French Public Health Code
In forceThe purpose of learning programmes is to enable patients to acquire the technical skills needed to use a medicinal product.
They are implemented by healthcare professionals acting on behalf of an operator who may be financed by the company exploiting the medicinal product.
There may be no direct contact between the company and the patient or, where applicable, the patient's relatives, legal representatives in the case of a minor or the person responsible for the legal protection measure in the case of a protected adult.
The learning programme is proposed by the prescribing doctor to the patient; it may not give rise to financial benefits or benefits in kind.
Implementation of the learning programme is subject to the written consent of the patient, his legal representatives in the case of a minor, or in the case of an adult subject to a legal protection measure with representation relating to the person who is not capable of expressing his wishes, the person responsible for the legal protection measure, taking account of his opinion.
This participation may be terminated at any time and unconditionally, on the initiative of the patient or the prescribing doctor.
These learning programmes, as well as the documents and other media relating to these programmes, are subject to authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), after obtaining the opinion of the associations mentioned in Article L. 1114-1 and for a limited period of time.
If the learning programmes or the materials relating to these programmes do not comply with the provisions of the authorisation issued pursuant to this article, the Agency shall withdraw the authorisation and, where appropriate, order the immediate cessation of the actions put in place and the withdrawal of the documents distributed.
