ECJ Menarini judgement

A Menarini-Industrie Farmaceutiche Riunite Srl and European Federation of Pharmaceutical Industries and Associations v Commission of the European Communities: Case T-179/00

Decision of the Court of First Instance (Fourth Chamber), 3 July 2002

Short Conclusions ·

Administrative decisions that are not complex medico-pharmaceutical assessment sare subject to Judicial Review.

·

The logo of the local representative of the marketing authorisation holder for a medicinal product may be included on the outer packaging: this is in addition to the logo of the marketing authorisation holder.

Applicable Regulatory Law

The labelling provisions for a medicinal product subject to the centralised authorisation procedure (that were containing at the time in Directive 92/27) provide:

The particulars which must appear on the outer packaging or, where there is no outer packaging, on the immediate packaging include the name and address of the holder of the authorisation for placing the medicinal product on the market (Article 2(1))

The outer packaging may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature (Article 2(2))

Member States may, notwithstanding Article 5(1), require the use of certain forms of labelling making it possible to indicate information specific to a Member State.

The European Commission issued a guideline on packaging information for medicinal products which states:

"The information specific to a Member State should be accommodated on the label in a boxed area (the so-called "blue box"), to appear on one side of the pack. Each "blue box" should only be presented in the official language or languages of the Member State concerned... The location of the "blue box" on the package should be the same for all language versions. When one pack is intended for marketing in several Member States, it is preferable to have only one "blue box" on the pack. This box will contain different information in each Member State. This could be achieved in practice for instance by printing a blank "blue box" on this pack onto which a sticker with the appropriate Member State information can be securely affixed. When in exceptional circumstances, this cannot be achieved, each "blue box" should have the same dimensions and appear the same".

Facts

The European Commission issued a marketing authorisation for a medicinal product OPTRUMA under the centralised procedure to Eli Lilly Nederland BV ("Lilly"). Lilly then licensed its rights in the trademark of the product and the promotion and distribution of the product in Italy to Menarini International Operations Luxembourg SA, which was entitled to, and did, sublicence those rights exclusively to A Menarini-Industries Farmaceutiche Riunite Srl ("Menarini").

Lilly submitted mock-ups of the outer packaging of the product to the Commission for approval. The Italian packaging showed the name and logo of Lilly as marketing authorisation holder and, in a "blue box", the name and logo (a stylised "M") of Menarini. The Commission and the Pharmaceutical Committee agreed that Lilly's logo could be included on the outer packaging for identification purposes but, based on the views of the majority of Member States, refused to approve the inclusion of Menarini's log in the blue box, on the bases that, first, the logo would not add anything to the information which is "necessary for health instructions", as the sole indication of the name and address of the "local representative" would in itself be sufficient to guarantee a national contact for patients and, second, its inclusion might create confusion between the marketing authorisation holder and the local representative, where on the former is responsible for the product.

Decision

The Court of First Instance held that the Commission's decision was unlawful.

Decisions subject to open or limited judicial review

First, the Court held that the administrative decision was of a type in which it would interfere by way of judicial review. In previous cases, (Case C-120-97 Upjohn [1992] ECR I-223, paragraphs 33 and 34, and Order of the President of the Court of 11 April 2001 in Case C-459/00 P(R) Commission v Trenker [2001] ECR I-2823, paragraphs 82 and 83), the Court of Justice had held that administrative decisions which are the result of complex assessments in the medic-pharmacological field are only subject to limited judicial review. However, the Court held in this case that there is a distinction between, on the one hand, such complex assessments (such as, for example, assessments of the efficacy, safety and quality of a medicinal product) and, on the other hand, other assessments which are not of such complexity as to justify a restriction on the scope of judicial review. The assessment of the usefulness of a logo for health education is in the latter category as it does not call for any particular expertise or technical knowledge.

Review of a decision on the basis of justification

The Court went on to examine whether the refusal to authorise the inclusion of the logo of the local representative in the blue box was & "justified".

The Court noted that the logo accompanies by the word "Menarini" is a registered trade mark and represents the name and business identity of the company. Given that the Pharmaceutical Committee had accepted that the inclusion of the logo of the marketing authorisation holder is acceptable for identification reasons, the Court said that "the same holds" for the logo of the local representative. The Court stated:

"The logo plays an important role in identifying a company operating on the market. Its function is to constitute a unit in combination with the name of the company in order to facilitate identification of that company. Since the aim of Directive 92/28 is, according to its fifth recital, in particular to ensure a high degree of consumer protection, inclusion of the logo in the blue box, which facilitates identification of the local representative, helps to increase consumer protection. Given that consumers may contact the local representative more easily in the event of problems with the medicinal product and ask questions of him in their mother tongue and that, as regards questions of responsibility, the local representative can suggest to consumers that they contact the holder of the marketing authorisation, the inclusion of the logo of the local representative in the blue box is useful for health education within the meaning of Article 2(2) of Directive 92/27.

The Court also rejected that the inclusion of the logos of both companies would create confusion between them and their separate roles. "In assessing whether the inclusion of the logo of the local representative may create confusion between the holder of the marketing authorisation and the local representative, it is necessary to distinguish between the general and common information appearing on the outer packaging and the information specific to a Member State which appears in the blue box. According to Article 2(1) of Directive 97/27, the name and address of the holder of the marketing authorisation may also display his logo on the packaging. In the packaging guideline it is stated that the name and address of the local representative may be included in the blue box (Section C, point 5). That being the case, a logo which constitutes a unit in combination with the name and address of the local representative cannot create a risk of additional confusion for the confusion, since the name and address of the local representative are already included in the blue box".