Political work for Tibetan Medicine in Europe. Topics. Tibetan Medicine in Asia today. Tibetan Medicine. Traditional Medicine

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1 Political work for Tibetan Medicine in Europe Dr. Herbert Schwabl AG Innsbruck, 12 October 2012 Topics Tibetan Medicine Traditional Medicine Strategies / Next Steps Tibetan Medicine in Asia today 1

2 Tibetan Medicine in Asia Tibetan Medicine is the medicine of the areas influenced by Tibetan culture (not the medicine of Tibet ) Originally not standar-dized and uniform, many regional differences Tibetan Formulas in Europe Movement to Switzerland Swiss beginnings:

3 Padma AG Switzerland founded employees Swiss based: Production (Kempten, 1986) QC-Laboratory (Kempten, 1998) Administration (Hinwil, 2012) Produkts: herbal formulas based on Tibetan medicine Our goal: Natural Tibetan formulas for people living in the We Products in Switzerland since 1970 since1977 3

4 Topics Tibetan Medicine Traditional Medicine Strategies / Next Steps Regulatory authorities want _ no risk Toxicological safety _ known ingredients Problems with non-european herbs Problem: multicompound formulations _ structured information on product Labeling of boxes, consumer information Clear language, no esoteric descriptions _ want to keep Asian products out of the market? No official statement, but Working Hypothesis: Padma products are 1 Herbal medicines (Traditional route) 2 Food supplements 4

5 Question: Food vs. Medicine? Padma in Europe Switzerland* PADM PAD PADM 28 DIGES A MA A Nerven- Venen Leber- LAX Magen- Tonikum Toniku Regul brenm ans nenformel Denmark plus Italy PADM PAD PADM BASIC DIGES A MA A HEPA LX ACIBE TEN N CIRCOS DIGES NERVO AN TONIN Latvia Lithuania PADM CIRCOS DIGES A AN HEPA TEN Netherlands PADM BASIC DIGES A HEPA TEN Austria PADM CIRCOS DIGES A AN HEPA NERVO TONIN PADM A NERVO VENAB ACIBE TONIN EN N NERVO TONIN Padma in Europe Switzerland* PADM PAD PADM 28 DIGES A MA A Nerven- Venen Leber- LAX Magen- Tonikum Toniku Regul brenm ans nenformel Denmark plus Italy PADM PAD PADM BASIC DIGES A MA A HEPA LX ACIBE TEN N CIRCOS DIGES NERVO AN TONIN Latvia Lithuania PADM CIRCOS DIGES A AN HEPA TEN Netherlands PADM BASIC DIGES A HEPA TEN Austria PADM CIRCOS DIGES A AN HEPA NERVO TONIN PADM A NERVO VENAB ACIBE TONIN EN N NERVO TONIN 5

6 Regulatory Framework in Europe CITES National agencies, e.g.: (Traditio nal Medicin e Guidelin e) Switzerlan d UK Austria Germany Italy Poland, Netherlands, Denmark, Challenges in European Union At the moment it is almost not possible to register medicinal products from Asian medical systems in Europe. The only chance at the moment is traditional medicine guideline (DIRECTIVE 2001/83/ EC*)! Quality (GMP)! Camphor issue! Safety profile! 15 years of traditional use in EU (Switzerland is not in EU!) * DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use 6

7 Definition Traditional Medicine by WHO, by EU? Contact at WHO Headquarters: Challenges in Switzerland! Registration of natural products is possible " Swissmedic under constant reorganization " Simplified application possible (in principle) # Appenzell products # Need to cut timeframe for traditional application to 10 years Example drug registration Se bru kant. registration Kt. AR use of formula, no side effects 2006 Start project 2008 hand in of registration dossier 2010/11 registration 2011 Introduction on market 7

8 After 40 years working in Europe Padma products are Tibetan tradition? Swiss tradit Few Tibetan doctors in Europe Edinburgh Amsterda m London Paris Freiburg i.b. Barcelona Copenhag en Warsaw Vienna Milano Rome Glarus, CH (compiled to the best of our knowledge) Few schools for Tibetan Medicine in Europe Edinburgh Zurich Hüttenber g ITTM (Rome + courses in various cities) New Yuthog Institute " Milano " Rome " Bad Homburg " Naples (compiled to the best of our knowledge) 8

9 Problem: Tibet issue $ Tibetan Medicine many traditions / regions Mongolian Medicine Bhutanese Medicine Bön Medicine Amchi medicine. $ Tibet is no independent state in China: TCM in India: Ayurveda $ Dharamsala / Men Tsee Khang has only NGO status Challenges on a global level Tibetan medicine is (unfortunately) not a state medical system Example WHO Tibetan Medicine is not recognised as a unique traditional medical system Definition Traditional Medicine WHO collaborating centres for Traditional Medicine: 9

10 Education of Tibetan doctors / practitioners in Europe I.I.H.T.S. - International Institute of Higher Tibetan Studies Hüttenberg, Austria Dr. Lobsang Shresta IG Tibetische Medizin, Zurich, CH Dr. Nida Chenagtsang IATTM in many countries Dr. Pasang Yonten International status is changing Mainly China & India start to recognise Tibetan Medicine India " University of Sarnath " AYUSH China " Chinese Pharmacopoia " Factories in China produce Tibetan Formulas " University Courses (Lhasa, Xining, Lanzhou, Beijing, etc) Bhutan Mongolia Russia Sowa Rigpa, Tibetan medicine system, officially approved From: "Secretary, Bureau of HH the Dalai Lama <secretary@tibetbureau.in> To: "TMAI" tmai@men-tsee-khang.org Subject: Tibetan medicine system, officially approved Date: Mon, 14 Sep :52: New Delhi, September Through a proposed amendment in Medicine Central Council Act, the center accorded legal status to the Tibetan medicine Sowa Rigpa, one of the oldest healing traditions practiced in many countries that originated and developed in ancient Tibet. The decision to grant official approval to the Tibetan medicine as part of the Indian medicine system and to put it at par with other systems of traditional medicines came Thursday, following representations from various quarters. 10

11 Topics Tibetan Medicine Traditional Medicine Strategies / Next Steps Political Network # SVKH Swiss Association of Manufacturers of Complementary Medicines # SMGP Swiss Association of Phytotherapy # Swiss Umbrella Organization of CAM # Vienna Academy of CAM # EITAM European Initiative on Asian Medicines # ECPM European Council for Plurality in Medicine Tibet Network - IATTM Political process: Switzerland 11

12 CH: Simplified registration for traditional herbal products Lobbying for adoption of new paragraphs in Swiss HMG _ establishing of Swiss MP group for CAM _ stakeholder meetings with Swiss Agency (Swissmedic) EITAM - European Initiative for Traditional Asian Medicinal Products The medicines and their application practice must satisfy high standards of safety and quality. The current European legal situation does not sufficiently consider the special circumstances of Asian traditional medical therapies, making the registration of traditional Asian medicines almost impossible. EITAM promotes the use of medicinal products of the Asian medicinal systems with - high quality and safety standards, - in sufficient variety and - legalised as medicines. The Asian traditional medical therapies represented by EITAM are Traditional Chinese Medicine (TCM), Indian Medicine (Ayurveda), and Tibetan Medicine. 12

13 Thank you for your attention Dr. Herbert Schwabl AG Innsbruck, 12 October

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