In an opinion given on 10 July 2008 in Case C-452/06 The Queen, on the application of: Synthon BV v The Licensing Authority of the Department of Health (represented by the Medicines Control Agency the Advocate General (whose recommendations the ECJ usually follows) has recommended that the ECJ answer the questions posed to it in this matter by the English High Court:
- Article 28 of Directive 2001/83/EC … on the Community code relating to medicinal products for human use must be interpreted as meaning that a Member State, receiving an application for mutual recognition of a marketing authorisation issued by another Member State, under the abridged procedure referred to in Article 10(1)(a)(iii) of Directive 2001/83, is bound to recognise that authorisation within a period of 90 days following receipt of the application and of the assessment report, unless it invokes the exception set out in Article 29(1) of Directive 2001/83, based on the existence of a potential risk to public health.
- It is contrary to Article 28 of Directive 2001/83 for a Member State, receiving an application for mutual recognition of a marketing authorisation issued by another Member State, under the abridged procedure referred to in Article 10(1)(1)(a)(iii) of Directive 2001/83, to investigate afresh the essential similarity of the two medicinal products and to reject the application in question on the ground that the two products are not essentially similar within the meaning of that provision.
- In circumstances such as those in the main proceedings, the interpretation of the meaning and scope of Article 28 of Directive 2001/83 adopted by the Member State receiving such an application, is capable of constituting a serious breach of Community law.’
This Opinion is the latest stage in the paroxetine mesylate saga, in which the ECJ held in 2005 in Case C-74/03 Smith Kline Beecham that the Danish Medicines Agency had been right to grant Synthon an abridged authorisation for paroxetine mesylate in the light of an earlier authorisation granted to Smith Kline Beecham for a different salt of the active paroxetine, namely paroxetine hydrochloride. However the UK regulators (at that time the Medicines Control Agency (MCA), now replaced by the Medicines and Healthcare products Regulatory Agency (MHRA)), had, prior to the decision of the ECJ, in that case disagreed with the Danish Medicines Agency’s approach, and had refused, in the context of the mutual recognition procedure for medicinal products under Article 28 of Directive 2001/83, and in which Denmark was the reference Member State (RMS), to grant a UK authorisation for paroxetine mesylate once the Danish one had been given. There was no suggestion that the UK regulators had any grounds for believing that the authorisation might present a risk to public health, and which would have been a legitimate basis for refusing to recognise the authorisation and for initiating the consultation and arbitration procedure set out in Articles 29 to 34 of Directive 2001/83. Instead they disagreed with the Danish regulators’ interpretation of the law as to abridged authorisations. But the Advocate General does not consider that it was open to the UK regulators (as opposed to the Danish ones, as RMS) to take that into account, as to do so would render the principle of mutual recognition meaningless. The Advocate General also considers that the breach on the part of the UK regulators is capable of constituting a serious breach of Community law, but that the determination as to this, and as to the potential liability of the UK regulators to Synthon for damages, is a matter for the national courts in the UK.