PURPOSE: to amend the European Union’s legislative framework in order to ensure the better control of the spread of the bluetongue virus and reduce the burden on the agricultural sector posed by that disease.
PROPOSED ACT: Council Directive.
BACKGROUND: Council Directive 2000/75/EC of 20 November 2000 lays down specific provisions for the control and eradication of bluetongue, including rules on vaccination. In the past, only sporadic incursions of certain serotypes of the bluetongue virus were recorded in the Union. Those incursions mainly occurred in the southern parts of the Union. However, after the adoption of Directive 2000/75/EC, and particularly after the introduction into the Union of bluetongue virus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue virus has become more widespread in the Union, with the potential of becoming endemic in certain areas. It has therefore become difficult to control the spread of that virus.
The rules on vaccination against bluetongue laid down in Directive 2000/75/EC are based on experience of the use of so-called "modified live vaccines", or "live attenuated vaccines" that were the only vaccines available when that Directive was adopted.
In recent years, as a result of new technology, "inactivated vaccines" against bluetongue have become available, which do not pose that risk to unvaccinated animals. It is now widely accepted that vaccination with inactivated vaccines is the preferred tool for bluetongue control and the prevention of clinical disease in the Union. Under the current rules, the use of vaccines against bluetongue is prohibited outside "restricted zones" where the disease has appeared and where animal movement has been restricted.
PREFERRED OPTION AND ASSESSMENT OF ITS IMPACTS: 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.
LEGAL BASIS: 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. This article 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.
CONTENT: in order to ensure the better control of the spread of the bluetongue virus and reduce the burden on the agricultural sector posed by that disease, it is appropriate to amend the current rules on vaccination laid down in Directive 2000/75/EC in order to take account of the recent technological developments in vaccine production.
The proposed amendments should make the rules on vaccination more flexible and also take into account the fact that inactivated vaccines are now available, which can also be successfully used outside areas subjected to animal movement restrictions.
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.
BUDGETARY IMPLICATION: the proposal has no implication for the European Union’s budget.