21 Amendments of Tudor CIUHODARU related to 2020/0321(COD)
Amendment 118 #
Proposal for a regulation
Recital 2
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, but it has also demonstrated the need for closer cooperation and faster exchanges of information between Members States and the European institutions on the measures implemented. 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.
Amendment 146 #
Proposal for a regulation
Recital 6
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 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 tohat will ensure monitoring of shortages of medical devices resulting from a public health emergency and to propose measures that can be agreed and implemented jointly across Europe.
Amendment 156 #
Proposal for a regulation
Recital 8
Recital 8
(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary through joint undertakings by public authorities, the private sector and academia, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted sub-optimal coordination and decision- making as regards multinational clinical trials, and Union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the Union, causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.
Amendment 164 #
Proposal for a regulation
Recital 9
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 and Member States, had to be found to achieve the objective of making available to the Member States 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 199 #
Proposal for a regulation
Recital 17
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 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, as well as existing minimum stock levels needed to manage the crisis adequately, 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 the development of such medicinal products.
Amendment 208 #
Proposal for a regulation
Recital 21
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 issues of medical devices, and to establish a list of critical devices and minimum stock levels required in the case of a public health emergency.
Amendment 212 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices, alongside enhanced protection of data infrastructure and dissemination from possible cyberattacks. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data.
Amendment 215 #
Proposal for a regulation
Recital 26
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, but with clear rules on controlling access to the data (users with access, data retention period) and ensuring adequate protection of the data.
Amendment 309 #
Proposal for a regulation
Article 3 – paragraph 1
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 as often as needed, either in person or remotely, in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3). The Agency shall provide its secretariat.
Amendment 316 #
Proposal for a regulation
Article 3 – paragraph 2
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, as well as one alternate for unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 447 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing the critical medicines lists and the minimum stock levels required to ensure continuity of medical care;
Amendment 562 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened as often as needed during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 587 #
9a. The Agency shall use traditional and social media to issue periodic communications, agreed by all Member States, to keep the general public informed, using accessible language and providing explanations that can be understood by all;
Amendment 607 #
Proposal for a regulation
Article 17 – paragraph 1
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 of the Emergency Task Force, as well as its decisions, proposals and recommendations to the national and European authorities.
Amendment 626 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
ensure enhanced protection of electronic tools and disseminated data against cyberattacks, deciding in conjunction with the Member States how the data in question can be accessed (users with access, data access period, data retention period);
Amendment 629 #
Proposal for a regulation
Article 19 – paragraph 1
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 as often as needed, either in person or remotely, in preparation for or during a public health emergency. The Agency shall provide its secretariat.
Amendment 634 #
Proposal for a regulation
Article 19 – paragraph 2
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, including one alternate in case of unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 651 #
Proposal for a regulation
Article 20 – paragraph 1
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 shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’) as well as minimum necessary stock levels. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 673 #
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) develop streamlined electronic monitoring and reporting systems, including for existing or potential stock levels;
Amendment 685 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including production and supply capacity, so as to ensure the minimum stock levels required;
Amendment 709 #
Proposal for a regulation
Article 27 – paragraph 1
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 and its proposals and recommendations.