22 Amendments of Dolors MONTSERRAT related to 2020/0321(COD)
Amendment 116 #
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 in a coordinated way between public authorities, industry and other entities of the pharmaceuticals' manufacturing, distribution and provision chains. A two- way dialogue between authorities and all the industry stakeholders is key and should be ensured to prevent and better manage medicines shortage. 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 122 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) As experienced during the COVID-19 crisis, regulatory capacity to adapt and activate exceptional measures to facilitate Marketing Authorisations for emergency medicines and medical devices is key for an effective and coordinated response to health emergencies at Union level. This capacity should be applied even beyond crisis situations, for example applying the Rolling Review procedures to critical medicinal products, covering procedures for changes in suppliers of APIs or for the designation of new manufacturing sites, leading to prevention and better mitigation of medicines shortage, in coherent and consistent coordination with Member States, avoiding fragmentation of the internal market and inefficient outcomes. The National Agencies should align their regulatory capacity to the EMA enhanced one, in terms of reduced times, efficiency and flexibility to prevent shortages and effectively respond to patients' clinical needs.
Amendment 140 #
Proposal for a regulation
Recital 5
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 ability to rapidly and effectively react to such challenges during public health crises and the need for a more active and extended involvement of the European institutions addressing the health of the European citizens.
Amendment 150 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) During the first stages of the COVID-19 pandemic, uncoordinated actions at national level, such as national hoarding and stockpiling, undermined industry ability to deliver equitable supply in all markets. This represents a lesson learned to avoid in any future crisis situations and highlights the urgent need for a more solid and effective coordination at Union level.
Amendment 177 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) This Regulation aims at establishing the foundations of a European Union of Health coordination and early-warning digitalized interoperable system, to monitor and report medicines shortage, based on shared definitions and procedures, in order to be prepared and better react during a crisis. The existing best practices of digital reporting systems at national level should be shared and taken into account after a common evaluation.
Amendment 184 #
Proposal for a regulation
Recital 13
Recital 13
(13) A harmonised system of monitoringEuropean Union of Health digitalized and interoperable early-warning system 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 improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask and obtainccess information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact, relevant entities of the pharmaceuticals' supply chain and Member States' national agencies, directly via the uploaded information at national level available in the European Union of Health early-warning, interoperable and digitalized system, avoiding duplications of reporting requirements at different levels.
Amendment 190 #
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 lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice and recommendations 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. The Steering Group should take into account and integrate in its works the outcomes of the ongoing discussions in the context of the European Commission Structured Dialogue on manufacturing and supply chain among institutions, national authorities and stakeholders, in order to achieve the best results in preventing and responding to shortage of medicines.
Amendment 214 #
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. teroperable infrastructure, taking advantage of all the potential of the supercomputing, the Artificial Intelligence and the Big Data science to develop predicting models and take better and more timely-effective decisions, without compromising the privacy rights.
Amendment 242 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and managevent, prepare for, manage and coordinate at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 248 #
Proposal for a regulation
Article 1 – paragraph 1 – point a a (new)
Article 1 – paragraph 1 – point a a (new)
(aa) Set up the European Union of Health digitalized and interoperable early-warning system of shortages of medicinal products and medical devices, interconnecting national reporting systems, with common definitions and data collection procedures, as a basis to better prevent, manage and coordinate health emergencies at Union level;
Amendment 278 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device, no matter the cause;
Amendment 290 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medicinal product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients, while following real, adequate prescription needs.
Amendment 307 #
Proposal for a regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a The setting of a European Union of Health digitalized and interoperable early-warning system 1. In order to better manage health crisis, a European Union of Health digitalized and interoperable early-warning system to monitor and report all medicines shortage is hereby established, through an infrastructure which is in place and functional also under normal circumstances. 2. Through such a harmonized, digitalized and interoperable system, the reporting shall be based on collecting data at the national level, with data collected on common definitions and procedures, covering both Centralised and National Marketing Authorisations. The Agency shall receive, when relevant, aggregated data from national databases to monitor any potential cross-border shortages.
Amendment 313 #
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, a representative of the Patients' organizations, a representative of the Healthcare Professionals' organizations 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 list of the members of the Steering Group shall be transparent and made public on the EMA web-portal.
Amendment 324 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and, marketing authorisation holders to attend its meetings, representatives of healthcare professionals, and of patients to attend its meetings, when their contribution may inform the discussions of the Steering Group.
Amendment 423 #
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 435 #
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 450 #
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) specify the methods of and criteria for the monitoring, data collection and reporting through the European Union of Health digitalized and interoperable early-warning system of shortage of medicines, established in Article 2bis(new), and provided for in Articles 4, 7 and 8;
Amendment 480 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients, potential alternative production sites, minimum stock levels, etc.;
Amendment 541 #
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 to support them in their work and in the communication with patients;
Amendment 696 #
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 both patient and product safety;
Amendment 701 #
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 both patient and product safety;