30 Amendments of Stanislav POLČÁK related to 2020/0320(COD)
Amendment 62 #
Proposal for a regulation
Recital 1
Recital 1
(1) The Union is committed to protect and improve human health, in particularensuring a high level of protection of human health and, for that purpose, inter alia, to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health.
Amendment 73 #
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 requiredappropriate 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 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 78 #
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 drafting forecastings, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. IOutput from its actions should be consistent with a One- Health approach, recognising the interconnections between human and animal health and the environment. ItThe Centre 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. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelinerecommendations 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 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.
Amendment 119 #
Proposal for a regulation
Recital 10
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and facilitate evidence-based response action, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advisescooperates with the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
Amendment 124 #
Proposal for a regulation
Recital 11
Recital 11
(11) The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation of the network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible fore purpose of this network is the promotion of good practice and alignment on diagnostics, testing methods, and use of tests, in order to ensure uniform surveillance, notification and reporting of diseases, as well as strengthened quality of testing and surveillance.
Amendment 130 #
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 develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventthe causes and factors facilitating the spread of communicable diseases, vaccination as prevention of communicable diseases, antimicrobial resistance, health education, health literacy and behaviour change.
Amendment 146 #
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development of Union and national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities tofor the prevention, prepareation and respondse to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection.
Amendment 174 #
Proposal for a regulation
Recital 22
Recital 22
(22) Since the objectives of this Regulation to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the requiredappropriate scientific expertise and to support actions which combat serious cross-border threats to health in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the cross- border nature of the health threats and the need for rapid, coordinated and coherent response, be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Amendment 175 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 851/2004
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) ‘competent body’ means any structure, institute, agent or other scientific body recognised by Member States authorities as providing independent scientific and technical advice or capacity for action in the field of the prevention and control of human disease;
Amendment 193 #
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 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 and local level, if necessary.
Amendment 214 #
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 d
Article 3 – paragraph 2 – point d
(d) exchangshare information, expertise and best practice;
Amendment 217 #
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
Article 3 – paragraph 2 – point e
(e) monitor national health systems’ capacity relevant to the management of communicable disease threats and other special health issues;
Amendment 223 #
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 g
Article 3 – paragraph 2 – point g
(g) provide, upon request of the Commission or the HSC, or its own initiative, guidelinerecommendations for treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societiesprofessional societies, professional associations and research and educational institutions involved in healthcare;
Amendment 247 #
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 a
Article 4 – paragraph 1 – point a
(a) communicate to the Centre in a timely manner and according to agreed case definitions, indicators, standards, protocols and procedures data on the surveillance of communicable diseases and other special health issues undertaken in accordance with Article 13 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], and available scientific and technical data and information relevant to the Centre’s mission, including on preparedness, and national health systems capacities to detect, prevent, respond to and recover from outbreaks of communicable diseases;
Amendment 287 #
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 – pointe
Article 5 – paragraph 2 – subparagraph 2 – pointe
(e) draft, harmonise and rationalise the operating methodologies;
Amendment 297 #
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 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, while respecting the precautionary principle, including through the identification of specifications for harmonised data collection from member states;
Amendment 305 #
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 national health systems’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety;
Amendment 306 #
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 e
Article 5 – paragraph 4 – point e
(e) identify population groups at risk and in need of targeted prevention and response measures, and ensure thatstablish whether those measures are accessible for persons with disabilities;
Amendment 314 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
(h) identify risk factors for disease transmission, including zoonotic transmission, groups most at risk, including the correlation of disease incidence and severity with societal and environmental factors, and research priorities and needs.
Amendment 319 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 5 – subparagraph 2
Article 5 – paragraph 5 – subparagraph 2
The national focal points shall form networks that cooperate strategically advisewith the Centre.
Amendment 345 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 2
Article 5a – paragraph 2
2. The Centre shall develop a framework for the prevention of communicable diseases and special issues, including vaccine preventthe determination of the causes and factors of the transmission of communicable diseases, antimicrobial resistance, health education, health literacy and behaviour change.
Amendment 350 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 3
Article 5a – paragraph 3
3. The Centre shall evaluate and monitor communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve these programmes at the national and Union level, and where appropriate at international levels.
Amendment 372 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
(i) assess national health systems’ capacity to detect, prevent, respond to and recover from outbreaks of communicable diseases, identify gaps and provide recommendations for the strengthening of national health systems, to be implemented with Union support as appropriate;
Amendment 393 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
(c) at the request of the Commission; andor
Amendment 397 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
3. The Centre shall issue scientific opinions within a mutually agreed time frameissued on request in a time frame agreed with the requester.
Amendment 398 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Where different requests are made on the same issue or where the request does not comply with paragraph 2, the Centre may decline to issue a scientific opinion or propose amendments to that request in consultation with the institution or Member State that made the requester. In case the request is declined, a justification shall be given to the institution or Member States that made the requester.
Amendment 399 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Where the Centre has already delivered a scientific opinion on the specific issue covered by a request and it concludes that no scientific elements justify the re-examination of the issue, information supporting that conclusion shall be given to the institution or Member State that made the requester.
Amendment 438 #
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 e
Article 11 – paragraph 1a – point e
(e) national health systems data required for managing cross-border health threats.;
Amendment 466 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point a
Article 1 – paragraph 1 – point 15 – point a
Regulation (EC) No 851/2004
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
The Centre shall communicate information about health threats on its own initiative in the fields within its mission, after having given prior information to the Member States and to the Commission.
Amendment 471 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point b
Article 1 – paragraph 1 – point 15 – point b
Regulation (EC) No 851/2004
Article 12 – paragraph 2
Article 12 – paragraph 2
(b) pParagraph 2 is deleted;replaced by the following: ‘2. When communicating information about health threats, the Centre shall make efforts to closely collaborate with the Commission and the Member States to promote the necessary coherent education of the public.’