Chapter III: Conditions for setting up certain healthcare activities and heavy equipment

I.-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…

The authorisation holder has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is informed of the proposed therapeutic decision, in accordance with the guidelines defined by the National Cancer Institute in application of 2° of Article L. 1415-2, including information about temporary or permanent side-effects, the impact on quality of life and, where appropriate, the preservation of fertility, reconstructive surgery…

The authorisation holder ensures that patients have access to innovative treatments and clinical trials, either on its own or by referring them to other health establishments which hold the cancer treatment authorisation. Where appropriate, it promotes access to innovative treatments in conjunction with an existing structure in a foreign country.

The authorisation holder is recognised as a hospital cancer molecular genetics platform by the Institut National du Cancer in application of article L. 1415-2 or has a cooperative organisation with other health establishments holding a cancer treatment authorisation, at least one of which is recognised as a platform, in order to carry out or have carried out, where applicable, in compliance with the provisions of articles L. 1131-2-1,: 1° Genetic…

Authorisation may only be granted if the applicant has an organisation, set up where appropriate in conjunction with other cancer treatment authorisation holders, which provides each patient, where appropriate, with support and access, as close as possible to their place of life, to the fertility preservation techniques mentioned in Article L. 2141-11. To this end, the organisation set up involves at least one holder of the authorisation for medically assisted…

The authorisation holder has an organisation that ensures that each patient receives treatment that complies with the recommendations or guidelines for good clinical practice defined by the National Cancer Institute, the Haute Autorité de Santé, the Agence Nationale de Sécurité du Médicament et des Produits de Santé, the Agence de la Biomédecine and, failing this, with recommendations that are the subject of a consensus by learned societies.

I.-The authorisation may only be granted if the applicant has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is treated throughout the course of the disease and in accordance with the best practice guidelines defined by the Institut national du cancer in application of 2° of article L. 1415-2 : 1° Assessment of patients’ needs and access to the necessary…

I.-The holder of the authorisation organises the continuity of care and, where appropriate, the coordination of care for the patients it treats, within the establishment and by means of agreements with other establishments or persons holding the authorisation referred to in article R. 6123-86-1. II.-It has an organisation for the treatment of complications and emergency situations, under the same conditions as those mentioned in I. This organisation is set up,…

I.-The holder of the authorisation collects and sends to the Regional Health Agency and the National Cancer Institute, on an annual basis, anonymised indicators for monitoring the quality of its healthcare activity, set by order of the Minister for Health on a proposal from the National Cancer Institute. II – For each authorised cancer treatment modality, a self-assessment of care activity practices is carried out annually in the establishment as…

I.-The provisions of the present sub-section also apply to holders of neurosurgery authorisations, when they perform therapeutic procedures aimed at curing cancerous tumours and associated with this authorisation, with the exception of the provisions of 2° of article R. 6123-91-1 and articles R. 6123-91-4 and R. 6123-91-12.