The healthcare system is an increasingly complex environment continuously challenging those operating within it. Accessibility and affordability are factors requiring perpetual attention. On top of that, the public sector imposes new demands every day: governance, transparency, competition, privacy, and much more. As a result, the sector is a regulatory system of such complexity that it requires specialist knowledge. AKD's Healthcare and Life Science teams are at home in the healthcare and life sciences sector, understand the market and its players, and know the law inside out.
Our lawyers assist care providers, sectoral organisations, pharmaceuticals (manufacturing human as well as veterinary medicinal products), medical device manufacturers, wholesalers, specialists, and local authorities on a daily basis. Our assistance encompasses the following fields, and more:
- Mergers and acquisitions, forms of collaboration
- Contracts with healthcare insurers, care administration offices, and municipal authorities
- Compliance monitoring by healthcare insurers and care administration offices
- Regulatory, including the Medicines Act (Geneesmiddelenwet), Medical Devices Act (Wet op de medische hulpmiddelen), market access for medicines and medical devices, permits, GMP and GDP
- Advertising and marketing of medicinal products and medical devices
- Governance
- Supervision by the Dutch Healthcare Authority and the Inspectorate for Health and Youth Care
- Rates and performance regulation and funding by the Healthcare Authority
- Quality standards imposed by the National Healthcare Institute
- Merger review by the Healthcare Authority and the Netherlands Authority for Consumers & Markets
- Patient privacy
- Product liability
- Litigation, against authorities, suppliers, customers, competitors and/or other parties
- Drafting and negotiating various agreements and contracts, including clinical trial agreements, material transfer agreements, research (& development) agreements
Where necessary, AKD's Healthcare and Life Sciences teams will draw upon the expertise of colleagues in other fields, guaranteeing a service characterised by comprehensive sector knowledge and in-depth legal advice.