Machteld Hiemstra
Machteld is a civil liability and regulatory law specialist with a specific focus on highly regulated sectors or products and services, in particular the Life Sciences sector. She is a litigator and advises clients in civil and administrative courts from first instance up to the supreme court or before the European courts. Typically, companies call her for assistance on issues in relation to judicial review, enforcement actions, market access, product liability and commercial conflicts. Her expertise also includes highly significant legal areas, including GDPR and the AI Act. Machteld furthermore has a wealth of experience in handling SPC litigation (Patent Supplementary protection Certificates) which is a niche legal expertise in the cross-over of patent law and medical regulatory law. Due to the nature of the clients, cases very often require technical affinity and deep understanding not just of the law, but especially also of the product or services at stake. Her sector knowledge is deep and practical and includes industry experience having been a global inhouse counsel at Akzo Nobel for several years and fulfilling several interim positions as well. In recent years she advised and represented clients in cases with regard to data protection and trade secrets, open government, GDPR, consumer protection, pharmaceutical and medical devices legislation advertising and promotion, product pricing and reimbursement, pharma and medical devices tender disputes, market access, authorisation and withdrawal proceedings and product liability cases. Machteld speaks, teaches and writes regularly on topics relevant to her fields of expertise. · Simmons & Simmons
About
Machteld Hiemstra is a civil liability and regulatory law specialist with a specific focus on highly regulated sectors or products and services, in particular the Life Sciences sector. She is a litigator and advises clients in civil and administrative courts from first instance up to the supreme court or before the European courts. Her expertise includes judicial review, enforcement actions, market access, product liability, commercial conflicts, GDPR, AI Act, and SPC litigation—a niche area at the intersection of patent law and medical regulatory law. She has industry experience as a former global inhouse counsel at Akzo Nobel and has held several interim positions. She speaks, teaches, and writes regularly on topics relevant to her fields of expertise.