Bluetongue virus serotype 3 is currently posing a threat to ruminants such as sheep, cattle and goats as well as camelids in Switzerland too. Faced with the spread of this disease, agricultural associations and breeders' organisations are calling for the swift authorisation of vaccines in Switzerland. However, to date Swissmedic has not received any relevant applications. The assessment of such applications will be given top priority.
Bern, 13. September 2024
Therapeutic products agency Swissmedic has been following the epidemiological situation of bluetongue virus serotype 3 for months now and is in close contact with the Federal Food Safety and Veterinary Office (FSVO) and the veterinary medicinal product industry. Despite discussions with the industry, Swissmedic has not yet received any authorisation applications for relevant vaccines, and the authorities have no way of demanding such applications be made. In line with the principle of economic freedom, companies are responsible for deciding if and when to bring a medicinal product to the Swiss market. Swissmedic has made these companies aware of the option of fast-track authorisation procedures for vaccines against serotype 3. Swissmedic would process such applications with top priority.
Differing legal frameworks in Switzerland and the EU
In contrast to Switzerland, the EU possesses a legal framework that, under certain circumstances, allows member states to introduce a vaccine that has not yet been authorised. However, this is associated with risks due to the limited availability of data regarding efficacy, safety and quality. The use of such vaccines may represent a danger for the affected animals and must always be weighed up against the current epidemiological situation. Some EU countries (Germany, Netherlands, Belgium and France) have already made use of this legal exemption. Switzerland has no legal framework for a similar procedure. The Swiss Therapeutic Products Act and its ordinances state that medicinal products may only be marketed in Switzerland once they have been authorised by Swissmedic. Moreover, in Switzerland there is no legal basis that would allow the FSVO – the responsible body – to approve the import of these vaccines, since they are not authorised in other countries.
The bluetongue virus causes severe symptoms such as fever, inflammation of the mucous membranes, oedema and lameness, particularly in sheep. Other ruminants are also affected, yet the course of disease is often milder in these animals.