French Public Health Code
In forceI.-A.-Early access authorisations granted under article L. 5121-12 are subject to compliance with a therapeutic use and data collection protocol defined by the Haute Autorité de santé. The protocol is drawn up in conjunction with the Agence nationale de sécurité du médicament et des produits de santé when the authorisation is granted under 1° of II of Article L. 5121-12.
When the early access authorisation is granted in application of A of II of Article R. 5121-69, the draft protocol appended to the opinion of the Agence nationale de sécurité du médicament et des produits de santé mentioned in III of Article L. 5121-12 is deemed to apply.
B.-When the early access authorisation concerns a medicinal product mentioned in 1° of II of Article L. 5121-12, this protocol includes the following information:
1° The conditions under which the early access authorisation is granted and the purpose of the therapeutic use and data collection protocol;
2° The procedures for prescribing, dispensing and using the medicinal product, as well as the procedures for monitoring patients treated;
3° The procedures for collecting data relating in particular to:
a) The characteristics of the patients treated;
b) The actual use of the medicinal product;
c) The efficacy of the medicinal product, where applicable, in relation to quality of life;
d) Adverse reactions resulting from this use;
4° The obligations relating to pharmacovigilance and the procedures for implementing these pursuant to article R. 5121-172;
5° The procedures for informing the patient, their legal representative or the trusted support person they have designated in application of article L. 1111-6 on the absence of therapeutic alternatives, the risks incurred, the constraints and the benefit likely to be provided by the medicinal product;
6° The role of each of the parties involved in the early access arrangements, in particular health professionals, the holder of the exploitation rights and the regional pharmacovigilance centre, if any, designated to carry out national pharmacovigilance monitoring of the medicinal product concerned;
7° The characteristics of the patients likely to be treated, established in accordance with the summary of product characteristics.
C.-When the early access authorisation concerns a medicinal product mentioned in 2° of II of Article L. 5121-12 and this authorisation is issued under the conditions mentioned in I of Article R. 5121-69, the therapeutic use protocol is made up, for the scope of the indication benefiting from the early access authorisation, of the summary of product characteristics obtained under its marketing authorisation and, where applicable at the request of the Haute Autorité de santé, the elements mentioned in 3° of B.
When the authorisation is granted under the conditions mentioned in B of II of Article R. 5121-69, this protocol consists solely of the summary of product characteristics obtained under its marketing authorisation.
D.-The protocol specifies the frequency with which the summary report referred to in Article R. 5121-70-1 is to be submitted.
II. -This protocol is sent at their request to doctors likely to prescribe the medicinal product and to pharmacists or persons mentioned in article L. 5126-10 likely to dispense it, as well as to the regional pharmacovigilance centres mentioned in article R. 5121-158 and to the poison control centres mentioned in article L. 6141-4, by the holder of the exploitation rights or, where applicable, his authorised representative.
The holder of the exploitation rights for the medicinal product or his authorised representative, the prescribing doctors and the pharmacists or persons mentioned in Article L. 5126-10 concerned shall comply with the obligations set out in the protocol.
Prescribers and pharmacists are obliged to participate in the collection of data. An agreement between the proprietor and the health establishment within which the information is collected sets out the terms and conditions for compensating the latter in application of the third paragraph of IV of article L. 5121-12. This agreement conforms to the model laid down by order of the ministers responsible for health and social security.
When data is collected using an interface enabling electronic data entry, identification and authentication enabling access to this interface are provided using a dematerialised service designated by order and implemented by the agency referred to in Article R. 6113-33.
III - Following the granting of a marketing authorisation for an indication benefiting from the early access authorisation mentioned in article L. 5121-12, the Haute Autorité de santé will adapt, if necessary in collaboration with the Agence nationale de sécurité du médicament et des produits de santé, the provisions of the therapeutic use and data collection protocol mentioned in IV of article L. 5121-12, the modification of which has become necessary as a result of this granting.
