23 March 2020 - Authored by:Eveline Van Keymeulen
On 5 February 2020, the French Administrative Supreme Court (Conseil d’Etat) annulled a decision from the Economic Committee for Health Products (CEPS) from 15 March 2018, considering that it negated the useful effect of the regulation applicable to orphan medicines.
Under Article 8 of the Orphan Medicinal Products Regulation ((EC) No 141/2000), a manufacturer who obtains orphan designation for a medicinal product must benefit, for a period of ten years following the marketing authorisation (MA), from market exclusivity. Member states cannot grant an MA or accept applications for MAs and extensions thereof for a product with the same therapeutic indication. This scheme constitutes an incentive for the industry to develop and market orphan medicinal products and ensure that patients suffering from rare conditions have access to the necessary treatment.
Here, the orphan medicine Carbaglu® (marketed by Recordati Rare Diseases or “Recordati”) obtained its MA for a first therapeutic indication in 2003, and a new MA for three other indications (all under orphan designations) on 27 May 2011.
On 15 March 2018, the CEPS set a unified tariff as a basis for reimbursement applicable to both Carbaglu in its four indications and to Ucedane, a generic product for the first indication of Carbaglu. The unified tariff was based on the lowest price, that is, that of Ucedane. The aforementioned exclusivity period, for the latest three indications of Carbaglu, was still in effect (set to expire in 2021) when the decision entered into force on 31 October 2018.
The court considered that by setting the unified tariff for both Carbaglu in its four indications and the generic medicinal product to the first indication of Carbaglu, when Recordati still benefited from the exclusivity period on some indications, the CEPS decision favoured off-label prescriptions of Ucedane for such indications covered by market exclusivity.
Further, by assimilating a product benefitting from market exclusivity for one or more of its indications to a similar product not authorised for the same indications, the CEPS decision deprived Recordati of the benefits expected from that exclusivity, the purpose of which was to encourage its marketing despite the amount of investment required.
This article was co-authored by Alexandra Lauré.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2020 Issue (Thomson Reuters).