France: Modification and simplification of the reimbursement evaluation procedure for certain medicinal products
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On 3 July 2019, a new Decree was published which modifies the evaluation procedure of generic and biosimilar medicines by the Transparency Commission of the High Health Authority (HAS). This Decree seeks to simplify the assessment procedures of such medicines in order to speed up their financing by French Social Security.
The principle set out by the Decree is that there is no more review by the Transparency Commission for generic and biosimilar medicines whose originator is listed on the list(s) of reimbursed medicines. They are presumed to have the same Medical Benefit (SMR) as the originator. The Decree harmonises the practice for all generics and biosimilars (so far generics whose originator was listed on the list of reimbursed hospital products had to be submitted to the Transparency Commission).
The Decree is part of the aim by public authorities to strengthen and ease access to French market for generics and biosimilar medicines.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, August 2019 Issue (Thomson Reuters).