Since the 1990s, specific rules have been developed at EU level for certain products used in therapies that fall under the umbrella of complementary and alternative medicine (CAM). For example Directive 92/73/EEC ¹ was adopted with a view to harmonising the legal provisions and administrative practices applicable to homeopathically produced medicinal products with a proven use in homeopathic medicine. In 2002 and 2004 additional directives were adopted in the field of food supplements² and traditional herbal medicinal products.³ The improved market access of these products in Member States, which lacked specific legislation prior to the EU Directives, has led to increased demand of patients for CAM related services. This adds to the already existing trend of increased demand for these therapies.

At this moment the national laws of the Member States and the administrative practices applicable to CAM vary from highly sophisticated regulatory systems to absolute absence of regulation or a practical ban on the provision of CAM by either doctors or practitioners. Due to these differences and the availability of a considerable number of CAM products on the national markets, patients are frequently unable to seek specialist advice on the use of CAM products. Even though an increasing number of doctors and practitioners seek vocational training outside their Member State of residence, they are often not allowed to apply their newly acquired skills in their own Member States.⁴ The same goes for doctors and practitioners moving from one Member State to another with the aim of providing health services. With the European Parliament already asking the Commission for regulation of certain CAM therapies in the light of the free movement of services and the freedom of establishment,⁵ one may wonder why this has still not happened.

According to the Commission, harmonising measures in the field of CAM are not possible either because it lacks competence⁶ or because such action is not compatible with the subsidiarity principle. This article will briefly explain the mechanism of the subsidiarity principle and provide arguments as to why the Commission’s position is only partially acceptable.

The subsidiarity principle was introduced in the EC Treaty in 1992 with the creation of the European Union. It is derived from the German Constitution which contains a comparable concept that regulates the division of powers between the federal state and the Länder.⁷ It essentially tries to limit action where the Community is not exclusively competent to regulate. This is at least the case where the legislative competences are shared with the Member States. In legal terms of the EC Treaty this reads as follows:

’Article 5

The Community shall act within the limits of the powers conferred upon it by this Treaty and of the objectives assigned to it therein. In areas which do not fall within its exclusive competence, the Community shall take action, in accordance with the principle of subsidiarity, only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community.

Any action by the Community shall not go beyond what is necessary to achieve the objectives of this Treaty.’

In the established academic literature the subsidiarity principle leads to a three stage test. To begin with, one has to establish whether the Community has the competence to regulate the topic that requires action. If this is the case, then in the next stage the scope of the Community’s competence must be examined. If the Community has the exclusive competence to take action – basically meaning that the Member States are not allowed to adopt legislation on their own – the subsidiarity principle does not come into play. The principle only needs to be applied where both the Community and the Member States individually are in principle competent to regulate. In that case the Commission will start its ‘subsidiarity calculus’. This means that it will first apply the test of comparative efficiency: a) can the action not be achieved sufficiently by the Member States? And b) can the action (by reason of scale effects) be better achieved by the Community? In the third stage the Commission will have to apply a proportionality test: Does the action stay within the boundaries of what is necessary to achieve the aims of the EC Treaty? If all these questions are answered affirmatively, then the action may be taken by the Commission.⁸

As pointed out above, the Commission has not undertaken any action with regard to harmonising measures in the field of CAM therapies. On the one hand, it certainly does not have the competence to regulate every aspect related to these therapies. For example Article 152(5) of the EC Treaty states that the Community has to respect the ‘responsibilities of the Member States for the organisation and delivery of health services and medical care’. In combination with Article 152(4)(c) of the EC Treaty,⁹ mere action in the field of public health is not allowed under the EC Treaty, nor may it be circumvented via the use of other competences in the Treaty.¹⁰ On the other hand, where the Commission has the competence to regulate, it should strive for a high level of public health protection according to Article 152(1) of the EC Treaty.¹¹

This brings me to where I disagree with the Commission’s general position that it cannot or should not take any action in the field of CAM therapies. Taking into consideration that the harmonisation of laws and administrative practices of the Member States has brought many CAM products to markets where these hitherto did not (legally) exist, and that doctors and practitioners that have received vocational training in one Member State seek to provide services in another, there are at least two arguments for the Commission to take action in this field. Undeniably there are limitations to the powers of the Community, but these may not be projected to the general problem which European doctors, practitioners, and patients face as a consequence of other Community measures.

Therefore, since the Community has the competence to adopt harmonising measures that take away obstacles to the freedom to provide services (Article 52 of the EC Treaty) and the freedom of establishment (Articles 44 and 47 of the EC Treaty), it should take those measures which allow doctors to practise in another Member State at least those CAM therapies which make use of products that are available Community-wide due to harmonising measures. Of course, this is on the condition that they have received accredited training, or that they possess diplomas that are recognised in the Member State of origin. For CAM practitioners a similar reasoning should apply, with the limitation that Community action in this field cannot apply to Member States that only allow doctors to provide medical interventions. Such an approach would run counter to the idea of Article 152(5) of the EC Treaty.

Taking the abovementioned competences of the Commission to regulate certain aspects related to CAM therapies as a starting point, the subsidiarity principle comes into play. I will now show that this principle does not oppose Community action in the field of CAM.
First of all the action cannot be achieved sufficiently by the Member States. In a number of Member States such as for example the UK, France, Germany, Belgium and the Netherlands, rules are in place to allow doctors and/or practitioners to practice CAM therapies, however it is generally speaking impossible for these doctors and/or practitioners to practice outside their Member State of origin. Thus a Dutch CAM doctor cannot practice in France without getting the appropriate French diplomas. In a number of other Member States the practice of CAM therapies is officially forbidden. For example, a doctor in Sweden having received vocational CAM training in Germany and the UK is not allowed to practice CAM. An Austrian doctor moving to Slovenia will have similar problems. At the same time patients have access to the products that are being used, creating a need for proper advice and monitoring. It seems therefore rather obvious that this issue cannot be solved by the Member States themselves, even though there is a clear need.

Secondly, the action can better be achieved by the Community. Due to the considerable differences between the Member States, it will be significantly more efficient to take Community action. The Community does not only have a better overview, but also a comparatively easy task to harmonise certain requirements such as the recognition of diplomas. Moreover, one should bear in mind that the knowledge within a number of Member States with respect to CAM is far too limited to be capable of taking appropriate action. This will lead to paternalistic protectionism which does not only hinder the freedom to provide services and the freedom of establishment, but indirectly (and already) also hinders the free movement of goods. Finally, a synergy effect of the proposed Community action may be that the general knowledge on the risks and (cost-) benefits of certain CAM therapies will improve on a Community level – which is fully in line with the second paragraph of Article 152(1) of the EC Treaty:

‘Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education.’

It goes without saying that the proposed Community action has to comply with the third stage of the subsidiarity principle as well. The measures to be adopted have to be proportional – meaning that they should not go beyond what is necessary to achieve the objectives within the meaning of the EC Treaty.

From the above we can derive that neither the subsidiarity principle, nor Article 152 of the EC Treaty stand in the way of taking specific Community action in the field of CAM therapies – especially where this action relates to products for which harmonising measures have been adopted. One can even argue that Article 2¹² in conjunction with Articles 3¹³ and 152 of the EC Treaty require certain Community action in this field.

Johan Hulshof
Van Benthem & Keulen, Advocaten en Notariaat