38 Amendments of Antoni COMÍN I OLIVERES related to 2020/0320(COD)
Amendment 67 #
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 in the Union’s framework for health crisis preparedness and response should be strengthened and improved taking into account the lessons learned during the pandemic in order to better use the Centre’s potential to face future outbreaks.
Amendment 81 #
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. Its actions should be consistent with a One- Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies. In this sense, the Centre should also take into account the complex links between biodiversity loss and zoonotic disease risk. 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. 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, 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, both globally and internally, with the aim to communicate smoothly with specialists at Union, Member States and regional level. Finally, the Centre should keep a network with its peers in third countries, and share best practices achieved both in the Union and elsewhere.
Amendment 89 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Ensuring supply chain resilience across the Union is not a primordial mission of the Centre, yet the Centre should provide data, knowledge, and skills, to the Commission and the European Medicines Agency in order to ensure supply chain resilience in the Union. Supply chain resilience is part of the four working groups of the COVID– 19 taskforce of the European Medicines Agency, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 97 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) The Centre should keep a thorough vigilance on modern epidemics such as mental health consequences deriving from communicable diseases, or mental health pathologies such as depression, anxiety, or sleep deprivation. In this regard, the Centre should follow up and share information with the Member States and the regions on how to improve the situation.
Amendment 110 #
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 digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence distributed ledger technology (DLT), in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance and follow- up 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 113 #
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, identify possible zoonotic spillovers, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities, also in the field of anticipatory research for health, knowing that this type of research puts its focus more on anticipating and preventing future health risks, complementing that research that seeks to solve current health challenges. The Centre should work with nominated national and, where appropriate, regional 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 121 #
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 for the promotion of good practice and alignment on diagnostics, testing methods, training in current and innovative procedures 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 127 #
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 and urgent 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 133 #
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 addressetaking into account the close relationship between nature deterioration and increasing emergence of zoonotic diseases. This framework should address such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy, mental health, interlinkages between health and nature and behaviour change.
Amendment 141 #
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at regional, 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, regional centres where appropriate, 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. 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, zoonotic disruptions and spillovers, 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 both in the Union and abroad.
Amendment 153 #
Proposal for a regulation
Recital 15
Recital 15
(15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence technologies and interoperable and privacy-preserving digital tools, such as distributed ledger technology, or mobile applications, with tracing functionalities identifying at- risk individuals.
Amendment 155 #
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. 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 recommendations should be highly regarded in all Member States in case an outbreak is considered by the Centre to be a high threat. 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 167 #
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should not confer any regulatory powers on the Centre. For this purpose, the Centre should take all technological means necessary to strengthen its cybersecurity processes and hardware.
Amendment 181 #
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 6 a (new)
Article 2 – paragraph 1 – point 6 a (new)
(6a) ‘Health in All Policies’ means Health in All Policies as defined in point (10) of Article 2 of Regulation (EU)2021/522 of the European Parliament and of the Council (‘EU4Health Programme’); __________________ 1a Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).
Amendment 182 #
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 6 b (new)
Article 2 – paragraph 1 – point 6 b (new)
(6b) ‘One Health approach’ means a One Health approach as defined in point (5) of Article 2 of Regulation (EU) 2021/522;
Amendment 183 #
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 6 c ( new )
Article 2 – paragraph 1 – point 6 c ( new )
(6c) ‘zoonosis’ means an infectious disease that has jumped from a non- human animal to humans through zoonotic spillover;
Amendment 184 #
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 6 d ( new )
Article 2 – paragraph 1 – point 6 d ( new )
(6d) ‘zoonotic spillover’ means the spread of a non-human disease to humans resulting in zoonosis;
Amendment 194 #
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, such as zoonotic spillovers, 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 body upon request from that body.
Amendment 198 #
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 comprehensiveness, coherence and complementarity of action. Special cooperation shall be foreseen with the European Medicines Agency, the European Environmental Agency and the Commission.
Amendment 211 #
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 b a (new)
Article 3 – paragraph 2 – point b a (new)
(ba) identify possible zoonotic spillovers;
Amendment 215 #
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 health systems’ capacity and support health administrations in their assessment of the capacity of their health systems relevant to the management of communicable disease threats and other special health issues;
Amendment 233 #
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
Article 3 – paragraph 2 – point j
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’), easily accessible and evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
Amendment 234 #
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) ensure vigilance on modern epidemics such as mental health consequences deriving from communicable diseases, or mental health pathologies such as depression, anxiety, or sleep deprivation.
Amendment 237 #
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) cooperate with relevant Union bodies and agencies to help ensure supply chain resilience across the Union;
Amendment 238 #
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 c (new)
Article 3 – paragraph 2 – point j c (new)
(jc) provide recommendations to relevant Union bodies and agencies on how to improve policies under the Health in All Policies principle; those recommendations shall be established done together with the European Environmental Agency;
Amendment 252 #
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
Article 4 – paragraph 1 – point c
(c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States regions and, where necessary, third countries, in order to provide expert advice and field investigations in the event of disease clusters or outbreaks.;
Amendment 270 #
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, including the platform for surveillance established under Article 14 of Regulation (EU) .../... [the SCBTH Regulation], supporting Member States and, where applicable, regions and local entities, with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services;
Amendment 302 #
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 provide support to relevant Union bodies and agencies, Member States, and regions and local entities, where appropriate;
Amendment 320 #
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 3
Article 5 – paragraph 5 – subparagraph 3
National focal points and operational contact points nominated for disease- specific interactions with the Centre shall form disease-specific or disease-group- specific networks whose tasks shall include the transmission of national surveillance data as well as mandatory guidelines for the prevention and control of communicable diseases, such as those of zoonotic spillover, to the Centre.
Amendment 326 #
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 of the network of Member State services supporting transfusion, transplantation, plasma-derived medicines, 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. Participation in that network by Member States shall be compulsory.
Amendment 337 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 1
Article 5a – paragraph 1
1. The Centre shall support Member States, and regions where appropriate, to strengthen their communicable disease prevention and control systems.
Amendment 342 #
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 zoonotic spillover, vaccine preventable diseases, antimicrobial resistance, health education, health literacy, mental health and behaviour change.
Amendment 346 #
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 a (new)
Article 5a – paragraph 2 a (new)
2a. The Centre shall provide recommendations to the relevant Union bodies and agencies on how to improve policies under the ‘Health in All Policies’ principle. Those recommendations shall be established together with the European Environment Agency.
Amendment 436 #
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 c
Article 11 – paragraph 1a – point c
(c) unusual epidemic phenomena or new communicable diseases of unknown origin, including thosezoonotic spillovers, happening both in the Union and in third countries;
Amendment 442 #
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 c
Article 11 – paragraph 2 – point c
(c) work in close cooperation with the competent bodies of the organisations operating in the field of data collection from the Union, third countries, the WHO, and other international organisations, ensuring robust safeguards concerning transparency and accountability; and
Amendment 448 #
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 4
Article 11 – paragraph 4
4. In the situations of urgency related to severity or novelty of a serious cross- border threat to health or to the rapidity of its spread among the Member States, the Centre shall make available epidemiological forecasts as referred to in point (g) of Article 5(4), upon request of the Commission, the European Medicines Agency, or a Member State, in an objective, reliable, transparent and easily accessible way and on the basis of the best available information.
Amendment 477 #
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 and in all languages of the Union.
Amendment 488 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6a. For the purpose of confidentiality, the Centre shall provide itself with high- quality cybersecurity technology.