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Why the ECJ has changed its stance on the import of pharmaceutical drugs

The court's inconsistent approach reveals a dramatic transformation in its role, says Paul Stanley QC

23 April 2012

A member state has a rule regulating the importation of pharmaceutical drugs. If the imports contain “the same active substance or substances, the same dosage and [have] the same form” as drugs that are already authorised, they may be freely imported – but only if the national authorities accept that their price is “competitive” in relation to the authorised product.

Anyone who has studied EC law will recognise this sort of fact pattern – so-called ‘parallel imports’ – from studying the law of free movement of goods. One might dimly recall the ECJ’s encouragement of such imports, and the cold water that it poured on attempts to justify restrictions on them. Did the court not say, in Case 104/75 De Peijper [1976] ECR 613, that prohibiting such imports would be justified only if the evidence showed “differences which have a therapeutic effect”? If the proposed imports have “the same active substance”, the “same dosage” and the “same for...

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