Directive 2001/83/EC, which lays down harmonised rules on medicinal products in the EU (EU Medicines Directive), includes a specific procedure for the regulation of homeopathic medicinal products. The imposition of special rules on homeopathic medicinal products stems from the idea that homeopathic medicinal products are used in a medical setting which is fundamentally different from allopathic medicine. Furthermore, the active substances used in homeopathic medicinal products may generally not be compared to the substances used in allopathic medicinal products. For anthroposophic medicinal products currently no such special regime exists although the above applies equally to these medicinal products.

Due to these differences between homeopathic and allopathic medicinal products, the European Commission waited a long time before submitting a proposal for the harmonisation of the legal rules and administrative practices on homeopathic medicinal products in Europe. It was not until the early 1990s that homeopathic medicinal products came into the picture, almost 25 years after the introduction of harmonised rules on medicinal products in Europe in 1965 (Directive 65/65/EEC). With its harmonisation proposal for homeopathic medicinal products, the European Commission tried to strike a balance between preservation of a special branch of medicine on the one hand, and the protection of the public health in combination with free movement of homeopathic medicinal products in the internal market on the other. 

Earlier harmonisation efforts for the regulation of medicinal products in Europe had explicitly excluded homeopathic medicinal products from their scope. Considering the apparent differences between homeopathic and allopathic medicinal products and the fact that homeopathic medicinal products were barely regulated in most Member States, this did not come as a surprise. In fact, it partially explains why most manufacturers and distributors of homeopathic and anthroposophic medicinal products, but also many national medicines’ agencies are still struggling today with the legal regimes and administrative practices that apply to these products. 

This article provides some examples of the difficulties manufacturers of homeopathic and anthroposophic medicinal products face in relation to the current legal framework. From the experiences drawn out of daily practice, it also points to a number of issues which hamper the effective harmonisation of homeopathic and anthroposophic medicinal products in the EU. 

The position of medicines agencies in Europe
Before harmonising measures for homeopathic medicinal products were introduced, homeopathic medicinal products were barely regulated by most Member States. This was largely due to the relatively low market share of these products in combination with a generally shared view among national administrations that these products were not specifically hazardous. 

With the rules imposed from ‘above’, national administrations had to start all of a sudden regulating a sector of medicinal products of which they had no specific knowledge at all. Furthermore, homeopathy was and still is not much accepted in many national administrations and more specifically medicines agencies. This can be exemplified by the hesitation of the Dutch Medicines Evaluation Board to take up the responsibility for the registration and authorisation of homeopathic medicinal products. 

Through the years certain medicines agencies have made a strong effort to build up expertise in the field of homeopathic and anthroposophic medicinal products. However, effective harmonisation of administrative practices in the EU – for example via the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies – is hampered by those medicines agencies which have failed to do so. The foregoing stresses the need for the creation of centres of expertise in the field of homeopathic and anthroposophic medicinal products to rule out paternalism and improve harmonisation. 

No special regime for anthroposophic medicinal products
As established in the Antroposana-case[1], no specific regime exists for anthroposophic medicinal products. This implies that these products need a marketing authorisation which is based on an evaluation according to the standards for allopathic medicine. Since anthroposophic medicinal products come from a different medical tradition than allopathic medicinal products and the market share of these products is considerably smaller, the imposition of the authorisation rules for allopathic medicinal products effectively rules out these products coming on the market. This is specifically problematic for patients who explicitly prefer to make use of a branch of medicine which has been traditionally available in Europe. 

Stability-testing and natural active substances
Homeopathic medicinal products are mainly produced from natural substances. This is in contrast to allopathic medicinal products, which are mainly produced from synthetic or chemical substances. Therefore, the stability of the latter group of products can be controlled relatively easily compared to homeopathic medicinal products. The stability of a tincture that has been derived from plant material for example can play serious tricks as a result of a large mixture of active principles, the composition of which tends to change in a manner much less predictable than synthetic substances. 

Moreover, a plant substance differs from harvest to harvest. As a result the amounts of active principles in a tincture will vary naturally from year to year.  It is difficult to catch nature in a bottle!

As a result there is much discussion on the indication of relevant markers and admitted boundaries for fluctuations of the relevant substances in a tincture. Here one can clearly see the difficulty of applying a regime that is fit for one group of products (in this case allopathic remedies) to a group of products with different characteristics (in this case homeopathic remedies). Such issues need practical solutions. The more know-how that is available at a medicines agency, the greater the likelihood is that such solutions are attained. Local expertise may not be up to standard to meet such challenges, leading to considerable differences in evaluations and therefore inefficient and diverse implementation. 

No uniform rules for homeopathic medicinal products
For homeopathic medicinal products there exist two different procedures. On the one hand, the special simplified registration procedure laid down in Articles 14 and 15 of the EU Medicines Directive is compulsory for all Member States. On the other hand, the marketing authorisation procedure laid down in Article 16 is optional. This leads to the awkward situation that Member States are currently free to evaluate certain homeopathic medicinal products either in accordance with the regime for allopathic medicinal products, or in accordance with a regime that takes into account the specificities of homeopathic tradition. 

As is the case with anthroposophic medicinal products, the first option factually bars certain homeopathic medicinal products from coming to the market. The main argument used for not applying option two is safety of users. There are however, less stringent possibilities under the EU Medicines Directive to protect the safety of the users. For example, Title VI of the EU Medicines Directive provides the option of making these products subject to a doctor’s prescription. Such approach leads to more supervision of the user without effectively ruling out the use of such products. 

Considering the above, it is questionable whether the ‘safety argument’ is proportional in relation to the fact that less stringent options exist. This is even more so since the number of users of these products is relatively low compared to users of allopathic medicinal products. One can therefore question whether this really constitutes a serious public health issue. 

MRP and DcP do not work
Finally, a few words on the availability of the Mutual Recognition Procedure (MRP) and the Decentralized Procedure (DcP) for homeopathic medicinal products: these were introduced in 2004 with the amendment of the EU Medicines Directive by means of Directive 2004/27/EC. Problematic about these procedures is the lack of the possibility for arbitration that is available for allopathic medicinal products. The EU Medicines Directive remains silent on what should happen if Member States disagree on the safety of a homeopathic medicinal product. This effectively means that MRP and DcP do not lead to a harmonised approach in case medicines agencies disagree. 

Such an outcome would be economically unsustainable for the applicants for a registration. In addition, it could damage the reputation of the reference Member State. Both applicants and medicines agencies are therefore reluctant to use MRP and DcP for the registration of homeopathic medicinal products. The low number of MRP and DcP registrations in the last six years supports this argument - it is possible to count the initiatives on one hand.

Conclusion
There is clearly a need to improve the harmonised approach EU-wide with respect to homeopathic medicinal products as many problems still exist. Furthermore, there is a need to adopt harmonised rules for anthroposophic medicinal products in Europe, as these are part of a long-standing tradition in European medicine. 

The EU Institutions have a responsibility to safeguard safe access for patients to homeopathic and anthroposophic medicinal products, as well as economic sustainability for the European industry that produces medicinal products used in homeopathic and anthroposophic medicine. Personal convictions on the desirability of these forms of medicine should be irrelevant. The needs of the stakeholders involved should be carefully considered in line with the basic principles of the European Union.


Johan Hulshof
Attorney at Law at Van Benthem & Keulen