16 Amendments of Inese VAIDERE related to 2020/0320(COD)
Amendment 64 #
Proposal for a regulation
Recital 1
Recital 1
(1) The Union is committed to protect and improve human health, in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health with significant social impact throughout the Union.
Amendment 66 #
Proposal for a regulation
Recital 3
Recital 3
(3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced in responding to the pandemic it became clear that the Centre’, which has particularly affected people with chronic non- communicable diseases being more vulnerable to COVID-19 infection. Given the unprecedented challenges experienced in responding to the pandemic and in view of the effectiveness gaps which have been identified in the Centre's performance in that regard, it became clear that its role in the Union’s framework for health crisis preparedness and response should be strengthened to better use the potential of the Union's and Member States' capacities to respond to future pandemics.
Amendment 74 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross- border threats to health in the Union, including cross-border threats, communicable diseases and major chronic diseases and especially the interconnections between them, in accordance with Regulation EU …/… of the European Parliament and of the Council10 [ISC/2020/12524]. __________________ 10Regulation (EU) XXXX/XXXX of the European Parliament and of the Council of DATE on serious cross-border threats to health and repealing Decision No 1082/2013/EU [OJ: please, insert full title and publication reference to Regulation on serious cross border threats to health (SCBTH).]
Amendment 80 #
Proposal for a regulation
Recital 6
Recital 6
(6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases, prevention of excess mortality among patients, notably those suffering from chronic diseases and the increase of infection-caused chronic diseases and other pathogens associated with chronic diseases. This should also contribute to efficiently responding to current and emerging threats to human health posed by non-communicable diseases, either directly or indirectly, due to increasing risks associated with communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between communicable and chronic diseases, as well as between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans, with a view to enabling Member States to better assess their health systems' capacities. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, including their interconnection with chronic diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases and their effect on the health-related quality of life of patients with chronic diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity. It should also work to ensure that there is sufficient, comparable and high quality data for the Union-wide surveillance and monitoring of major communicable diseases such as HIV, viral hepatitis B and C and Tuberculosis.
Amendment 101 #
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and Member States through dedicated networks with competent coordinating bodies, including by encouraging cooperation within newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,.
Amendment 132 #
Proposal for a regulation
Recital 13
Recital 13
(13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should, working in conjunction with Member States so as to take account of their experiences and respective situations, develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, awareness of transmission routes, antimicrobial resistance, health education, health literacy and behaviour change. and links with non- communicable diseases including vulnerable groups, health literacy, health promotion and disease prevention and behaviour change. Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks.
Amendment 185 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans, their interconnection with chronic conditions and those related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess, and report on current and emerging threats to human health from communicable diseases, and provide recommendations for response at Union and national levels, as well as at regional level, if necessarys, and provide recommendations for response and coordinated action at Union and national levels, as well as at interregional and regional level, where appropriate. In providing such recommendations, the Centre shall take into account existing national crisis management plans and the respective circumstances of each Member State. The Centre shall also provide forecasts on the development of the identified health threats, that will help predict the demand of key medical technologies during the evolution of a possible health emergency, and specifically a forecast of Intensive Care Units usage and related device and diagnostic needs.
Amendment 219 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point e a (new)
Article 3 – paragraph 2 – point e a (new)
(ea) support national monitoring of the response to major communicable diseases to measure progress in tackling them across the Union;
Amendment 250 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) notify the Centre of any serious cross-border threats to health, including spread of communicable diseases, unpredicted rise of known or unknown severe non-communicable diseases or chronic conditions and health-related environmental hazards, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; and
Amendment 279 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point b
Article 5 – paragraph 2 – subparagraph 2 – point b
(b) provide quality assurance by monitoring and evaluating epidemiological and health surveillance activities (including setting surveillance standards and monitoring data completeness) of the dedicated surveillance networks to ensure optimal operation;
Amendment 296 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point a
Article 5 – paragraph 4 – point a
(a) monitor and report on trends in communicable diseases and their interconnection to chronic conditions and implications for patients with severe non- communicable diseases and chronic conditions over time and across Member States and in third countries, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from member states
Amendment 300 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point d
Article 5 – paragraph 4 – point d
(d) monitor and assess health systems’ capacityhealth systems and support Member States in their assessment of the capacity of their health systems for diagnosis, prevention and treatment of specific communicable diseases, such as HIV, viral Hepatitis and Tuberculosis, as well as patients’ safety;
Amendment 370 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
(i) assesssupport Member States in their assessment of the capacity of their health systems’ capacity to detect, prevent, respond to and recover from outbreaks of communicable diseases and related health risks, identify gaps and provide recommendations for the strengthening of health systems, to be implemented with Union support as appropriate;
Amendment 417 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 2
Article 8a – paragraph 2
2. The risk assessment shall includes referred to in paragraph 1 shall include, where possible, general and targeted recommendations for response as a basis for coordination in the HSC. , including, but not limited, to: (a) a forecast on the evolution of a health crisis and the risk of health emergency; (b) a forecast on the demand of medicines, vaccines, medical equipment, protective equipment and hospital capacity; (c) identification of vulnerable groups in the society, such as patients, suffering chronic conditions, patients with severe non-communicable diseases, elderly, children, pregnant women and professions with a high risk of infection or transmission, including specific needs for medicines and hospital capacity for those most vulnerable groups; (d) identification of possible protective measures and assessment of their efficacy; (e) assessment of the possible need for activation of the Health Task Force and the Union Civil Protection Mechanism.
Amendment 435 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point b
Article 11 – paragraph 1a – point b
(b) the progression of epidemic situations, including for modelling, anticipation and scenario development, the assessment of vulnerable groups and the forecast on specific demand for medicines, equipment and hospital capacity;
Amendment 454 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
1. The Centre shall establish a permanent capacity, as well as an enhanced emergency capacity to mobilise and deploy the EU Health Task Force including the Centre’'s staff and experts from Member States and fellowship programmes, to assist local response to outbreaks of communicable diseases in Member States and in third countries.