Bart Jong
Bart Jong advises organizations of all sizes, including pharmaceutical and biotechnology companies, on the European and Dutch regulation of medicinal product development, including marketing authorization procedures, manufacturing and distribution, regulatory exclusivities (data and marketing protection and orphan and pediatric exclusivities) and related enforcement, pharmacovigilance, inspections, and pricing and reimbursement. Bart is fluent in Dutch and English. He is admitted to practice in the Netherlands only.
Bart’s experience extends to administrative law pertaining 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).
Bart’s cross-border litigation for pharmaceutical companies concerns the authorization of medicinal products through centralized or national (including decentralized or mutual recognition) marketing authorization procedures and/or the enforcement of regulatory exclusivities. He also frequently advises pharmaceutical companies on issues regarding the administrative authorities and healthcare insurers’ pricing, reimbursement, and substitution policies for biologicals and other expensive medicinal products.
Bart assists clients in interactions with EU regulators, the European Medicines Agency and the European Commission, and national competent authorities, including inspections and investigations and, where necessary, representations before the EU and national courts. Over the last two decades, Bart has been involved in many of the landmark cases about regulatory exclusivities before the Court of Justice of the EU.
Prior to joining Morgan Lewis, Bart was a partner at another international law firm.
