French Public Health Code
In forceThe 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 on the consent form, the attending physician is informed by the latter of the patient's enrolment in a programme. Both the attending physician and the prescribing physician receive information about the progress of the programme.
The operator sets up a telephone call centre, available around the clock, to respond to patients on the programme. Calls are handled by healthcare professionals employed by the operator. These professionals are placed under the responsibility of the pharmacist or doctor employed by the operator.
The operator provides the healthcare professionals it employs with the means to anonymise the data collected. The data collected as part of the learning programme may not be used for purposes other than those of the programme and its evaluation.
If necessary, a healthcare professional, acting on behalf of the operator, may visit the patient to explain how to administer the treatment. Each contact between this healthcare professional and the patient, or between the call centre's healthcare professionals and the patient, is recorded in writing, including the questions asked and the answers given. This information is sent to the doctor or pharmacist in charge of the programme, who forwards it to the prescribing doctor and the treating doctor; it is kept by the doctor or pharmacist in charge of the programme for the duration of the patient's participation in the programme.
The doctor or pharmacist in charge of the programme anonymises the information and sends it to the operator and the company marketing the medicinal product.
