Explanatory Memorandum to COM(2011)866 - Serious cross-border threats to health - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)866 - Serious cross-border threats to health. |
|---|---|
| source | COM(2011)866  |
| date | 08-12-2011 |
The aim of the proposed Decision is to streamline and strengthen European Union capacities and structures for effectively responding to serious cross-border health threats. These threats can be events caused by communicable diseases, biological agents responsible for non-communicable diseases, and threats of chemical, environmental, or unknown origin. Threats deriving from the effects of climate change (i.e. heat waves, cold spells) are included in the scope of this Decision and covered under the same heading as environmental threats.
Health threats of radiological or nuclear origin causing exposure to ionising radiation are not covered by this proposal because they are already dealt with by the provisions of the Treaty establishing the European Atomic Energy Community (Articles 2(b) and 30-39), which constitutes the ‘lex specialis’ in relation to Article 168 of the Treaty on the Functioning of the European Union.
Based on lessons learnt from recent public health emergencies and building on existing EU-level instruments related to health threats, this proposal will set up a coherent framework for crisis response.
Although the Member States have the responsibility to manage public health crises at national level, no country can tackle a cross border public health crisis on its own. In the current financial turmoil it is more important than ever to focus on actions in areas where the added value is evident, such as minimising the negative effects of a potential public health crisis. Recent cross-border events such as the H1N1 pandemic in 2009, the volcanic ash cloud and toxic red sludge in 2010, or the outbreak of E. coli STEC O104 in 2011, had significant effects on society and demonstrated that none of the impacts of these emergencies can be confined to only one sector. Therefore, through improved multi-sectoral cooperation at EU level other sectors need to be equally prepared to manage the impacts of a public health crisis.
At EU level, the legal basis for addressing serious cross-border health threats has been reinforced with the Lisbon Treaty. The EU can now take action in this field, except for any harmonisation of the laws and regulations of the Member States. Also, the Treaty stipulates that the EU must complement and support national policies and encourage cooperation between Member States, without superseding their competence in that field.
So far, EU legislation in this area only addresses threats related to communicable diseases. The EU network for surveillance and control of communicable diseases has specific mechanisms for monitoring communicable diseases, giving alerts and coordinating the EU response. Because its scope is limited to communicable diseases, however, the network no longer meets the current standards or needs for an improved EU response to all serious cross-border health threats and will therefore be replaced by this Decision. The Decision covers all serious cross-border threats to health except for those caused by radiological or nuclear exposure.
The objectives of the proposed Decision are as follows:
Firstly, in the area of preparedness planning, the Decision provides for the coordination of the efforts of the Member States in terms of improved preparedness and capacity building. To this end, the Commission will ensure coordination between national planning and between key sectors such as transport, energy and civil protection, and will support Member States in setting up a joint procurement mechanism for medical countermeasures.
Secondly, in order to provide the relevant information and data for risk assessment and monitoring of emerging threats, an ad hoc network will be set up in situations where a Member State has raised an alert on a serious threat other than a communicable disease. Communicable diseases will continue to be monitored as they are today.
Thirdly, the Decision expands the use of the existing Early Warning and Response System to cover all serious threats to health, and not only communicable diseases as is the case today.
Fourthly, the proposal introduces coordinated development of national or European public health risk assessments for threats of biological, chemical, environmental or unknown origin in a crisis situation.
Finally, the Decision sets up a coherent framework for the EU response to a public health crisis. In concrete terms, by formalising the existing Health Security Committee, the EU will be in a better position to coordinate national crisis responses in a public health emergency.
The proposal will help implement the European Health Strategy and also contribute to Europe 2020 by promoting health as an integral part of the smart and inclusive growth objectives. The proposal will also contribute to implementing the Internal Security Strategy in its crises and disasters management component, notably the overall objective to establish a coherent risk management policy linking threat and risk assessment to decision making. The Health Security Initiative will appropriately take into account the EU external cooperation activities for health crises prevention and responses with third countries and activities supported under the Union's programmes for research, and explore synergies with the numerous bilateral EU assistance and cooperation programmes with a significant health component.
Many activities related to preparedness and response planning and risk assessment for communicable diseases but also for chemical threats to health and events caused by climate change have been supported by the previous and current health programme. It is planned that for important elements of the initiative, specific actions will be supported by the future Health programme currently under development.
The EU already has policies, mechanisms and instruments in place for the prevention and control of serious cross-border threats and for the development of capacities to manage crises. A non-exhaustive list includes the EU Civil Protection Mechanism, the Cohesion and Solidarity Funds, the EU action plan on chemical, biological, radiological and nuclear security[7], and European alert networks such as ECURIE[8].
In addition, to support the EU security framework and to protect citizens against serious cross-border threats, different alert, information and management systems, scientific committees and agencies are already operating to ensure food and feed safety, animal and plant health, medical products safety, and consumer protection. Systems have been put in place to control chemical accidents and radiological events, for border security and for protection against crime and terrorism.
In order to avoid overlaps with these areas and duplicating existing disaster prevention and control structures, a gap analysis has been carried out to assess how far these existing systems cover the monitoring of threats to health, their notification, risk assessment and crisis management capacities and structures from the public health perspective. This gap analysis revealed that the existing structures and mechanisms at EU level do not address these threats sufficiently[9] as far as public health is concerned. For example, there is a variety of monitoring and alert systems for different threats at EU level, but these are not systematically linked to EU public health institutions. In addition, the International Health Regulations (IHR) (2005)[10] — an international treaty for the coordination of all health emergencies — stipulate that Member States must notify the World Health Organisation of any event that may constitute a public health emergency of international concern, independently of its origin (including biological, chemical or environmental). But there are no similar notification obligations at EU level under any of the existing structures.
As regards risk assessment, national public health risk assessments exist, but may not be comprehensive and consistent when considered from the EU perspective, and there is currently no mechanism for a coordinated approach at EU level. The lack of public health risk assessment at EU level leads to discrepancies in evaluating the danger of a given threat, duplication of assessments between Member States and inconsistent measures at EU level. Such a situation can also lead to inefficient use of the limited resources currently available and may delay appropriate public health measures, potentially putting at risk the overall response at EU level. The absence of a comprehensive or proper evaluation of risks may lead to unclear communication and may undermine public confidence in measures proposed or taken by public health authorities in Member States.
Apart from the instruments in the area of radiological protection, existing mechanisms do not provide a comprehensive basis for decisions on public health measures for the population where there is a severe health impact such as contamination or poisoning caused by chemical, biological or environmental events. This has led to a situation where today there is no possibility for a coordinated EU response with public health measures or agreements on prophylaxis and treatment. These kinds of cross-border public health emergencies are addressed case by case on an ad hoc basis. Therefore, the proposal will build on the existing instruments, step up cooperation and strengthen coordination in the area of notification and risk assessment.
As regards preparedness planning, during the H1N1 influenza pandemic in 2009, Member States procuring pandemic influenza vaccines individually were competing with each other for limited amounts of available vaccine, which weakened their purchasing power. Contractual confidentiality clauses often prevented Member States from exchanging information, leading – as shown in an independent evaluation[11] – to considerable variations between Member States as regards contractual conditions, particularly regarding liability for side effects being transferred from the manufacturers to the Member States. In addition, the lack of flexibility in contracts to include conditions under which the reserved amount of doses could be changed or excess vaccines could be returned resulted in a huge waste of resources. The Member States that could not accept those unfavourable conditions had no guarantee of being able to obtain pandemic influenza vaccines, thus weakening the preparedness across the EU for such a cross-border health threat. This could have had very serious health consequences if the pandemic had proved more virulent and deadly.
Furthermore, in the aftermath of the H1N1 pandemic in 2009, the European Parliament in its resolution of 8 March 2011 and the Council in its conclusions of 13 September 2010[12] stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such purchases.
This proposal provides a legal basis for an EU mechanism for the joint procurement of medical countermeasures in which contracting parties[13] could participate on a voluntary basis in order to purchase medical countermeasures, such as pandemic influenza vaccines, thereby improving preparedness for future pandemics.
In relation to crisis management, and in view of the lessons learnt from recent emergencies, health ministers have repeatedly called for a review of the health security framework, including options for a legal basis for the Health Security Committee, and stressed the need to review pandemic preparedness planning.
The Health Security Committee is currently an informal structure at EU level for the coordination of public health risk assessment and the management of serious cross-border threats to health. It was set up by the EU health ministers in the aftermath of the 11 September 2001 terrorist attacks in the United States. At the beginning, its mandate was limited to tackling bioterrorism[14], but it has subsequently been extended to cover all types of public health-related crisis[15]. It is composed of representatives of the Member States’ health authorities and chaired by the Commission.
Due to the informal nature of the Committee, the involvement and commitment of Member States is voluntary and there is insufficient coordination of public health responses and no cross-sectoral interlinking of decision-making processes in public health. The Commission can prepare and table recommendations and advice. By formalising the Health Security Committee, it can be expected that public health preparedness planning and crisis management can be taken forward in a more consistent and comprehensive manner at EU level. In addition, Member States will benefit from pooling scarce resources related to risk assessment or crisis management, for example.
The Community network for the epidemiological surveillance and control of communicable diseases established under Decision No 2119/98/EC comprises the epidemiological surveillance of communicable diseases and the Early Warning and Response System (EWRS). Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control[16] (ECDC) provides the ECDC with a mandate covering surveillance and risk assessment of threats to human health from communicable diseases and illnesses of unknown origin. In this context, the ECDC has taken over the epidemiological surveillance of communicable diseases and the operation of the EWRS from the Community network. For this reason the proposed Decision repeals Decision No 2119/98/EC.
The Treaty on the Functioning of the European Union (TFEU) covers several aspects of health security, including EU disaster prevention and control. Mechanisms related to EU disaster prevention, response and control are dealt with under civil protection (Article 196 TFEU), the solidarity clause (Article 222 TFEU), EU financial assistance to Member States (Article 122 TFEU), and humanitarian aid to third countries (Article 214 TFEU).
In addition, some health security aspects are already addressed within areas of common safety concern in public health matters (such as food safety, animal and plant health, the quality and safety of pharmaceuticals and medical devices, or organs and substances of human origin, blood and blood derivatives), consumer protection, health and safety at work, the environment, transport safety and security, respectively covered by Articles 168, 169, 153-156, 191-193, 141 and 91 of the TFEU. Furthermore, an information system will be put in place by 1 June 2015 by the Directive 2010/65/EU. It will help Member States to improve the monitoring and early warning of threats deriving from sea vessels. The Directive includes provisions permitting an electronic exchange of data notified in the dangerous goods declaration and the marine declaration of health.[17]
Furthermore, EU secondary legislation establishes specific rules for monitoring, giving early warning of and combating serious cross-border threats to health (e.g. the Seveso II Directive[18] and the CAFE Directive[19]) and requires in a few instances Member States to develop joint activities to address transboundary air pollution including recommended behaviour (CAFE Directive). For these reasons this Decision does not impinge on the provisions that already exist but seeks to close the gaps in relation to notifications, monitoring, risk assessment and crisis management from the public health perspective. Therefore, the Decision extends the Early Warning and Response System to cover all serious cross-border threats to health (except radio nuclear), adds a monitoring requirement in a crisis for threats to health other than communicable diseases and provides for a crisis management structure for addressing health threats, as these are not covered under other legislation.
The International Health Regulations (2005) already require Member States to develop, strengthen and maintain the capacity to detect, assess, notify and respond to public health emergencies of international concern. Under this agreement, the World Health Organisation is empowered to declare public health emergencies of international concern and to issue recommendations including health measures. The proposed Decision aims to support the consistent and coordinated implementation of the International Health Regulations by the EU Member States. In particular, it will ensure adequate coordination between the Member States to achieve a consistent level of preparedness and interoperability between national preparedness plans, while respecting the Member States’ responsibility for the organisation of their health systems.
Against this background, the Decision should apply without prejudice to other legally binding provisions relating to health security, not least as regards preparedness, monitoring, alerting, assessment and management of serious cross-border threats to health. However, where gaps have been identified in relation to monitoring, alerting, risk assessment or crisis management these are addressed in the Decision. In order to address the gaps, the Decision requires the Member States to coordinate their preparedness efforts, extends the early warning and response system to cover all serious cross-border threats to health, provides for coordinated public health risk assessment by bringing together risk assessments and stressing their public health aspects, adds monitoring requirements in a crisis for threats to health other than communicable diseases and, finally, provides for a crisis management structure for addressing health threats.
Contents
- RESULTS OF CONSULTATIONS
- BUDGETARY IMPLICATIONS
- 1.2. General context
- 1.3. Existing European Union and international provisions in this area
- WITH INTERESTED PARTIES 2.1. Consultation with interested parties and use of expertise
- 2.2. Impact assessment
- 3. LEGAL ELEMENTS OF THE PROPOSAL 3.1. Legal basis
- 3.2. Subsidiarity
The open stakeholder consultation on health security in the European Union took place between 4 March and 31 May 2011. In all 75 responses to the online questionnaire were received: 21 on behalf of national, regional or local authorities, 31 on behalf of organisations and 23 from individual citizens[20].
The key outcome of these stakeholder consultations is that most stakeholders are strongly in favour of having all serious cross-border health threats included in the EU health security policy[21].
The Health Security Committee was consulted six times on the initiative. The EWRS network discussed the health security initiative at their meeting in February 2011. The European office of the World Health Organisation is represented on both committees as an observer. In addition, bilateral meetings with six Member States were held at their request and the initiative was also presented to the EU Health Policy Forum on 19 May 2011.
Adding to the expertise of the Member States, the European Centre for Disease Prevention and Control provided useful input as regards the scientific risk assessment issues.
The Commission has carried out detailed analysis of three options:
– Option 1: Status quo: maintaining the current level of activities;
– Option 2: Separate and different handling of serious cross-border threats to health — enhanced EU cooperation through the use of soft instruments based on a voluntary approach;
– Option 3: Establishing a common EU legal framework covering all serious cross-border threats to health through improved cooperation and legally binding measures.
The results of the analysis led to the conclusion that option 3 has the strongest positive health impacts as it improves the protection of citizens against serious cross-border threats to health. It proposes a comprehensive framework for health security structures and systems including obligations on Member States in terms of preparedness and response planning.
The EU added value will be increased through streamlining and coordinating all aspects of preparedness and response planning, risk assessment and risk management by setting up strategic and technical-level cooperation on health security at EU level. This would be guaranteed by the establishment of a sound legal basis for all serious cross-border health threats. By also providing a legal basis for operating a joint procurement mechanism for medical countermeasures, this option would help strengthen the preparedness and response capacity to deal with cross-border health threats across the EU.
In the Member States, administrative savings in public health risk management will also be achieved through enhanced coordination under the Health Security Committee, which allows pooling and exchange of expertise.
With the entry into force of the Lisbon Treaty, the Union has been empowered to support, coordinate or supplement the action of Member States in the area of the protection and improvement of human health (Article 6(a) TFEU). The Treaty also states that Union action must be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health; in particular, it must cover ‘monitoring, early warning of and combating serious cross-border threats to health’ (Article 168 TFEU). EU action should, however, exclude any harmonisation of the laws and regulations of the Member States and respect their responsibility for the definition of their health policy and for the organisation and delivery of health services and medical care.
Furthermore, the Union should take into account requirements linked to a high level of protection of human health while defining and implementing its policies and activities (Article 9 TFEU). The principle of ‘health in all policies’ is particularly relevant in the multi-sectoral context due to the transnational dimension of serious cross-border threats to health.
At international level, a comprehensive framework on health security exists since 15 June 2007 in the form of the International Health Regulations which have been ratified by all Member States.
Serious cross-border threats to health and public health emergencies of international concern have, by their nature, transnational implications. In a globalised society, people and goods are moving across borders and illnesses and contaminated products can circulate within hours across the globe. Public health measures therefore need to be consistent with each other and coordinated to contain further spread and minimise the consequences of such threats.
Measures taken by an individual Member State to respond to such threats may touch upon the competences of the EU or other national governments, and can therefore damage the interests of Member States and run counter to the fundamental principles and goals of the EU if they are not consistent with each other and are not based on shared scientifically objective and comprehensive risk assessment. As an example, the lack of coordination at EU level in the E. coli outbreak in 2011 led to loss of life and economic loss for the food industry and also had consequences for trade. With respect to the H1N1 pandemic in 2009, there was a drastic drop in medication compliance for pandemic vaccines, potentially endangering the health of citizens, including health care workers, and jeopardising the capacity of the health sector to efficiently respond to that crisis. In addition, the pandemic led to economic losses for the Member States’ budgets due to unused vaccines, resulting from the different public perceptions both about the severity of the threat and the safety and efficacy of those products. Furthermore, measures that are effective from a public health standpoint (e.g. isolation, quarantine, social distancing, workplace and school closures, travel advice and border controls) can have adverse consequences for civil liberties and the internal market. Therefore, the coordination of the response at Union level should ensure that measures taken at national level are proportionate and limited to public health risks related to serious cross-border health threats, and do not conflict with obligations and rights laid down in the Treaty, such as those relating to the restriction of travel and trade. Preparedness measures would need to pay particular attention to protecting workers potentially exposed to the threat.
Since the objectives of the action to be taken cannot be sufficiently achieved by the Member States alone due to the cross-border aspects of those threats and can therefore, for reasons of effectiveness, be better achieved at EU level, the EU 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 set out in that Article, the proposed Decision does not go beyond what is necessary in order to achieve those objectives.
The proposal builds on positive experience with coordination in the field of communicable diseases, and proposes extending the existing systems and applying the lessons learnt to ensure that citizens enjoy equal protection against all health hazards.
For the purpose of achieving the objectives, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union, in order to supplement or amend certain non-essential elements of the basic act.
In order to achieve uniform conditions for the implementation of the basic act, particularly with regard to the procedures for information sharing, consultation and coordination of preparedness and response, the Commission should be empowered to adopt implementing acts in accordance with Article 291 of the Treaty on the Functioning of the European Union.
This legal proposal does not impact on decentralised agencies.
In addition, the current EU health programme already covers some activities in relation to monitoring, alerting and risk assessment of some health threats.After 2013 the Commission intends to cover these activities under the proposed Health for growth programme 2014-2020. The cost is included in the proposed envelope of the new programme.
The joint procurement, as a voluntary mechanism, may have a budgetary impact in case the EU Institutions were to participate as a Contracting Authority for the procurement of medical countermeasures to cover EU staff. Member States remain responsible for procuring medical countermeasures to cover their citizens.
The budgetary implications for EU institutions are difficult to forecast as it depends on the type of medical countermeasure that is procured, the staff coverage pursued, and, in the case of pandemic influenza, the unknown characteristics of the next pandemic influenza virus in terms of whether 1 or 2 vaccine doses will be required to achieve immunity. The expenditure should be covered within the medical expenditure foreseen by each institution.
During the 2009 influenza H1N1 pandemic, 10,000 doses of pandemic influenza vaccine were bought by the EU institutions at a price of 6 euro per dose. For Commission staff 5,000 doses were reserved of which 3,000 were administered (vaccination was offered on a voluntary basis). The Medical Service envisages a similar approach for an eventual future influenza pandemic. In the case of a serious pandemic where a higher number of staff may wish to get vaccinated, it is envisaged that staff is vaccinated through the health care services of the host country. In conclusion, it is expected that the budgetary implication of vaccine procurement for a future pandemic will be similar to the situation in 2009.