European Medicines Agency publishes interim fee advice for bluetongue-vaccine manufacturers

7 June 2013

The European Medicines Agency has published a Public statement on authorisation of bluetongue vaccines, which proposes changes to the implementing rules of the fee regulation related to inactivated vaccines against bluetongue disease. This is to reflect the change in the epidemiological situation of the bluetongue disease and the availability of vaccines since the Agency put incentives in place to promote availability of bluetongue vaccines in 2008.

The 2008 decision by the Agency's Executive Director granted fee reductions for inactivated-bluetongue-vaccine applications. This was part of a package of measures taken by the Agency to promote the rapid availability, at European level, of safe and effective vaccines in response to the epidemiological situation of bluetongue disease at the time and the lack of authorised vaccines.

This decision expired in March 2013, removing any fee reductions in place until that date.

Rather than adopt a new decision, the Agency has proposed to amend the implementing rules of the fees regulation to introduce certain fee reductions for bluetongue vaccines.

These proposals will be considered by the Agency's Management Board as part of the regular review of the implementing rules at its meeting in March 2014. Interim measures are therefore necessary in order not to disadvantage marketing-authorisation holders of existing bluetongue vaccines, or applicants for new authorisations. Exceptional fee exemptions will be applied when these authorisations or applications are aligned with the public statement. Companies are advised to seek guidance from the Agency on the procedure to follow.

In addition, the Agency has now gained sufficient experience with the annual re-assessments of existing marketing authorisations for bluetongue vaccines under exceptional circumstances, and their subsequent conversion to standard authorisations. Guidance on this subject is also provided in the public statement.

Bluetongue disease is caused by a non-contagious virus spread by a species of midge and is most commonly seen in the late summer and autumn. All ruminants, such as cattle, goats, deer and sheep, are susceptible, although symptoms are generally most severe in sheep.

The disease represents an ongoing threat to European Union (EU) livestock, and there is a continued need both to encourage the maintenance of existing authorisations and to promote the introduction of new strains into existing vaccines as the need arises. Bluetongue is now viewed as an endemic disease due to the ability of the midge vector that is responsible for its transmission to survive over winter in certain parts of the EU, thereby maintaining the disease year on year.

Since 2008, 12 vaccines against bluetongue have been authorised on the recommendation of the Agency.