The Pharmaceutical Journal
Vol 269 No 7216 p386
21 September 2002

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Minor formulation changes cannot stop parallel importing in Europe

The European Court of Justice (ECJ) has upheld an advocate-general's opinion that parallel import product licences do not become void if the product licences for parent products are withdrawn by their manufacturers (PJ, 2 March, p275).

Ruling on parallel imports of Ferring's Minirin (desmopressin spray) into Germany from Sweden, the ECJ ruled that invalidating a parallel import licence because the marketing authorisation of its parent product had been withdrawn was a restriction of free trade that could only be justified if it was necessary to protect public health.

In this case, the original product was withdrawn from the German market and reformulated. The original product continued to be available in Sweden.

However, the court agreed that the parallel import licence could be cancelled if having two different versions of essentially the same medicine on the market in one country posed a demonstrable risk to public health.

Donald Macarthur, secretary general of the European Association of Euro-Pharmaceutical Companies, said that he hoped the ruling would stop manufacturers reformulating products merely in order to obstruct parallel trade. The EAEPC (www.eaepc.org) represents companies involved in parallel trading of medicines in Europe.

The full judgment (case C-172/00) can be found in the case law section of the ECJ website.