Competencies:
Regulatory matters, marketing permissions (central, decentral, and national procedures), business permissions, marketing, questions in relation to medical staff, clinical trials, and contracts with investigators; pricing matters, subsidies to medicinal products, re-examinations of subsidies, RADS, KRIS, the Health Law, legal matters regarding the EU (such as for instance, directive 201/83 regarding medicinal products, Regulation 726/2004, and the Transparency Directive 89/105) as well as related subjects, such as the free movement of goods, the rules on competition, state aid, distribution etc. Product liability, insurance/patient insurance, procurements, and neighboring subjects, especially medical equipment and food/food supplements, etc.
Experience:
Counselling the Danish Association of the Pharmaceutical Industry, Lif, during the whole period, with regards to several matters such as for instance a product liability arrangement, Amgros, price agreements of the trade, RADS, legal matters for pharmacists, distributors, subsidies for medicinal products (general, reassessments, and individual subsidies), marketing permissions, generic medicine, parallel import, etc.
Assisting Lif towards the European Commission in matters of subsidies for medicinal products, regarding the standstill on prices for medicinal products (the free movement of goods), and competition matters with regards to the price agreements of the trade.
Conducting cases at the courts regarding parallel import and subsidies for medicinal products.
In 1997, co-founder of Conference Bleue whose members are law firms from all the member states of the European Union that are concerned especially with regulatory matters.
On an ongoing basis, advice to pharmaceutical companies, medico-companies, and food businesses, counselling on regulatory matters within all kinds of subjects; business permissions, marketing permissions, the wholesale chain, logistics, advertising regulations, all kinds of subsidies, procurements, sale and dispensing of medicinal products, etc.
Medical equipment – delimitation to medicinal products, marketing, M & A cases, etc.
Food – herbal medicine and marketing, cases regarding delimitation to medicinal products, sports products, food supplements, herbal medicine, negotiations with the food safety authorities and the National Board of Health.