Should Anthroposophic Medicinal Products Be Regulated in Europe?

European Commission's reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

Ethical and legal issues in cross-system practice in India: Past, present and future.

Recent changes in policies allowing practitioners of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) to integrate into the mainstream of healthcare and also allowing practitioners of Ayurveda and Homoeopathy to perform medical termination of pregnancy (MTP) under the proposed amendment to the MTP bill have brought crosssystem practice into the limelight. We evaluate cross-system practice from its legal and ethical perspectives. Across judgments, the judiciary has held that cross-system practice is a form of medical negligence; however, it is permitted only in those states where the concerned governments have authorized it by a general or special order. Further, though a state government may authorize an alternative medicine doctor to prescribe allopathic medicines (or vice versa), it does not condone the prescription of wrong medicines or wrong diagnosis. Courts have also stated that prescribing allopathic medicines and misrepresenting these as traditional medicines is an unfair trade practice and not explaining the side-effects of a prescribed allopathic medicine amounts to medical negligence. Finally, the Supreme Court has cautioned that employing traditional medical practitioners who do not possess the required skill and competence to give allopathic treatment in hospitals and to let an emergency patient be treated by them is gross negligence. In the event of an unwanted outcome, the responsibility is completely on the hospital authorities. Therefore, there is an urgent need to abolish cross-system practice, invest in healthcare, and bring radical changes in health legislations to make right to healthcare a reality.

THE MEDICO-SCIENTIFIC MARGINALISATION OF HOMEOPATHY: INTERNATIONAL LEGAL AND REGULATORY DEVELOPMENTS.

The 2010 report of the United Kingdom Science and Technology Committee of the House of Commons and the 2015 report of the Australian National Health and Medical Research Council have overtaken in significance the uncritical Swiss report of 2012 and have gone a long way to changing the environment of tolerance toward proselytising claims of efficacy in respect of homeopathy. The inquiry being undertaken in the United States by the Food and Drug Administration during 2015 may accelerate this trend. An outcome of the reports and inquiries has been a series of decisions from advertising regulators and by courts rejecting medically unjustifiable claims in respect of the efficacy of homeopathy. Class actions have also been initiated in North America against manufacturers of homeopathic products. The changing legal and regulatory environment is generating an increasingly scientifically marginalised existence for homeopathy. That new environment is starting to provide effective inhibition of assertions on behalf of homeopathy and other health modalities whose claims to therapeutic efficacy cannot be justified by reference to the principles of evidence-based health care. This has the potential to reduce the financial support that is provided by insurers and governments toward homeopathy and to result in serious liability exposure for practitioners, manufacturers and those who purvey homeopathic products, potentially including pharmacists. In addition, it may give a fillip to a form of regulation of homeopaths if law reform to regulate unregistered health practitioners gathers momentum, as is taking place in Australia.

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.

Death by homeopathy: issues for civil, criminal and coronial law and for health service policy.

Homoeopathy has a significant clinical history, tracing its roots back to Hippocrates and more latterly to Dr Christian (Samuel) Hahnemann (1755-1843), a Saxon physician. In the last 30 years it has ridden a wave of resurgent interest and practice associated with disillusionment with orthodox medicine and the emergence of complementary therapies. However, recent years have seen a series of meta-analyses that have suggested that the therapeutic claims of homeopathy lack scientific justification. A 2010 report of the Science and Technology Committee of the United Kingdom House of Commons recommended that it cease to be a beneficiary of NHS funding because of its lack of scientific credibility. In Australia the National Health and Medical Research Council is expected to publish a statement on the ethics of health practitioners' use of homoeopathy in 2013. In India, England, New South Wales and Western Australia civil, criminal and coronial decisions have reached deeply troubling conclusions about homoeopaths and the risk that they pose for counter-therapeutic outcomes, including the causing of deaths. The legal decisions, in conjunction with the recent analyses of homoeopathy's claims, are such as to raise confronting health care and legal issues relating to matters as diverse as consumer protection and criminal liability. They suggest that the profession is not suitable for formal registration and regulation lest such a status lend to it a legitimacy that it does not warrant.

Pre-trial beliefs in complementary and alternative medicine: whose pre-trial belief should be considered?

Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide a satisfactory justification for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community.

European Union directives and their effect on the registration and authorisation of anthroposophic and homeopathic medicines.

This paper discusses the question of whether anthroposophic medicinal products can be treated in the European Union as regards registration and marketing authorization, in the same way as homeopathic medicinal products. European Union legislation, European official pharmacopoeias, and bibliography in this regard have been revised. European Directives make a single reference in one of its whereas clauses to anthroposophic medicinal products "described in an official pharmacopoeia and prepared by a homeopathic method". It is referring to those which comply with these two conditions, but it happens that there is no anthroposophic medicinal product "described" in any European official pharmacopoeia. Legislators have known this and continue to be aware of it and have not agreed to extend (since 1992), the reference to anthroposophic products neither do they accept the inclusion of that peculiarity on the label of homeopathic medicinal products. Anthroposophy presents notable variations from homeopathy and it introduces philosophical and "spiritual" variables that are difficult to assess objectively. It is necessary for these products to show, using a scientific methodology, that they are truly bringing patients the therapeutic benefits they claim. In any case, their authorization and registration should not be at the expense of homeopathy, already a highly complex field in its own right.

George Deacon and the circulation of homeopathic therapies in Lima (1880-1915).

Homeopathy arrived from the United States to Peruvian soil in the last decades of the nineteenth century, broadening the repertoire of existing medical knowledge, which included an emerging medical profession, Chinese herbalists, and indigenous practitioners. This article examines the circulation and use of homeopathic therapies and medicines in Lima from the time when the American homeopath George Deacon initiated his practice, in the 1880s, until his death, in 1915. Although homeopathy was not the most widely used medical therapy in the country, it nevertheless posed a threat to professional medicine and the School of Medicine's desired monopoly of the field of medicine.

[Defending entitlement: struggles and fate of the practice of homeopathy in Colombia (1905-1950)]. / Defensa de los derechos adquiridos: luchas y albures del ejercicio de la homeopatía en Colombia (1905-1950).

This article analyzes the practice and professional status of Colombian homeopaths in the twentieth century, based on applications for licenses in the "Teguas" series in the Archivo General de la Nación. Within the historical context of the practice of medicine in Colombia, it studies homeopathic practice within the framework of the debate between licensed and permitted medicine. In that context, the field of homeopathy was subordinate to university medicine and homeopaths were a group of practitioners who were neither homogeneous nor organized, but characterized by their shared struggle to become "entitled" to practice, and their advocacy of professional status through constant litigation against official reprimands.

El artículo analiza la práctica y el estatuto profesional de los homeópatas colombianos en el siglo XX, según las solicitudes de licencia de la serie "Teguas" del Archivo General de la Nación. Desde el contexto histórico del ejercicio de la medicina en Colombia, se estudia la práctica homeopática en su inserción en el debate entre medicina diplomada y medicina permitida. Ahí aparece la homeopatía como un campo subordinado a la medicina universitaria y los homeópatas como conjunto de practicantes no homogéneo ni organizado, pero caracterizado por compartir la lucha por el "derecho adquirido" a ejercer y por la defensa de un estatuto profesional mediante la judicialización constante de la reprobación oficial.

Breaking the boundaries of professional regulation: medical licensing, foreign influence, and the consolidation of homeopathy in Mexico.

As doctors sought state support to regulate professional training and practice after Independence, Mexicans also developed different attitudes toward foreign ideas, influences, and professionals. Leveraging the allure of the foreign among Mexicans, homeopaths strategically used work, products, and organizations from abroad to establish their practices and fight changing professional policies in the country that threatened homeopathic institutions. Homeopaths inhabited the blurry and shifting boundary between professional and lay medical practice during the early Republican period, the Porfiriato, and the post-revolutionary era, and used the ambivalent feelings about medical licensing, and foreign influence in Mexican society to consolidate their position.

Will new regulations reverse the 'drop' in homeopathy?

The use and regulation of homeopathy has long been the focus of debate, lacking as it does in scientific evidence of its clinical effectiveness. Claimed to be 'harmless', it is often argued that there is no reason for it not to be used in conjunction with conventional treatments, and that there is the possibility that it may be beneficial. Lizzy Hay discusses whether in fact patients are at risk from this 'harmless' treatment if their confidence stretches to using homeopathy solely as an alternative treatment when really only 'a spoonful' should be taken to help the conventional medicine go down.