by the PHARMACEUTICAL COMMITTEE of the EU-Commission (Health systems and products- Medicinal products – authorizations, European Medicines Agency) in relation to the Matrix-Report of 2012, referring to the Herbal aspect.
By Nora Laubstein (inspired by Dr. Mathias Schmidt and Dr. Hubert Schwabl)
The summary of comments about the Matrix report gives a fairly good overview about the regulatory difficulties of herbal medicinal products. But in the report a rather neutral position prevails.
An example - Looking back in German Herbal Medicines history:
Practically all of the registrations mentioned in the report for Germany are NOT new products or switches from food supplement to drug status; they are generally products that existed for many years as authorized herbal medicinal products.
ECHAMP warmly welcomes the publication of the ‘External Study Report on the Availability of Medicinal Products for Human Use,’ which gives significant prominence, for the first time, to the situation concerning the availability of homeopathic and anthroposophic medicinal products in the EU. Although the report contains some statements that are not fully correct from ECHAMP's point of view, the overall positive aspects clearly outweigh the deficits.
The long-awaited study investigates the availability of medicinal products for human use in the EU and EEA, focusing on the authorisation procedures for medicinal products. It investigates different reasons for lack of availability and the effectiveness of existing European legislative provisions in addressing these problems, exploring six case studies, including the use of Article 126a of Directive 2001/83/EC (Cyprus Clause) and the availability of herbal, homeopathic and anthroposophic medicinal products.
The study quotes ECHAMP’s own report ‘The Availability of Homeopathic and Anthroposophic Medicinal Products in the EU’ as its main source of information on this topic. ECHAMP is now working hard to analyse the new report and we will share our conclusions with Members before Christmas. For now, we welcome the fact that the report acknowledges the need to improve the national implementation of simplified procedures for homeopathic and anthroposophic medicinal products as one example of a specific area for improvement.
This study report is presented as a working document of the Pharmaceutical committee, an advisory Committee to the Commission that consists of senior experts in public health matters from the Member States' administrations; it is an independently written document, which means it does not necessarily reflect the official opinion of the European Commission. Nevertheless, it is hoped it will add significant weight to ECHAMP’s goal of suitable regulation for our products.
Press Release: CAM — an important role to play in combating Antimicrobial Resistance (AMR)
A delegation headed by Shri Nilanjan Sanyal, Secretary, Deptt. of AYUSH, Ministry of Health and Family Welfare visited Hungary on 21-24th September 2014. Accompanied by Shri Bala Prasad, Joint Secretary, Deptt. of AYUSH and Dr. Abhimanyu Kumar, Director, All India Institute of Ayurveda and Director Incharge Central Council for Research in Ayurvedic Sciences, New Delhi, the delegation came to visit Hungary with the aim to promote Ayurveda in the country, and to participate in the International Ayurveda conference which was held on 22-23rd September in cooperation with the Traditional Indian Medicine for the Public Health in Hungary Foundation.
On 22nd Sept. the inaugural session of the conference was held at the ASCC auditorium of the Embassy from 1500-18:15 featuring a short film on Ayurveda, welcome addresses by Ambassador Malay Mishra and Dr. Peter Medgyessy, Founder, Traditional Indian Medicine for the Public Health in Hungary Foundation and several presentations.
AGTCM-Congress 2014, Rothenburg o.d.T.
Report by Nora Laubstein
International Classification of Diseases (ICD-11)-revision by WHO/ Enhanced recording of morbidity in TM terms
In connection with the ICD which classifies all relevant diseases on international level (in the beginning 1900, later in 1948 accepted worldwide) the European TCM-Association (ETCMA) and the German organization AGTCM presented Mister Nenad Kostanjsek, Technical Officer for statistics CTS of the WHO in Geneva and his team. He was invited to give a review in three parts about the last three years of working together for a TM-alignment included into the ICD-system.
Until now (ICD-10) all diseases are listed but without any concrete definition. This situation should be changed with the new version ICD-11 which should be finished in 2017: Additionally to this process the department of Mister Kostanjsek works together with the WHO-T&CM department of Dr. Zang Qi. They have founded an internal Working-Group (ICTM) to develop categories for the health workforce in the so called WHO-TM-Modul-1.
Currently only three countries were represented in this group and give financial support: China, Japan and Korea. In the past eight CAM-disciplines have been standardized (under all TCM, Homeopathy, Chiropractic and Osteopathy) and connected with the WHO-benchmark-directive for T&CM (former called TM/CAM).
Mister Kostanjsek contested: Yes, T&CM is part of the health section, BUT „TM does not count, until we do not count TM!” More and more demands for quality and safety are strengthening the pressure. Because of growing necessarily we have to find a high level categorization!
For the WHO this situation leads to the following perspectives:
On 29 April 1999, in line with the international and national recommendations on complementary and alternative medical (CAM) therapies expressed by bodies such as the Council of Europe and the European Parliament, the Belgian Parliament voted in the Colla Law in order to initially regulate practitioners of four of the most popular CAM practices in Belgium: acupuncture, chiropractic, homeopathy and osteopathy.
In the years to follow professional bodies for these practices were founded and accredited by the Ministry of Health, among which the Liga Homeopathica Classica was established for homeopathy. The Liga established high standards for the education and professional profile of homeopaths in line with the guidelines of the European Central Council of Homeopaths in preparation for an eventual specific legal framework for the profession.
Eventually, after legal pressure was brought to bear, the Ministry of Health set up 4 commissions, one for each practice, in order to establish the specific details concerning the regulation the four disciplines. Unfortunately the homeopathy commission was neither democratically constituted, nor did they include adequate representation of the most important interest of all, patients and citizens.
On Monday 12 May 2014, 15 years after the Colla Law was introduced, a Royal Decree was published by the Ministry of Health that completely denies the autonomy of the profession of the homeopath and deprives Belgian patients of their freedom of choice to have homeopathic treatment now and into the future.
Dr. Vera Paola Termali, President of SIHeN, Professional Association of Italian Heilpraktikers and Naturopaths
Last month the discussion about CAM in Italy became hot, when the Ministry of Health realized that at the beginning of 2013 a law was issued which allowed all professions without a dedicated regulation to be practiced under the supervision of professional associations and through a UNI Norm, a quality standard certification.
This framework law includes a variety of professions, ranging from web designers to graphologists, but some professional associations of naturopaths decided to put also naturopathy under this umbrella.
What about the concern of the association „shamanic network Europe e.V.“ under the umbrella of ANME e.V.?
We just finished our first festival at castle Ludwigstein, right in the middle of Germany. Not only Germans, but Norwegian, Estonian, Austrian, Finnish and Irish guests came to the 4 day event of „Shamanic Network Europe e.V.“ The topic there was „traditional healing work and spiritual customs in Europe“. Till now we arranged only week-end seminaries about the same subjects. For us, these both aspects are closely connected. We will show this by an important example.