Dr. Thomas Peinbauer ECH President
[email protected]
European Standard for Service Provisions of Medical Doctors with additional Qualification in Homeopathy This presentation will give general information about CEN and the European Standard. The following questions will be addressed. -
What is CEN? What is the role of CEN? What is a standard? What is the role of a standard in the context of laws, regulations and private specifications?
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What are the ECH’s objectives? How can such a CEN standard help to reach them?
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What have been the most prominent arguments against this CEN standard?
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What is the timeframe for the CEN process?
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How much will this CEN process cost?
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What is the state of affairs?
What is CEN? CEN, the European Committee for Standardisation (Comité Européen de Normalisation, Europäisches Komitee für Normung), is an international non-profit organisation set up under Belgian law. Through its services, it provides a platform for the development of European Standards (ENs) and other consensus documents. CEN has 33 National Members working together to develop these publications in a large number of sectors to help build the
European internal market in goods and services. More than 60,000 technical experts from industry, associations, public administrations, academia and societal organisations are involved in the CEN network that reaches over 480 million people. The European Commission and the EFTA (European Free Trade Association) Secretariat act as CEN's Counsellors in terms of regulatory or public interest. CEN works in a decentralised way. Its members – the National Standardisation Bodies (NSBs) of the EU and EFTA countries – operate the technical groups that draw up the standards; the CEN-CENELEC Management Centre (CCMC) in Brussels manages and coordinates this system. CEN is one of the three European Standards Organisations (ESOs). It is a partner of the International Organisation for Standardisation (ISO). It has 3 decision layers at technical level: the Technical Board decides on proposals for new projects, the Project Committee develops standards within a specific scope and the Working Group undertakes a specific task, e.g. provides a draft of a standard.
What is the role of CEN?
CEN provides the platform for stakeholders in a specific area to come together and reach a consensus at European level in the framework of voluntary standardisation and it helps to ensure that the system respects the principles of transparency, openness, coherence and consensus. And the aim is to raise quality and harmonise services at European level.
What is a standard?
A standard (French: Norme, German: Norm, Italian: standard) is a document designed to be used as a rule, guideline or definition. Over 14,000 EN’s exist today, with about 1,000 new publications every year. In addition to industrial products and equipment, standardisation covers new fields, such as services, risks management and more. This involves an increasing number of participants: local councils, consumer associations, professionals, craftsmen, etc. It is a kind of “soft regulation” of “self regulation”, drawn up on a voluntary basis at European level guaranteeing openness, consultation and it reflects consensus. Standards are created by bringing together all interested parties. This is a consensus-built, repeatable way of doing something and should have the objective of facilitating long term convergence of national standards collections towards eventual homogeneity without, however, imposing national changes in domains where subsidiarity is enforced (i.e. regulatory measures remain the competence of the various Member States). A European Standard (EN) automatically becomes a national standard in the 33 member countries. Conflicting national standards are withdrawn! This presupposes that European standardisation does not cover those subjects clearly belonging to the domain of regulation of the Member States, unless this is explicitly supported by the national authority. European standards are, from a legal point of view, voluntary in their use. They do not, in themselves, impose obligations upon anyone to use them, but at the same time, they are unavoidable in practice! They are a tool to underpin the details of directives. Standards provide a benchmark for acceptability and may be taken into account by the courts. Neither national standards bodies nor international or European organisations have the legal authority to make the use of their standards compulsory. Although standards’ specifications take the form of requirements, compliance is only obligatory when claimed in the trade description of a product, process or service, required by a contract or made mandatory by law or regulation.
What is the difference between standard and regulation? The respective characteristics are: Standards • Recommendations • Use is voluntary • Available to the public • Established by consensus of all parties concerned • Bottom-up-process • Based on consolidated results of science, technology and experience • Approved and published by recognized Standardisation Body
Regulations • Binding legislative rules • Use is mandatory • Available to the public • Providing Technical Specifications directly or by reference ‐ e.g. to standards • Top-down-process • Adopted by an authority
Regulations may refer to standards, either in an indicative way, then the standards are voluntary, or in an exclusive way, then standards are mandatory.
A normative reference to EC directives is not permitted. Compliance with the law is obligatory irrespective of compliance with standards.
What is the difference between European standard and private specification? The main difference between standard and specification is in the area of consensus. A European Standard must reach full consensus between all stakeholders on technical content, whilst a private specification can invite comments from certain interested parties but does not necessarily incorporate them. They offer the sponsor complete control over content. Specifications can be produced for products, codes of practice, guidelines or vocabularies.
ECH specifications The ECH subcommittees have developed several definitions and guidelines in the field of homeopathy over the past few years. These were adopted by the General Assembly held in November 2012 and became official for all member organisations. The process within ECH is very similar to the necessary steps of the CEN project. The difference is that in the end, all ECH guidelines are only private specifications. The proposed European Standard (EN) will refer to the ECH definitions and guidelines,
European Standardization: Health Care Services The following health care services have already started either a CEN or an ISO process. CEN/TC 394 was adopted in July 2012 and became the European Standard EN 16224:2012 “Healthcare provision by chiropractors”. • CEN/TC 394 Services of Chiropractors - EN 16224:2012 “Healthcare Provision by Chiropractors” • CEN/TC 403 Aesthetic Surgery Services - prEN 16372:2013 “Aesthetic Surgery and Aesthetic Non-surgical Medical Services“ • CEN/TC 414 Services in Osteopathy • CEN/TC 424 Care Services for Cleft Lip and/or Palate • CEN/TC 427 Services of Medical Doctors with additional Qualification in Homeopathy Traditional Chinese Medicine followed the international standardisation process of ISO: • ISO/TC 249 Traditional Chinese Medicine
CEN/TC 427 “Project Committee - Services of Medical Doctors with additional qualification in Homeopathy” The European Committee for Homeopathy (ECH) initiated the information process at their meeting in Rome in April 2011. In November of the same year, the Political Subcommittee endorsed this project and the ECH Council outlined the financial implications. In May 2013, upon request and in consultation with ECH, the Austrian Standards Institute proposed the creation of a Project Committee to the European Committee for
Standardisation (CEN). After a Draft Decision by Correspondence, the creation of the proposed Project Committee was adopted by the Technical Board of CEN (CEN/BT) on 6 August 2013. The first meeting of the CEN/TC 427 Project Committee will take place in January 2014. The process will take a maximum of 3 years to complete the process.
ECH aims
to promote the scientific development of homeopathy; to ensure high standards in the education, training and practice of homeopathy by medical doctors; to harmonise professional standards in homeopathic practice across Europe; to provide high-quality homeopathic care in a medical context; to integrate high-quality homeopathy into European healthcare.
The CEN TC/427 meets 3 of the ECH’s main objectives. It will help to ensure high standards in the education, training and practice of homeopathy by medical doctors. It will help to harmonise professional standards in homeopathic practice across Europe. And it will help with the integration of high-quality homeopathy into European
WHO Traditional Medicine Strategy 2014 – 2023 The WHO are developing a new Traditional Medicine Strategy for the years 2014- 2023 because the major challenges and the needs of its member countries in the area of traditional medicine have changed over the past decade. There are many WHO member countries where a lack of knowledge in formulating national policy has led to a lack of regulation on the practice of traditional and complementary medicine (T&CM) and their practitioners. Additionally, there is a lack of integration of traditional and complementary medicine services into health service delivery and selfhealth care. The challenges beyond efficacy are unregulated practice, knowledge gaps, standardisation, etc. The proposed overarching objective of the strategy is to guide and support WHO member countries to integrate T&CM into their national health systems, as appropriate, and to maximise the potential contribution of T&CM to health and health security, health equity, social inclusion and participation, sustainable well being for all as well as garnering trust in health authorities. In more detail the objectives and directions demand • • •
To build a knowledge base for management and policies: - understand and recognise; protect and build evidence and resources Strengthen the safety, quality and effectiveness data: - product regulation; practice and practitioner regulation based on benchmarking for training, services and interventions Promote universal health coverage through integration:
- capitalise on the potential contribution for improving people-centred integrated health services; informed choice and self-care; standardisation, including terminology and classification We can see that benchmarking and standardisation will play an important role in the proposed WHO Traditional Medicine Strategy 2014 – 2023.
Objections and Counterarguments In the European-wide consultation process we became aware of two strong movements against the proposed Project Committee (PC). In April 2013, the Council of the World Medical Association (WMA) adopted a Resolution on Standardisation in Medical Practice and Patient Safety where it states the following:
Ensuring patient safety and quality of care is at the core of medical practice. For patients, a high level of performance can be a matter of life or death. Therefore, guidance and standardisation in healthcare must be based on solid medical evidence and has to take ethical considerations into account. Currently, trends in the European Union can be observed to introduce standards in clinical, medical care developed by non-medical standardisation bodies, which neither have the necessary professional ethical and technical competencies nor a public mandate. The WMA has major concerns about such tendencies which are likely to reduce the quality of care offered, and calls upon governments and other institutions not to leave standardisation of medical care up to non-medical self selected bodies.
It is clear that the argument “developed by non-medical standardisation bodies” stated in the second paragraph is incorrect, because CEN only provides a professional platform. The standard itself is developed by all interested stakeholders. Nevertheless, this resolution resulted in votes against the proposed CEN project, e.g. in Germany. The second movement against the CEN project came from the European Central Council of Homeopaths (ECCH), which is the European umbrella organisation of non-medical homeopaths. They highlighted three main concerns: 1) Definition of homeopathic medicine a] ‘Homeopathic medicine is a system of medicine requiring a distinct qualification in addition to the regular medical qualification’ i] ECCH stated: “If the CEN standardisation project proceeds on the basis of this definition then it will set a principle and precedent written into any resulting standards that will be difficult to reject or change, i.e. that homeopathic medicine can only be practised by those who studied homeopathy having first done a conventional medical training.” 2) Standards are already established
i] “We do not see a need to establish new standards for one section of the professional providers who deliver homeopathic treatment when there are already standards in place.” 3) Quality of homeopathy i] “We fear that this will eventually lead to the establishment of a set of standards for homeopathy that could be described as the lowest common denominator.” Ad 1: This is the definition which ECH has been using in all its documents. Ad 2: All ECH and ECCH “standards” are only private specifications as explained about. Ad 3: ECH aims – according to the statutes – at ensuring high standards in the education, training and practice of homeopathy by medical doctors. Regarding CEN, the aim is to raise quality and harmonise services at European level.
How is the CEN standard developed? 1. Creation of a new Technical Committee On 7 August 2013 the CEN technical board (BT) approved the creation of a new Project Committee, CEN/TC 427 “Project Committee - Services of Medical Doctors with additional Qualification in Homeopathy”. The Committee will be responsible for developing European Standards on the services, competences and training of medical doctors with an additional qualification in homeopathy according to the specifications provided in BT N 9207. The Secretariat of CEN/TC 427 was allocated to Austrian Standards Institute (ASI) and the new CEN/TC 427 was asked to submit its programme of work for BT approval by February 2014. There will be 3-4 meetings of the CEN Project Committee which will take place around Europe. The first meeting will be held in Vienna, on 9-10 January, 2014. Around 10 to 50 experts will usually take part. The document has to be completed within 12 months. After 1-2 meetings of the national CEN mirror committees, the second meeting of the CEN Project Committee will take place, most probably in the autumn of 2014. After that, the draft document will be sent to the National Standardisation Bodies (NSBs) who will put this on an open internet platform for public comment. On a national level, all comments will be forwarded onto the national working group. The working groups will forward the different national statements to the CEN Project Committee who will then have a maximum of 8 months to incorporate these statements into the final draft (1-2 meetings). The final draft will be sent back to the NSBs. 2. The CEN/CENLEC enquiry This is implemented for the drafts established under the responsibility of a TC. Requests for national deviations to take account of a legal requirement must be presented as early as possible and at the latest during the CEN/CENELEC enquiry, which lasts for 5 months. 3. The formal vote Approval of the final text of a draft European standard (EN), presented in the three official languages (English, French and German), is granted by means of a formal vote by members.
The vote is open for two months. Each vote must be submitted unconditionally, although there is the possibility of adding editorial comments. The voting can be a ‘Yes’ or ‘No’. The national vote will be weighted according to size and economic power of the respective country. A European standard is approved if 71% of the weighted votes cast are in favour (abstentions are excluded). If the European Standard is accepted, then it has to be implemented by the National Standardisation Body (ÖNORM, DIN,...) within 6 months. 4. Regular review of European standards (confirmation, revision or cancellation) Every European standard is reviewed after the fifth year of its creation and thereafter every five years by the responsible TC/SC with a view to confirming, revising or cancelling it.
ECH delegates involved Project Committee Chairperson nominated by ECH Dr. Karin Bandelin, ECH Vice President ECH Liaison to TC/CEN 427 Dr. Thomas Peinbauer, ECH President ECH delegates to the CEN national working groups (=national mirror group): Dr. Wolfgang Eichler (Austria) Dr. Jean Louis Smout (Belgium) Dr. Florence Paturel (France) Dr. Gerhard Bleul (Germany) Dr. Antonella Ronchi (Italy) Dr. Ileana Rindasu (Romania) There are 6 meetings of the national working group taking up a half to full-day. Being one of three national delegates at the CEN Project Committee there would be 6 further meetings (4 x 2 days, 2 x 1 day)
How much will the CEN process cost ECH?
85.850 €: estimated expenses for the initial EN process, including daily expenses and participation of 5 national delegates at the meetings of the CEN Project Committee 37.950 €: flat rate for the Austrian Standards Institute (ASI) making the Secretariat for the proposed CEN Project Committee both including 10% VAT – provided that ECH is not entitled to reclaim input tax – and the costs for 3 members of the Austrian working group 6.000 €: Starter packages for 4 delegates working in 4 different national working groups sponsored by ECH for 3 years (estimated cost) 5.700 €: expenses for TC chairperson nominated by ECH (estimated cost) 3.700 €: expenses for ECH Liaison to TC/CEN 427 (estimated cost)
32.500 €: expenses for 5 ECH experts delegated to 5 different national working groups (estimated cost) 60.850 €: -without daily expenses
The faster the process, the less expensive it is.
EFHPA President – Mrs, Enid Rendall presents Dr. Thomas Peinbauer – ECH President
Dr. Thomas Peinbauer – ECH President, Mrs. Vega Palombi Martorano – A.P.O. Italia President, Mrs. Endi Seagall – EFHPA President, Mr. Christiaan Mol – ECHAMP General Secretary
