Explanatory Memorandum to COM(2020)726 - Amendment of Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2020)726 - Amendment of Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control. |
|---|---|
| source | COM(2020)726  |
| date | 11-11-2020 |
1. CONTEXTOFTHE PROPOSAL
• Reasons for and objectives of the proposal
As a building block of the European Health Union, this proposal reinforces the mandate of the European Centre for Disease Prevention and Control (‘the Centre’) addressing surveillance, preparedness, early warning and response under a strengthened EU health security framework. The COVID-19 pandemic has revealed shortcomings in Union mechanisms for managing health threats, which call for a more structured Union-level approach, which is also built on the European value of solidarity, to future health crises. This should include a reinforced role for the Centre. It should also take a One-Health approach, together with other relevant EU Agencies, to the issue, considering the interactions between humans, animals and the environment.
The Centre’s mandate, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council1, was adopted before the mechanisms and structures under the current EU health security framework under Decision 1082/2013/EU on serious cross-border threats to health2.
Given the review of this framework, the Centre’s founding regulation needs to be
for an amending Regulation on serious cross-border threats to health. The review will
also ensure that the Centre fully complies with the ‘common approach’ for
decentralised agencies, as laid down in the ‘Joint Statement of the European
Parliament, the Council of the EU and the European Commission on decentralized agencies’3.
• Consistency with existing Union measures in this field
The proposal is part of a package of closely associated measures, and forms part of the Union’s overall health response to COVID-19 as well as an improved crisis management framework.
The amendments proposed will therefore be in compliance with the ‘common approach’ for decentralised agencies, from 2012.
• Consistency with other Union policies
This proposal is in line with the Union’s overarching objectives, including a stronger health Union, a smooth functioning of the single market, complementarity with the Union Civil Protection Mechanism, sustainable and resilient health systems, and an ambitious research and innovation agenda. In addition, it will provide useful input to and synergies with the EU Digital Single Market agenda and the future European Health Data Space, encouraging innovation and research, facilitating information sharing (including of real-time data), and supporting the development of EU-level IT infrastructure for epidemiological surveillance and monitoring.
https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_statement_and_co mmon_approach_2012_en.pdf
2
3
2. LEGALBASIS, SUBSIDIARITYAND PROPORTIONALITY
• Legal basis
The proposed Regulation is based on Article 168(5) of the Treaty on the Functioning of the European Union (TFEU). This approach is based on the specific objectives of the proposal, namely to adopt measures to protect and improve human health and in particular combating major cross-border health threats, especially through monitoring and early warning.
• Subsidiarity (for non-exclusive competence)
Although the Member States are responsible for managing public health crises at national level, no country can tackle a cross-border public health crisis alone. Under Article 2(5) TFEU, the Union has competence to carry out measures to support, coordinate or supplement actions by Member States, without thereby superseding their competence in this area.
Serious cross-border threats to health have, by their nature, transnational implications. In a globalised society, people and goods are moving across borders in high numbers, facilitating illnesses and contaminated products to circulate rapidly across the globe. Public health measures at national level therefore need to be consistent with each other and be coordinated to contain any further spread and minimise the consequences of these threats.
Public health emergencies of the magnitude of COVID-19 have an impact on all Member States. The proposal builds on lessons learnt during the COVID-19 crisis, and proposes to strengthen the existing Union level structures and mechanisms for improved levels of protection, prevention, preparedness and response, against all health hazards across the EU.
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States alone due to the cross-border dimension of the threats described and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5(3) of the Treaty on European Union (TEU).
• Proportionality
The proposal constitutes a proportionate and necessary response to the problems described in section 1. In accordance with the principle of proportionality, as set out in Article 5 i TEU, this Regulation does not go beyond what is necessary to achieve those objectives.
• Choice of the instrument
The proposal takes the form of an amendment of the existing Regulation. This type of instrument is considered most suitable, considering that a key element of the proposal is to establish well-aligned procedures and structures for joint work at Union level, focussing on giving additional tasks to the Centre. The measures do not require the implementation of national measures and can be directly applicable.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
Contents
- CONSULTATIONS
- amended, to ensure consistency with other Union instruments and with the proposal
- OJ L 142, 30.4.2004, p. 1 OJ L 293, 5.11.2013, p. 1
- reinforcing surveillance
- monitoring and assessing health systems capacity and identifying population groups at risk and in need of targeted prevention and response measures
- This
- regarding structure and
- Joint Statement
ANDIMPACTASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
As part of a package of urgent measures based on lessons learnt so far from COVID-19, the initiative is supported by the findings of the recent evaluation of the functioning of the Centre4, by an assessment of data collected and by exchanges held with public and private stakeholders on issues encountered during the COVID-19 pandemic and possible means to address them. Due consideration is given also to the findings of the Court of Auditors’ Report on the EU health security framework5. This information is summarised in the Commission Communication accompanying the whole package. Considering that the initiative proposes to enlarge the scope of existing legislation, it will not be based on an ex-post evaluation, as the needs identified where not addressed by the existing framework.
It is proposed that the Commission will report, by 2023, on the Centre’s activities, including an analysis of how the amended mandate has been implemented, the interaction and consistency of the Centre’s activities with the proposed Regulation on serious cross-border threats to health, and, by 2028, possible amendments to the mandate of the Centre. This will also include an analysis of the Centre’s relevance in relation to international, Union and national health priorities, as well as the relationship between the Centre’s outputs and Member States’ capacities. This report will be accompanied by a study, commissioned by the Commission. Moreover, every five years the Commission will evaluate the Centre's performance in relation to its objectives, mandate, tasks, procedure and location, in accordance with Commission Better Regulation guidelines.
Stakeholder
consultations
At the informal Health Council meeting on 16 July 2020, Germany’s Presidency of the Council of the EU chaired a discussion about strengthening the Centre. Member States showed support for an initiative directed at doing so as part of the overall EU health crisis preparedness and response mechanism. This implies an amendment of the Centre’s founding Regulation. The informal Health Council Working Party on Public Health on 29 October 2020 further discussed draft Council conclusions on COVID-19 lessons learnt in health. Bilateral meetings at political and technical levels were further held, and a public webinar was organized on 29 October to discuss the package.
Impact assessment
Due to its urgent nature, this proposal is not accompanied by a formal impact assessment. Instead, the changes are mainly based on an assessment of the data collected during the first months of the pandemic and exchanges with public and private stakeholders on COVID-19 issues and possible means to address them and are based on the findings of a recent evaluation. This information has been summarised in a Commission Communication that accompanies the overall package of proposals providing or referring to all available evidence, given that a public consultation and an impact assessment could not be delivered in the timeframe available prior to the adoption of this proposal.
www.ecdc.europa.eu/en/publications-data">https://www.ecdc.europa.eu/en/publications-data www.eca.europa.eu/en/Pages/DocItem.aspx?did=40126">https://www.eca.europa.eu/en/Pages/DocItem.aspx?did=40126
• Fundamental rights
The proposal contributes to achieving a high level of human, gender-sensitive, health protection, as well as to upholding the highest standards in the protection of human rights and civil liberties, as enshrined in the Charter of Fundamental Rights and in the European Pillar of Social Rights, during health crisis. Where personal data is processed under this Regulation as proposed, it will be done in accordance with the relevant Union legislation on personal data protection, in particular Regulation (EU) 2018/1725 and Regulation (EU) 2016/679.
4. BUDGETARYIMPLICATIONS
The implementation of this proposal has no impact on the current Multiannual Financial Framework 2014-2020.
The financial impact of this proposal on the Union budget will be part of the next Multiannual Financial Framework 2021-2027.
The budgetary implications are mainly related to the following objectives:
• setting-up a new vaccine monitoring platform hosted jointly by the European Medicines Agency and the Centre;
• preparedness and response planning activities including modelling, anticipation, monitoring and assessment;
• new networks on Union reference laboratories and on transfusion, transplantation and medically assisted reproduction;
• •
systems and the Early Warning and Response System;
monitoring and assessing health systems capacity and identifying population groups at risk and in need of targeted prevention and response measures
creating a ‘EU Health Task Force’ to support countries with preparedness strengthening and quickly intervene in a health crisis;
improving international collaboration and gathering of regional/national intelligence.
5. OTHERELEMENTS
• Detailed explanation of the specific provisions of the proposal
The proposal aims to provide reinforced capacities of the Centre, to support preparedness, surveillance, risk assessment, and early warning and response to face future cross-border health threats.
Key areas of the proposal:
• situational awareness: rapid digitalisation of integrated surveillance systems;
• better preparedness in Member States: develop prevention and response plans against future epidemics and stronger capacities for integrated rapid epidemic and outbreak response;
• reinforced measures to control epidemics and outbreaks: provision of non-binding recommendations for risk management;
• expanded capacity to mobilise and deploy the EU Health Task Force to assist the response in Member States;
• reinforced capacity and building key competences to monitor and assess health systems capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patient safety;
• reinforced capacity and to identify population groups at risk and in need of targeted prevention and response measures;
• linking research and preparedness and response: liaise between public health and research communities, contribute to defining research priorities related to preparedness and response, ensure integration of research findings in policy recommendations;
• building up the key competences for health protection in Member States: the Centre will be tasked with coordinating a new network of Union reference laboratories for public health and a new network of national services supporting transfusion, transplantation and medically assisted reproduction;
• expanding work on the prevention of communicable diseases and specific health issues, e.g., antimicrobial resistance, vaccination and biosecurity;
• reinforcing the contribution to the EU’s international cooperation and development and EU commitment to global health security preparedness.
The proposal will also seek to ensure smooth cooperation during such emergencies between the Centre and the EU’s other decentralised agencies, most notably with the
European Medicines Agency.
proposal is aligned with the
Common Approach6
governance, its operations, programming and accountability.
Common Approach (Parliament, Council & Commission), 2012;
https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_statement_and_co mmon_approach_2012_en.pdf
6
and