Working to develop the scientific basis for a permanent regulatory framework for anthroposophic medicinal products in Europe

Evaluation strategy: One system vs. many single products

Central issues for regulatory assessment of medicinal products are the pharmaceutical quality, efficacy/effectiveness and safety of the products. The usual procedure, according to current regulations, is the separate assessment of each product or substance ("single product approach"). However, in medicine there exists also an opposite approach, for which the primary assessment concerns whole therapy systems such as psychotherapy, surgery or physiotherapy while the evaluation of system components comes as a secondary step. Such a "system approach" seems more appropriate for the evaluation of anthroposophic medicinal products (AMPs) [1;2]. Accordingly, the ESCAMP strategy gives priority to the system approach as a first step, while the need for singular monographs is implemented on medium and long term. The ESCAMP strategy includes three evaluation stages:

  1. Description of Anthroposophic Medicine and AMPs
  2. Evaluation of AMP therapy as a whole system
  3. Evaluation of single AMPs and AMP groups in monographs

Stage 1 – Description of Anthroposophic Medicine and AMPs

A number of descriptions and introductory texts on Anthroposophic Medicine already exist, particularly in the German language. The description drafted for ESCAMP is aimed at politicians, scientists and governmental representatives without prior knowledge of Anthroposophic Medicine. This description is based on the existing literature, with particular emphasis on conceptual compatibility with the Anthroposophic Pharmaceutical Codex [3].

The description includes an assessment of Anthroposophic Medicine as a scientific system. The starting point for this assessment is the pluralist conception of science in the 20th century. This is followed by a description of some common features of scientific systems (theory, empiricism, discourse, stability, development) and the investigation into whether these features apply to Anthroposophic Medicine and, as a consequence, whether Anthroposophic Medicine can be considered a scientific system of medicine.

Stage 2 – Evaluation of AMP therapy as a whole system

In this evaluation, data on the pharmaceutical quality, efficacy/effectiveness and safety of the entirety of AMPs will be compiled. Relevant data include data on the system level (e. g. system evaluation studies such as AMOS, IIPCOS, rheumatoid arthritis study) as well as data on single products, such as clinical studies, reports of physicians' clinical experience, and pharmacovigilance data. A detailed data analysis for each single product does not take place here but at the third stage.

The whole system evaluation will address frequency questions, such as: How many AMPs have been evaluated in clinical single-product studies and system evaluation studies, respectively? For how many AMPs are there e. g. at least five physician reports of clinical experience? How often do adverse reactions to AMPs occur altogether?

Stage 3 – Evaluation of single AMPs and AMP groups in monographs

Data on single AMPs with relevance for regulatory assessment will be compiled in ESCAMP monographs. The requirements for these monographs will be more strict than for the earlier AMP monographs of the Commission C [4,5]. As templates for the ESCAMP monographs the structure of corresponding herbal monographs of the European Medicines Agency can be used, with some modifications. In addition to single product monographs, ESCAMP monographs on product groups such as organ preparations or metal AMPs may be compiled.

The Evaluation Stages 1-3 shall be realised in this temporal sequence; however, the Stage 3 will be initiated before the Stages 1 and 2 are completed.

Reference List

  1. Fønnebø V, Grimsgaard S, Walach H, Ritenbaugh C, Norheim AJ, MacPherson H, Lewith G, Launsø L, Koithan M, Falkenberg T et al. Researching complementary and alternative treatments - the gatekeepers are not at home. BMC Med Res Methodol 2007;7(7). doi 10.1186/1471-2288-7-7
  2. Kienle GS, Albonico H-U, Fischer L, Frei-Erb M, Hamre HJ, Heusser P, Matthiessen PF, Renfer A, Kiene H: Complementary therapy systems and their integrative evaluation. Explore: The Journal of Science and Healing 2011;7(3):175-187. doi 10.1016/j.explore.2011.02.001
  3. Anthroposophic Pharmaceutical Codex APC, Third Edition. Dornach: The International Association of Anthroposophic Pharmacists IAAP; 2013.
  4. Anthroposophische Arzneimittel. Aufbereitungsmonographien der Kommission C. [Anthroposophic medicinal products. Monographs of the Commission C]. Filderstadt: Physicians’ Association for Anthroposophical Medicine in Germany; 1999.
  5. Glöckler M, editor. Anthroposophische Arzneitherapie für Ärzte und Apotheker [Anthroposophic medication therapy for physicians and pharmacists]. Stuttgart: Deutscher Apotheker Verlag; 2008.

Last update: March 2017