Updates

New working arrangements between Dutch Food Safety Authority and Inspection Board Health Products

In the Netherlands, advertising disputes over health products rarely reach the civil courts. Instead, self-regulation by the Inspection Board plays a central role, working hand in hand with the Dutch Food Safety Authority (NVWA). New working arrangements between the two bodies, in force until the end of 2027, set out exactly when a case stays within self-regulation and when NVWA steps in directly. With the line between a lawful health claim and an unauthorised medical claim often razor-thin, knowing which route applies matters.

Axon assists medical technology companies in structuring their collaborations with hospitals and universities. We draft and negotiate cooperation agreements that protect our clients’ IP while fostering innovation.

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).

We have assisted a large company in setting up a patient support program.

We have advised a client on collaborations between pharmaceutical companies and healthcare providers and contract research organisations, including the negotiation of framework agreements for clinical research.

We have advised a digital health start-up on the qualification of its services under Dutch healthcare law, including the determination of whether the company qualifies as a healthcare provider and the resulting regulatory obligations.

We have advised a healthcare provider on compliance with the Dutch Healthcare Quality, Complaints and Disputes Act (Wkkgz), including the implementation of an internal complaints procedure and the appointment of a complaints officer.

We have assisted a medical device manufacturer in assessing whether its product is eligible for reimbursement under Dutch healthcare insurance law.

We have assisted a healthcare start-up with the regulatory requirements for establishing a healthcare institution in the Netherlands, including the required permits and governance structure.