The Danish healthcare industry is characterised by a vast number of companies, including pharmaceutical companies, manufacturers and distributors of medical equipment, private hospitals, etc. The industry is subject to extensive regulation – both EU and Danish legislation.
BACH Law offers advisory services on regulatory issues concerning pharmaceuticals and medical equipment, including the rules on advertising, affiliation with health-care providers (HCP’s) and the approval and registration of products. We have insight into the regulations on medical equipment, which entered into force in 2020, and which will involve significant changes when compared with the previous rules.
We also offer advice on contractual matters relating to the industry, including contracts about clinical (and other) trials, contract research, distribution agreements, license agreements, etc.
As a particular area of expertise, we have experience in offering advice on the design and implementation of compliance programmes, and we also offer advice to companies in the industry on procurement rules, including the submission of bids for public-sector contracts and the handling of complaints or legal proceedings in this respect.