Parallel importation of a medicinal product into Italy
On 28 February 2017, the Italian Medicines Agency (AIFA) granted to Medifarm S.r.l. (Medifarm) an authorisation for the parallel importation of a medicinal product commercialised in France by Menarini S.a. (Menarini) under the trademark BILASKA. The same medicinal product is commercialised by Menarini in Italy under the different trademark ROBILAS.
The applicant did not put forward a specific request for a change of the name (from BILASKA to ROBILAS). However, it nonetheless expected AIFA to approve the parallel importation under the trademark ROBILAS as a matter of course, which did not happen.
The applicant appealed the decision of AIFA on the ground that the authorisation for parallel importation must approve the importation with the name currently used for the product in Italy (ROBILAS), as otherwise it would de facto make it impossible to market the product in Italy.
Judgment of the court
The Administrative Court of Lazio first clarified that parallel importation of medicines for human use means the distribution by a Member State of medicines already authorised, manufactured and marketed in another Member State. A parallel imported medicinal product is subject to an authorisation granted by AIFA, following a “simplified” procedure, provided that:
- the imported product has been granted a marketing authorisation in the Member State of origin and,
- the imported product is essentially “similar” to a product which has already received a marketing authorisation in the Member State of destination.
Having said that, as regards the alleged infringement of the provisions of the EU Treaty and of Italian legislation on free trade among Member States, the Court observed that, based on trademark law and the case law of the Court of Justice of the European Union, as a general rule the parallel importer must retain the name of the medicinal product used in the country of origin. Such a rule may be derogated from when either;
- regulatory restrictions or impediments to the marketing of the imported product exist in the country of destination under the trademark used in the country of destination, or
- the use of the trademark of the country of origin may pose a “risk of confusion as to public health”, this is to say, a confusion between the imported product and other medicinal products (e.g. with a different composition or therapeutic indication) already on the market in the country of destination.
According to the Court, in the case of BILASKA there was neither regulatory restriction to the use of the trademark of the country of origin, nor a risk of confusion that may adversely affect the public health that could ground a right for the parallel importer to obtain a change of name. Instead, the Court evaluated that obtaining a commercial advantage was behind the name change.
The Judgement of the TAR Lazio is still subject to appeal. The case is particularly interesting with regard to the importation of medicinal products which are placed on the market in Europe under different trademarks and which enjoy a reputation on the market due to a longstanding use and/or significant efforts put in the promotion of the brand. The Court held the view that the right to parallel import a medicinal product shall not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the State of origin.
Authored by Riccardo Fruscalzo and Carlotta Busani