Bart specialises in European and Dutch regulatory matters concerning pharmaceuticals and biologicals. He advises and represents clients, including the world’s leading pharmaceutical and biotechnology companies as well as medium and small size companies, on all aspects of medicinal product development, from marketing authorisation procedures, manufacturing (GMP) and distribution (including import and export), regulatory exclusivities and enforcement thereof, pharmacovigilance and pricing and reimbursement. Bart has extensive experience in administrative law as it pertains to procedures against administrative authorities such as the Ministry of Health, the Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) and the Dutch Healthcare Authority (Nederlandse Zorgautoriteit).
- Advised and represented pharmaceutical companies in cross-border litigation cases concerning the authorisation of medicinal products and/or enforcement of regulatory exclusivities through national or international (decentralised, mutual recognition or centralised) procedures.
- Advised and represented pharmaceutical companies on issues concerning the pricing, reimbursement and substitution policies of administrative authorities and healthcare insurers for biologicals and other expensive medicinal products.
- Engaged many times, on behalf of clients, in interactions with the EU regulators, the European Medicines Agency and the Commission, and national competent authorities on these issues, and where necessary presented them before the EU and national courts.
University of Amsterdam, Master of Law