News - New regulation found after the CAMbrella deliveries:
No new regulation found.
Notice! All text below is copied from the CAMbrella report - delivered Dec 31, 2012
In this summary, you will find:
- Direct links to the legislation of specific CAM therapies in Romania
- The legal and regulatory status of CAM and CAM practices in Romania
- The governmental supervision of CAM practices in Romania
The reimbursement status of CAM practices and medicinal products in Romania
Go directly to legislation of specific CAM therapies in Romania:
Acupuncture – Anthroposophic medicine – Ayurveda – Chiropractic – Herbal medicine/Phytotherapy – Homeopathy – Massage – Naprapathy – Naturopathy – Neural therapy – Osteopathy – Traditional Chinese Medicine (TCM) - Other treatments
Romania has been a member of the European Union since 1 January 2007 (11). Romania became a member of the Council of Europe in 1993 (12).
The legal and regulatory status of CAM and CAM practices
In 2005 and 2007 national CAM legislation was introduced and from 2007 adjusted to EU Directives and Regulations. The new classification of occupation issued by order of the government 1832/2011 includes for the first time the denomination “non-MD associate practitioners of CAM” (237).
From 2007 citizens’ rights and access to CAM therapies are regulated by “Law on Complementary and Alternative Medicine nr. 118/2007” (238). The law regulates the activities and practices of Complementary and Alternative Medicine for the prevention of illnesses and the promotion of health, healing of diseases and optimization of the human health from the biopsychosocial and spiritual points of view (28, 238).
According to chapter III, Art.16 in the Law on CAM nr. 118/2007 (238) all persons have free access to the treatments and practices of complementary and alternative medicine, regulated according to the law. Law nr. 118/2007 states that patients receiving CAM treatment must receive information, preferably written, accessible and easy to understand of the benefits and risks of CAM treatment (237).
CAM therapies legally practised in Romania are grouped in pharmacologic and biological therapies, herbal practice, dietnutrition and lifestyle, alternative therapies, manual therapies, energetic and bioelectromagnetic applications. The therapy group “alternative therapies” includes among others acupuncture, homeopathy, naturopathy, ayurveda and Chinese medicine (237). Among others the group “manual therapies” includes chiropractic, osteopathy and massage.
In 2005 the Ordin nr. 418/2005 National Catalogue of Programmes for CAM studies was established. The studies were organized, according to Art I, in order to certify the competence of medical doctors, dentists and pharmacists and the methodological standards for its organisation and progress (28, 239). CAM studies included were among others acupuncture, homeopathy phytotherapy and apitherapy.
According to the Ordin nr. 418/2005 “Certification of graduation in the programme of complementary studies implied obtaining a competence issued exclusively by the Ministry of Health through the National Center of Continuous Education Bucharest only for medical doctors, dentists and pharmacists” (239). Only medical doctors (MDs), dentists and pharmacists are allowed to practise acupuncture, homeopathy, apitherapy, phytotherapy, chiropractic, osteopathy and TCM.
CAM practices are regulated by the Ministry of Health (29) and the CAM professions are recognized as an additional qualification for medical doctors (240). “In order to become a practitioner of complementary/alternative medicine, the persons (medical doctors, dentists, pharmacists, psychologists) are obliged to add the specific competence obtained (acupuncture, phytotherapy, homeopathy..), with the approval of the National Center of Continuous Education for Medical Doctors, Dentists and Pharmacists Bucharest (238) on the authorization of free practise provided, according to the law, by the Ministry of Public Health”. CME is not obligatory for approved CAM therapy doctors (240).
According to the CAM Medical Practitioners Order specialized committees for certain areas of practice (e.g. acupuncture, herbal therapy, homeopathy, apitherapy) will regulate professionals (239). “In medical schools or faculties of pharmacy, students can take optional courses in homeopathy, phytotherapy or acupuncture, but none of the CAM modalities are taught in the core curriculum. Attempts are being made to arrange postgraduate courses in integrative medicine, accredited by the Romanian College of Physicians and addressed mainly to general practitioners”(29).
Romanian national CAM law on patients’ rights complement the formulations given in the 2011/24/EU Directive on the application of patients’ rights in cross-border healthcare (6, 29). “Practitioners without a diploma of MD, dentist or pharmacist are authorized to practise CAM therapies (except those allowed only to MDs) after a short special training accredited by the Ministry of Health” (29). We found no CAM professions registered for Romania in the EU regulated professions database (Directive 2005/36/EC) (7).
The governmental supervision of CAM Practices
Supervision and practice control activities of CAM in Romania is regulated by the law on
professional organizations of medical practitioners of CAM (237).
- With the Medical Practitioners Order, CAM specialized committees for each area of practise of CAM, are bound to regulate professional practitioners in the specific area.
- The Order of Practitioners of CAM is required to develop code of ethics, supported by specialist committees. Code of ethics includes the rights to practise, disciplinary sanctions for professional incompetence, practise restrictions in case of incompatibility or damage to patient health.
- A register of practitioners of CAM is held at the headquarters of the Order of Practitioners of CAM, communicating with the National Centre for Training in Healthcare.
- The Ministry of Public Health, College of Physicians in Romania, Dental College and College of Pharmacists in Romania shall, in consultation with the Order of Practitioners of CAM, approve studys curricula for institutions that prepare practitioners of CAM to ensure level qualification.
- The Ministry of Public Health and the National Training Center in Healthcare, Department of CAM directs and controls activities in the field, including professional training for practitioners of CAM. Department of CAM supplies and accredits training programs for practitioners of CAM (237).
The reimbursement status of CAM practices and medicinal products
CAM treatment and medicinal costs are partially covered for acupuncture, homeopathy, phytotherapy and psychotherapy (House of National insurance of Health) (106, 240). Since 2010 manual therapies are not covered anymore due to the economic crisis in Romania (237).
6. DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011, on the application of patients’ rights in cross-border healthcare (OJ l 88, 4.4.2011, p.45), (2011).
11. EUROPA. Gateway to the European Union; member countries. Brussels EUROPA
Communication department of the European Commission; 2011 [cited 2011 November 3]; Available from: http://europa.eu/about-eu/countries/index_en.htm.
12. Council of Europe. Council of Europe. Strasbourg: Council of Europe; 2011 [cited 2011
November 7]; Available from: http://www.coe.int/lportal/web/coe-portal.
28. ECH (European Committee for Homeopathy). ECH in European Countries. Brussels: ECH; 2011 [cited 2011 September 12]; Available from: http://www.homeopathyeurope.org/countries.
29. CAMbrella. CAMbrella news. Münich: CAMbrella; 2011 [cited 2011 November 03]; Available from: http://www.cambrella.eu/home.php?il=1&l=deu.
106. CAMDOC Alliance ECH ECPM ICMART and IVAA. The regulatory status of Complementary and Alternative Medicine for medical doctors in Europe. Brussels 2010 January 2010. Report No.: 2010.
237. Dragan S. Email: Legislation of CAM in Romania. Timisoara: University of Medicine and Pharmacy Victor Babes, Romania; 2011.
238. Law nr. 118/2007 privind organizarea şi funcţionarea activităţilor şipracticilor de medicinăcomplementară/alternativă (Concerning the organisation and functioning of the practices of complementary/alternative medicine), The Parliament of Romania(2007).
239. Ordin nr. 418 din 20/04/2005 for the approval of the National Catalogue of Programmes for Complementary studies organised to certify the competence of medical doctors, dentists and pharmacists and the methodological standards for its organisation and progress., Parliament of Romania(2005).
240. Hegyi G. Questionnaire about the status of CAM therapies Romania. 2011.