French Public Health Code
In forceI. - Except when the Agence nationale de sécurité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is accompanied by a protocol for therapeutic use and patient follow-up. This protocol specifies in particular
1° The procedures for monitoring patients and the data to be collected concerning the efficacy and safety of the medicinal product in the indication or indications in question, as well as information enabling the actual conditions of use of the medicinal product to be reported;
2° The frequency and procedures for sending the Agency summary reports of the data and information mentioned in 1° of this I;
3° The role of each of the parties involved in patient monitoring, in particular prescribers, pharmacists and the marketing authorisation holder or the company operating the marketing authorisation and appointed for this purpose.
II. - Each periodic summary report is drawn up by the marketing authorisation holder or by the company operating the marketing authorisation and appointed for this purpose by the marketing authorisation holder. If the treatment concerns a rare disease, the protocol may stipulate that the report is drawn up with the support of the centres of reference and centres of competence in charge of the disease concerned, in accordance with the procedures laid down by an order of the Minister for Health.
The periodic summary report includes in particular
1° A summary of all the information collected as part of the implementation of the protocol, relating to the conditions of use of the medicinal product, its efficacy and safety in use, as well as any information likely to affect the assessment of the benefit/risk profile of the medicinal product;
2° An analysis of the risk-benefit balance of the medicinal product in the indication or indications concerned, taking into account all available data.
The proprietor or operator draws up a draft summary of each report, with a view to publication as provided for in Article R. 5121-76-10, and sends it to the Agency with the report.
III. - Prescribers and pharmacists are required to take part in data collection.
The compassionate prescribing framework may authorise the marketing authorisation holder or the company operating the marketing authorisation and appointed for this purpose by the marketing authorisation holder to subcontract, under a written contract, all or part of the monitoring of patients.
For the implementation of the first paragraph of V of Article L. 5121-12-1 concerning healthcare establishments, an agreement conforming to a model laid down by order of the ministers responsible for health and social security is concluded between each establishment concerned and the marketing authorisation holder, its authorised representative or subcontractor in order to set out the terms and conditions for compensating the establishment for its participation in data collection.
When data collection is carried out by means of an interface allowing electronic data entry, identification and authentication allowing access to this interface are ensured by using a dematerialised service designated by order and implemented by the agency mentioned in article R. 6113-33.
