31 Amendments of Nathalie COLIN-OESTERLÉ related to 2020/0102(COD)
Amendment 137 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between the authorities and the parties concerned, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross- border threats to health and, to safeguard the health and well- being of people in the Union, and to take all necessary measures to combat shortages by increasing the resilience of health systems in order to ensure that European citizens have access to medicines and medical equipment. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.2020.
Amendment 175 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include European strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the ‘One Health’ approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 177 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices and personal protective equipment needed in the Union during the pandemics. In the event of health crises and pandemics, but also for recurrent shortages, the Programme should promote actions that encourage the production, purchase and management of relevant products by ensuring that they complement other EU instruments.
Amendment 200 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuringour dependence on third countries for the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should enable the Commission and the Member States to take all the necessary measures to guarantee European independence in health matters, by provideing support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 251 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, rare diseases and diabetes represent major causes of disability, ill- health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non- communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems and the supply of appropriate medicines.
Amendment 289 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) Today, there is a lack of awareness about chronic diseases, such as migraines, despite their psychological and socioeconomic impact; it is important to ensure that neurological disorders, including migraines, are given proper consideration in European policies. The EU and the Member States should include migraines and other chronic diseases in their health priorities.
Amendment 350 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to develop a pan-European monitoring, reporting and notification system to monitor shortages of medicines, medical devices and other healthcare products to strengthen the Single Market, and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 387 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) The mobility of cross-border medical workers should be guaranteed in order to ensure the continuity of healthcare services within the European Union.
Amendment 436 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10a) ‘shortage’ means the temporary unavailability of a medicinal product as a result of an upstream stock shortage and/or a downstream supply shortage;
Amendment 439 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 b (new)
Article 2 – paragraph 1 – point 10 b (new)
(10b) ‘supply strain’ means that the manufacturer has insufficient quantities of medicines available, resulting in a temporary inability to supply the usual market and a risk of disruption;
Amendment 440 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 c (new)
Article 2 – paragraph 1 – point 10 c (new)
(10c) ‘supply disruption’ means the medicine is manufactured but not distributed to all pharmacies;
Amendment 441 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 d (new)
Article 2 – paragraph 1 – point 10 d (new)
(10d) ‘stock shortage’ means a break in the manufacturing chain of the medicines, which may have several explanations: either the medicines cannot be manufactured or they are not allowed to enter the distribution channel because the quality of the medicines does not fully meet the required standards.
Amendment 484 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support and strengthen existing and future EU health legislation to improve the availability in the EU of medicines, medical devices and other products that are required in case of shortages, and contribute to their accessibility and affordability;
Amendment 508 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) support the creation, development and implementation of a strategy to tackle shortages of medicines and medical devices in order to ensure all patients in the European Union are able to access treatment;
Amendment 519 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
Article 4 – paragraph 1 – point 2 a (new)
(2a) support the creation, development and implementation of a strategy on health personnel in order to ensure an effective public health workforce, with the same high standards across the Union, and promote the excellence of medical and healthcare professionals; to this end, simplify the rules to allow cross-border health workers effective mobility, particularly in the event of a crisis or pandemic;
Amendment 522 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies, by improving information systems so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 561 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer; including cancer, cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions, with the aim of improving the quality of life of EU citizens;
Amendment 598 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9a) Create one or more non-profit- making European pharmaceutical establishments of general interest to produce certain priority medicines that are important from a health and strategic point of view;
Amendment 650 #
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1a. Stress tests shall be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.
Amendment 675 #
Proposal for a regulation
Annex I – point c – point i
Annex I – point c – point i
(i) Surveys, studies, collection of centralised and accessible data and statistics, methodologies, classifications, microsimulations, indicators, knowledge brokering and benchmark exercises;
Amendment 681 #
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels, incorporating all of the relevant stakeholders, providing advice, evaluations, data and information to support health policy development and implementation;
Amendment 691 #
Proposal for a regulation
Annex I – point c – point iii a (new)
Annex I – point c – point iii a (new)
(iiia.) The creation and management of a policy-oriented Pharmaceutical Forum comprising health authorities and stakeholders, with a view to defining specific priorities and measures to be implemented at a technical level;
Amendment 698 #
Proposal for a regulation
Annex I – point c – point iv
Annex I – point c – point iv
(iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on ‘Consumer Safety’ and on ‘Health, Environmental and Emerging Risks’, and the Expert Group on Health Systems Performance Assessment.
Amendment 706 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) DEvaluation, development and implementation of Union health legislation and action, in particular through support to:
Amendment 719 #
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and, operation and maintenance of databases and digital tools and their interoperability, including projects already established, such as the centralised common repository for all medicines in Europe and the SPOR portal, where appropriate with other sensing technologies, such as space-based;
Amendment 722 #
Proposal for a regulation
Annex I – point d – point v
Annex I – point d – point v
(v) Auditing and, assessment and inspection work in accordance with Union legislation;
Amendment 748 #
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement of goods and services, using the MEAT criteria in particular, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 960 #
Proposal for a regulation
Annex I – point i – point vi
Annex I – point i – point vi
(vi) Support action to monitor, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to compile the identified shortages in a centralised database that is interoperable with the drug regulatory databases, to address such shortages, and to increase security of supplies;
Amendment 969 #
Proposal for a regulation
Annex I – point i – point viii
Annex I – point i – point viii
(viii) Action to strengthen the environmental risk assessment of pharmaceuticals and to reward such investments in contract award procedures;
Amendment 971 #
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobialmedicines, especially antimicrobials; technological incentives to neutralise waste in production plants;
Amendment 1072 #
Proposal for a regulation
Annex II – part 2 – point 8 a (new)
Annex II – part 2 – point 8 a (new)
8a. Common and shared approach to notification, reporting and definition of shortages, reflecting the real impact on patients