Homeopathy has both a systematized theoretical and therapeutic basis. It is a system of natural medicine based on the similarity principle. The similarity principle means that substances capable of causing disorder on any level in healthy subjects can be used as medicines to remedy similar patterns of disorder experienced by people when they are ill. In fact, homeopathy relates individual patterns of responding to environmental influences, infectious agents and potential stressors to specific homeopathic medicines that can remedy these susceptibility patterns. Skilled homeopathic prescribing requires that the state of being that can be elicited by the chosen medicine (in a proving) should be as similar as possible to the disease state of the patient. The more detailed the understanding of the state of the patient, the more accurate the prescription.

Consequently any substance can be used as a homeopathic medicine, which means that a wide variety of homeopathic medicinal products in a large range of potencies are needed by doctors and practitioners in order to undertake successful homeopathic treatment. Any registration system of homeopathic medicines therefore needs to be flexible, simple, practical and inexpensive.

Need for appropriate regulation
Public health must be safeguarded by assessing the quality, safety and efficacy of medicines available to patients in Europe. On the other hand, EU Directives and other regulations must not result in restrictions to the production and the distribution of homeopathic medicinal products. Inappropriate medicine safety requirements and approval costs must not unreasonably impair the availability of homeopathic medicinal products.

Efficacy
Medicines must be able to provide a clinically measurable effect, i.e. be efficacious and preferably also beneficial. For each individual conventional prescription drug, efficacy has to be proven. This requirement is not applicable to homeopathy, because homeopathic medicines are by definition efficacious when they are properly prescribed, i.e. when the medicine pattern is as close as possible to the disease pattern. Homeopathy is a coherent and consistent therapeutic system in itself.

Quality
The quality of homeopathic medicines is influenced both by the quality of the raw material and the quality of the procedure used during their production. The quality of the raw material is defined by the authenticity and the origin of the starting materials according to the homeopathic tradition. In this respect, adherence to information in pharmacopoeias or monographs and to GMP rules is essential. Identification and assay of source materials may not be feasible at high potencies. In such cases the quality should be demonstrated by complete validation of the manufacturing and dilution process.

Safety
Understandably there is a need for reasonable and comprehensible requirements for the safety of medicines. Although homeopathic medicines are in general considered to be safe when administered appropriately, toxicological aspects should not be neglected especially when using lower dilutions of unsafe starting material. After all, the raw materials for many homeopathic medicines are known poisons and all materials of animal or human origin are at risk of containing pathogenic agents. Still, patient safety can be guaranteed if the end product is safe and it is therefore strongly recommended that risk assessment of homeopathic medicinal products should exclusively be related to the end product.

For the simplified registration procedure according to Directive 2001/83/EC a sufficient degree of dilution guarantees the safety of the medicinal product; in particular, the medicinal product may not contain more than one part per 10 000 of the mother tincture. This arbitrary limit is to be replaced by the first safe dilution, individually defined for each substance or for groups of source substances. Above this level the distribution of a homeopathic single medicine and a combination of them is then possible without any further safety concerns.

In the case of raw materials from biological origin there is an additional issue of viral safety. The unproven assumption that even one single prion may cause Creutzfeldt–Jakob disease (CJD) in humans has led to disproportionate and inappropriate requirements to ensure the safety of homeopathic medicinal products from animal and human origin. With regard to homeopathic medicinal potencies above a suitable potency level, however, even in the case of biological raw materials, such requirements are not necessary. A dilution grade ‘safe by dilution alone and per se’, applicable to any homeopathic medicine derived from any raw substance, allows, together with GMP guidelines, to produce safe medicines, without further safety requirements related to the raw substances. The advantage of potentising according to Hahnemann’s method is that it includes fewer imponderables in the calculation of risks than other well-established methods. Different from other methods, Hahnemann’s potentising method allows for a direct calculation of the risk even without providing evidence through experiments. Even in a worst-case scenario and in requiring an additional ‘safety margin’, a dilution of log 10^-23 (C12/D23) and above can be counted as safe.

Swiss alternative
A more practical approach in the registration of homeopathic medicinal products is in place in Switzerland. The Swiss medicines agency Swissmedic was in close communication with all groups of stakeholders when it worked out a system that meets the ‘needs for safety, high quality and availability of homeopathic medicinal products in a pragmatic way’. It was laid down in the Ordinance of the Swiss Agency for Therapeutic Products on the simplified authorisation of complementary and herbal medicinal products of 22 June 2006. The registration fees are reasonable at 500 Swiss Francs (€375) – in the EU they vary between € 600 and 7,600 – and allow the maintained availability of the large number of medicines that are needed for high quality homeopathic treatment.

Rarely prescribed medicines
Even if the regulation and registration of homeopathic medicinal products are more flexible, simple, practical and inexpensive, and many more registered homeopathic medicines are available on the market, there still may be a need for magistral formula prescription in case of rarely prescribed homeopathic medicines. In several EU Member States specific pharmacies can be authorised to prepare delegated magistral and even officinal preparations. This authorisation should be implemented in legislation throughout the European Community.


Dr. Ton Nicolai
President of European Committee for Homeopathy (ECH)