In fact, in 2020, 45% of the 29 specialties authorized under cohort ATU were in the oncology field (ANSM). Today, the issued ATU are mainly for anti-cancer drugs (ANSM). This system was initiated in 1994 to make anti-HIV products available to patients (LEEM). To meet these needs, the French system provides an exceptional procedure for drugs that do not have a MA or still still in the P&R process: the ATU (Temporary Use Authorization). In France, the average time between marketing authorization (MA) and market access process completion is about 500 days: a relatively long time for patients with life-threatening conditions or suffering from a rare, serious or disabling disease for which there is no therapeutic alternative. The temporary authorization of use (ATU) system: an opportunity for patients In this article, we decipher the major changes in these systems and their consequences for pharmaceutical companies. Article 38 of the Social Security Financing Bill for 2021 (PLFSS 2021), published in October 2020, proposes a global revision of the current derogatory access to medicines, by reorganizing the ATU around two main access categories: early access and compassionate access. Long considered a strength of the French model, the ATU system has now become extremely complex for pharmaceutical companies due to constant legislative changes. The Temporary Authorization for Use (ATU) system allows patients with serious diseases to obtain early access to innovative medicines.
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