Explanatory Memorandum to COM(2010)666 - Amendment of Directive 2000/75/EC as regards vaccination against bluetongue - Main contents
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| dossier | COM(2010)666 - Amendment of Directive 2000/75/EC as regards vaccination against bluetongue. |
|---|---|
| source | COM(2010)666  |
| date | 15-11-2010 |
Bluetongue is a disease affecting ruminants (such as cattle, sheep and goats) and is transmitted by insect vectors that spread the virus from one animal to another. This means that its occurrence and spread is largely influenced by environmental conditions and that the measures usually applied for the control of contagious animal diseases such as Foot-and-mouth disease are not appropriate for the control and eradication of bluetongue. When favourable environmental and climatic conditions exist, epidemic waves of disease may occur, in fully receptive (i.e. non-immune) ruminant populations in late summer-autumn, that are extremely difficult to control. In general, bluetongue control is based on a combination of vaccination, protection from vectors and restrictions on animal movements.
This disease was considered exotic to the EU until the late 1990s, as only sporadic incursions in the southern part of the EU had been reported at that time. However, the situation dramatically changed from the early 2000s: several epidemic waves of disease have occurred in many Member States, including in central and northern Europe, causing significant losses in terms of morbidity, mortality and disruption of trade in live animals. In the last few years the situation has significantly improved, as a result of massive vaccination campaigns largely co-financed by the Union (~150 MEUR in 2008, and allocation of ~120 MEUR in 2009 and ~100 MEUR in the years after), that have been based on new 'inactivated vaccines', that have become available as from 2008. However, the disease has also shown a tendency to become endemic in some areas, and it is possible that from there further epidemic waves of disease may start in the future.
Council Directive 2000/75/EC of 20 November 2000 lays down specific provisions for the control and eradication of bluetongue, including rules on vaccination. These rules are based on experiences with the so-called 'modified live vaccines', or 'live attenuated vaccines' that were the only vaccines available when the Directive was adopted a decade ago. Those vaccines may lead to undesired circulation of the vaccine virus in unvaccinated animals in the areas where the vaccine has been used. However, in the last few years inactivated vaccines have been developed by a number of companies and largely used in the EU. These inactivated vaccines do not pose the risk of undesired vaccine virus circulation.
It is now widely agreed that vaccination with these vaccines is the preferred tool for bluetongue control and prevention of clinical disease in the EU. Their use is, however, limited by the current rules, that in particular foresee the use of vaccines only in areas where the disease occurred and which have therefore been subject to animal movement restrictions.
In order to ensure better control of bluetongue and reduce the burden on the agricultural sector posed by this disease, it is appropriate to update the current rules on vaccination to the recent technological developments in vaccine production. This proposal amends the rules on vaccination currently laid down in Directive 2000/75/EC to make them more flexible, taking into account the fact that inactivated vaccines are now available, which can also be successfully used outside areas subject to animal movement restrictions. However, the use of live attenuated vaccines should not be excluded provided that appropriate precautionary measures are taken, as their use might still be necessary under certain circumstances, such as following the introduction of a new bluetongue virus serotype against which inactivated vaccines may not be available.
2. PREFERRED OPTION AND ASSESSMENT OF ITS IMPACTS
2.1. Reasons for modification of EU legislative framework compared to other options
Under the current rules, the use of vaccines against bluetongue is prohibited outside 'restricted zones'. Consequently, Member States that wish to carry out preventive vaccination must either retain a restricted zone beyond the two years of absence of virus circulation, while other Member States decide to become part of a restriction zone although bluetongue has never occurred. This situation leads to unnecessary restrictions in the concerned areas with additional burdens for the farmers and the national authorities.
In the past three years modern inactivated vaccines against bluetongue have become available which could be safely used outside restricted zones. The provisions on vaccination against bluetongue should therefore be amended to allow the Member States to develop their national strategies on the prevention and control of the disease without the unnecessary intervention of the Union.
2.2. Economic and social impacts of the proposal
The proposal is expected to reduce the adverse economic and social impact, and the burden related to the implementation of certain veterinary restrictions as a result of bluetongue, by increasing the number of options available to control the disease. It is, however, difficult to quantify these benefits precisely, as they will vary dependent on the largely unpredictable nature of the evolution of the disease in Europe.
2.2.1. Economic impacts
A. Effects on co-financed animal disease control programmes
The proposal does not have an effect on the control measures, including vaccination programmes that take place within areas that are affected by bluetongue disease. Therefore, the proposal will not have a direct impact on the EU annual and multi annual programmes for the eradication, control and monitoring of certain animal diseases.
B. Effects on agricultural sector
By allowing the wide use of vaccination in the Union, this proposal has the potential to reduce the negative economic impact of bluetongue caused by both direct and indirect losses (morbidity and mortality, disruption of trade in live ruminants) caused by this disease. In addition, a positive effect can be expected on the burden on farmers due to disease control measures and restrictions on trade currently applied in areas where vaccination is applied and that are therefore currently included in restricted zones (see 2.1).
C. Effects on other types of operators
The proposal will allow a wider use of vaccination and therefore a potential increased market for the pharmaceutical companies who produce the inactivated vaccines against bluetongue.
D. Effects on administrative costs
It is not expected that the wider and more flexible use of inactivated vaccines against bluetongue will have any effect on the administrative burden for Member States. No additional registration or procedures are required, except for the information Member States must provide to the Commission of their intention to put in place a vaccination programme.
2.2.2. Social impacts
Apart from a certain positive effect that arises from the flexibility that will be allowed for Member States, farmers and other animal keepers in the decision making on bluetongue control strategy, it is expected that the proposal will have no significant social impact.
2.3. Conclusion
The Commission considers that the amendment of the legislation is necessary to reflect the technological progress in the field of vaccine development. The current obstacles for preventive vaccination outside areas subjected to animal movement restrictions are not necessary when modern safe 'inactivated vaccines' are used. The proposed amendment will facilitate decision making on bluetongue control strategies on the basis of the specific situation within the Member States without unnecessary intervention by the Union.
This approach is expected to address the demands of several Member States and receive the support of stakeholders. It is also estimated that the potential economic and social benefits of this proposal are likely to outweigh potential disadvantages. The expected impacts are not considered significant enough to merit a full format impact assessment.
The legal basis of Directive 2000/75/EC is the second indent of Article 15 of Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (the 'basic act'), which provides that the Council may adopt specific provisions relating to the control and eradication measures for any of the animal diseases listed in Annex I to the Directive, acting on a qualified majority on a proposal from the Commission. Since the basic act providing for this legal basis is still in force, the legality of the powers vested in the Council in this act are not affected by the entry into force of the Lisbon Treaty and these powers remain solely with the Council.
4. RELATION TO OTHER EU INITIATIVES
This proposal is in line with the Animal Health Strategy (2007-2013) 'Prevention is better than cure', as it moves towards a more flexible approach to vaccination, as well as improving current measures to control major animal diseases.