REPORTS
2009
During 2009 the IAAP focussed on the development of the Anthroposophic Pharmaceutical Codex APC as well as on the development of standards to obtain qualifications in anthroposophic pharmacy.
In January 2009 the Swiss Pharmacopoeia implemented a monograph on anthroposophic preparations. See English translation under “publications”.
In July the German Medicines Act implemented the definition of anthroposophic medicinal products (AMG §4, N° (33)). It bases on 3 aspects: Conception of the medicine according to the anthroposophic understanding of man and nature, manufacture according to homeopathic methods used in anthroposophic pharmacy or special anthroposophic methods and the compliance of the medicine with the system of anthroposophic therapeutic use. (See http://bundesrecht.juris.de/amg_1976/index.html). The IAAP contributed to this success anf necessary clarification within the legal framework.
On its meeting in december 2009 the European Pharmacopoeia Commission accepted different methods of manufacturing from the German Homoeopathic Pharmacopoeia, that are used in anthroposophic pharmacy, into the European Pharmacopoeia (monograph 2371).
The further development of the Anthroposophic Pharmaceutical Codex APC includes the validation and publication of quality monographs of anthroposophic preparations. These substances are defined by their way of preparation. Also other therapeutic directions, such as homoeopathy, ayurvedic medicine, traditional chinese medicine use active substances defined by their way of preparation. Prior to install validation work, the IAAP wanted to discuss at an academic level which quality parameters will be adequate within the context of quality assurance of active substances defined by their way of preparation with other therapeutic directions. On October 8th the concerning workshop entitled
“Active substances of complementary medicine, that are defined through their way of preparation, aspects concerning their quality assurance”
took place in the Institute of pharmaceutical technology of the University of Tübingen, Germany, chaired by its Director Professor Rolf Daniels, who also is the chairman of the committee on manufacturing methods of the German Homoeopathic Pharmacopoeia and member of the working group on homoeopathic manufacturing methods of the European Pharmacopoeia.
Amongst others the participants at the workshop were:
- Dr. Giancarlo Cimino, anthroposophic medical doctor and member of the monograph drafting group at the herbal medicinal product committee, EMA.
- Prof. em. Dr. Gerhard Franz, pharmacist, chairman of the expert group on traditional chinese herbs of the European Pharmacopoeia Commission, chairman of the working party of pharmaceutical biology of the German Pharmacopoeia, as well as member of the German Pharmaceutical Codex as well as supervisor in ESCOP.
- Dr. Dietrich Schnädelbach, pharmacist, former representative of the Germany in the European Pharmacopoeial Commission, expert concerning homoeopathic medicinal products.
- Dr. Hartwig Sievers, pharmacist, CEO at Phytolab and expert of herbal medicines.
- Mag. Pharm. e. phil. Erich A Stöger; pharmacist, major expert in pharmaceutical practises in traditional chinese medicine and sinology.
The result of the workshop can be summarised as follows:
The experts agreed that best quality of active substances defined by their way of preparation is achieved by a well monitored supplier chain, as well as well described and documented manufacturing procedures. Analytical methods are of substantial help in particular for checking safety related parameters, e.g. the maximum limit of a toxic constituent. A good quality however cannot be achieved through analytical testing, as a number of good quality issues frequently cannot be detected by analytics (e.g. pretreatment of chinese drugs accoridng to tradition, aspects of manufacturing processes carried out according to anthroposophic methods, e.g decoction time). Therefore the resources concerning quality assurance should be merely invested in the accuracy of the production chain, from the first source, such as cultivation etc. until finished product. Analytics plays a more confirmatory role. Its extend should be balanced.
The work on training standards in anthroposophic pharmacy also continued. The strategy is as follows: the IAAP will set requirements for the training in “Anthroposophc Pharmacy” and will certify requesting national associations, whether the concerning national standards comply. Such a mode of proceeding is in line with the basic rule of the international anthroposophic pharmacists’ community to think globally but to act locally.
The following subjects amongst others are dealt with in anthroposophic pharmacy training:
System of Anthroposophic Medicine/concept of the human being
- concept of health and illness/ Salutogenesis and Pathogenesis, etc.
Substance research
- the understanding of the substances in natural remedies
- (metals, minerals, medicinal plants, animal. Substances...), etc.
Manufacturing procedures/manufacture of medicines
- Anthroposphic Pharmaceutical Codex
- procedures based on steps of warmth
- rhythmical procedures
- potentising –solid, fluid, etc.
Special Anthroposophic Remedies/ groups of remedies in relation to rationale, manufacture and therapy.
Customer Advice: advice on Anthroposophic Remedies. Communication skills to enhance an empathic and objective comprehension of the customers.
2008
In general 2008 has been a very successfull year for the IAAP. Thanks to intensive work and the interest of European Authorities as well as Regulators (see below) it has been possible to make anthroposophic medicine and pharmacy more known and understood.
From January up to the beginning of March the IAAP intensely worked on a presentation on anthroposophic pharmacy and medicine to be held upon the invitation of the Herbal Medicinal Products Committee – HMPC – at the London Medicines Evaluation Agency, EMEA. Together with the association of the anthroposophic pharmaceutical industry as well as the doctors’ association it was possible, we believe, to present an overview of the anthroposophic approach to medicine and pharmacy on March 6th. The IAAP is very grateful to the HMPC at EMEA for their interest.
The presentation as well as the summary by EMEA can be downloaded from the publications section http://www.iaap.org.uk/publications/index.html.
During the spring and summer months the IAAP has begun to draft international guidelines on the training of pharmacists. This work is still ongoing. The difficulty is to draft consensus guidance with regard to the numerous national differences.
In September during the annual Conference of the Medical Section of the School of Spiritual Science in Dornach, Switzerland, pharmacists from different countries, a.o. Sweden, France, Austria, Brazil, Italy, the UK, Germany, Lithuania met to exchange news and to share views on common goals, such as the further development of the Anthroposophic Pharmaceutical Codex and the international training standards.
On September 29th the European Commission issued the „Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional harbal medicinal products“
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/
2008_09/comm_2008_584_en.pdf . In that document the European Commission recognizes the reality of anthroposophic medicine as a European tradition. The EU Commission refers to the Anthroposophic Pharmaceutical Codex as main pharmaceutical publication. As anthroposophic medicinal products can be used both, as single products for circumscribed pathological conditions as well as part of clinical setting with more medicines and therapeutic measures, a suitable EC regulation for anthroposophic medicinal products must consider both approaches for the granting of marketing authorisation, a „product approach“ and a „system approach“. For the latter the Commission states that „...the suitability of a separate legal framework for products of certain traditions should be assessed.“
We believe that the Commission document contributes substantially to the preparation of a suitable legislation.
On December 18th, upon demand of the Homoeopathic Medicinal Products Working Group – HMPWG – the IAAP contributed with a presentation on the clarification how „anthroposophic use“ of medicinal products can be understood and could be regulated (see also April 2005 further above). The summary of the presentation can be downloaded under the publications section http://www.iaap.org.uk/publications/index.html. The IAAP is grateful to the HMPWG for this opportunity during which we believe it was possible to contribute to an understanding of anthroposophic medicine and pharmacy in view of best regulatory practise.
2007
In January the the Belgian/Dutch Association BNVAA (Belgisch-Nederlandse Vereniging van Antroposofisch georiënteerde Apothekers - Belgian Dutch Association of AnthroposophicPharmacists) is founded and applies for IAAP membership.
On June 25th, 26th and 27th the IAAP participated in the finalisation of the WHO paper now called “WHO guidelines on key issues of quality impacting on the safety of homeopathic medicines“. The consultation group provided several recommendations and proposals to both WHO Member States and the WHO.
With regard to anthroposophic medicine the most interesting recommendation for WHO´s further projects was the proposal:
“to develop appropriate technical guidelines addressing specific aspects of quality and safety of homeopathic medicines used in homeotherapy (e.s. microbial safety, viral safety)”.
This recommendation is the most important for anthroposophic medicine as it gives the WHO the possibility – although among other medical systems of homeotherapy – to take a closer look also on anthroposophic medicine.
In July the IAAP commented the draft document “Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products”. In the draft document anthroposophic medicine is recognised as a medical direction having a tradition in Europe.
On August 16th the speciality „Anthroposophic Pharmacy“ as well as the "Anthroposophic Pharmaceutical Codex, APC" have been recognised in Brazil. Warm congratulations for the Brazilian collegues of the Brazilian association Associação Brasileira de Farmácia Antroposófica- FARMANTROPO!
In October the IAAP sent its position paper to the European Commission within the context of the public consultation on the future of pharmaceuticals for human use in Europe. The statement of the IAAP focusses availability of anthroposophic medicinal products as well as on the need of information on anthroposophic medicines available to pharmacists.
In November the IAAP publishes the fully revised second edition of the "Anthroposophic Pharmaceutical Codex, APC".
2006
The website was reorganised and redesigned in June.
In July the APC Committee was founded with the task to prepare the second edition of the APC.
The following new organisations are in the course of gaining membership:
- Società Italiana Farmacisti Antroposofi, SOFAI, Italy
- Association Française D’étude et de Recherche sur la Pharmacie Anthroposophique, AFERPA, France
- Associação Brasileira de Farmácia Antroposófica- FARMANTROPO, Brazil
The IAAP was invited to participate to the „Homeopathic Workshop“ at the European Medicines Agency EMEA on October 27th. The event was requested by members of the European Parliament. The IAAP presented the characteristics of anthroposophic medicinal products and the need to apply specific regulation.
The IAAP commented the draft “WHO Guidelines on the control and safety of homeopathic medicines” in December.
2005
On February 15th the European Directorate for the Quality of Medicines EDQM held the Symposium "Quality of Homeopathic Medicinal Products in the new European Legislative Framework" in Strasbourg. Anthroposophic medicinal products were presented on that occasion by BAAP member Ian Wiggle. Ian Wiggle's speech has been well accepted and the overall impression was, that the awareness towards anthroposophic medicine and pharmacy is growing. In the prior speech of the German Authority BfArM there had been several references to anthroposophic medicinal products: the "terrain" for Ian's speech was therefore well prepared.
On April 20th a hearing of the Homeopathic Medicinal Product Working Group (HMPWG) was held in Amsterdam. The HMPWG represents the highest International Regulatory Authority for homeopathic medicinal products. Quite a number of anthroposophic medicinal products are manufactured by production methods described in homoeopathic pharmacopoeias, therefore the IAAP was represented by Christiaan Mol, who spoke about anthroposophic medicinal products in the context of mutual recognition procedure and the requirement to submit evidence concerning the “anthroposophic use”.
Christiaan Mol could clearly state the existing legal context of anthroposophic medicinal products (preamble 22 of Council Directive 2001/83) and the need of a specific approach concerning biographical data.
In July the IAAP publishes the first edition of the "Anthroposophic Pharmaceutical Codex, APC".