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 NO
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 form' as an authorised product, how could it be justifiable to prevent parallel imports? How could price be a relevant consideration?
It might therefore come as a surprise to learn that in Case C-185/10 Commission v Poland (29 March 2012) the ECJ condemned Poland for having such a rule '“ not because it was too restrictive, but because it was too permissive. For times have changed. When De Peijper was decided there was no properly unified EU law governing pharmaceuticals. Now there is. Directive 2001/83 prohibits marketing without either a national or an EU authorisation.
Poland tried to argue that its rule was permissible under a provision that permitted member states to allow unauthorised products to be supplied in exceptional cases, such as when a doctor considers that there is a medical need to use it for a particular patient. That justification was rejected, because the Polish law was not about individual medical needs in particular cases, but was quite general. It did not fall within the derogation permitted under the directive, which was to be 'interpreted strictly' so as to avoid conflicting with the need to protect 'public health'.
Of course, there is no legal inconsistency between De Peijper and Commission v Poland. The issues were different. In the older case the ECJ was considering whether member states could avoid free movement of goods within the EU by relying on a public health justification. In the recent one it was interpreting harmonising legislation in the context of attempts to import products from outside the EU.
Role reversal
But there is a rhetorical or philosophical inconsistency. In 1976 the ECJ, looking at national law, insisted that strict enforcement of bureaucratic requirements for prior authorisation could not be justified on public health grounds. In 2012, looking at EC law, it insists, with apparently equal conviction, that such requirements are essential safeguards. In 1976 the overall effect of the ECJ's approach was deregulatory, subjecting rules to a sceptical test of necessity. Not so in 2012, now that the source of those rules is the EU itself '“ with the practical result that the Polish taxpayer must pay more for necessary drugs.
In one sense, such differences demonstrate how far EU law has come of age; the sceptical approach was, it turns out, principally a strategic move to wrest sovereignty from member states. The cynic might be reminded of the final scene in Animal Farm, in which the animals watch the pigs dining with their neighbouring human farmers: 'The creatures outside looked from pig to man, and from man to pig, and from pig to man again; but already it was impossible to say which was which.' For the fact is that the EC now enforces, as essential to public health, laws of a type which, in another time, it condemned as unnecessary. How this benefits Polish patients or taxpayers is questionable.