Temporary authorisation for use (ATU)

The temporary authorisation for use was the French regime that allowed, on an exceptional basis, the use of a medicinal product without a marketing authorisation to treat a serious or rare disease where no appropriate treatment existed. Issued by the ANSM, it took two forms: the cohort ATU, requested by the company for a group of patients, and the named-patient ATU, requested by the physician for a designated patient. On 1 July 2021 the scheme was replaced by early access and compassionate access, introduced by the Social Security Financing Act for 2021.

How the regime worked

The cohort ATU concerned medicinal products whose efficacy and safety were strongly presumed on the basis of clinical trials, and for which an application for authorisation had been filed or the company undertook to file one. The named-patient ATU, more exceptional, concerned medicinal products whose efficacy and safety were presumed in the light of current knowledge, where the patient could not take part in a clinical trial. A so-called post-ATU period ensured continuity of reimbursement between authorisation and inclusion on the reimbursement list.

Financial regime and settlement

During the ATU, the company freely set the indemnity invoiced to healthcare institutions, which was paid by the national health insurance system. Once the price or tariff was set, the company paid back, in the form of a rebate, the difference between the turnover generated under the indemnity and the turnover that the final price would have produced. This mechanism still has effects for medicinal products that entered the ATU scheme before the reform and may give rise to disputes over the basis and calculation of the repayment.

Current relevance of the concept

Transitional measures allowed ongoing ATUs to continue to produce effects for a limited period before they switched to the new regime. The concept remains useful when reading licence, distribution or partnership agreements concluded before 2021, which often refer to the ATU as a milestone or as the trigger for milestone payments. Like early access, the ATU was not a marketing authorisation and started neither the period of data exclusivity nor the term of a supplementary protection certificate.

Key points

The ATU belongs to the law predating the 2021 reform of derogatory access, but it has not disappeared from case files. In any older contract, it should be checked how the clause referring to the ATU is to be read since the reform, particularly where it triggers a milestone payment or a diligence obligation. For repayments still in dispute, the turnover generated under the ATU and the price finally set must be reconstructed precisely.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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