 #
Proposal for a regulation Recital 15 (15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish
Amendment 91 #
Proposal for a regulation Recital 15 (15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group sh
Amendment 92 #
Proposal for a regulation Recital 17 (17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the
Amendment 93 #
Proposal for a regulation Recital 17 (17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed, if necessary, and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in
Amendment 94 #
Proposal for a regulation Recital 18 (18)
Amendment 95 #
Proposal for a regulation Recital 18 (18) The work of the Emergency Task
Amendment 96 #
Proposal for a regulation Recital 19 (19) The establishment of the
Amendment 97 #
Proposal for a regulation Recital 19 (19) The establishment of the Emergency Task Force should build on the support provided by the Agency during the COVID-19 pandemic, notably as regards scientific advice on clinical trials design and product development, the transparency of related activities, including the rapid publishing clinical data for the products in question, as well as the ‘rolling’ review i.e. on an on-going basis, of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.
Amendment 98 #
Proposal for a regulation Recital 19 a (new) Amendment 99 #
Proposal for a regulation Recital 20 (20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would strengthen the research environment in the Union,
source: 691.131
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