Synathon BV v. Licensing Authority of the Department of Health

Wednesday 13th October 2010 Written Statements

[The Minister of State, Department of Health (Mr Simon Burns)]

In 2001 and 2002, the Medicines Control Agency (a forerunner to the Medicines and Healthcare products Regulatory Agency) refused to accept certain marketing authorisation applications from Synthon. Synthon challenged the decision by way of judicial review.

In 2008 the European Court of Justice issued a judgment in relation to C-452/06 Synthon v. Licensing Authority of the Department of Health following a decision grant by the then Licensing Authority (the Medicines Control Agency) to refuse to grant a marketing authorisation for Synthon’s paroxetine mesylate product.

The Court’s judgment was that the United Kingdom should pay compensation for Synthon’s consequential lost profits.

Following a mediation held on 23 and 24 September 2010 the Department of Health has agreed to pay Synthon €33.25 million inclusive of legal costs in full and final settlement of their claim.