ECJ Watch

This is a review of the recent case in which the ECJ explored the notion of maximum harmonisation. The review was written by Dr Vanessa Mak, who is going to speak on the concept of maximum harmonisation in consumer protection law on 21 November at the European and Comparative Law Institute of the University of Oxford:

The Netherlands v Antroposana (C-84/06) – maximum harmonisation and consumer protection

An increasingly important topic in European consumer law is to what extent harmonisation can and should be pursued. Should directives aim for maximum harmonisation? Would this benefit consumers? And does the EU have the competence to lay down rules of maximum harmonisation?

The recent judgment in The Netherlands v Antroposana, in which a preliminary reference was asked from the ECJ, highlights some of these issues. At issue was whether certain drugs falling outside the traditional categories of medicines and homeopathic cures would have to comply with the authorisation and registration procedures laid down in Directive 2001/83 on medicinal products for human use in order to be placed on the market in the Member States. The medicines concerned were so-called anthroposophic medicines, based on a branch of medicine founded in the 1920s by the Austrian philosopher and scientist Rudolf Steiner, which are prepared by a specific method and may contain different vegetable, mineral, animal or metallic substances. Following the opinion of Advocate General Bot, the ECJ held that such medicines fall within the definition of ‘medicinal products’ laid down in Article 1(2) of the Directive, though not within the sub-categories of homeopathic or herbal medicines for which special registration procedures are in place. Holding, however, that the Directive was meant to be an instrument of maximum harmonisation, it followed that the general authorisation procedure laid down in Chapter 1 of the Directive had to be applied.

The ECJ’s conclusion that Directive 2001/83 was intended to lay down rules of maximum harmonisation is not surprising. This interpretation is in accordance with the objectives which Directive 2001/83 seeks to attain, namely, the elimination of hindrances to trade in medicinal products between the Member States and the protection of public health (see the judgment at 36 and the opinion of the Advocate General at points 56 to 60). Harmonisation of authorisation procedures eliminates hindrances to trade in medicinal products between the Member States, and at the same time it may secure consumer protection by, in accordance with Article 95(3) EC, taking as a basis a high level of protection of health. Taking into account the strict procedures laid down by Directive 2001/83 for authorisation and registration of medicinal products, consumer protection seems benefited by such a decision. One may wonder, however, whether a similar conclusion would have been reached in this case had Dutch law contained stricter procedures for anthroposophic products than the general procedures implemented by the Directive. Do we want to prevent Member States from having in place rules that offer a higher standard of protection than Community law?

One thing that becomes clear from the judgment is that maximum harmonisation does not imply that a standard has been fixed from which no divergence is possible. However, adaptations will have to be made at European level rather than by the Member States. In the words of the Advocate General, ‘I do not think that complete harmonisation in a given field means harmonisation which is fixed or definitive. In other words, the fact that harmonisation is exhaustive is not incompatible with its continuing to evolve’ (at 62). Such then is the competence of the EU with regard to issues relating to the internal market. But to what extent may we see similar developments in areas such as consumer protection, for which the EU as yet does not bear prime responsibility (the Member States do, Article 153(1) EC), but in which it appears increasingly to be pushing towards maximum harmonisation?