The Centre for Biosecurity and Biopreparedness (CBB) is the Danish national authority that issues licences to research institutions, pharmaceutical companies, hospitals etc. to allow them to work with biological dual-use components. 

Laws and Regulations

The Danish biosecurity system is based on Act no. 474 of 17 June 2008 on securing specific biological substances, delivery systems and related materials and Act no. 53 of 11. January 2017 on control of animal pathogens.

Act no. 474 of 17 June 2008 empowers the Minister of Health to implement relevant regulation concerning possession, production, use, storage, acquisition, sale, and other forms of transferral, distribution, transport, and movement of specific biological substances as well as delivery systems and related materials. The biological substances, delivery systems, and related materials are in general the same as listed in the EU regulation for export control of products and technology with dual-use, which can be used in biological attacks on people and thus represent a danger to public safety and security.

Act no. 474 of 17 June 2008 has been followed by the Executive Order no. 981 of 15 October 2009. The Executive Order sets out the specific regulations for companies who wish to obtain a licence to hold, produce, use and store etc. biological substances, delivery systems and related materials listed in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments.

The duties and powers of Act no. 53 of 11 January 2017 on control of animal pathogens that are assigned to the Danish Veterinary and Food Administration by the Ministry of Environment and Food of Denmark are exercised by the Danish Centre for Biosecurity and Biopreparedness on behalf of the Danish Veterinary and Food Administration. Executive Order no. 803 of 22 June 2017 sets out the specific regulations that Centre for Biosecurity and Bioprepareness administers. This means that companies who wish to hold, produce, use and store etc animal pathogens that can be used in connection with biological attacks on animals must apply Centre for Biosecurity and Biopreparedness to obtain a licence. The controlled animal pathogens are listed in the Annex 1 of Executive Order no. 803 of 22 June 2017.

Confidentiality

According to Section 27 of the Danish Public Administration Act, the Centre for Biosecurity and Biopreparedness has a duty of confidentiality in relation to companies regarding all confidential or otherwise sensitive information. Examples are financial information that is not available from public sources, information about operational conditions, business relations, trade secrets, patent information etc.