Regulation of Anthroposophic Medicinal Products (AMPs)
Anthroposophic medicine and its products
As with other integrative medicines, anthroposophic medicine is based on a holistic approach; it merges conventional and complementary medicine and it includes all dimensions of the patient: physical, emotional, mental and spiritual, as well as the impact of a person’s environment and social context. Anthroposophic medical doctors are qualified physicians who have received additional training to integrate anthroposophic medicine into their conventional practices.
Like other complementary medicinal products, anthroposophic medicinal products (AMPs) have a long tradition of medical use. AMPs contain substances, dilution levels, manufacturing methods and descriptions of indications that are specific to anthroposophic medicine. Many studies have shown that anthroposophic treatments have few adverse effects, can be combined easily with conventional medicines in an integrative approach and are, in many cases, cheaper than most conventional medicines in the treatment of chronic diseases.
There is growing evidence that the anthroposophic medical approach, including AMPs, increase both patient satisfaction and overall health outcomes. It may also limit antimicrobial resistance.
There is also growing interest in this medical approach: an ECHAMP study on Homeopathic and Anthroposophic Medicinal Products in the EU found a steadily increasing demand, with an annual market growth rate of 6.5% between 2010 and 2013, even though there are countries “where there is a clear consumer demand [and where] availability is limited.”
Authorisation and registration of AMPs in Europe
In 2008 and 2014, the European Commission released two studies on the availability of medicinal products in the European Union. Both highlighted, e.g., the pressing need to tackle the unsatisfactory legal situation of AMPs. Furthermore, the 2014 Matrix Insight Report underlined that AMPs, together with homeopathic medicinal products (HMPs), are an indispensable part of the European pharmaceutical market and clearly stated that the availability of AMPs is generally worse than in the case of HMPs.
Following the Directive 2001/83/EC on medicinal products for human use, the marketing of medicinal products is, as a general rule, subject to a marketing authorisation by the competent national authority. The Directive also contains specific chapters on homeopathic and herbal medicinal products that, given their long use and low risk of side effects, allow a registration rather than authorisation, via a simplified procedure.
AMPs are only recognised but not specifically regulated by this EU pharmaceutical law. In general, the Directive 2001/83/EC does not consider the specific features of the AMPs. In consequence, requirements for a simplified licensing, set out by the EU pharmaceutical law, do not work with all AMPs. Only in the case that AMPs meet the criteria to qualify as homeopathic or traditional herbal medicinal products do they benefit from the simplified licensing. If not, market authorisation procedures developed for chemical medicinal products apply. In practice, many AMPs do not qualify as homeopathic or traditional herbal medicinal products due to their composition (substances, dilution levels), manufacturing processes, or use. These AMPs are faced with a grey legal area. As a result, many AMPs have problems being placed on the national markets in the EU. This situation makes it difficult for anthroposophic physicians to prescribe them and for patients to access them.
Moreover, some regulatory authorities have additional and divergent national requirements, that make the licensing procedure even more burdensome and so demanding that even fewer AMPs are licensed.
Many arguments are in favour of an EU legal framework for AMPs. Firstly, anthroposophic medicine is an established practice that has become part of the European health environment; the safety and efficacy of AMPs is demonstrated by scientific studies and their regular use by qualified doctors since the 1920s. More importantly, the characteristics shared with homeopathic or traditional herbal products justify subjecting them to the same or very similar simplified and more appropriate regulatory procedure. The example of Switzerland demonstrates that another, adequate authorisation regime for AMPs is possible, a regime which is compliant with the demands of patients and doctors, as well as with the necessary standards of good manufacturing practice and safety requirements.
The Swiss marketing authorisation system is very similar to the EU one, but the authorisation of complementary and alternative medicine (CAM) products, including AMPs, has been adapted by the Ordinance on Complementary and Herbal Medicines; the Ordinance defines AMP and sets out a legal regime that recognises their specific nature and low level of risks. As a result, many AMPs are available in the Swiss market. Also, the definition of AMPs and directions for their preparation is available in the Swiss Pharmacopeia. This document facilitates access to all AMPs in Switzerland, but no such parallel document exists within an EU member state or in the EU as a whole. Switzerland is, however, a member of the European Pharmacopeia convention.
IVAA Position on AMP Regulation
- The almost 100 years of European tradition and outstanding safety record of AMPs justify granting them appropriate access to the markets in the EU, especially as they improve the quality of life of patients.
- There is a need to adapt the existing legal framework to guarantee access to AMPs in Europe.
- Member states should recognise the technical standards on AMPs as worked out by the Swiss pharmacopeia, as Switzerland is a member of the European Pharmacopeia convention.
- The European Medicines Agency and heads of national regulatory authorities should include anthroposophic sections in homeopathic and herbal monographs or even adopt monographs for anthroposophic medicinal substances.
- The EU should implement a much leaner process for a mutual recognition of the marketing authorisations or registration of AMPs within Europe. That would result in less burden for the national authorities, who have little resources and know-how and would profit from the regulatory authority with more knowledge and resources. This would support a smart regulation.
- AMPs are mentioned by the Directive 2001/83/EC and should be appropriately ruled in the Annex.