On 13 July, the English High Court referred to the European Court of Justice questions on the mutual recognition procedure on marketing authorisation for medicinal products (designed to facilitate a single European market in medicinal products). This reference should yield the first ECJ guidance on the operation of the procedure (R (on the application of Synthon BV) v Licensing Authority (SmithKline Beecham Plc as an interested party) [2006] EWHC 1759).
The drug paroxetine, used to treat depression, had been marketed in the form of its hydrochloride hemihydrate salt. Synthon BV and Smithkline Beecham discovered that a different salt, paroxetine methanesulfonate, has better properties for pharmaceutical formulation. Synthon obtained a Danish marketing authorisation for its product from the Danish Medicines Agency on the basis that the two salts were "essentially similar". SKB challenged that decision on the ground that the active principals were not the same, and so there could not be essential similarity. The ECJ ruled in favour of essential similarity, but Synthon was refused marketing authorisation in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Synthon was subsequently granted a UK marketing authorisation, but nevertheless continues to pursue this case.
Synthon is seeking relief on two grounds. First, it claims that the MHRA’s refusal was unlawful under the mutual recognition procedure in the light of the previous authorisation by the Danish Medicines Agency. Secondly, it claims that the MHRA’s inflexible policy that different salts of the same active principal could never be essentially similar was also unlawful. The MHRA conceded unlawful conduct in relation to the second ground in the light of the earlier ECJ ruling, but not on the first ground. It also refused to agree a reference to the ECJ on that issue. It argued that a reference was not necessary because, even if Synthon could prove that the MHRA had acted unlawfully by failing to apply the mutual recognition procedure, no declaratory relief would be granted and Synthon’s claim to damages would be unaffected. However, the High Court held that Synthon had a good, arguable case that the MHRA had breached the mutual recognition procedure which meant that Synthon could be entitled to declaratory relief and damages. The MHRA’s continued assertion that it was entitled to refuse authorisation under the validation process raised an issue of general importance in the EU. Furthermore, Synthon had a continuing interest in establishing the true interpretation of the mutual recognition procedure. The High Court concluded therefore that the reference should be made to the ECJ.
While this reference is largely academic as far as the current dispute is concerned, it may yield useful ECJ guidance on the operation of the mutual recognition procedure.
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