42 Amendments of Martin HOJSÍK related to 2020/0321(COD)
Amendment 119 #
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 from an early stage and in coordination with the national authorities, the industry and other entities of the pharmaceutical supply chain. 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 130 #
Proposal for a regulation
Recital 3
Recital 3
(3) The often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of those goods, and uncertainty related to their supply and demand in the context of the COVID-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the Union, with dire consequences for its citizens.
Amendment 133 #
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with tThe issue of shortages of medicinal products has been a long- standing and insufficiently addressed priority for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))
Amendment 145 #
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 and placed Member States in competition with each other to respond to the legitimate needs of their citizens, contributing to uncoordinated actions at national levels such as national hoarding and stockpiling. Those issues further resulted in new entities being involved in the rushed 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, as well as increased and early dialogue with the industry to prevent and mitigate these shortages.
Amendment 153 #
Proposal for a regulation
Recital 7
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 COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices in the most efficient way and so as to avoid creating unnecessary burdens for stakeholders which may strain resources and cause additional delays.
Amendment 167 #
Proposal for a regulation
Recital 10
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, with a view to strategically complement the efforts of the Commission and other existing Agencies to that end, as well as that of future key agencies such as the proposed European Health Emergency Preparedness and Response Authority (HERA).
Amendment 179 #
Proposal for a regulation
Recital 12
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, while remaining flexible enough to tackle any future health crisis in the most efficient way to the benefit of public health and patients.
Amendment 186 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) However, in order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, it would be necessary for the Union and Member States to set up an electronic platform capable of determining the volume of stocks and detecting, predicting and preventing shortages of medicinal products. To facilitate the development of such a system, lessons could be learnt from projects such as CISMED, funded by the Union through Horizon Europe. The platform should provide the national competent authorities with real-time access to unmet demands from wholesale distributors, community pharmacies and hospital pharmacies, providing accurate data in order to understand the functioning of the supply chain and anticipate potential shortages of medicinal products. The platform should also act as the sole portal for marketing authorisation holders and wholesale distributors to provide the information required during major events and public health emergencies once fully implemented, with a view to increase efficiency, predictability during crises, and speed-up the decision making process while avoiding duplication of efforts and unjustified burden on all stakeholders. In order to facilitate the coordination role of the Agency, Member States' supply monitoring platforms should be interoperable and replicate their information in a Union database managed by the Agency. To accelerate the implementation of the system at Union and national level, its development and implementation should be supported by Union funding from, inter alia, the EU4Health Programme or the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council1a. _________________ 1a1a Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).
Amendment 193 #
Proposal for a regulation
Recital 15
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 single European lists of critical medicinal products in consultation with the industry and healthcare professionals, to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection.
Amendment 203 #
Proposal for a regulation
Recital 19
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 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 while guaranteeing a high level of human health protection.
Amendment 213 #
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 SPOR data management for human medicines and the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data.
Amendment 223 #
Proposal for a regulation
Recital 27
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 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. This cooperation should also include strategic discussions with relevant entities of the Union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event, or prevent future similar public health emergencies or major events, such as the proposed European Health Emergency Preparedness and Response Authority (HERA).
Amendment 227 #
Proposal for a regulation
Recital 29
Recital 29
(29) In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for the work provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue.
Amendment 261 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is placed on the national market by a marketing authorisation holder, a manufacturer, a distributor, or any other actor in the distribution chain respectively;
Amendment 326 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders, representatives of healthcare professionals, patients and consumers to attend its meetings.
Amendment 358 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report without delay 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 authorities, through the working party referred to in Article 3(5).
Amendment 372 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group 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 and it is confirmed that the assistance of the Medicines Steering group is no longer needed as per Article 4(4).
Amendment 379 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the industry and representatives of health professionals, the Medicines Steering Group 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 public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 415 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1 a. Reports of any potential or actual shortages of medicinal products included on the critical medicines lists shall also be made available to industry and other entities of the pharmaceutical supply chain, where relevant.
Amendment 416 #
Proposal for a regulation
Article 8 – paragraph 2
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. The aggregated data and forecasts of demand shall also be made available to industry and other entities of the pharmaceutical supply chain, where relevant, with the view to better prevent or mitigate potential or actual shortages.
Amendment 425 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, 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 434 #
Proposal for a regulation
Article 8 – paragraph 5
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 466 #
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1 a. The Agency shall publish the information referred to in paragraph 1 (a), (b), (f) on its web portal without delay.
Amendment 485 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans, including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;
Amendment 490 #
Proposal for a regulation
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 545 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals;
Amendment 553 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Amendment 559 #
The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform without delay the public and interest groups with regard to the work of the Medicines Steering Group, and respond to disinformation as appropriate.
Amendment 581 #
Proposal for a regulation
Article 14 – paragraph 5
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, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 592 #
Proposal for a regulation
Article 15 – paragraph 5 a (new)
Article 15 – paragraph 5 a (new)
5 a. Where a clinical trial reviewed as part of an accelerated scientific advice process is authorised, the developer of the clinical trial shall: (a) publish the study protocol at the start of the trial through the European Union clinical trials register; (b) publish the summary of the results of the trial through the European Union clinical trials register by a deadline set by the Agency shorter than that laid down in Article 37 of Regulation (EU) No 536/2014, taking into consideration the public interest and nature of the health emergency.
Amendment 599 #
4. Following receipt of the recommendation, the Committee for Medicinal Products for Human Use shall adopt an opinion on the conditions for use, the conditions for distribution and the patients targeted. The opinion shall be updated where necessary, and made public on the Agency's web-portal.
Amendment 608 #
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 without delay the public and relevant interest groups with regard to the work of the Emergency Task Force, and respond to disinformation as appropriate.
Amendment 614 #
Proposal for a regulation
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
(b) coordinate independent vaccineutilisation, effectiveness and safety monitoring studies of medicinal products intended to treat, prevent or diagnose a disease using relevant data held by public authorities. S; for vaccines, such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;
Amendment 641 #
Proposal for a regulation
Article 19 – paragraph 3
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, representatives of patients and healthcare professionals, to attend its meetings.
Amendment 681 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;
Amendment 695 #
Proposal for a regulation
Article 25 – paragraph 4 – point a
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 a high level of patient and product safety;
Amendment 699 #
Proposal for a regulation
Article 26 – paragraph 1 – point a
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 a high level of patient and product safety;
Amendment 710 #
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 without delay the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, and respond to disinformation.
Amendment 712 #
The Agency shall, on behalf of the Commission, from 1 March 2022 onwards, provide the secretariat of the expert panels designated in accordance with Implementing Decision (EU) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in Article 106(9) and (10) of Regulation (EU) 2017/745. The Agency shall:
Amendment 718 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a Protection against cyber-attacks The Agency shall be equipped with a high level of security controls and processes against cyber-attacks to ensure the normal functioning of the Agency at all time, and especially during public health emergencies and major events at Union level. To that end, the Agency shall actively pursue and implement best cybersecurity practices within Union institutions and bodies to prevent, detect, mitigate, and respond to cyber-attacks.
Amendment 734 #
Proposal for a regulation
Article 31 – title
Article 31 – title
31 Entry into Force and date of application
Amendment 736 #
Proposal for a regulation
Article 31 – paragraph 1 a (new)
Article 31 – paragraph 1 a (new)
Chapters IV shall apply from… [date of entry into force + 12 months].