Explanatory Memorandum to COM(2008)545 - Action plan for the implementation of the EU Animal Health Strategy - Main contents
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| dossier | COM(2008)545 - Action plan for the implementation of the EU Animal Health Strategy. |
|---|---|
| source | COM(2008)545  |
| date | 10-09-2008 |
Brussels, 10.9.2008
COM(2008) 545 final
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
ACTION PLAN
for the implementation of the EU Animal Health Strategy
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
ACTION PLAN
for the implementation of the EU Animal Health Strategy
Background
In December 2004, the Commission launched an external evaluation to thoroughly review the outcomes of EU action on animal health and the direction it may wish to take in the future. Based on the evaluation's results and a wide stakeholder consultation, the Commission presented its Communication for a new animal health strategy in September 20071. It was the first time that the Commission set out its strategic aims and objectives for animal health.
The Council2, the European Parliament3 and the European Economic and Social Committee4 have welcomed the development of a strategic approach to EU animal health policy and support the overall aims, objectives and principles set out in the Animal Health Strategy, which covers the period 2007-2013.
Based on the results of discussions in different EU inter-institutional fora, the Commission is pleased to present its Action Plan on Animal Health to deliver the strategy’s vision over the next five years and beyond. This action plan should be read in conjunction with the EU Animal Health Strategy. The major items indicated will become part of the yearly cycle of the Commission Legislative Working Programme (CLWP). It aims to simplify and improve the existing legislation, to better design new legislation and to reinforce the respect and the effectiveness of the rules, all this in line with the EU proportionality principle and the EU's Better Regulation policy. Legislative proposals will be systemically assessed, and a wide range of options - regulatory and non-regulatory – will be examined for each initiative in accordance with the Better Regulation Action Plan of the Commission5. The Commission will involve stakeholders closely in the preparation and will use the impact assessment system to prepare the new legislative initiatives. An indicative timeline is set out in this action plan for “legislative initiatives”. The implementation of specific actions announced in this Action Plan will therefore depend on the outcome of each impact assessment.
Structure of the action plan
The Action Plan is structured around four main pillars or areas of activity:
1. Prioritisation of EU intervention;
2. The EU Animal Health framework;
4. Science, Innovation and Research.
General animal welfare legislation will be revised in the context of the second pillar. Specific actions on animal welfare are already described in the Community Action Plan on the Protection and Welfare of Animals 2006-20106, which now forms an integral part of the EU Animal Health Strategy. Therefore this Action Plan does not provide details on particular actions for Animal Welfare.
1. Prioritisation of EU intervention
The world has changed considerably. Globalisation, climate change and the movement of people are factors favouring the spread of animal diseases, which makes controlling them more difficult. Diseases such as BSE, which posed a great threat to animal and human health 10 years ago, are now considered to be of much lower risk thanks to the measures subsequently put in place. However, there are new and emerging challenges to face such as diseases that have become more prevalent thanks to global warming. In short, there is now a need to re-evaluate priorities based on careful risk assessment and solid scientific advice. The Commission will develop a profiling and categorisation of animal disease risks which will provide the basis to prioritise actions. The Commission will consider integrating this approach in the new EU Animal Health legal framework (possibly CLWP 2010). Interventions and resources will be focused on diseases with high public relevance.
2. The EU Animal Health framework
The main objective of the Animal Health Strategy is the development of a EU Animal Health Law. The Commission will prepare a legislative proposal by 2010. It will re-define interfaces with the acquis on animal health, welfare, animal nutrition, food safety, public health, environmental protection, pharmaceutical products, common agricultural policy legislation and rules established by relevant international organisations (OIE, Codex Alimentarius) as well as responsibilities – all this having an impact on subsequent financing rules. In the preparation of the Animal Health Law, the Commission will duly consider the recommendations of the European Parliament, the Council and the European Economic and Social Committee. In particular, it will analyse the recommendations concerning the obligations of animal owners (including animals kept for non-commercial purposes), disease prioritisation, vaccination, density of animals and farms, the possible introduction of a system of audits for farms and the accreditation of veterinary schools.
The Commission should also adopt by 2011 a legislative proposal introducing a harmonised EU framework for responsibility- and cost-sharing to ensure that all players assume their responsibilities and play a part in detecting and eradicating disease. The Commission will consider basing the compensation system on the categorisation of animal diseases combined with risk-prevention incentives. Mechanisms to prevent distortions of competition between farmers in different Member States and solidarity aspects will also be considered.
Furthermore, by the end of 2008, the Commission will launch a consultation process to assess the need and opportunity for the development of a harmonised EU framework of financial guarantees in the feed sector.
The Commission will also strengthen its role in negotiating EU export conditions and tackling export problems through the development of locally based EU Market Access Teams drawn from Commission Delegations, Member State Embassies and business organisations, where appropriate.
Given the wide competence of the Community in OIE’s areas of activity, in the long term it is also desirable for the Community to become a member of OIE, as it has of the Codex Alimentarius. This will help reinforce coherence between standards, guidelines and other provisions adopted by the OIE and other relevant international obligations of the European Community. Subject to a consultation with the OIE on the possibilities to modify its legal statute, the Commission will launch the process to obtain a Community membership of the OIE by 2010.
3. Prevention, surveillance and preparedness
Identifying problems before they emerge while being ready to manage outbreaks and crises is a major EU objective.
The Commission will encourage stakeholders to develop EU biosecurity guidelines addressing isolation of new animals brought to the farm, isolation of sick animals, regulation of the movement of people, animals, and equipment, correct use of feed, and procedures for cleaning and, disinfecting facilities. It will explore the scope to make the fullest use possible of the current 'veterinary fund' and other Community related funds (e.g. rural development fund, structural fund, regional fund, fishery fund, mutual funds and research) when addressing actions which will have a positive impact on animal health such as investments in farm infrastructures, training for farmers, farm advisory services, and implementation of legal standards. The Commission will also reflect, in the framework of the 2008/2009 budget review, on the role of the EU budget in promoting animal health.
Better border biosecurity is particularly important in view of the fact that the EU is the world's largest importer of food, including animal products. To improve the level of protection, import controls should focus on high risk imports. In 2010, the Commission will adopt a legislative proposal to deliver a better risk-based approach to border inspections and to better target illegal trade. The Commission will also, within the framework of its assistance programmes, continue efforts to help third countries combat threats to animal health and food safety at the source and meet required sanitary standards.
Threat prevention and crisis management are aided by surveillance mechanisms such as the EU traceability framework. The framework comprises identification systems, labelling, and TRACES (the Community TRAde Control and Expert System for traceability). The Commission will aim to create by 2011 a wider, integrated electronic system, with a unified database encompassing all elements of the current system under certification, animal identification, and animal health and welfare status. Based on the results of a feasibility study, the Commission may adopt by 2011 a regulatory proposal for the introduction of bovine electronic identification.
In 2011, the Commission should have also developed an Animal Diseases Information System (ADIS), compatible with the OIE system, providing key information to the citizen on the animal health situation in Europe.
When an emergency does occur, the ability of the EU to take fast-track decisions is of high importance in limiting and controlling animal-related threats at EU level. The EU will continue to improve measures already in place and strengthen its rapid response network. It will also launch a reflection on how to ensure the reinforcement of the EU antigen and vaccine banks.
4. Science, Innovation and Research
Science is at the core of the Community food safety policy. The new Animal Health Strategy aims at strengthening the scientific foundation of the Community animal health policy. It increases the EU’s standing on the international stage and supports the EU in resolving differences with trading partners. It will also be the key to maintaining a high level of consumer confidence and trust across the EU.
The Commission will continue to use the best available science in developing its animal health measures. The European Food Safety Authority (EFSA) will continue to mobilise and coordinate scientific resources throughout the EU in order to provide the best scientific advice.
Based on an external evaluation (2008-2009), the network of Community and national reference laboratories will be further developed, thereby maximising the knowledge and expertise that exists in Europe.
The Commission has also welcomed the initiative from Industry to bring together all partners including the agricultural sector, governments, veterinarians and international institutions with the creation of the Technological Platform for Global Animal Health. The Commission is very confident that this industry driven platform will contribute to the development of better diagnostics, vaccines and medicines for the benefit of the whole animal health sector. The Strategic Research Agenda is a very valuable document as it results from a broad consensus among all stakeholders from academia, research institutions, industry, producers, decision makers from the EU and also from relevant international organisations. It has important consequences for animal health research and is in line with the Lisbon agenda which aims to make the EU an important science and technology driven society by 2010.
The 7th Research Framework Programme (2007-2013) is an important tool in supporting this Strategic Research Agenda into animal health issues. With that in mind, the Commission will work to stimulate scientific innovation and research, and to ensure sufficient funding in this area through public-private partnerships.
With the support of the European Medicines Agency (EMEA), the Commission will ensure that a suitable framework at Community level provides more incentives to manufacturers to develop new medicines and diagnostic tools. It will launch a reflection on the policy on the use of authorised vaccines within the context of the Animal Health Law. It will also facilitate the change and the addition of strains to an already authorised vaccine by proposing in 2008 a revision of the Variation Regulations (Regulations 1084/2003 and 1085/2003) and a revision of Annex 1 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products in 2009. EMEA will also increase knowledge on the availability of EMEA Assistance to Small to Medium Sized Enterprises and applicants for Minor Uses Minor Species products.
Antimicrobial resistance remains an important source of concerns. EFSA will provide an opinion on food-borne antimicrobial resistance as biological hazard in the following months. In the light of EFSA opinion, the Commission may decide to strengthen its policy as regards the surveillance and control of antimicrobial resistance (AMR) in zoonotic agents caused by the use of antibiotics in animals.
Finally, the Commission will provide support for research in third countries (international cooperation), especially for exotic diseases of high relevance or for neglected zoonoses which have a serious impact on those countries, within the framework of its research programmes.
Partnership and communication
Two key underlying principles apply to all the work of the Commission: partnership and communication.
The action plan acknowledges the importance of dialogue between citizens, civil society associations and the EC institutions (particularly the Commission). This will facilitate the involvement of stakeholders, organisations and citizens in the European decision making process.
The strategy can only bring about real change if everyone involved in animal health works together and with all interested citizens. The EU will take advantage of existing collaborative efforts, encourage new initiatives and make more use of non-legislative alternatives to regulation. An 'Animal Health Advisory Committee' is already in place since February 2008. It includes representatives from non-governmental organisations spanning the animal health sector, consumers and governments. The Committee will provide strategic guidance on the appropriate or acceptable level of animal or public health protection, and on priorities for action and communication. The Committee will also follow the strategy's progress. It will be consulted on all impact assessments and advise the Commission on how best to deliver agreed outcomes.
The Commission will carry out a mid-term review and report to the European Parliament and the Council on the implementation of the Action Plan in 2011 which will reflect any possible changes in priorities. Stakeholders will be able to follow the progress of the different activities through a dedicated website. The Commission encourages all partners involved to consider how they may contribute to the action plan.
Summary of key actions and timetable
| Main actions | Indicative date for completion |
| 1. Prioritisation of EU intervention | |
| Categorisation of animal diseases | 2010 |
| 2. The EU Animal Health framework | |
| EU animal Health Law (legislative proposal) | 2010 |
| EU cost and responsibility sharing schemes (animal diseases) (legislative proposal) | 2011 |
| Assessment for the need of an EU framework of financial guarantees in the feed sector (consultation process) | 2008 - 2009 |
| Negotiation EU export conditions: prioritisation and creation of locally based EU Market Access Teams | 2008 - 2013 |
| Community membership of the OIE | 2010 - 2011 |
| 3. Prevention, surveillance and preparedness | |
| Development of EU biosecurity guidelines | 2009 - 2013 |
| To explore possibilities of funding to finance and promote biosecurity measures and training for farmers | 2008 - 2013 |
| TRACES: a wider, integrated electronic system | 2011 |
| Electronic identification (bovine) | 2011 |
| Revision of import legislation: risk-based approach to border inspections - targeting illegal trade | 2010 |
| Animal Disease information System (ADIS) | 2011 |
| Evaluation of the Community Rapid response network (crisis) | 2009 - 2010 |
| Reinforcement of the Community vaccine/antigen banks | 2008 - 2009 |
| 4. Science, Innovation and Research | |
| Mobilise and coordinate scientific resources with EFSA support | 2008 - 2013 |
| Strategic Research Agenda (European Technology Platform on Animal Health) and the 7th Research Framework Programme (2007-2013) | 2008 - 2013 |
| Evaluation of the Community reference laboratories | 2008 - 2009 |
| Surveillance/control of antimicrobial resistance (supported by an EFSA opinion) | 2008 - 2010 |
| More incentives to develop new medicines and diagnostic tools with EMEA support - including a revision of the Variation Regulations (Regulations 1084/2003 and 1085/2003) | 2008 - 2013 2008 |
| Partnership and communication | |
| Animal Health Advisory Committee | February 2008 - 2013 |
| Mid term review and report | 2011 |
The implementation of legislative proposals announced in this Action Plan will depend on the outcome of each impact assessment.
1COM 539(2007) adopted on 19 Sept 2007
ec.europa.eu/food/animal/diseases/strategy/docs
2Council Conclusions - Doc 15481/07 ADD 1 Adopted on 17 Dec 2007
ec.europa.eu/food/animal/diseases/strategy/docs
3European Parliament Resolution - A6-0147/2008 adopted on 21st May 2008.
4Opinion of the European Economic and Social Committee NAT/376 (2008) adopted on 16 Jan 2008 ec.europa.eu/food/animal/diseases/strategy/docs
5COM(2002)278.
6Community Action Plan on the Protection and Welfare of Animals 2006-2010
ec.europa.eu/food/animal/welfare/actionplan
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