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Anti-depressants led to damages for the UK

November 2010 - Intellectual Property. Legal Developments by Norrbom Vinding Law Firm, member of ius laboris.

More articles by this firm.

It cost the UK EUR 33.25 million to breach EU law in a case concerning marketing authorisation of an anti-depressant.

Under EU law, pharmaceutical companies only have to undergo one detailed examination of their application in one EU member state when they apply for authorisation to place a medicinal product on the market. The decision of whether or not to authorise the product must then be recognised by the other EU member states.  

A Dutch company had obtained a marketing authorisation in Denmark for one of their anti-depressants because it was essentially similar to an already existing product. But in the UK, the authorities turned their thumbs down on the product, ignoring the Danish decision. The UK authorities did not believe the anti-depressants could be said to be essentially similar to the existing product.  

The case came before the British courts, which decided to ask the European Court of Justice if the UK's refusal to recognise the decision of the Danish authorities was compatible with EU law.  

A clear message
The ECJ ruled that other member states cannot overrule the reference member state's decision. Otherwise, the system of mutual recognition would not work. The ECJ added that if authorities in other member states disagree with a decision, their only option is to apply the special procedures for collaboration between authorities which are provided in the applicable EU Directive. And the UK had not done that.   The ECJ also noted that member states who fail to comply with the Directive may incur liability.  

Solidarity, please
The case was recently decided by the British courts. The British Department of Health accepted paying the Dutch company EUR 33.25 million in damages for the loss suffered by the company in not obtaining a marketing authorisation and having to go to court.

Norrbom Vinding notes:

  • that, in principle, the question of liability is not a matter for the ECJ, but it gave a not-so-subtle indication that the conduct of the UK authorities was actionable; and
  • that the case shows that even national medicinal authorities can sometimes make mistakes in applying these EU rules - mistakes that may have serious implications for the applicant companies and the authorities themselves.