Raising the Standards in European Homeopathy Dr Annette

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 www. austrian-standards. at

Contents § Standards and regulation § Contrarian positions on the European Homeopathy Standard § Outlook www. austrian-standards. at

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 www. austrian-standards. at

Some characteristics of standards and legislation Legislation Standards 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 www. austrian-standards. at Status 2014

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

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 www. austrian-standards. at

Contents § Standards and regulation § Contrarian positions on the European Homeopathy Standard § Outlook www. austrian-standards. at

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

Taking into account justified concerns § Exclusive national legislative rights § Standards are no laws and thus do not infringe § In areas of conflicts: A-Deviations § Evidence based medicine § Standards are based on consolidated science and experience and are not contrary to evidence § Relationship doctor – patient § Focus on technical aspects of service § Individual relationship is emphasized throughout § Regulating a free profession § Aspects dealing with security of consumers and transparency are always subject to legal oversight § 2 classes of homeopathy § 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 § Political aspects of healthcare § Just because something is political does not mean you cannot legitimately contribute to the discussion www. austrian-standards. at

Contents § Standards and regulation § Contrarian positions on the European Homeopathy Standard § Outlook www. austrian-standards. at

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 www. austrian-standards. at

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

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

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

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

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 www. austrian-standards. at