Mandate

Gleiss Lutz assists Federal Ministry of Health in defending ordinance on vaccinations for the 2022/2023 flu season

​In preliminary injunction proceedings brought by Sanofi Aventis Deutschland GmbH, Hesse Regional Social Court has upheld a decision by Frankfurt Social Court on the legality of the Ordinance on Entitlement to Vaccination against Flu and Measles.

As the manufacturer of the only authorised high-dose flu vaccine, Sanofi Aventis considered its fundamental rights under Article 12 in conjunction with Article 3(1) Basic Law (Grundgesetz) to have been violated by the Ordinance in view of a potential loss of turnover of around EUR 60 million. Germany's vaccination guidelines are drawn up by the country's Federal Joint Committee on the basis of the Standing Committee on Vaccination's recommendation. They currently favour giving persons aged 60 years and older the high-dose flu vaccine, but despite this, the Ordinance makes the continued use of conventional influenza vaccines possible. Its aim is to avoid supply bottlenecks during the 2022/2023 flu season, even if a new wave of flu cases coincides with the coronavirus pandemic.

Hesse Regional Social Court confirmed that the Ordinance can be based on section 20i(3), sentence 1 Social Security Code, Book V (Sozialgesetzbuch, Fünftes Buch) and put forward substantive arguments that fundamental rights have not been violated. Despite the medical benefits of the high-dose vaccine for persons aged 60 years and older, Hesse Regional Social Court stated that Sanofi Aventis had no claim to being the only flu vaccine supplier.

The Federal Republic of Germany was represented before both courts by Dr. Reimar Buchner (partner) and Dr. Enno Burk (counsel, both Healthcare, Berlin).

 

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