Over the past few years, numerous M&A transactions have involved medical products law. Various small and medium-sized companies active in the sector have merged to take advantage of economies of scale and …
Subsequent to the "Act for the Protection of the Population in the Event of an Epidemic Situation of National Significance" dated 25 March 2020 (see our blog post dated 30 March 2020), the German Parliament passed the draft bill of the Second Act for the Protection of the Population in the Event of an Epidemic Situation of National Significance, proposed the parliamentary groups of the Christian Democratic Union (CDU/CSU) and the Social Democratic Party (SPD) on 14 May 2020, with votes of the CDU/CSU and SPD parliamentary groups. The bill was approved by the German Bundesrat, the Federal Council, on 15 May 2020.
The purpose of the Act is mainly to protect people particularly vulnerable to infection with the coronavirus and to gain a better insight into the course of the pandemic. Among other things, the Act establishes that the Federal Ministry of Health (BMG) is authorised to issue a regulation obliging statutory health insurance companies to generally pay for coronavirus or antibody tests. Furthermore, the public health service will be supported by federal measures, in particular to promote digitisation (EUR 50m will be made available for this purpose). In view of the recently enacted Digital Health Applications Ordinance (see our blog post of 28 April 2020), this is another step towards the digitisation of the health care system. As with the European Commission's announcement that the EU Medical Devices Regulation (EU) 2017/745 will be postponed to 2021 (see also our blog post from dated 1 April 2020), the Act also postpones the entry into force of the new Medical Devices Implementation Act by one year, and the Medical Devices Act will now apply one year longer, until 26 May 2021.
The corresponding communication of the Federal Ministry of Health with further explanations as well as the draft bill and the recommendation for a resolution (all of them in German) can be obtained through the following links:
Communication of the Federal Ministry of Health
Recommendation for a resolution
