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

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

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

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

Some characteristics of standards and legislation Mandatory Voluntary Created by legislator Developed by interested parties through standardization organizations Consultation depending on public authorities‘ policies Processes based on WTO principles transparency, openness, impartiality, etc Decision based on legislative majority Decision based on consensus Revised when legislator decides Considered for revision at least every 5 years Sets requirements determined by legislator Provide state of the art solutions based on science and experience Publicly accessible Valid in entire country / region Status 2014

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

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majority EU standards have to be adopted by all countries in the EU and conflicting national standards have to be withdrawn Potential conflicts with national laws A-Deviation

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

Reaching consensus Exclusive national Regulation of a free 3 major groups have been voicing concerns on the European Homeopath Standard National ministries of health National chamber of medical doctors Nonmedical practitioners of homeopathy 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

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

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

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 on project proposed Committee prepares standard proposal Standard is used Inputting experiences Standard is finalized Standard is published Commenting on draft standard

What‘s next - 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

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

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

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

Thank you very much! Dr. Annette Altenpohl Austrian Standards Institute Heinestraße 38 | 1020 Vienna Austria T: M: E: +43 1 213 00-724 +43 6991 710 9010 a.altenpohl@austrian-standards.at