PHARMACEUTICAL REGULATIONS: REIMBURSEMENT OF A MEDICINAL PRODUCT FOR A USE NOT COVERED BY ITS MARKETING AUTHORIZATION
Judgment of 21 November 2018 in Case C-29/17 Novartis Farma SpA / Agenzia Italiana del Farmaco (AIFA) e.a.
The EU Court of Justice (ECJ) has ruled that under Articles 3 and 6 of Directive 2001/83 relating to medicinal products for human use and Articles 3, 25 and 26 of EU Regulation n° 726 / 2004 establishing Community procedures for the authorisation and supervision of medicinal products for human use, national legislation can allow the reimbursement by the National Health Insurance Scheme (NHS) of a reconditioned medicinal product for non-use market authorisation (MA) without the need for a new MA, subject to the following cumulative conditions: the existence of a marketing authorisation and a manufacturer’s authorisation, no modification of the medicinal product, prescribed medicinal product by a doctor through an individual prescription, its repackaging must be performed by pharmacies authorised for administration in hospitals.
In this case, an Italian company marketing a drug for age-related up id degeneration (AMD) complained that another similar drug that had obtained a marketing authorisation for a use other than AMD could also be reimbursed by the Italian national health insurance system when used in case of AMD.
The Italian company considered that allowing the use of this competing drug to treat AMD outside the marketing authorisation was a disadvantage as the price of the competing drug is much lower. The Italian Council of State, hearing the case, asked the ECJ to determine if the national measures concerning the conditions of use of the competing drug outside its MA (i.e. its reimbursement by the SSN, for economic reasons as a reconditioned medicinal product) comply with EU legislation on pharmaceuticals and patient safety.
In its response, the ECJ first recalled that the Member States have competence in the organisation and management of health services, in the pricing of medicines and in regards to their inclusion of the national health insurance systems subject to compliance with the European Medicines Directive 2001/83. Additionally, the ECJ Court highlighted that, even when reconditioned, the competing medicinal product continues to fall within the scope of Directive 2001/83. Please note that this directive does not prohibit the prescription of a medicinal product outside its marketing authorisation or its repackaging, but requires them to comply with certain conditions, in particular the existence of a marketing authorisation and a manufacturing authorisation.
According to the ECJ, it is not necessary to obtain a new marketing authorisation in order to authorise the use of a repackaged medicine for treatments not covered by its MA, provided that the medicinal product does not undergo modifications, is prescribed by a doctor on the basis of an individual prescription and is reconditioned by pharmacies authorised to use this medicine in a hospital.
Therefore, the ECJ ruled that EU law does not preclude national rules providing for the conditions regarding the repackaging of a medicinal product for use outside its MA.
