22 Amendments of Frédérique RIES related to 2020/0320(COD)
Amendment 63 #
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,prevention, preparedness, monitoring, assessing, communicating early warnings of and combating serious cross-border threats to health.
Amendment 70 #
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’s role mandate and capacities within the Union’s framework for health crisis preparedness and response should be strengthened and extended.
Amendment 99 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) The Centre should provide guidelines to Member States on standardising collection and communication of relevant data.
Amendment 105 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) One of the lessons of the COVID- 19 pandemic was that the Centre needs to be strengthened and that there is a need for more Union coordination of disease prevention and control mechanisms. Good coordination at Union level of the prevention and control of diseases that are cross-border health threats is essential. To this end, the Centre should have the ability to inspect at source how national coordinating bodies apply this Regulation.
Amendment 115 #
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 identify emerging health threats, 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, inspect and assess the capacity of national health systems for diagnosis, prevention and treatment, treatment and containment of the spread 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 advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
Amendment 135 #
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 preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change. The Centre should provide guidelines and monitor the implementation of the framework by Member States.
Amendment 176 #
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 a ( new )
Article 2 – paragraph 1 – point 1 a ( new )
(1a) ‘prevention and control of human disease’ means the range of recommendations issued and measures taken by the competent public health authorities in the Member States and the Union, such as the Centre, to prevent, contain and mitigate the spread of disease;
Amendment 186 #
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 in collaboration with competent bodies of the Member States or on its own initiative through the dedicated networks and field missions, provide recommendations and provide support in coordinating the response at Union and national levels, as well as at regional and local level, if necessary.
Amendment 195 #
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 2
Article 3 – paragraph 1 – subparagraph 2
In the case of other outbreaks of illnesses of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not caused by a communicable disease, the Centre shall act only in cooperation with the competent bodyies upon their request from that bodyand provide a risk assessment.
Amendment 218 #
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 and inspect health systems’ capacity relevant to the management of communicable disease threats and other special health issues;
Amendment 222 #
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, Member States or the Health Security Committee (‘HSC’), or its own initiative, guidelines for treatment protocols and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societies, and continually review and update guidelines as new scientific data becomes available;
Amendment 241 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 3 – subparagraph 1 a (new)
Article 3 – paragraph 3 – subparagraph 1 a (new)
The inspections at source shall be organised in each Member State, by an inspector from the body of inspectors appointed by the Centre for a period of four years. Each Member State shall have at least one inspection within the four- year period, but more inspections may be mandated on a case-by-case basis to offer additional support and monitor progress. The results of the inspection in a Member State shall be submitted in a report to the Commission, the European Parliament, the Council and relevant Union agencies. The report shall assess Member State's compliance with the obligations imposed by this Regulation and recommendations from the inspectors in order to improve the situation.
Amendment 285 #
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 d
Article 5 – paragraph 2 – subparagraph 2 – point d
(d) communicate the results of the analysis of data to the Commission and Member States and propose communications to inform the public;
Amendment 303 #
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’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety; and the resilience of the national health systems in case of major health threats outbreaks ;
Amendment 310 #
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 f
Article 5 – paragraph 4 – point f
(f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disa, disability and patients’ comorbildityies;
Amendment 323 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 6
Article 5 – paragraph 6
6. The Centre shall ensure and coordinate the operation of the network of EU reference laboratories referred to in Article 15 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], for the diagnosis, detection, identification, genetic sequencing and characterisation of infectious agents that may present a threat to public health.
Amendment 363 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 2 – point c
Article 5b – paragraph 1 – subparagraph 2 – point c
(c) assess and inspect Member States’ preparedness and response planning as well as facilitate self-assessments and external evaluation of Member States’ preparedness and response planning, and contribute to reporting and auditing on preparedness and response planning under Articles 7 and 8 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];
Amendment 375 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 2 – point i
Article 5b – paragraph 1 – subparagraph 2 – point i
(i) assess and inspect 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 health systems, to be implemented with Union support as appropriate;
Amendment 381 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point a
Article 1 – paragraph 1 – point 7 – point a
Regulation (EC) No 851/2004
Article 6 – paragraph 1a
Article 6 – paragraph 1a
1a. The Centre shall provide concrete analyses and recommendations for actions to prevent and control communicable diseases or any cross-border health threats upon request of the Commission.;
Amendment 390 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EC) No 851/2004
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. The Centre shall use its own resources, and make use of reference laboratories in order to perform field research and data gathering and data analysis if there is no reliable data available and no research is conducted by other relevant national or Union bodies or agencies.
Amendment 456 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
1a. The Centre shall develop capacities to conduct field research and gather relevant data, such as genetic variation of communicable diseases, using the dedicated reference laboratory network or its own resources.
Amendment 464 #
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 on its own initiative within the scope of its mission, after having given prior information to the Member States and to the Commission. The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to the results of its work, shall share verified information and shall fight against disinformation. The Centre shall make available information for the general public, including through a dedicated online communication portal. It shall also publish its opinions produced in accordance with Article 6.’