Objection That Law Is Insufficiently Clear
In October and November 2021, the general practitioner prescribed the medication seven times for the treatment of patients with COVID-19. He disagrees with the fine. He finds the legal article he allegedly violated insufficiently clear. According to him, the text of the legal article does not prohibit a doctor from deviating from protocols or standards that advise against off-label use of medication.
Law Is Sufficiently Clear, Fine Is Justified
According to the Administrative Jurisdiction Division, the text of the article in the Medicines Act is sufficiently clear and the general practitioner violated the law. Off-label prescribing of medicines means that doctors prescribe drugs outside the indications registered by the Medicines Evaluation Board. The Medicines Act only allows this if protocols or standards have been developed within the professional group. A doctor can prescribe a medicine off-label if there are protocols and standards that permit such prescriptions. But that was not the case here. On the contrary, there was an advice from the Dutch College of General Practitioners that discouraged the use of ivermectin for COVID-19. The law therefore offers no possibility for doctors to prescribe medicines off-label. The general practitioner violated the law and the minister was therefore allowed to impose a fine, according to the Administrative Jurisdiction Division, which thereby confirmed the ruling of the Zeeland-West-Brabant court that reached the same conclusion in July last year.
Fine Will Not Be Reduced
The Administrative Jurisdiction Division further considers in the ruling that the general practitioner intended to conscientiously fulfill his professional responsibility as a doctor by prescribing ivermectin in these exceptional circumstances. Earlier this year in March, the Administrative Jurisdiction Division also issued rulings on off-label prescribing of medicines and then reduced the fines imposed on doctors for that reason. The Administrative Jurisdiction Division does not do so in todays ruling. The general practitioner asked patients to destroy their files after the prescriptions were made because he “risks large fines by prescribing.” The minister rightly took the view that this approach conflicts with exercising professional responsibility as a doctor. Good, accessible, and understandable documentation in the medical file is of great importance for the quality and continuity of care and guidance. Moreover, a doctor has the professional responsibility to be accountable and is legally obliged to keep a patient file. This responsibility and obligation conflict with a practice in which a patient is asked to destroy the file. This is all the more serious because this request was not motivated by the patients interest but by the doctors own financial interest to avoid fines.
