The undersigned organisations, supportive of the Declaration on Good Off-Label Use Practice, welcome Professor Guido Rasi’s, Executive Director of the European Medicines Agency, response to our letter addressed on 8 November 2016.
Off-label use is the practice of using a medicine outside its authorised indications. 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, a clear approach at European level on the use of medicinal products off-label is still lacking and an increasing trend of promoting the off-label prescription for reasons beyond the medical need of patients is increasing.

Professor Guido Rasi shares our view that the off-label use is becoming an issue of concern for public health. It is in this light that we have drawn Professor Rasi’s attention to the Declaration on Good Off-Label Practice. These good practices stem from decades of research and clinical practice. By providing a harmonized approach for the occurrence of off-label use, they aim to maintain the highest levels of patient safety and minimize any adverse events for patients. The criteria identified reaffirm that patient safety should always prevail over considerations of cost and physicians should be supported by the public authorities responsible for the approval and use of medicines whose role is to protect public health.

As organisations calling for a clear and harmonised approach on this matter, we expect the European Commission’s study on the use of off-label medicinal products in the EU, which has been almost two years in the making, to trigger much needed action at the European level on this crucial issue. An increasing number of patients’ lives are at risk, and doing nothing is no longer an option. Now is the time for action! We look forward to continue working with the European Medicines Agency to ensure the highest medical standards for patients in Europe.
You can find our letter and the response of Professor Rasi below.

Response from EMA: Upholding the Good Off-Label Use Practice: Adressed to Mr. Destrebecq

Call to EMA: Upholding the Good Off-Label Use Practice