Assessment margin of Concerned Member State in European authorisation procedure – A small step beyond the ECJ Synthon judgment

03 May 2011

Colette Mulder

In order to obtain a marketing authorisation for a medicinal product in more than one EU Member State, one of the European authorisation procedures must be followed. Both the mutual recognition and decentralised procedure are based on the principle of recognition by one or more Member States (the Concerned Member State(s)) of the assessment of the medicinal product by another Member State (the Reference Member State). A Concerned Member State may not refuse this recognition of the assessment unless it has objections on the grounds of a potentially serious risk to public health.

Furthermore, applications for a marketing authorisation for generic medicinal products are not required to submit a complete file. An applicant may refer to the complete file of the reference medicinal product (originator product) when the data exclusivity of the reference product has lapsed; the abridged procedure. When an application for a marketing authorisation has been submitted through the abridged procedure, the generic product must either be a true generic (article 10(1) of Directive 2001/83/EG as amended) or the application must be a hybrid application (article 10(3) of Directive 2001/83/EG as amended). In the latter case, the hybrid application must contain additional results of clinical and/or non-clinical research; so-called bridging studies.

In two recent procedures before the Administrative Courts in the Netherlands (Court Breda 02 February 2011, LJN:BP5365, UCB Pharma v. MEB and Pharmachemie and Court Arnhem 11 February 2011, LJN:BP9060, Novartis Pharma v. MEB and Actavis) objections were made against the granting of a marketing authorisation for generic medicinal products. The Dutch Medicines Evaluation Board (MEB) was the Concerned Member State in both cases.

The Dutch courts were of the opinion that the assessment margin of the Concerned Member State to reject the assessment report of the Reference Member State partly or entirely is limited as a result of article 29 of Directive 2001/83/EC as amended (which governs the referral procedure to the coordination group in case of grounds of potential serious risk to public health). The Concerned Member State can only refuse the approval of the assessment report of the Reference Member State when there is a valid reason to assume that the medicinal product presents a serious risk for public health.

This is apparent from the purpose of the procedure laid down in title III, chapter 4 of the Directive (which governs the mutual recognition procedure and the decentralised procedure), the binding formulation of article 28(4)(5) (which governs the approval of the assessment and the adoption of a decision by the Concerned Member States in a mutual recognition and decentralised procedure), and article 29(1) of the Directive. The explanation of the court is also, in accordance with the purpose of the Directive, to eliminate the obstacles to free movement of medicinal products in the European Community and to prevent needless duplication of tests and trials. Both the mutual recognition procedure and the decentralised procedure are based on the principle of recognition of the assessment which has already been done by another member state, the Reference Member State.

The European Court of Justice (ECJ) has judged in the Synthon judgment of 16 October 2008 (Case C-452/06) (the ‘Synthon Judgement’) that each Member State has to assess whether the application for a marketing authorisation fulfils the validity criteria as set out in article 28 of Directive 2001/83/EC as amended. However, the validation of this information and the scientific assessment of the application is to be done by the Reference Member State and the Concerned Member State shall need to accept this.

The Court Breda has added in more detail to the Synthon Judgment, expressing that, with regard to a generic application, the Concerned Member State cannot independently assess whether the bridging data is sufficient, or whether the file protection (data exclusivity) of the reference medicinal product has been violated.

The Court Breda in addition states, in line with the Synthon Judgment, that a Concerned Member State solely assesses - on the basis of the assessment report of the Reference Member State - whether there is a serious risk to public health. The assessment margin of the Concerned Member State is therefore very limited. The other member states must rely on the conclusions and the scientific assessment which the Reference Member State has performed. Also the Court Arnhem concludes that the assessment margin of the Concerned Member State is limited to whether there is a serious risk to public health.

The Courts came to the final decision in both cases, that given the fact that there is no potential serious risk to public health, the granting of the generic marketing authorisations by the Dutch MEB was justified and the marketing authorisations remain valid in the Netherlands.