On Friday, May 27, France’s Council of State (Conseil d’Etat) cancelled the provisions of the decree dated January 5, 2010 allowing the introduction of a new 15% reimbursement rate for certain drugs, in addition to the existing 35% and 65% rates.
The Council of State also cancelled, with effect from November 1, 2011, the April 9, 2010 decision of the Chief Executive of UNCAM, the organization that runs France’s public health insurance system, to apply this new rate to certain pharmaceutical specialties including arthritis drugs.
Although the Council of State had been consulted before the decree was adopted, it nevertheless decided to cancel the provisions allowing the lower reimbursement rate to be applied to specialities included on the January 5, 2010 reimbursable drugs list but whose therapeutic value had previously been qualified as limited.
These specialties were identified in a series of decisions by UNCAM’s Chief Executive issued on April 9, 2010, as published in the Journal Officiel on April 16, 2010.
The Council of State’s ruling retrospectively renders all of these decisions illegal and the manufacturers of the specialties concerned can therefore apply for their withdrawal or even their repeal. Many pharmaceutical laboratories are potentially concerned by the ruling.
Expanscience, Negma and Pharma 2000, which brought the legal challenge, were represented before the Council of State by Bernard Geneste, a Partner of CMS Bureau Francis Lefebvre.