25th July, 2016

The European Brain Council is glad to announce the launch of the website related to the Good Off-Label Use Practices (GOLUP) Declaration.

Off-label use is the practice of using a medicine outside its authorized 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. However, the current trend of promoting the prescription of medicines off-label for reasons other than the medical need of patients is creating unnecessary risks for patients.

A number of organizations, including EBC, are convinced that there is an urgent need for a clear approach on the issue at European level and for this reason they are supportive of the GOLUP Declaration, which provides a clear framework on when and how the off-label use of medicinal products could safely take place.

Our proposal does not intend to limit the off-label use, but aims to provide a harmonized approach for its occurrence in order to maintain the highest levels of patient safety and minimize any adverse events. The criteria identified reaffirm that patient safety should always prevail over considerations of cost and physicians should be supported by the public bodies and authorities responsible for the approval and use of medicines whose role is to protect public health. Physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.

To find out more about this initiative and the Declaration, please visit our website.