Raising the Standards in European Homeopathy

1. Raising the Standards in European Homeopathy • Dr. Annette Altenpohl • Brügge. November 14, 2015.

2. Contents • Standards and regulation • Contrarian positions on the European homeopathy standard • Outlook

3. Contents • Standards and regulation • Contrarian positions on the European Homeopathy Standard • Outlook

4. Definition of Standard • No single definition • Broad definition Tool to get something organized Alternative tools are laws, regulations, contracts, science, religion, …. • Definition of CEN Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context Source: EN 45020:2006

5. Some characteristics of standards and legislation Status 2014

6. Links between standards and regulation • Standards can be • adopted by law • referenced by law • Standards influence the interpretation of legal concepts such as • state of the art of science and technology • common practice and usage • obligation to exercise due care • Standards can be referenced by contracts • public procurement • interpretation of contracts • specification of agreed service Effort Laws and regulations Standards Guidelines of trade associations Company guidelines Contracts Mandatory

7. The EU and standardisation • Standardization is a EU policy tool in support of the EU internal market (also for services) • Objective is the education of non-tariff barriers to trade (including services) • All EU members must have a national standardization system • European standards are approved by a weighted majority • EU standards have to be adopted by all countries in the EU and conflicting national standards have to be withdrawn • Potential conflicts with national laws • A-Deviation

8. Contents • Standards and regulation • Contrarian positions on the European Homeopathy Standard • Outlook

9. Reaching consensus • 3 major groups have been voicing concerns on the European Homeopath Standard • National ministries of health Nonmedical practitioners of homeopathy National chamber of medical doctors • Medicine should be • evidence-based • Relationship doctor to • patient is individual • and should not be • regulated • Exclusive national • legislative rights in • healthcare • Health care is highly • political • Regulation of a free • profession • Creation of 2 classes • of homeopathy

10. Taking into account justified concerns • Exclusive national • legislative rights • Evidence based • medicine • Relationship doctor – • patient • Regulating a free • profession • 2 classes of homeopathy • Political aspects of • healthcare • Standards are no laws and thus do not infringe • In areas of conflicts: A-Deviations • Standards are based on consolidated science and • experience and are not contrary to evidence • Focus on technical aspects of service • Individual relationship is emphasized throughout • Aspects dealing with security of consumers and • transparency are always subject to legal oversight • What a medical doctor can do is objectively different from • what a non-medical practitioner can do • Nonmedical practitioners are of course free to create own • standard • Just because something is political does not mean you • cannot legitimately contribute to the discussion

11. Contents • Standardsandregulation • Contrarianpositions on the European Homeopathy Standard • Outlook

12. Where does the project stand? Idea,project proposal • Criteria for acceptance • are met: 81% country • weighted approval • Text to be finalised and • to be published in 2016 • Next important stage: • Implementation Updating standard, if necessary Commenting onproject proposed Committee prepares standard proposal Standard is used Inputtingexperiences Standard is finalized Standard is published Commenting on draft standard

13. What‘snext - implemenation • Get the standard out into the market as state of the art • apply it in your medical practice • communicate to customers and the public • Propose the standard to authorities/governments • endorsement or reference of standards in legislation and regulations • reference in law-suits • Promote the standard via your associations • promote the use of the standard • entry requirements into the association • Use certification • for schools • for practitioners

14. What is Certification? Indenpendent Certification Body (3rd party) Certification Certification Evaluation of Supplier Customer (Patient) Service Provider (Medical Doctor) Self-Declaration • Attestation of conformity with the • requirements of a standard • For service provider • For service • For school • Can be direct or via a third party

15. Typical 3rd party certification process • Documentation • Application Preparation • Auditor(s) • On-site visit Audit Periodic surveillance and confirmation • Audit follow-Up • Audit report Follow-Up • Conformity assessment • Issue of the certificate Certificate

16. Example – EN 16686 Osteopathic healthcare provision OsEAN – Osteopathic European Academic Network / OsEAN Standard CEN EN 16686 OsEAN OsEAN standard Austrian Standards Certification Certification Scheme f. OsEPs Training, authorisation Appointment Audit Pool of auditors Member Certificate is a prerequisite for membership in OsEAN Certificate Osteopathic Education Provider

17. Thankyouverymuch! Dr. Annette Altenpohl Austrian Standards Institute Heinestraße 38 | 1020 ViennaAustria T:M:E: +43 1 213 00-724 +43 6991 710 9010 a.altenpohl@austrian-standards.at