Title II: Sanitary equipment

I.-Authorisation may only be granted if the applicant is a member of the specific regional cancer scheme recognised by the Institut national du cancer. II-The holder of the authorisation meets the accreditation criteria defined by the Institut National du Cancer in application of 2° of article L. 1415-2 with regard to the quality of cancer treatment.

Authorisation may only be granted if the applicant: 1° Has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is informed of the diagnosis and of a therapeutic proposal based on multidisciplinary consultation in accordance with the care guidelines defined by the Institut National du Cancer in application of 2° of Article L. 1415-2 and set out in a personalised care…

I.-The holder of a B surgical oncology authorisation is responsible for organising multidisciplinary referral consultations for the purposes of making therapeutic proposals likely to include the complex surgical oncology treatments he provides. This organisation is set up, if necessary in conjunction with other holders of a B surgical oncology authorisation, without prejudice to the application of the provisions of 2° of article R. 6123-91-1. Therapeutic proposals likely to include the…

I.-Without prejudice to the application of the provisions of I of article R. 6123-91, the establishment authorised to treat cancer in children and adolescents under the age of eighteen is a member of an inter-regional paediatric oncology referral hospital organisation, identified by the Institut National du Cancer in application of article L. 1415-2. This organisation is responsible in particular for organising and providing inter-regional paediatric multidisciplinary consultation for patients under…

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.