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Update: Entry into Force of the SARS-CoV-2 Pharmaceuticals Supply Regulation of the Federal Ministry of Health (BMG)

The SARS-CoV-2 drug supply regulation announced on 8 April 2020 (see our Article of 17 April 2020) came into force on 22 April 2020 (SARS-CoV-2-Pharmaceuticals Supply Regulation).

The Regulation deviates considerably from the draft bill in some sections. The selling and commitment ban in section 8 of the draft bill is now regulated in section 7 of the SARS-CoV-2 Pharmaceuticals Supply Regulation. The obligation of manufacturers and distributors to provide information, which is regulated in section 8 (2) of the draft bill, has been adopted and extended to include information on the storage location of the products concerned, section 7 (1) of the SARS-CoV-2 Pharmaceuticals Supply Regulation.

The initially envisaged authority of the Federal Ministry of Health ("BMG") to issue a ban on the sale of products of medical need was deleted. The regulation provided for in the draft bill that a ban can also extend to other obligations to supply as well as to the supply to fulfil obligations already undertaken was also not adopted. Rather, section 7 (2) of the SARS-CoV-2 Pharmaceuticals Supply Regulation stipulates that manufacturers and distributors of products of medical need relevant to healthcare must ensure, within the scope of their responsibility and what is reasonable for them, an adequate and continuous supply of products of medical need relevant to healthcare so that the needs of the population within the scope of the Regulation are covered. The prices of such products must be based on the costs of provision, and manufacturers and distributors may not impose surcharges on consumers on account of the epidemic situation of national dimensions. Also, the concept of "Factual circumstances relating to products of medical need relevant to the provision of healthcare" was newly introduced in section 7 (3). According to this provision, products of medical need relevant to the provision of healthcare are pharmaceuticals, their active substances, starting materials and auxiliary materials, medical products, laboratory diagnostics, auxiliary materials, items of personal protective equipment, products for disinfection and their individual components, for which the BMG has determined that they are of essential importance for the provision of care to the population in an epidemic situation of national dimensions. The respective statements are published in the Federal Gazette.

Section 5 (2) no. 6 of the German Infection Protection Act must be observed. Accordingly, the BMG is authorised to issue the necessary orders to implement the measures regulated in the enacted regulations. Thus, the BMG can issue orders to ensure that the obligations of manufacturers and distributors as defined in section 7 of the SARS-CoV-2 Pharmaceuticals Supply Regulation are fulfilled. As a result, corresponding selling and commitment bans can be ordered. In order to protect manufacturers and distributors from any damage caused by this, section 7 (2) of the SARS-CoV-2 Pharmaceuticals Supply Regulation provides for a reimbursement claim for manufacturers for expenses incurred if, as a result of an order pursuant to section 5 (2) no. 6 of the Infection Protection Act, they are no longer in a position to fulfil their obligations arising from contractual relationships already entered into. Accordingly, the manufacturer or distributor may claim reimbursement of the expenses they have to bear in relation to the other contracting party.

Dr Silke Dulle

Robert Schmid

Contact us

Dr. Silke Dulle T   +49 30 26471-155 E   Silke.Dulle@bblaw.com
Robert Schmid T   +49 30 26471-262 E   Robert.Schmid@bblaw.com