On March 28, 2020, the “Federal Act for the Protection of the Population against an Epidemic of National Significance” (Bevölkerungsschutzgesetz) went into effect.  The law forms part of an emergency legislative package introduced by the German government in response to COVID-19.

The law amends the Social Code V (SGB V) by introducing a new provision (sec. 287a) that aims to overcome fragmentation across the German regulatory landscape for scientific research in the health sector generally.  In particular, research projects in the health sector are often hampered by the 16 federal states’ hospital acts and data protection acts that place various restrictions on researchers.

Under the new law, scientific research projects in the health sector conducted in two or more federal states will only be subject to Section 27 of Federal Data Protection Act (BDSG) if public or private bodies from two or more federal states or federal agencies participate in the project.  Moreover, the data controllers concerned must appoint a “principal controller”, and the Supervisory Authority responsible for the principal controller’s main establishment will have exclusive competence to oversee the project.  According to the official rationale of the draft law, this new rule is based on the opening clauses in Art. 9(2)(i) and (j) GDPR.

Photo of Ulrike Elteste Ulrike Elteste

Ulrike Elteste is an experienced technology, media and intellectual property lawyer in the firm’s Frankfurt office. She also advises on related regulatory aspects, in particular, privacy law, financial services supervisory law, and telecommunications law. She is regularly involved in cross-border transactions with a…

Ulrike Elteste is an experienced technology, media and intellectual property lawyer in the firm’s Frankfurt office. She also advises on related regulatory aspects, in particular, privacy law, financial services supervisory law, and telecommunications law. She is regularly involved in cross-border transactions with a focus on technology or IP. Ulrike also represents clients in commercial and IP litigation.

Photo of Kristof Van Quathem Kristof Van Quathem

Kristof Van Quathem advises clients on data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of…

Kristof Van Quathem advises clients on data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of advising clients on government affairs strategies concerning the lawmaking, to compliance advice on the adopted laws regulations and guidelines, and the representation of clients in non-contentious and contentious matters before data protection authorities.