The EU Treaties stipulate that health policy is a national responsibility for the member states. This is adjusted and confirmed in the Lisbon Treaty in TITLE XIV Public Health Article 168 number 7(4): “7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood”. Nevertheless several EU Directives and Regulations influence how the member states organize their national health policy and services.
The European Parliament (Resolution A4-0075/97) and the Parliamentary Assembly of the Council of Europe (Resolution 1206(1999) have both passed resolutions recommending a stronger harmonization of, what they call, non-conventional medicine in Europe.
The EU has repeatedly confirmed that it is up to each member state to organize and regulate their health care system. This will, of course, also apply to CAM.
Regulation of homeopathy and other CAM modalities varies from one EU Member State to the other. Homeopathy is recognised by law in Belgium (1999), Bulgaria (2005), Germany (1998), Hungary (1997), Latvia (1997), Portugal (2003), Romania (1981), Slovenia (2007) and the United Kingdom (1950). Nineteen of 39 European countries have a general CAM legislation, 11 of these have a specific CAM law and 6 countries have sections on CAM included in their health laws. In addition to the general CAM legislation some countries have regulations on specific CAM treatments.
Homeopathy is the second most frequently provided CAM modality, i.e. 27% of all practitioners (after acupuncture – 53%) with 45,000 physicians and 4,500 non-medical practitioners trained.
CAM provision in the EU27+12 is maintained by more than 150,000 registered medical doctors (MDs) with additional CAM certification and more than 180,000 registered and certified non-medical CAM practitioners. This suggests up to 65 CAM providers (35 non-medical practitioners and 30 physicians) per 100,000 inhabitants, compared to the EU figures of 95 general medical practitioners per 100,000 inhabitants.
More regulatory information on the provision of homeopathy and other CAM modalities can be found in the CAMbrella report ‘Health Technology Assessment (HTA) and a map of CAM provision in the EU’.
Homeopathic medicines, or officially ‘homeopathic medicinal products’ constitute a subset of medicinal products, and the EU has established special regulations for them. They are regulated by the following European Union Directives:
– Directive 2001/83/EC of the European Parliament and of the Council, of 6 November 2001 (on the Community code relating to medicinal products for human use).
– Directive 2003/63/EC which inserted specific provisions on the proof of quality and safety of homeopathic medicinal products in the amended Annex I of Directive 2001/83/EC providing more clarity for the assessment of applications.
– Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (amending Directive 2001/83/EC on the Community code relating to medicinal products for human use).
EU Member States have an obligation under EU law to transpose the provisions for medicinal products into national law and must communicate the text of any such laws and other administrative measures to the European Commission.
Relevant institutions regarding homeopathic medicinal products in the EU.
• The Heads of Medicines Agencies (HMA) is a network of the Heads of the National Competent Authorities whose organizations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area. The Heads of Medicines Agencies is supported by working groups covering specific areas of responsibility and by the Heads of Medicines Agencies Management Group and Permanent Secretariat.
• The Homeopathic Medicinal Products Working Group (HMPWG) is a working group of the HMA composed of heads and staff of the regulatory department for Homeopathic Medicinal Products in the national medicines agencies; the aim of the work of this group is to harmonize the assessment of homeopathic products amongst the Member States and to create a network of assessors to facilitate cooperation in National and Mutual Recognition Procedures.
More details about registration of homeopathic medicinal products can be found here.
More regulatory information on homeopathic medicines can be found in the CAMbrella report ‘Herbal and homeopathic medicinal products’.
European Union programmes including Complementary and Alternative Medicine
Both the Public Health Programme 2008-2013 and theinclude references to Complementary and Alternative Medicine.
The Public Health Programme 2008-2013 includes the following phrase: ‘The Programme should recognise the importance of a holistic approach to public health and take into account, where appropriate and where there is scientific or clinical evidence about its efficacy, complementary and alternative medicine in its actions’.
The 7th Research Framework Programme includes the following phrase: ‘[Concerning] Optimising the delivery of health care to European citizens — Translating clinical outcome into clinical practice: to create the knowledge bases for clinical decision- making and to address the translation of outcomes of clinical research into clinical practice, especially addressing patient safety and the better use of medicines (including some aspects of pharmacovigilance and scientifically tested complementary and alternative medicines) as well as the specificities of children, women and the elderly population’.
CAMbrella is an EU funded project that looks into the situation of Complementary and Alternative Medicine (CAM) in Europe as it presents itself in 2012. The European Commission took the decision to fund a project under the 7th Framework Programme (FP7) because to date there has been no proper evaluation of the situation of CAM in Europe: this applies to almost all member and associate EU countries, with the noticeable exceptions of UK, Switzerland and Norway. No other countries have investigated the topic, nor has the European Commission, i.e. Directorates-General Research and Health.
The project was aimed to harmonise existing knowledge and to determine the knowledge gaps in this field. Both parts come together in recommendations to the European Commission and the European Parliament on the way forward in Europe for research into CAM – the ‘Road map for European CAM research’.
More detailed information can be found here.