Annexes to SEC(2011)1520 - Executive summary of the impact assessment - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | SEC(2011)1520 - Executive summary of the impact assessment. |
|---|---|
| document | SEC(2011)1520  |
| date | December 8, 2011 |
5.Policy options
In order to cover all aspects of crisis management in a coherent framework, each of the options presented includes solutions for preparedness and response planning, risk monitoring, assessment and management.
The measures identified in each option vary according to the level of implementation of preparedness planning and core capacity requirements and the level of obligation on Member States in terms of implementation, the informal or formal nature of the expertise provided for risk assessment, and the power conferred on the EU with regard to risk management:
- Option 1 (the status quo) envisages no additional action and corresponds to the baseline scenario.
- Option 2 comprises additional action based on soft instruments, in particular Council recommendations, to ensure the involvement of the Member States and closer cooperation between existing structures and systems. There are no legally binding measures under this option.
- Option 3 proposes a legal framework that lays down binding measures for Member States as regards preparedness planning, provides a legal basis for voluntary measures and implements a robust structure for crisis management. This option seeks to amend the existing Council and European Parliament Decision on communicable diseases and extend it to serious cross-border health threats caused by biological (other than communicable diseases), chemical or environmental events. The provisions for risk assessment under this option are not included in the legal framework as they also build on closer cooperation between existing structures and systems and are intended to cover existing gaps in these areas.
A summary of the measures related to the three options is attached in Table 3 in the Annex.
6.Analysis of the impacts
6.1.Option 1: Status quo/baseline scenario — maintain the current level of activities
Under this option the current situation including the problems described in Section 2 would remain unchanged.
6.2.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 — no legally binding measures
Public health impact. The impact on public health would be improved as the overall situation in terms of preparedness for and response to a crisis would be strengthened along with the effectiveness, efficiency and coherence of public health security structures and mechanisms. This would be achieved through EU-wide recommendations supported by Member States. However, these positive impacts would rely on the commitment of the Member States to agree on these recommendations and implement them on a non-binding basis. To a certain extent, this option could lead to increased coherence of overall preparedness, improved coordination of existing notification tools and strengthened risk assessment capacities. The risk management structures supporting the coordinated response at EU level would be sustainable with clearer mandates, thereby improving the effectiveness of health crisis management, including communication. Regarding equitable access to medical countermeasures, the impact of this option is expected to be an improvement on individual national procurement procedures. However, the proposed activities would remain at the level of cooperation between individual authorities in charge of procurements, and purchasing power and the ability to obtain better contractual conditions would remain weak at best.
Social impact. Provided that the Member States implement the agreed guidance and recommendations, improved risk management and in particular better coordination of risk communication would have a beneficial effect on citizens as messages issued to the public would be more consistent within the EU, thereby boosting confidence in the ability of public health authorities to manage a health crisis. Inter-sectoral cooperation to improve public health protection would be strengthened. As regards equitable access to medical countermeasures, this option would enable expertise to be pooled among the Member States and solidarity to be improved in terms of preparation of the procurement procedures.
Economic impact. Option 2 could lead to more rapid risk assessment and management of a given threat. These improved structures and systems at EU level would result in strengthened capacities to contain and mitigate a serious cross-border health threat and its related economic consequences. As a result, the disruption of the internal market and external trade functions might be minimised and economic losses reduced. However, these potential impacts would rely essentially on the commitment of the Member States. Option 2 could positively impact on innovation and R&D efforts related to the development of such products. However, this would not ensure improved access to medical countermeasures.
Financial implications. No additional costs would arise for Member States and stakeholders, because the financial situation would be the same as described in option 1.
Administrative burden. Under this option, the administrative burden for the Member States and the Commission would be reduced as the mandates of the two relevant committees — the Early Warning and Response System Network and the Health Security Committee — would be clearly defined, thereby limiting the risks of overlap. As regards access to medical countermeasures, the administrative burden could also be reduced for Member States, as national expertise would be pooled.
EU added value. The EU added value would be increased as the coordination of preparedness for and response to cross-border health threats would be enhanced at EU level.
6.3.Option 3: Establish a common EU legal framework covering all serious cross-border health threats by extending existing legislation — improved cooperation and legally binding measures
Public health impact. Under this option, the protection of EU citizens against serious cross-border health threats and the effectiveness of public health security structures and mechanisms at EU level would be considerably improved. This would allow coherent preparedness planning based on shared and common mandatory standards and a better coordinated and balanced response to all types of serious cross-border health threats. For example, all Member States would need to have preparedness plans in place that would cover both health measures and other critical sectors, and structures and capacities would need to be set up in compliance with agreed check lists. This option would also result in a more coherent and comprehensive approach to the identification, notification and assessment of serious cross-border health threats. By setting up a legal basis allowing joint procurement, this option would considerably improve equitable access to medical countermeasures by Member States, thereby ensuring a higher level of protection of EU citizens across the Union. Furthermore, inter-sectoral cooperation would be improved in the event of cross-border health threats, also contributing to better public health protection.
Social impact. Along with the impacts related to improved coordination of communication already identified for option 2, a coordinated approach to access to medical countermeasures would raise confidence in measures undertaken by public health authorities, as they would rely on a robust legal instrument. For those Member States that had opted to participate in joint procurement, the mechanism would lead to a higher level of protection for vulnerable groups by ensuring a guaranteed supply and would promote solidarity between the Member States by providing common minimum coverage for vulnerable groups of society.
Economic impact. The positive impacts already described under option 2 could increase, because the planned measures under option 3 would be based on binding agreements. The setting-up of a joint procurement mechanism for medical countermeasures would boost the supply of medical products and encourage development of new products based on long-term contracts agreed with the public health sector.
Financial impact. As regards preparedness, additional costs could be expected, particularly in relation to human resources and the provision of technical equipment in the Member States and at EU level. In order to cover gaps in risk assessment, additional financial resources in the region of EUR 500 000 annually would be needed from the EU health programme to establish a framework contract so as to gain access to expert knowledge when needed. The aim would be to establish permanent networks of national correspondents between health authorities and agencies competent in assessing specific threats. However, proposed measures relating to enhanced cooperation would have no substantial financial impacts, because they would be based on the existing mechanisms and structures in place.
Administrative burden. Governance in public health risk management would be significantly improved, as only one expert committee would need to be operated.
EU added value. Under option 3, the EU added value would be increased across all aspects of preparedness and response planning, risk assessment and risk management by setting up strategic and technical cooperation on health security at EU level. This would be guaranteed by the establishment of a robust legal instrument for all serious cross-border health threats. By also providing a legal basis for operating a joint procurement mechanism for medical countermeasures this option could add value to strengthening preparedness and response capacity to deal with cross-border health threats across the EU.
Impact at international level. Better coordination in the EU of IHR implementation by the Member States and closer collaboration between the EU and WHO on preparedness for and response to public health emergencies of international concern would contribute to enhancing global health security.
7.Comparing the impacts
Table 2: Comparison of the policy options
Rating: 0 Baseline scenario, neutral
+ positive impact ++ significant positive impact
- negative impact -- significant negative impact
| Assessment criteria | Option 1 | Option 2 | Option 3 |
| 1 Improved protection of EU citizens against serious cross-border threats to health | 0 | + | ++ |
| 2. Improved public health security structures and systems | |||
| 2.1 Coherent and comprehensive overall approach for all serious cross-border threats to health | 0 | + | ++ |
| 2.2. Improved preparedness and response planning, common approach at EU level for all serious cross-border threats to health | 0 | + | ++ |
| 2.3. Improved risk monitoring and assessment | 0 | + | ++ |
| 2.4. Improved coordination and risk management | 0 | + | ++ |
| 2.5.Improved crisis communication | 0 | + | ++ |
| 3. Social impacts | 0 | + | ++ |
| 4. Economic impacts | 0 | + | ++ |
| 5. Financial implications | 0 | - | - |
| 6. Administrative burden | 0 | 0 | - |
| 7. EU added value | 0 | + | ++ |
| 8. Impact at international level | 0 | + | ++ |
| Total | 0 | 9 | 18 |
This comparison focuses on options 2 and 3, where new impacts can be expected. There are a number of differences between options 2 and 3 which demonstrate the added value of choosing option 3.
As regards the public health impact, both options improve the overall situation for preparedness and response to a crisis. However, as option 2 depends on a voluntary approach the positive impacts would not be guaranteed as they would rely only on the commitment of the Member States. In comparison, option 3 also establishes common mandatory standards that would lead to considerably improved coordination at EU level. Both options also strengthen risk notification and assessment. However, option 3 would provide for a more coherent and comprehensive approach as a coordination system would be put in place. Risk assessment capacities would be improved by filling gaps in current risk assessment capacities under option 3. For risk and crisis management, option 2 would improve the overall situation as the mandates of the two committees would be clarified. However, option 3 would merge the two committees, providing a sound basis for crisis management of all serious cross-border health threats. Risk and crisis communication would be also be improved under both options, but under option 3 the linking of communicators and crisis managers would ensure that communication strategies could be developed within the overall approach of response to public health events.
8.Conclusions and proposal for implementation
Option 3 has the strongest health impacts as it provides improved protection of citizens against serious cross-border health threats. It proposes a comprehensive framework for health security structures and systems including obligations on Member States in terms of preparedness and response planning. It makes notifications at EU level mandatory and establishes a clear mechanism to address all types of public health event by merging the two existing committees.
Option 3 also offers the best possible EU added value and best fulfils the fundamental goal of the Lisbon Treaty of ensuring a high level of human health protection against all serious cross-border health threats.
The legal form under this option would be a legislative act of the European Union adopted by ordinary legislative procedure that would repeal but take over the provisions of the current EP and Council Decision of 1998 on communicable diseases and extend them to health threats caused by biological, chemical and environmental events.
9.Monitoring and evaluation
Systematic follow-up of the policy measures in the field of preparedness and response planning, risk assessment and risk management will be ensured by evaluating the implementation of the legislative instrument.
The Commission will submit to the European Parliament and the Council regular reports evaluating the implementation of the legal act. Evaluation of the effective operation of the structures and mechanisms provided for by the Health Security Initiative will be based on information from Member States supplied annually, with scientific support from specialised agencies and organisations such as the ECDC, WHO and EMA. The reporting system will be approved and implemented by the new committee.
A more detailed inventory of existing capacities, measures and plans in terms of preparedness, risk assessment and risk management and communication at the level of each Member State and for all threats other than communicable diseases is currently being drawn up. It will allow indicators to be further refined and serve as the benchmark against which progress will be measured after approval of the legal initiative.
10.Annex
Table 3: Overview of measures proposed under the three options
ANNEX: Table 3: Overview of measures proposed under the three options
| Option 1: Status quo | Option 2: Soft instruments | Option 3: Establish common EU legal framework covering all serious cross-border threats to health | |
| Preparedness and response planning | Follow up implementation of guidance on generic and pandemic preparedness; organise exercises and training; exchange best practice | Shared approach to preparedness planning; identify core capacity standards related to IHR requirements; guidance on improved cross-sectoral preparedness and interoperability | Common EU framework for MS to: - put in place common features of preparedness planning; - report regularly on implementation of preparedness plans; - cooperate in cross-sectoral preparedness and response planning; - implement requirements on common minimum core capacity standards; - agree and implement EU tailor-made criteria for notification of serious cross-border health threats at EU level |
| Procurement of medical countermeasures | Support for Member States, e.g. in preparing tender specifications; promote production capacity for pandemic influenza vaccines | Ditto option 1, plus: increase support for the Innovative Medicines Initiative and/or EU stockpile of medical countermeasures, better exchange of information on contractual conditions | Establish legal basis for EU coordination of joint action for purchasing medical countermeasures |
| Risk monitoring and assessment | No strengthening of existing notification and monitoring mechanisms and structures; risk assessment on the basis of ad hoc support networks | Recommendation to Member States to notify threats with tailor-made EU criteria; improve coordination for risk monitoring and assessment by informal arrangements; develop Memoranda of Agreement with entities dealing with alert systems | Put in place coordination mechanism to notify at EU level cases of serious cross-border threats to health; require MS to notify the EU level in all cases relevant to IHR; close gaps in public health risk assessment capacities; Commission to support this by mapping existing risk assessments in order to improve coherence at EU level (linked to SG initiative on overall threat assessment) |
| Risk management | Maintain current informal mandate of the Health Security Committee (HSC) | Replace HSC by expert committee | Improve coherence and coordination of risk management; EU action to cover advisory activities on preparedness and response planning and public health response coordination, non-legislative acts and mutual agreements between MS; establish new instrument for joint action, in particular joint procurement of medical countermeasures |
| Risk and crisis communication | Informal HSC communicators’ network to continue to facilitate exchange of information | Develop EU coordination related to shared communication approaches and guidelines | Develop common communication strategies, integrate communicators into the crisis management process and link communicators directly to risk managers/decision makers |
1E.g. in 2010 under the “Instrument for Stability” the EU started a project that will allow third countries to collaborate in numerous regions of the world to build capacities for mitigating risks from chemical, biological, radiological and nuclear materials, irrespective of the origin of the risk (natural, criminal, industrial accident). Possible synergies will be explored under the Health Security Initiative with this initiative to create regional CBRN Centres of Excellence.
2The name of this body might be changed in the legal proposal.