The European Court of Justice last week judged the UK's MHRA to be in breach of EU law when it rejected Synthon's marketing application for its generic Varox (paroxetine), submitted through the mutual recognition procedure (MRP). This judgement, hailed as a victory for the generics industry, sets the limits for the way member states handle MRP applications and could even lead to new guidance.
The case started in 2000 when Synthon applied for a marketing authorisation for Varox from the Danish Medicines Authority (DKMA) using the abridged procedure. Under this procedure applicants do not have to present results of certain preclinical and clinical trials if they can demonstrate that the medicine is "essentially similar" to the reference product. The Dutch company cited GlaxoSmithKline's Seroxat (paroxetine hydrochloride) as its reference product as both drugs contain the same active moiety - paroxetine. The DKMA found that Varox (paroxetine mesilate) met the condition of essential similarity, and subsequently authorised the product.
Synthon then applied to the MHRA for mutual recognition of the DKMA's marketing authorisation under directive 75/319, article 9. This says that member states should recognise the marketing authorisation granted by the reference member state within 90 days of receiving the application and assessment report, unless there are concerns over risks to public health. However, in January 2001 the MHRA rejected the application on the grounds that Varox and Seroxat contained different salts from the same moiety and were therefore not "essentially similar".
In 2002 the Dutch company applied again for mutual recognition, this time under Article 28 of Directive 2001/83 (which reproduces Article 9 of Directive 75/319). After the MHRA rejected the application on the same grounds, Synthon took its case to the High Court, seeking damages and an annulment of the MHRA's second decision.
Meanwhile, in 2003 the MHRA decided to accept applications claiming an essential similarity between products containing different salts from the same moiety. Varox finally won MHRA approval in 2006 following Synthon's third application in 2005.
However, the company chose to pursue both a declaratory judgement and damages given the implications of the case. The UK court referred key questions to the European Court of Justice. It asked if Directive 2001/83, Article 28 precludes a member state from refusing mutual recognition of marketing authorisations issued by another member state under the abridged application procedure because of concerns over essential similarity. It also asked if failure of a member state to recognise authorisation granted by another state on such grounds constituted a serious breach of community law, therefore making the state liable for damages. To both these questions the court answered yes.
The judgment limits the options open to member states which have received an application under the MR procedure: the authority must either recognise the marketing authorisation granted by the first member state, or initiate arbitration procedures. There is "no scope to adopt a third course of action such as refusing to validate the incoming application for mutual recognition on the basis that the similarity criteria are not fulfilled", said SJ Berwin, the law firm representing Synthon.
"The judgement will affect the way all member state authorities handle the validation aspects of applications received in the MR procedure," the MHRA told Scrip. New guidance on this will be needed from the co-ordination group for mutual recognition and decentralised procedures, the authority added.
The generics industry also stands to benefit from the judgement. "It clarifies the application of the regulatory framework for mutual recognition of generic medicinal products," said Stephen Kon, a partner at SJ Berwin.
The UK High Court is to determine the MHRA's liability for damages when the case returns.
Source & copyright: SCRIP - World Pharmaceutical News - www.scrippharma.com
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