Legislative landscape for traditional health practitioners in Southern African development community countries: a scoping review.

BACKGROUND AND OBJECTIVES: Globally, contemporary legislation surrounding traditional health practitioners (THPs) is limited. This is also true for the member states of the Southern African Development Community (SADC). The main aim of this study is to map and review THP-related legislation among SADC countries. In order to limit the scope of the review, the emphasis is on defining THPs in terms of legal documents. METHODS: This scoping review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews methods. Two independent reviewers reviewed applicable legal definitions of THPs by searching the Southern African Legal Information Institute (SAFLII) database in April 2018 for legislation and bills. To identify additional legislation applicable in countries not listed on SAFLII and/or further relevant SADC legislation, the search engines, Google and PubMed, were used in August 2018 and results were reviewed by two independent reviewers. Full texts of available policy and legal documents were screened to identify policies and legislation relating to the regulation of THPs. Legislation was deemed relevant if it was a draft of or promulgated legislation relating to THPs. RESULTS: Four of 14 Southern African countries have legislation relating to THPs. Three countries, namely South Africa, Namibia and Zimbabwe, have acknowledged the roles and importance of THPs in healthcare delivery by creating a council to register and formalise practices, although they have not operationalised nor registered and defined THPs. In contrast, Tanzania has established a definition couched in terms that acknowledge the context-specific and situational knowledge of THPs, while also outlining methods and the importance of local recognition. Tanzanian legislation; thus, provides a definition of THP that specifically operationalises THPs, whereas legislation in South Africa, Namibia and Zimbabwe allocates the power to a council to decide or recognise who a THP is; this council can prescribe procedures to be followed for the registration of a THP. CONCLUSIONS: This review highlights the differences and similarities between the various policies and legislation pertaining to THPs in SADC countries. Legislation regarding THPs is available in four of the 14 SADC countries. While South Africa, Tanzania, Namibia and Zimbabwe have legislation that provides guidance as to THP recognition, registration and practices, THPs continue to be loosely defined in most of these countries. Not having an exact definition for THPs may hamper the promotion and inclusion of THPs in national health systems, but it may also be something that is unavoidable given the tensions between lived practices and rigid legalistic frameworks.

Guidance on Prescription of Homeopathic Treatments: Ramifications of a Failed Administrative Law Challenge.

In R (on the application of British Homeopathic Association) v National Health Service Commissioning Board [2018] EWHC 1359 (Admin) Supperstone J of the High Court of England and Wales delivered an internationally significant judgment on the processes required to be engaged in when guidance is given to medical practitioners about their involvement in homeopathic prescribing. This column explores the bases upon which the challenge by the British Homeopathic Association was lost and the repercussions of the judgment for the practice of non-evidence-based modalities, such as homeopathy.

[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria. METHODS: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering". CONCLUSIONS: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims.

Key elements of legal environments for medical use of cannabis in different countries.

Worldwide, a highly dynamic development of regulatory strategies for cannabis flowers and cannabis-derived products for medical use can be observed. Conditions laid down in the Single Convention on Narcotic Drugs are basic, and implementation in countries is diverse.As early as 1998, the Netherlands was the first Member State of the European Union (EU) to establish a strategy to provide patient access to cannabis for medical use. Since then, more and more Member States of the European Union have facilitated access to cannabis for medical use. A comparable development has taken place outside Europe. This article describes the current situation in the Netherlands and presents selected highlights of developments within and outside Europe to demonstrate the broad spectrum of strategies. Key parameters are identified that should be considered when changing or amending regulatory frameworks on cannabis for medical use. In addition to the establishment of adequate regulatory frameworks, there is a substantial need to generate adequate scientific data.

[Anal funnels and wonder pills-the dubious market for medical products in the Federal Republic of Germany until 1965]. / Analröhrchen und Wunderpillen ­ der graue Markt der Medizinalprodukte in der Bundesrepublik Deutschland bis 1965.

The Federal Republic of Germany was the last European Country without a drug legislation and a law about drug advertising until the 1960s. Therefore, a broad medical subculture flourished. Various dealers sold drugs and instruments for curing psychosomatic illnesses, especially anti-impotence pills or aids to reduce weight. Thus, the interested client could treat himself/herself without visiting a physician or a pharmacy. Some physicians tried to reduce this grey market, but they were not successful.

Regulatory Aspects of Traditional Indian Medicines (TIM) in India and in International Purview.

Background: Regulatory affairs play a crucial role in the pharmaceutical industry and are incorporated in all stages of drug development. Objective: Approval criteria practices were developed as a resolution of the government's desire to create policies to protect public health by controlling the safety and efficacy of merchandise in areas including pharmaceuticals, complementary color medicines, veterinary medicines, medical devices, and even food products and cosmetics. Method: Herbal health products are in practices in all parts of the world under either their legal system's or expert council's or agencies' guides. They include botanicals, health supplements, health foods, complimentary medicines, traditional medicines or following pathies like Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The requisite parameters for registration or recognition of products by various major global regulatory agencies were reviewed, and compiled under purview. Results: In India, licensing these products is under the act provisions and the rules known as the Drugs and Cosmetics Act, whereas globally regulatory provisions follow the guidelines of developed countries like the U.S. Food and Drug Administration, European Medicines Agency, the Therapeutic Goods Act, or the World Health Organization's regulations for herbal products. Conclusions: The present communication highlights the provisions of regulatory and/or licensing requirements related to corporates, product composition, specifications, quality parameters, manufacturing methodology, stability, safety, preclinical studies, clinical studies, etc. for herbal products and the respective guidelines at one site. Highlights: Ultimately, all regulatory agencies across the world highlight majorly the safety and thereafter the efficacy for any products under the category.

Rethinking Brain Death as a Legal Fiction: Is the Terminology the Problem?

Brain death, or the determination of death by neurological criteria, has been described as a legal fiction. Legal fictions are devices by which the law treats two analogous things (in this case, biological death and brain death) in the same way so that the law developed for one can also cover the other. Some scholars argue that brain death should be understood as a fiction for two reasons: the way brain death is determined does not actually satisfy legal criteria requiring the permanent cessation of all brain function, and brain death is not consistent with the biological conception of death as involving the irreversible cessation of the functioning of an organism as a whole. Critics counter that the idea that brain death is a legal fiction is deceptive and undemocratic. I will argue that diagnosing brain death as a hidden legal fiction is a helpful way to understand its historical development and current status. For the legal-fictions approach to be ethically justifiable, however, the fact that brain death is a legal fiction not aligned with the standard biological conception of death must be acknowledged and made transparent.

Santayana's Axiom: The South Dakota State Medical Association and Medical Practice Legislation in 1929 and 2017.

In 1928 members of the South Dakota State Medical Association (SDSMA or the Association) held a special meeting in Huron to consider a basic science bill that conformed "…in its entirety to the conditions existing in our state." Their draft bill proposed a standardized examination for all practitioners of the healing arts. A legislative committee, with its attorney, "…was in Pierre during the early part of the 1929 legislative session to make sure the bill was properly launched and in effective channels." Shortly after its introduction, the bill was withdrawn due to opposition from one SDSMA district whose legislative representatives were among the most influential in the legislature. A similar bill promoted by the SDSMA in 1933 also failed. It would be another six years before a basic science bill was enacted by the legislature. Eighty-nine years later, a bill governing the practice of certified nurse practitioners (NP) and certified nurse midwives (NM), including a board independent of the South Dakota Board of Medical and Osteopathic Examiners, was considered (Senate Bill 61). Introduced by a senator who characterized herself as representing the "House of Nursing," the bill challenged "…the overarching role that medicine thinks and perceives that they may have regarding advanced practice nursing practice." SB 61 passed in the senate and house and was signed by the governor. For this legislation in the 1930s and in 2017, the SDSMA's interest was defining and maintaining control of medical practice under the twin rubrics of quality and patient welfare. In both circumstances, legislators and other health care professional organizations contested not only the SDSMA's motivations, but also the evidence supporting their efforts. Our research explored (1) whether the collective viewpoints and conduct of the legislature, the SDSMA, and non-physician medical professionals are comparable in the two circumstances; and (2) if the circumstances are comparable, can we derive a useful concept or theme that could help guide the SDSMA in the future?

The National Medical Commission - More of the same.

The Cabinet chaired by the Prime Minister has accepted six amendments to the National Medical Commission Bill suggested by the Department-related Parliamentary Standing Committee (1). These amendments are: the proposed National Licentiate Examination has been replaced by a countrywide final MBBS examination called the National Exit Test (NEXT); the bridge course to train practitioners from AYUSH (Ayurveda, Unani, Siddha and Homeopathy) in modern medicine has been removed, and it has been left to individual states to take a decision about this; the percentage of seats in private medical training institutions under fee regulation has been increased from 40% to 50%; the number of nominees from the states and Union territories who are members of the Commission has been increased from three to six; the penalties for non-compliance with educational norms for colleges has been modified; and the punishment for practising modern medicine without qualification has been made imprisonment up to one year and a fine of Rs 5 lakh.

Ethical issues in medical cannabis use.

The increasing use of medical cannabis (MC) in the past decade raises several ethical considerations for the clinician. Regulatory issues stem from a gap between MC registration and certification in each country. Professional issues derive from the lack of sufficient knowledge of MC characteristics and the intersection between the physician, the patient and commercial interests. Finally, there are medical and psychological implications which are related to the use of MC regimens. We will discuss these issues in the light of the current era, in which policy has rapidly shifted toward legalization of cannabis, which influences the decisions of both clinicians and patients.

Medical use of cannabis and cannabinoids containing products - Regulations in Europe and North America.

In 1937, the United States of America criminalized the use of cannabis and as a result its use decreased rapidly. In recent decades, there is a growing interest in the wide range of medical uses of cannabis and its constituents; however, the laws and regulations are substantially different between countries. Laws differentiate between raw herbal cannabis, cannabis extracts, and cannabinoid-based medicines. Both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) do not approve the use of herbal cannabis or its extracts. The FDA approved several cannabinoid-based medicines, so did 23 European countries and Canada. However, only four of the reviewed countries have fully authorized the medical use of herbal cannabis - Canada, Germany, Israel and the Netherlands, together with more than 50% of the states in the United States. Most of the regulators allow the physicians to decide what specific indications they will prescribe cannabis for, but some regulators dictate only specific indications. The aim of this article is to review the current (as of November 2017) regulations of medical cannabis use in Europe and North America.

Abortion providers, professional identity, and restrictive laws: A qualitative study.

Most studies on the impact of restrictive abortion laws have focused on patient-level outcomes. To better understand how such laws affect providers, we conducted a qualitative study of 27 abortion providers working under a restrictive law in North Carolina. Providers derived professional identity from their motivations, values, and experiences of pride related to abortion provision. The law affected their professional identities by perpetuating negative characterizations of their profession, requiring changes to patient care and communication, and creating conflicts between professional values and legal obligations. We conclude that a holistic understanding of the impact of abortion laws should include providers' perspectives.

The Effect of California's Breast Density Notification Legislation on Breast Cancer Screening.

PURPOSE: Half of US states mandate women be notified if they have dense breasts on their mammogram, yet guidelines and data on supplemental screening modalities are limited. Breast density (BD) refers to the extent that breast tissue appears radiographically dense on mammograms. High BD reduces the sensitivity of screening mammography and increases breast cancer risk. The aim of this study was to determine the potential impact of California's 2013 BD notification legislation on breast cancer screening patterns. METHODS: We conducted a cohort study of women aged 40 to 74 years who were members of a large Northern California integrated health plan (approximately 3.9 million members) in 2011-2015. We calculated pre- and post-legislation rates of screening mammography and magnetic resonance imaging (MRI). We also examined whether women with dense breasts (defined as BI-RADS density c or d) had higher MRI rates than women with nondense breasts (defined as BI-RADS density a or b). RESULTS: After adjustment for race/ethnicity, age, body mass index, medical facility, neighborhood median income, and cancer history, there was a relative 6.6% decrease (relative risk [RR] 0.934, confidence interval [CI] 0.92-0.95) in the rate of screening mammography, largely driven by a decrease among women <50 years. While infrequent, there was a relative 16% increase (RR 1.16, CI 1.07-1.25) in the rate of screening MRI, with the greatest increase among the youngest women. In the postlegislation period, women with extremely dense breasts (BI-RADS d) had 2.77 times (CI 1.93-3.95) the odds of a MRI within 9 months of a screening mammogram compared with women with nondense breasts (BI-RADS b). CONCLUSIONS: In this setting, MRI rates increased in the postlegislation period. In addition, women with higher BD were more likely to have supplementary MRI. The decrease in mammography rates seen primarily among younger women may have been due to changes in national screening guidelines.

From transnational to regional magnetic fevers: The making of a law on hypnotism in late nineteenth-century Belgium.

In May 1892, Belgium adopted a law on the exercise of hypnotism. The signing of the law constituted a temporary endpoint to six years of debate on the dangers and promises of hypnotism, a process of negotiation between medical doctors, members of parliament, legal professionals and lay practitioners. The terms of the debate were not very different from what happened elsewhere in Europe, where, since the mid 1880s, hypnotism had become an object of public concern. The Belgian law was nevertheless unique in its combined effort to regulate the use of hypnosis in public and private, for purposes of entertainment, research and therapy. My analysis shows how the making of the law was a process of negotiation in which local, national and transnational networks and allegiances each played a part. While the transnational atmosphere of moral panic had created a seedbed for the law, its eventual outlook owed much to the powerful lobby work of an essentially local network of lay magnetizers, and to the renown of Joseph Delbœuf, professor at the University of Liège, whose work in the field of hypnotism stimulated several liberal doctors and members of Parliament from the Liège region to defend a more lenient law.

Implicancias del marco legal chileno en la prevención del embarazo adolescente: conflicto e inseguridad en los profesionales de la salud / Implications of chilean legal framework in teen pregnancy prevention: conflict and insecurity in health professionals

Background: Teenage pregnancy is a psychosocial and multifactorial problem described as a lack of exercise of rights in sexual and reproductive health. There are important aspects in the doctor-patient relationship and confidentiality that directly affect the continuity and quality of care. There are controversies in the laws relating to the provision of contraception and confidentiality, and those that protect the sexual indemnity, especially in adolescents under 14 years. Aim: To describe the implications of the legal framework for professional midwives in the care of adolescents younger than 14 years in sexual and reproductive health. Material and Methods: In-depth interviews were conducted to 13 female and 2 male midwives working at Primary Health Care Centers in the Metropolitan Region. Results: The attention of adolescents younger than 14 years in sexual and reproductive health involves medical-legal issues for health professionals. All professionals recognize that mandatory reporting sexual activity is a complex situation. All professionals notify pregnancies. In relation to the delivery of contraception, clinical care is problematic since professionals should take shelter from a legal standpoint. Conclusions: The medical-legal context of pregnant women under 14 years of age care generates a context of uncertainty and fear for professionals and becomes a source of conflict and insecurity in the exercise of the profession.

"No patient left behind": an alternative to "the War on Cancer" metaphor.

The War on Cancer began with President Nixon's National Cancer Act of 1971. Treatment-related 'collateral damage' to healthy cells and tissues that reduces quality of life is an unfortunate but inevitable consequence of the overriding imperative to "win the war." In the face of a quality of life decrement, patients are encouraged with militaristic turns-of-phrases to "soldier on," "fight it," and "never say die." Rather than this dysfunctional imagery, which relegates patients to the status of mere cogs in the ever-grinding wheel of the clinical war machine and encourages the practice of disease-centered medicine, we propose an alternate analogy/organizing principle borrowed from the realm of education: No patient left behind.

Unpacking the new proposed regulations for South African traditional health practitioners.

South Africa (SA) has legislation that regulates almost all of its healthcare systems. The Traditional Health Practitoners Act finally provides legitimisation of an overwhelmingly popular indigenous healthcare system. However, as a consequence of the legal acknowledgement of traditional health practitioners, traditional medicine products must now also be brought under regulatory measures. If traditional medicines are to be prescribed, marketed and sold as part of a healthcare system recognised under SA law, they must meet the same stringent standards.

Moral Legitimacy: The Struggle Of Homeopathy in the NHS.

This article deploys a well-established theoretical model from the accountability literature to the domain of bioethics. Specifically, homeopathy is identified as a controversial industry and the strategic action of advocates to secure moral legitimacy and attract public funding is explored. The Glasgow Homeopathic Hospital (GHH) is used as the location to examine legitimizing strategies, from gaining legitimacy as a National Health Service (NHS) hospital in 1948, followed by maintaining and repairing legitimacy in response to government enquires in 2000 and 2010. An analysis of legitimizing strategies leads to the conclusion that advocates have been unsuccessful in maintaining and repairing moral legitimacy for homeopathy, thus threatening continued public funding for this unscientific medical modality. This is an encouraging development towards open and transparent NHS accountability for targeting limited public resources in pursuit of maximizing society's health and well-being. Policy implications and areas for future research are suggested.

[Implications of chilean legal framework in teen pregnancy prevention: conflict and insecurity in health professionals]. / Implicancias del marco legal chileno en la prevención del embarazo adolescente: conflicto e inseguridad en los profesionales de la salud.

BACKGROUND: Teenage pregnancy is a psychosocial and multifactorial problem described as a lack of exercise of rights in sexual and reproductive health. There are important aspects in the doctor-patient relationship and confidentiality that directly affect the continuity and quality of care. There are controversies in the laws relating to the provision of contraception and confidentiality, and those that protect the sexual indemnity, especially in adolescents under 14 years. AIM: To describe the implications of the legal framework for professional midwives in the care of adolescents younger than 14 years in sexual and reproductive health. MATERIAL AND METHODS: In-depth interviews were conducted to 13 female and 2 male midwives working at Primary Health Care Centers in the Metropolitan Region. RESULTS: The attention of adolescents younger than 14 years in sexual and reproductive health involves medical-legal issues for health professionals. All professionals recognize that mandatory reporting sexual activity is a complex situation. All professionals notify pregnancies. In relation to the delivery of contraception, clinical care is problematic since professionals should take shelter from a legal standpoint. CONCLUSIONS: The medical-legal context of pregnant women under 14 years of age care generates a context of uncertainty and fear for professionals and becomes a source of conflict and insecurity in the exercise of the profession.