From Europe

A patient safety initiative: promoting good practice for off-label use of medicines


EMSP is part of a coalition of European healthcare organisations endorsing a Declaration meant to ensure that patient safety always prevails over cost considerations in the off-label use of medicines.

Find the Declaration here.

The related website page is hosted by our partners the European Brain Council (EBC).

What is off-label use?

It is the practice of using a medicine outside its authorised indication. It plays an important part in some medical areas since it can be of benefit to patients when no other treatment option is available. It is often the case in rare diseases or in child and adolescent care.

What does the Declaration ask?

The signatories of this declaration call on the European Medicines Agency (EMA) to adopt strict guidelines to support healthcare practioners and ensure economic benefit does not prevail over public health.

Off-label Use of medicinal products should only occur if the following criteria are met:

  • Presence of a severe, life-impairing or life-threatening condition
  • Absence of authorised treatment or repeated treatment failure
  • Absence of alternative treatments authorised for the condition
  • The off-label use is supported by strong evidence in scientific literature
  • The patient has been educated and has given his or her informed consent
  • Presence of established reporting routes for adverse events and linked to off-label use

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