According to the KCE, the use of drugs for indications other than those provided in the manual concern as 80% of medicines prescribed in pediatrics and more half of those required in oncology. There are generally no guarantees that such use is effective and safe, says the center of expertise.

KCE offers to gather “as quickly as possible” reliable scientific evidence about the uses drugs off-label, in collaboration with producers or not, and to prohibit such practices in the event of negative evidence.

If the authorization to market a medicine is granted, it will valid only for the requested indication reminds the KCE. Any doctor, however free to prescribe a drug for indications other than those authorized, especially if conventional treatment does not give results, if there is no authorized medicinal product for the problem which the patient is suffering (which is often the case in pediatric), or if the drug is equivalent to a much more expensive alternative. In the latter case, in the treatment of a rare disease of the pulmonary arteries, doctors and prescribe Viaga instead of Revatio, much more expensive than the first.

Ideally, producers should introduce new applications for authorization to validate these practices but they do not always have an interest in doing so. This presupposes new investments in clinical studies, as they already receive income from the use of off-label drugs. The relevant market is generally limited. Finally, new studies may highlight unknown security problems, or less effective than expected, leading the KCE.