85 Amendments of Nicolae ŞTEFĂNUȚĂ related to 2020/0320(COD)
Amendment 13 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8 a) One of the lessons of the COVID- 19 pandemic was that the Center needs to be strengthened and that there is a need for more European coordination of disease prevention and control mechanisms. Good coordination at European level of the prevention and control of diseases that are cross-border health threats is essential. To this end, the Center should have the ability to inspect at source how national coordinating bodies apply this Regulation.
Amendment 15 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8 b) The fulfilment of the Centre's tasks and missions depends on an adequate budget and good cooperation and compliance by the Member States. In order to keep track of Member States' progress in implementing the obligations contained in the Regulation, the Centre may carry out source inspections.
Amendment 28 #
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 – introductory part
Article 3 – paragraph 2 – introductory part
2. The Centre shall, within its financial capacity and mandate, perform the following tasks:
Amendment 29 #
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 30 #
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 j a (new)
Article 3 – paragraph 2 – point j a (new)
(j a) provide timely information to the Commission, the Member States, Community agencies and international organisations active within the field of public health;
Amendment 31 #
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 j b (new)
Article 3 – paragraph 2 – point j b (new)
Amendment 32 #
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
Article 3 – paragraph 3
3. The Centre, the Commission, and the relevant Union bodies or EU agencies and the Member States shall cooperate to promote effective coherence between their respective activities.;
Amendment 33 #
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 a (new)
Article 3 – paragraph 3 a (new)
3 a. The Member States shall ensure without delay the coordination and collaboration with the Centre in all the missions and tasks mentioned in article 3.
Amendment 34 #
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 c a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) ensure the financial means and digital infrastructure for the coordinating competent body and facilitate the mission of the Centre by providing timely the information requested
Amendment 36 #
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 a (new)
Article 5 – paragraph 6 a (new)
6 a. The Centre shall provide technical assistance to European laboratories to develop their detection and sequencing capacities especially in Member States that do not have the necessary capacity.
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 86 #
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, establishing applicable risk indicators and providing relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between human and animal health and the environment. It should monitor and inspect periodically 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 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, personnel training 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 93 #
Proposal for a regulation
Recital 7
Recital 7
(7) To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States shouldhave to be tasked to communicate, in a timely manner, to the Centre data on the surveillance of communicable diseases and other special health issues such as antimicrobial resistance and healthcare- associated infections related to communicable diseases and their impact on non- communicable diseases including mental health, available scientific and technical data and information relevant to the Centre’s mission, to notify the Centre of any serious cross-border threats to health, information on preparedness and response planning and health system capacity, and provide relevant information that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats. Member States should be encouraged to develop the capacities to collect the data in the standard and time required by the Centre.
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 103 #
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 and strengthened 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 the Union's newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,
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 106 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) The fulfilment of the Centre's tasks and missions depends on an adequate budget and good cooperation and compliance by Member States. In order to keep track of Member States' progress in implementing the obligations contained in this Regulation, the Centre should be able to carry out source inspections.
Amendment 111 #
Proposal for a regulation
Recital 9
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of secure and interoperable digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.
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 122 #
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 thein an integrated manner of a dedicated network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible for the promotion of good practice and alignment on diagnostics, testing methods, and use of tests, in order to ensure uniform surveillance, notification and standardised reporting of diseases, as well as strengthened quality of testing and surveillance.
Amendment 125 #
Proposal for a regulation
Recital 12
Recital 12
(12) Where in case of cross-border health threats posed by communicable diseases, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services are dependent on rapid, comprehensive and accurate risk assessments by the Centre to safeguard patients in need of a therapy from a substance of human origin from the transmission of such a communicable disease. Such risk assessments serve as the basis for appropriate adaptation of measures setting standards for quality and safety of the substances of human origin. The Centre should therefore establish and operate a network of national blood and transplant services and their authorities to serve this purpose.
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 143 #
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 to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems, including by providing training and sharing of best practices. 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 secure 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 158 #
Proposal for a regulation
Recital 16
Recital 16
(16) The Centre should establish appropriate capacities to support international and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases and collect field data. The Centre should therefore ensure capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof.
Amendment 160 #
Proposal for a regulation
Recital 17
Recital 17
(17) To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a framework for the mobilisation the EU Health Task Force in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council11 and facilitate the participation of Union field response experts in international response teams in support of the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council12 , to effectively participate in field missions and crisis management. Therefore, the Centre should develop a framework of recognisable expertise levels. __________________ 11Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). 12Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44).
Amendment 165 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for a regularn annual Commission evaluation of the performance of the Centre.
Amendment 171 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Where it is necessary for the purposes of this Regulation to process personal data, this should be done in accordance with the Union law on the protection of personal data. Any processing of personal data based on this Regulation should take place in accordance with Regulations (EU) 2016/6791a and (EU) 2018/17251b and with Directive 2002/58/EC1c. __________________ 1aRegulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 1bRegulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 1cDirective 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
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 177 #
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 3
Article 2 – paragraph 1 – point 3
(3) ‘dedicated network’ means any specific network on diseases, special health issues or public health functions, set up, coordinated or supported by the Centre to ensure collaboration between the coordinating competent bodies of the Member States;
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 199 #
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 3
Article 3 – paragraph 1 – subparagraph 3
In pursuing its mission, the Centre shall take full account of the responsibilities of the Member States, the Commission and other Union bodies or agencies, and of the responsibilities of international organisations active within the field of public health, in order to ensure coordination, comprehensiveness, coherence, consistency and complementarity of action.
Amendment 201 #
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 – introductory part
Article 3 – paragraph 2 – introductory part
The Centre shall, within its financial capacity and mandate, perform the following tasks:
Amendment 205 #
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 a a (new)
Article 3 – paragraph 2 – point a a (new)
(aa) develop specific indicators for risk assessment and standardised data collection procedures;
Amendment 210 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
(ba) assess and monitor the impact of communicable diseases on non- communicable diseases, including mental health diseases;
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 231 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’) and in a timely manner, evidence-based communication messages, easily accessible to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
Amendment 235 #
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 j a (new)
Article 3 – paragraph 2 – point j a (new)
(ja) provide timely information to the Commission, the Member States, the Union agencies and international organisations active within the field of public health;
Amendment 236 #
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 j b (new)
Article 3 – paragraph 2 – point j b (new)
(jb) establish and continually update a database with recognised national competent bodies and public health experts that act within the scope of the mission of the Centre, with relevant data provided by Member States;
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 243 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
3a. The Centre shall put in place procedures and data protection safeguards designed to guarantee that its processing operations fully respect the data protection principles of lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity, confidentiality, and data protection by design and by default.
Amendment 244 #
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 a (new)
Article 3 – paragraph 3 a (new)
3a. Member States shall ensure without delay the coordination and collaboration with the Centre in relation to all the missions and tasks set out in Article 3.
Amendment 256 #
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 c a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) ensure the financial means and digital infrastructure for the coordinating competent body and facilitate the mission of the Centre by providing timely the information requested in a standardised format as needed;
Amendment 263 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Centre shall support and further develop the networking activities of the competent bodies recognised by the Member States through the provision of coordination and technical and scientific expertise to the Commission and Member States and through the operation of the dedicated networks, making use of the latest digital technologies.
Amendment 269 #
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 a
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the further development of the digital platforms and applications supporting epidemiological surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services and proven necessary and proportionate following a data protection impact assessment (DPIA), in line with European Data Protection Board guidelines, benefiting from existing EU space infrastructures and services; the digital platforms and applications shall be implemented with privacy-enhancing technologies taking into account the state of the art;
Amendment 275 #
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 a
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the further development of the digital platforms and applications supporting epidemiological surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU digital space infrastructures and services;
Amendment 278 #
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 surveillance activities (including setting surveillance standards and monitoring data completeness and assessment indicators) of the dedicated surveillance networks to ensure optimal operation;
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 290 #
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 g
Article 5 – paragraph 2 – subparagraph 2 – point g
(g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes after having conducted a data protection impact assessment and having mitigated any risks to the rights and freedoms of the data subjects, and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, and make use of other relevant data, for example environmental factors.
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 325 #
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 a (new)
Article 5 – paragraph 6 a (new)
6a. The Centre shall provide technical and scientific assistance to Member States to develop their detection and sequencing capacities, especially assisting those Member States that do not have sufficient capacities.
Amendment 329 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 8 – subparagraph 1
Article 5 – paragraph 8 – subparagraph 1
The Centre shall ensure the operation and coordination of the network of Member State services supporting transfusion, transplantation and medically assisted reproduction to allow for continuous and rapid access to sero- epidemiological data via sero- epidemiological surveys within the population, including assessment of donor population exposure and immunity. Member States shall ensure the means and digital infrastructure in order to be able to provide the required data in a timely matter.
Amendment 332 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 9
Article 5 – paragraph 9
9. The Centre shall cooperate with the competent bodies recognised by the Member States, particularly on preparatory work for scientific opinions, scientific and technical assistance, the collection of comparable data based on agreed common formats that allows for ease of aggregation, and the identification of emerging health threats.
Amendment 343 #
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 preventable diseases, antimicrobial resistance, health education, health promotion, health literacy and behaviour change.
Amendment 348 #
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 may, upon request, provide guidelines for creating communicable disease prevention and control programmes, and 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 the international levels.
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 368 #
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 h
Article 5b – paragraph 1 – subparagraph 2 – point h
(h) develop targeted activities addressing at-risk groups and community- based preparedness models;
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 385 #
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 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules, allowing for the health data to be solely used for healthcare, health research, and policy making and regulatory purposes in the domain of health. For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors, after it has proven the necessity and proportionality of using these data.;
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 395 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Requests for a scientific opinion referred to in paragraph 1 shall clearly explain the scientific issue to be addressed and the Union interest or necessity and be accompanied by sufficient background information regarding that issue.
Amendment 402 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Centre shall support and assist the Commission by operating the EWRS and by ensuring with the Member States the capacity to respond in a coordinated and timely manner.
Amendment 403 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
(b) provide information, expertise, advice, training and risk assessment to Member States and the Commission; and
Amendment 406 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. The Centre shall work with the Commission, the HSC and Member States to improve the reporting of relevant data through the EWRS, aiming to automate the process and integrate it into national surveillance systems.
Amendment 408 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
3. The Centre shall work with the Commission and the HSC on the EWRS updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence models, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States which shall be used for the sole purpose of fighting the pandemic and when proven to be adequate, necessary and proportionate, and in full compliance with Regulation (EU) 2016/679 and Directive 2002/58/EC, and on defining the functional requirements of the EWRS.
Amendment 428 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Regulation (EC) No 851/2004
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Centre may be requested by the Commission, the Member States, third countries, in particular EU partner countries, and international organisations (in particular the WHO) to provide scientific or technical assistance in any field within the scope of its mission. The assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance, mobilising and coordinating investigation teams and assessing the efficiency of response measures. The Centre shall provide scientific and technical expertise and assistance within its financial capacity and mandate, and in accordance with the appropriate working arrangements established with the Commission.
Amendment 431 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Regulation (EC) No 851/2004
Article 9 – paragraph 6
Article 9 – paragraph 6
6. The Centre shall, as appropriate, support and coordinate training programmes, in particular in epidemiological surveillance, field investigations, preparedness and prevention, and public health research.; and community-based health response
Amendment 432 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point a
Article 1 – paragraph 1 – point 13 – point a
1. The Centre shall coordinate data, standardisation, collection, validation, analysis and dissemination of data at Union level.;
Amendment 440 #
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 a (new)
Article 11 – paragraph 1a – point e a (new)
(ea) treatment procedures and protocol, as well as case management.
Amendment 447 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point c
Article 1 – paragraph 1 – point 13 – point c
Regulation (EC) No 851/2004
Article 11 – paragraph 2 – point d
Article 11 – paragraph 2 – point d
(d) develop solutions to access relevant health data made available or exchanged through digital infrastructures, in accordance with data protection rules, allowing for the health data to be solely used for healthcare, health research, and policy making and regulatory purposes in the domain of health; and provide and facilitate controlled access to health data to support public health research.;
Amendment 450 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point d
Article 1 – paragraph 1 – point 13 – point d
Regulation (EC) No 851/2004
Article 11 – paragraph 5 a (new)
Article 11 – paragraph 5 a (new)
5a. The Commission shall adopt delegated acts in accordance with Article [x] to supplement this Regulation by setting out the categories of data subjects under the scope of the processing and the categories of the personal data processed, together with a description of the specific measures to safeguard the rights and freedoms of the data subjects involved in line with relevant data protection legislation, in particular with regard to concrete safeguards to prevent abuse or unlawful access or transfer, and the storage periods.
Amendment 452 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point d
Article 1 – paragraph 1 – point 13 – point d
Regulation (EC) No 851/2004
Article 11 – paragraph 5 b (new)
Article 11 – paragraph 5 b (new)
5b. The Centre shall only process personal data, in particular in the case of health data relating to identified or identifiable individuals, when it is proven to be necessary and proportionate to do so. Whenever possible, in line with the principle of data minimisation, the Centre shall make use of anonymised data, achieved through techniques used such as randomisation or generalisation.
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.’
Amendment 474 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point a
Article 1 – paragraph 1 – point 16 – point a
Regulation (EC) No 851/2004
Article 14 – paragraph 2 – subparagraph 3
Article 14 – paragraph 2 – subparagraph 3
Members’ term of office shall be three years and can be extended, if necessary.;
Amendment 476 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Regulation (EC) No 851/2004
Article 14 – paragraph 5 – point i – subparagraph 1
Article 14 – paragraph 5 – point i – subparagraph 1
determine the rules governing the languages of the Centre, including the possibility of a distinction between the internal workings of the Centre and the external communication, taking into account the need to ensure access to, and participation in, the work of the Centre by all interested parties in both cases. These may include the use of qualified interpreters (sign language, oral or tactile) if needed.
Amendment 482 #
Proposal for a regulation
Article 1 – paragraph 1 – point 20 a (new)
Article 1 – paragraph 1 – point 20 a (new)
Regulation (EC) No 851/2004
Article 20 – paragraph 4
Article 20 – paragraph 4
(20a) paragraph 4 of Article 20 is replaced by the following: “4. Personal data shall not be processed or communicated except in cases where this is strictly necessary for the fulfilment of the mission of the Centre. In such cases, Regulation (ECU) No 45/2001 of the European Parliament and of the Council of18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (8)2018/1725 shall apply.”;
Amendment 483 #
Proposal for a regulation
Article 1 – paragraph 1 – point 20 b (new)
Article 1 – paragraph 1 – point 20 b (new)
Regulation (EC) No 851/2004
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
(20b) in Article 20, the following paragraph is added: “4a. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) 2016/679 and Directive 2002/58/EC on privacy and electronic communications, or the obligations of the Centre and the Commission relating to their processing of personal data under Regulation (EU) 2018/1725, when fulfilling their responsibilities.”;
Amendment 484 #
Proposal for a regulation
Article 1 – paragraph 1 – point 20 c (new)
Article 1 – paragraph 1 – point 20 c (new)
Regulation (EC) No 851/2004
Article 20 – paragraph 4 b (new)
Article 20 – paragraph 4 b (new)
(20c) in Article 20, the following paragraph is added: “4b. The Centre shall adopt specific measures for minimising risks that may emerge from the transfer of inaccurate or incomplete data from Member States’ databases to the Centre, as well as the establishment of procedures for data quality review”;
Amendment 490 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)
Article 1 – paragraph 1 – point 21 a (new)
Regulation (EC) No 851/2004
Article 21 a (new)
Article 21 a (new)