French Public Health Code
In forceI.-An authorisation for cancer treatment may only be issued, maintained or renewed if the holder of the authorisation complies with a minimum annual level of activity on its geographical site, defined by modality, indication and, where applicable, specific therapeutic practice, and set by order of the Minister for Health.
This minimum annual level of activity is established by reference to available knowledge in terms of the safety and quality of medical practices. It concerns certain therapeutic modalities or certain surgical procedures, possibly by anatomical device or by pathology, determined on the basis of their frequency, or the complexity of their performance or subsequent management. It takes into account the number of operations performed or the number of patients treated annually.
In the case of a new establishment, the minimum annual activity is forecast and is at least equal to 80% of the threshold, provided that the activity achieved reaches the level of the minimum annual activity provided for in the first paragraph no later than two years after the activity is implemented. This period is extended to thirty-six months when the authorisation concerns the provision of treatment by external radiotherapy.
II - In the event of an exceptional and temporary event leading to a significant drop in activity, the Director General of the Regional Health Agency, at the express request of the holder, may defer application of I for a maximum period of two years, provided that the holder has made commitments to resolve the said event.
