Named-patient supply: make sure it is applied in compliance with the requirements

The key principle in pharmaceutical law is that medicinal products may only be placed on the market after having obtained a marketing authorisation. In exceptional cases—such as when no authorised alternative is available—medicinal products may be supplied from abroad based on a physician’s statement. In practice, however, we perceive that named patient-supply is sometimes being continued, even when an ‘authorised medicinal alternative’ is already available.

⚖️ We recently challenged such a case. 

A medicinal product for which our client had obtained a marketing authorisation (so, there was an ‘authorised medicinal alternative’) was still reaching the market via another party via the named-patient exception. The other party had just obtained a renewed approval for named patient supply. By way of (timely) objection and lodging an enforcement request, we successfully protected the justified interests of our client.

The case underscores the importance of strict application of legal exceptions, to safeguard the balance between quality and availability. Named-patient supply plays an important role in the system,  but should be applied in compliance with the relevant legal requirements. 

However, a lot is going on in this space currently. 

Do you have questions about named-patient supply and/or the applicable (future) legal framework? 

Feel free to reach out.