Update: Entry into force of the Medical Need Health Care Assurance Regulation ("MedBVSV") of the Federal Ministry of Health (BMG)

The Health Care Assurance Regulation MedBVSV which was announced on 14 April 2020 (please also see our post dated 17 April 2020) entered into force on 27 May 2020 (LINK to MedBVSV).

The Regulation deviates from the draft bill to some extent. Many of the changes are of a purely editorial nature. In some cases, however, the provisions have been specified even more in order to specifically limit the scope of the standards. More extensive adjustments of content have also been carried out, for example, in the exceptions to the German Transfusion Act (Transfusionsgesetz) (section 5 MedBVSV), the German Pharmaceuticals Act Cost Regulation (AMG-KostV) (section 6 MedBVSV) and the Cost Regulation for any official acts of the Paul Ehrlich Institute under the German Pharmaceuticals Act (AMG) (section 7 MedBVSV). It is particularly noticeable in the case of sections 6 and 7 that the regulations are no longer merely optional provisions, but that the charging of fees is now waived in the corresponding cases if the subject matter is a drug for the treatment, prevention or diagnosis of COVID-19. In the draft bill, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute were still responsible for deciding if the charging of fees would be waived.

Section 9 MedBVSV forms ‑ as already in the draft bill ‑ the legal basis for facilitating the placing on the market of personal protective equipment (see also our post dated 2 April 2020). In comparison to the draft bill, almost only editorial adjustments were made here. Section 9 (1) MedBVSV now also includes that the marketable products are made available on the German market by an "economic operator in terms of Article 3 (8) of Regulation (EU) 2016/425". The standard is thus further specified.

Dr Silke Dulle

Robert Schmid