Title VI: Therapeutic patient education

The programme is run by an operator, chosen and contracted for this purpose by the company marketing the medicinal product. The operator is chosen on the basis of the guarantees of independence that it offers, in particular those mentioned in 1° of article R. 1161-24, its skills and the human and material resources it has available to carry out the tasks involved in implementing the learning programme. The agreement specifies…

The company informs doctors of the existence of learning programmes. The doctor prescribing the treatment may suggest that his patients who could benefit from this programme take part in it. If the patient agrees, the written consent form is sent by the prescribing doctor to the healthcare professionals employed by the operator. A copy of this form is kept by the patient. When the patient contacts the healthcare professional mentioned…

Operators must comply with all the following obligations: 1° The salaried director of the operator and the healthcare professionals in charge of carrying out the operations provided for in the programme have no professional or financial links with the company exploiting the medicinal product, apart from the contract between the operator and the said company for the implementation of the learning programme; 2° The healthcare professionals in charge of the…

The company exploiting the medicinal product produces a follow-up report at the end of each programme or at the latest when it is renewed. The report is sent to the treating doctor, the prescribing doctor and the Agence nationale de sécurité du médicament et des produits de santé.