It will be recalled that one of the main contributions of the LFSS for 2021 is the total overhaul of two derogatory medicinal product coverage regimes: temporary authorizations for use (ATU) and temporary recommendations for use (RTU). This article abolished the various ATU and RTU and replaced them with the early access (AP) and compassionate access (CA) systems, the latter covering compassionate access authorizations (CAA) – which broadly correspond to the former nominative ATU – and compassionate prescription frameworks (CPF) – which correspond to the former RTUs.
However, some details were still awaited on the financing of the data collection.
As a reminder, apart from a few exceptional cases, the law requires the collection of data relating to the use of medicinal products under AP, CAA or CPF. To this end, prescribers must transmit to the company operating these medicinal products the follow-up data on the patients treated.
As this mission sometimes involves a great deal of work, articles R. 5121-70, R. 5121-74-5 and R. 5121-76-6 of the Public Health Code (CSP) stipulate that the healthcare facilities within which the data is collected should be compensated by the manufacturers.
Nearly a year after the AP/CA reform went into effect, the terms and conditions for compensating healthcare facilities have just been defined by an order dated April 15, 2022, published in the official journal on Saturday.
Is the model agreement set by the order binding on manufacturers?
Appendix 1 of the Order of April 15, 2022 sets out a model agreement between the healthcare institutions and the company relating to compensation for the collection of data on medicinal product use.
All agreements entered into as of today (or, more accurately, yesterday) must conform to this model.
What are the terms of compensation?
Article 5 of the model agreement provides that the industry undertakes to compensate for the costs associated with data collection according to the schedule and rates it defines.
- By December 31, the company must complete a balance sheet that includes: (i) the list of medicinal products that have been collected, (ii) the number of patients for whom data have been collected, (iii) the total number of data expected and collected
- By January 31 at the latest, the company must send this report to the healthcare facility
- Within 6 weeks, the health care organisation may comment on the information transmitted
- By 31 March at the latest, the health care organisation must send the company a receipt or an invoice
- By 31 April at the latest, the company must pay the amount invoiced
The order specifies that the manufacturer and the health care facility may agree to a semi-annual period rather than an annual period.
The model agreement stipulates that compensation rates will be set according to the frequency of follow-up and the completeness of the data entered. In practice, they vary from 80 € HT to 625 € HT per year and per patient.
A question about early access or compassionate access? Contact us by e-mail: firstname.lastname@example.org