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Planned Enactment of SARS-CoV-2-Pharmaceuticals Supply Regulation and Medical Needs Supply Securing Regulation

Planned enactment of the Federal Ministry of Health (BMG) of the SARS-CoV-2-Pharmaceuticals Supply Regulation and Medical Needs Supply Securing Regulation within the course of the corona crisis

With this article we would like to inform you about further facilitations concerning the marketing of medical products and personal protective equipment ("PPE"). See also our articles of 1.April 2020 (LINK) and 2.April 2020 (LINK).

The Federal Ministry of Health (BMG) has announced further regulations which - according to the Ministry - will become effective soon. In addition to the "Regulation concerning the Supply of Medical Products and Personal Protective Equipment during the Epidemic caused by the Coronavirus SARS-CoV-2" (see our Article of 15 April 2020 ) the BMG has announced the "SARS-CoV-2 Pharmaceuticals Supply Regulation" and the "Medical Needs Supply Securing Regulation" ("MedBVSV"). The regulations follow the recommendations of the European Commission ("EU-Commission") of 13 March 2020 and create legal certainty, inter alia, for the marketing of medical products and PPE.

1. Draft bill of SARS-CoV-2 Pharmaceutials Supply Regulation of 8 April 2020

Based on the authorization to issue regulations pursuant to the revised section 5 (2) Infection Protection Law (IfSG) the BMG on 8 April 2020 announced the SARS-CoV-2-Pharmaceuticals Supply Regulation and published the relevant draft bill (Draft Bill). Inter alia, the Regulation in ยง 8 provides for a selling and commitment ban for products of medical need. Pursuant to section 8 (4) of the Regulation products of medical need include also medical products and PPE. Pursuant to section 8 (1) of the Regulation the BMG may order that products of medical need are subject to market control and monitoring by the BMG. Pursuant to section 8 (2) of the Regulation manufacturers and distributors of products accordingly monitored and controlled are obliged to provide the BMG or an authority designated by the latter with information abut the stocks, production, distribution and the prices of the products of medical neet forthwith and at any time. Furthermore, pursuant to section 8 (3) of the Regulation the BMG is authorized to restrict the trade with controlled products and to provide for further details for the distribution and price fixing. The BMG may prohibit the sale or other commitment to provide products of medical need as well as the provision of products for the performance of obligations already incurred, to the extent that this is required to secure the supply of the population. The BMG may order that products, which are subject to a ban pursuant to section 8 (3) of the Regulation, have to be sold to the Federal Republic of Germany, a Federal State or a community or other legal or private person specified at a price to be fixed by public authorities.The price fixed by public authorities shall be based on the normal selling price of the product the latter had prior to the determination of the epidemic situation. Violations of the selling and commitment ban may be punished as administrative offence (sectio 73 (1)a No. 24 IfSG).

Pursuant to the draft bill the selling and commitment ban is justified as follows. The provision with products of medical need might also be jeopardized due to the fact that manufacturers of those products enter or entered into other contractual obligations. The bans prevent the primary performance of other obligations and make it possible that the products can be used for the fight against the pandemic situation caused by the coronavirus SARS-CoV-2. The possibility of ordering that relevant products have to be sold to certain legal or private persons at a price to be fixed by public authorities would be required to guarantee that these products are used appropriately.

The Regulation also provides for further rules concerning deviations from Volume 5 of the Social Insurance Code, the Pharmacy Act, the Pharmacies Operation Regulation, the Pharmaceutical Prescription Regulation, the Narcotics Act and the Narcotics Prescription Act.

The Regulation will cease to be in force upon annulment of the finding of a nation-wide epidemic situation, however, upon lapse of 31 March 2021 at the latest.

2. Draft Bill of Medical Needds Suppy Securing Regulation of 14 April 2020

On the basis of the authorization to issue a regulation the BMG announced the MedBVSV and the draft bill (Draft Bill).

Inter alia, the Regulation enables the central provision of products of medical need by the Federal Government for the supply of the population during the coronavirus epidemic.
Pursuant to section 1 (2) MedBVSV medical products and PPE are products of medical need.

In section 9 the MedBVSV further determines a legal basis which is meant to facilitate the marketing of personal protective equipment ("PPE"). Accordingly, pursuant to section 9 (2) of the Regulation, PPP within the meaning of the Regulation (EC) 2016/425 ("PPE-Regulation") can be made available on the German market - even if marketability is not given or cannot be determined - in deviation from the provisions of the PPE-Regulation if in an evaluation procedure by a notified authority on the basis of an evaluation principle published by the Central Agency of the Federal States for Safety Technology ("ZLS") it has been established that the PPE offers a health and safety level similar to the basic requirements of the PPE-Regulation. Thus, also PPE without CE-label can be considered as marketable by the market control and monitoring authorities if the suitability of the PPE is confirmed by an appropriate evaluation procedure. Such an abridged procedure is, inter alia, the procedure for respiratory masks developed by DEKRA and IFA (see our Article of 2 April 2020). Further abridged evaluation procedures might follow and will be published on the website of ZLS (LINK). The justification of the law regardig section 9 (2) MedBVSV also refers to the fact that the abridged evaluation procedure does not replace a conformity assessment pursuant to the PPE-Regulation.

In addition to the PPE within the meaning of section 9 (2) MedBVSV, now, pursuant to section 9 (1) MedBVSV, also PPE marketable in the USA, Canada, Australia and Japan may be made available on the German market. The competent market control and monitoring authority decides on its marketability.

To secure that PPE within the meaning of section 9 (1) and (2) MedBVSV is traceable and cannot be confused with compliant PPE under the PPE-Regulation pursuant to section 9 (3) the PPE has to be provided with an official confirmation which has to be added to each selling unit and indicates that the equipment is PPE which is made available according to the provisions of the MedBVSV.

Furthermore, the MedBVSV regulates exemptions from the Pharmaceuticals Act, e.g. exemptions from the Pharmaceuticals Act, the Pharmaceuticals Trading Regulation, the Transfusion Act and from the GCP-Regulation.

The Regulation will cease to be in force upon annulment of the finding of a nation-wide epidemic situation, however, upon lapse of 31 March 2021 at the latest.

3. Conclusion

With the new regulations the BMG reacted to the recommendation of the EU-Commission of 13 March 2020 and established legal fundamentals which, inter alia, facilitate the marketing of, at present, urgently required PPE. In so doing, the BMG followed the exemption rules proposed by the EU-Commission in its recommendation (see in this respect our Article of 15 April 2020 ) so that it is now possible to provide for the German market also PPE without having executed the conformity evaluation procedure and without CE-label. Due to the non-legally binding nature of recommendations of the EU-Commission (Art. 288 TFEU) an appropriate legal basis was necessary to create legal certainty. Pursuant to the justification of the MedBVSV, this Regulation is also in line with EU-law, since in times of crisis national measures in the field of the products of medical need are justified by the primary right of Union law (see Art. 168 (7) TFEU).

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