Background <p>More and more treatments are available for patients with rare diseases. However, a marketing authorization (MA) for a new treatment does not mean access in France for all patients. Moreover, while rare diseases affect children mostly, paradoxically it seems that they are the ones who faces more difficulties to access treatments. In this context, the aim of this study is to analyze the French market access of drugs in rare diseases recently approved between July 2021 and July 2024, depending on their target population (adults, children or both).</p> Results <p>Overall, 43 orphan drugs were selected and 51 MA/extension of MA were analyzed. In the selected sample, there are four times fewer orphan drugs indicated only for children (7/51) than for adults (29/51). On 1 April 2025, 53% of these indications (27/51) were reimbursed in France with 57% being pediatric indications (4/7) and 48% being adult indications (14/29). Furthermore, the median delay between the granting of the MA and reimbursement through the standard procedure in France was 505 days. Even though there are longer delays of reimbursement and lower prices compared to the other four European largest pharmaceutical markets, France is the second country with the most indications reimbursed on 1 April 2025 behind Germany (80%, 41/51).</p> Conclusion <p>On 1 April 2025, patients in France had partial access to orphan drugs recently approved, regardless of the target population. The prices and delays associated with the standard reimbursement procedure are factors that have a considerable impact on access to the French market for drugs intended for the treatment of rare diseases.</p>