Explanatory Memorandum to COM(2020)727 - Serious cross-border threats to health - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2020)727 - Serious cross-border threats to health. |
|---|---|
| source | COM(2020)727  |
| 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 provides for a stronger and more comprehensive legal framework within which the Union can react rapidly and trigger the implementation of preparedness and response measures to cross-border threats to health across the EU in the form of a Regulation. The COVID-19 pandemic has shown that the EU’s mechanisms for managing health threats suffer from general shortcomings that require a more structured Union-level approach if we are to deal better with future health crises. Since the start of the outbreak, multiple discussions have taken place with Member States including at health ministers’ level, have seen calls for a more consistent and coordinated approach to preparing for and managing health crises in the EU.
The current health security arrangements, as established by Decision No 1082/2013/EU on serious cross-border threats to health1, provide a limited legal framework for EU level coordination, based essentially on the Early Warning and Response System (EWRS) and the exchange of information and cooperation within the Health Security Committee. Early lessons learnt with COVID-19 have shown that the current system has not ensured an optimal response at EU level to the COVID-19 pandemic.
Structures and mechanisms under the Decision, while essential in facilitating the exchange of information on the evolution of the pandemic and supporting the adoption of national measures, could do little to trigger a timely common EU level response, co-ordinate the crucial aspects of risk communication, or ensure solidarity among Member States.
The revision of the health security framework proposes a stronger and more comprehensive legal framework within which the Union can prepare for and respond to health crises.
The proposal provides a strengthened framework for health crisis preparedness and response at EU level by addressing the weaknesses exposed by the COVID-19 pandemic. In particular, it will:
– set out a comprehensive legislative framework to govern action at Union level
– enhance the Union’s guidance in the adoption of common measures at EU level
to face a future cross-border health threat.
• Consistency with existing policy provisions in the policy area
As part of a package of closely associated measures, this proposal forms the backbone of the Union’s overall health response to the COVID-19 pandemic and provides for an enhanced crisis management framework. The measures put forward in this proposal go hand in hand with those put forward in the other parts of the
OJ L 293, 5.11.2013, p. 1.
package, to revise the mandates of the European Medicines Agency (EMA) and that of the European Centre for Disease Prevention and Control (ECDC).
The proposed measures would complement the following current Union provisions in the fields of crisis response and health:
– strategic stockpiling under the rescEU scheme (Article 12 of Decision
No 1313/2013/EU on a Union Civil Protection Mechanism2);
– the EU emergency support instrument (Council Regulation (EU) 2016/369 on
the provision of emergency support within the Union3);
– the upcoming pharmaceutical strategy;
– the Commission’s proposal for a Regulation of the European Parliament and
the Council on the establishment of a programme for the Union’s action in the field of health for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (‘EU4Health programme’)4; and
– other structures supporting biomedical research and development at EU level
for enhanced capacity and readiness to respond to cross-border threats and emergencies.
The proposed measures also complement other policies and actions under the European Green Deal in the field of climate and environment that will support enhanced environmental health, disease prevention and increased resilience.
The EU’s international cooperation priorities, while not a central part of this revised legal framework, are important as the EU will not only support Member States but also EEA countries, candidate countries and potential candidates, as well as
European Neighbourhood Policy countries and EU partner countries, not only to access vaccines early on, but also to authorise and deploy them effectively, supporting health systems strengthening including global health security, as well as providing for international and field emergency responses. The Commission, the European Parliament and the Council have recently strongly affirmed the EU’s commitment to scaling up global health emergency preparedness. In October the European Council committed to strengthening EU support to health systems and the reinforcement of partners’ preparedness and response capacity in Africa.
Consistency with other Union policies
This proposal is in line with the EU's overarching objectives, including a stronger health union, the smooth functioning of the internal market, sustainable health systems including the cohesion policy supporting regional authorities for investments in public health and supporting cross-border cooperation notably in neighbouring regions and global healthy security preparedness, 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, by encouraging innovation and research, facilitating the sharing of information (including of real world evidence), and supporting the development of a Union-level IT infrastructure for epidemiological surveillance.
OJ L 347, 20.12.2013, p. 924.
OJ L 70, 16.3.2016, p. 1.
COM (2020) 405 of 28. 5.2020.
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The proposal also strengthens the framework of preparedness and response to threats of biological, chemical, environmental(including due to climate), or unknown origin threats at Union level in a coordinated One Health approach.
2. LEGALBASIS, SUBSIDIARITYAND PROPORTIONALITY
• Legal basis
Given that the proposal aims to address serious cross-border threats to health and the consequences thereof thereby ensuring the protection of human health, it is based on Article 168(5) of the Treaty on the Functioning of the European Union (TFEU).
• Subsidiarity (for non-exclusive competence)
Public health emergencies of the magnitude of the COVID-19 pandemic have an impact on all Member States, which are unable to provide a sufficient response on their own.
Although the Member States are responsible for managing public health crises at national level, no country can tackle a cross-border public health crisis on its own.
Under Article 2(5) TFEU, the Union is to take action to support, coordinate or supplement that of the Member States, without thereby superseding their competence in these areas.
By their nature, serious cross-border threats to health have transnational implications. In a globalised society- people and goods move across borders and illnesses and contaminated products can circulate rapidly across the globe. Public health measures at national level therefore need to be consistent with each other and coordinated, in order to contain further spread and minimise the consequences of such threats.
The proposal builds on lessons learnt from the COVID-19 crisis, and proposes that existing structures and mechanisms be strengthened for better protection, prevention, preparedness and response against all health hazards.
In particular, it aims to provide EU added value through the development of an EU health crisis and pandemic preparedness plan, complemented by:
– national plans and transparent reporting of capacities;
– strengthened, integrated surveillance systems;
– enhanced risk assessment for health threats;
– increased power to enforce a coordinated response at EU level through the
– an improved mechanism for recognition of and response to public health
emergencies.
Special attention should be paid to maintaining the free movement of people and goods, in order to ensure the smooth functioning of the internal market, while safeguarding the health of citizens. In particular, this concerns a coordinated approach for the adoption of measures directed at avoiding or limiting disruptions of the movement of health care personnel and medical countermeasures, as well as measures including screening, quarantine and contact tracing.
• Proportionality
The proposal constitutes a proportionate response to addressing the problems described in point 1, in particular, by requiring a more structured and more robust EU-level health security framework and strengthening of the EU’s key public health EU agencies (the European Centre for Disease Prevention and Control, ‘ECDC’, and the European Medicines Agency, ‘EMA’).
Since the objectives of this Regulation cannot be achieved sufficiently by the Member States alone due to the cross-border dimension of those threats but can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as also set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
• Choice of the instrument
The proposal takes the form of a new Regulation. This is considered to be the most suitable instrument as a key element of the proposal is to establish procedures and structures for cooperation on joint, EU-level work focussing on preparedness for and response to serious cross-border threats to health. The measures do not require the implementation of national measures and can be directly applicable.
3. RESULTS OF EX POST EVALUATIONS, STAKEHOLDER
Contents
- CONSULTATIONS
- on preparedness, surveillance, risk assessment, and early warning and responses; and
- Health Security Committee; and
- of-coronavirus-crisis-2
- 7 8 9 10
- reference laboratories for public
- enhanced capacities for risk assessment by the relevant agencies and risk assessment coordination where more agencies are concerned in an all-hazards approach; and
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 pandemic, the initiative will be supported by an assessment of data collected and exchanges held with public and private stakeholders during the COVID-19 pandemic on issues encountered and possible means to address them. The initiative will broaden the scope of existing legislation and will not be based on an ex-post evaluation, as the needs identified were not addressed by the existing framework. However, Article 29 of the proposal includes provisions for future evaluations, assessing the performance of this Regulation. The main findings of the evaluation will be presented in a report to the European Parliament and the Council.
Stakeholder
consultations
The need to strengthen the EU’s health security response has been raised in a variety of fora, such as the Council5, Member States, non-governmental organisations and EU citizens.6 This has been largely in response to the COVID-19 pandemic, which has exposed the limitations of the existing framework on serious cross-border threats to health to correctly respond to the disease and that the EU agencies (ECDC and the EMA) need to be bolstered.
www.consilium.europa.eu/de/meetings/epsco/2020/02">https://www.consilium.europa.eu/de/meetings/epsco/2020/02
https://europarl.europa.eu/at-your-service/en/be-heard/eurobaro meter/public-opinion-in-the-eu-in-ti me-
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Impact
assessment
Due to the urgency of the matter, this proposal is not accompanied by a formal impact assessment. The initiative will broaden the scope of the existing legislation, mainly on the basis of an assessment of data collected in the first months of the COVID-19 pandemic and exchanges held with public and private stakeholders in the framework of the COVID-19 pandemic on issues encountered and possible ways of addressing them. The findings have been summarised in a Commission Communication that accompanies the overall package to provide all available supporting evidence, as neither the public consultation nor an impact assessment could be delivered in the timeframe available prior to the adoption of this proposal. As regards medical devices, the proposal however takes into account the impact assessment carried out in preparation for the adoption of Regulations (EU) 2017/745 on medical devices7 and 2017/746 on in vitro diagnostic medical devices8.
The proposal also draws on the recommendations contained in the forthcoming joint opinion ‘Improving pandemics preparedness and management’ by the Group of Chief Scientific Advisors (GCSA), the European Group on Ethics in Science and New Technologies (EGE), and the Special Advisor to the President of the European Commission on the response to COVID-19.
• 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 of the European Union and in the European Pillar of Social Rights, during health crisis. Where personal data are 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) 2018/17259 and Regulation (EU) 2016/67910.
4. BUDGETARYIMPLICATIONS
The implementation of this proposal has no impact on the current (2014-2020) multiannual financial framework.
The financial impact on the EU budget after 2020 will be covered in the next multiannual financial framework.
The budgetary implications are related mainly to the following objectives:
• preparedness plans established at EU and national level accompanied by reporting and auditing;
• training programmes for specialists;
• digitalized, integrated surveillance system at EU level, better detection of early signals for accurate risk assessment and response;
• establishment of new EU networks of laboratories;
OJ L 117, 5.5.2017, p. 1.
OJ L 117, 5.5.2017, p. 176.
OJ L 295, 21.11.2018, p. 39.
OJ L 119, 4.5.2016, p. 1.
• reinforcement of risk assessments for chemical, environmental and climate threats; and
• established structure and processes for the recognition of emergency at EU level
5.
OTHERELEMENTS
Detailed explanation of the specific provisions of the proposal
The proposal puts forward the following key amendments:
• preparedness capacities: the development of an EU health crisis and pandemic preparedness plan and requirements for the plans at national level, coupled with a comprehensive and transparent framework for reporting and auditing;
• rules on the provision of training for healthcare and public health workforce;
• rules for a strengthened, integrated epidemiological surveillance system at EU level, supported by improved data collection tools and artificial intelligence, environmental surveillance, to detect early signals of a possible threat;
provision for designating and funding EU health;
rules for the surveillance of novel pathogens based on common EU case definitions, and for the reporting of health systems data and other relevant data for the management of cross-border threats;
increased EU and Member States capacity for accurate risk assessment and response;
enhanced capacities for risk assessment by the relevant agencies and risk assessment coordination where more agencies are concerned in an all-hazards approach; and
rules on the recognition of emergency situations, and for the activation of Union emergency mechanisms for the management of health crises (e.g. measures for medicinal products and medical devices).