Off-Label Prescribing of Medication: Case Law and Renewed IGJ Position

Medication is often prescribed for indications and target groups, or in dosages or forms of administration that are not included in the product information with the marketing authorisation. This practice is known as ‘off-label’ prescription or use. Off-label prescribing of medication happens often and legal problems have been surrounding this practice for a long time. The key question is when deviating from the registered indication is permitted and where the limits are. There is a field of tension between the physician’s professional autonomy and the normative effect of guidelines and standards in the medical profession. Section 68 of the Dutch Medicines Act offers room for off-label use, but sets express boundaries to that room to ensure the quality and safety of care.

Recent rulings of the Administrative Law Division of the Council of State and several (regional) disciplinary tribunals show that this standard is not always interpreted and applied identically. Against this background, the Health and Youth Care Inspectorate (“IGJ”) tightened its position on off-label prescriptions in 2026.

In this article we will describe the main conclusions from these recent rulings and the IGJ’s position. 

In its ruling of 25 February 2026 (ECLI:NL:RVS:2026:1069), the Administrative Law Division strictly followed medical substantive guidelines. The Division left little room to deviate from these guidelines. The case concerned a GP who had prescribed Ivermectin off-label to a COVID 19 patient, although the NHG expressly advised against the use of this drug. The Division held that such a “non-permissive guideline”, which advises precisely against off-label prescription of a certain drug, leaves no room for off-label prescribing. The doctor's arguments that this drug was used frequently in practice and that a group of doctors had prepared a Self-Care Covid Protocol were considered irrelevant; the decisive fact was the absence of consensus within the profession. Protocols from a limited group of doctors or foreign guidelines cannot override an applicable Dutch standard.

A different and broader approach emerges from two rulings of the Amsterdam Regional Disciplinary Tribunal of 24 February 2026 (ECLI:NL:TGZRAMS:2026:34 and :35). These dealt with GPs who prescribed Prednisolone off-label for a throat swelling, The Tribunal emphasized that prescribing off-label medication is permitted on certain conditions and that this is common and happens often. The contents of the guidelines are important, but not exclusively decisive. The Tribunal deems the key question to be whether the doctor has acted according to current scientific knowledge and practice, and whether the individual interests have been carefully weighed. One consideration was that off-label prescriptions happen frequently. Provided that there is a sound medical substantiation and careful execution, it may therefore be permissible to deviate from guidelines. Most accusations in these matters concerned poor documentation of a case and insufficient express informed consent.

By contrast, In its ruling of 12 March 2026, the Zwolle Regional Disciplinary Tribunal (ECLI:NL:TGZRZWO:2026:41) chose a stricter line. An anaesthesiologist had prescribed Enoximon off-label for home use, although there were no protocols or standards for such use (neither existing, nor under development). The Board held that this prescribing could not be justified by current scientific knowledge and practice. The absence of consensus, peer consultations and adequate monitoring were decisive. It made no difference that the doctor’s actions were inspired by a personal mission to help patients.

A more nuanced approach can be seen in the ruling of the ’s-Hertogenbosch Regional Tribunal dated 1 April 2026 (ECLI:NL:TGZRSHE:2026:62). In a complex psychiatric case, where regular therapies had not achieved sufficient effect, the Tribunal acknowledged that there may be room for unconventional treatment options. A permissive guideline – that allows off-label prescribing for the purpose used – existed for one drug, but not for the other. Although the off-label prescribing was considered substantively arguable, the absence of prior consultations with the pharmacist was culpable under disciplinary law. The lesson to be learned from this case is that medical complexity allows caregivers room to deviate from the guidelines, but does not relieve them from the formal requirements of Section 68 Dutch Medicines Act.

The rulings show that there is no uniform line and that the Division and the several disciplinary tribunals still use different interpretations. Sometimes guidelines almost reign supreme, whereas other cases leave room for medical assessment and individual considerations. But this room has its limits, especially if there are no guidelines, no consensus, or the decision-making process is not careful enough. The prescribers (who are registered in the BIG) may be subjected to disciplinary sanctions or administrative penalties. The attitude of the administrative courts seems somewhat stricter than that of the disciplinary tribunals. The latter use the standards of the BIG Act to test whether a care provider has acted as could be expected of him/her under the circumstances. The administrative courts, on the other hand, test primarily against the wording of the Dutch Medicines Act. 

With reference to this case law, among other things, the IGJ updated its position on off-label prescribing in line in 2026. The Inspectorate adopts a ‘no, unless’ approach and clearly follows the stricter line of the administrative courts described above.

At the heart of this is a step-by-step plan in which guidelines make up the first review framework. The first question is whether a registered drug can be prescribed within the registered indications; if yes, such prescribing is allowed. If no, the next question is whether off-label use is permitted in a guideline, in which case the drug can be prescribed according to that standard. If a guideline advises against prescribing, off-label use is not permitted. If there are no guidelines, it is in principle prohibited, save in exceptional and well-substantiated individual emergency situations.

The IGJ has also specified the requirements of due care. A doctor must expressly weigh the efficacy against the risks; a patient must expressly be informed and give consent; consulting a pharmacist is mandatory; the prescribing doctor must refer to the medication history; and extra monitoring of the patient is required.

Prescribing medication off-label remains possible, but comes with legal risks and points of attention. While disciplinary law sometimes allows room for medical considerations beyond guidelines, the IGJ and the administrative courts clearly prefer a normative framework in which guidelines prevail. For practice, this means that not only medical substance matters, but also that the correct normative framework should be followed, decision-making should be careful and recording should be adequate.

Are you in need of additional information or do you have questions after reading this article? Please contact Eline Lam or Floor Cornelissen.