Reflection on the enactment and impact of safety laws for regenerative medicine in Japan.

Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.

Clínica médica especializada: norma técnica No. 18-2020-DRACES / Specialized medical clinic: technical standard No. 18-2020-DRACES

DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de las clínicas médicas especializadas, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico.

"If the Problem Persists, Come Back To See Me ."-An Empirical Study of Clinical Negligence Cases Against General Practitioners.

The law of negligence, as it applies to General Practitioners (GPs), is underexplored in the literature. There has been no substantial research undertaken that has penetrated deeper into claims that have actually reached court in order to analyse judicial reasoning pertaining to both breach of duty and causation. Given the increased pressures that GPs now face, these are important questions to consider. It is against this backdrop that this article seeks to present the findings of an empirical investigation into a number of reported clinical negligence claims brought against GPs. This analysis provides an original contribution to the developing academic discussion surrounding the changing nature of the doctor-patient relationship, and how it has come to be viewed in the eyes of the law. It also assesses the extent to which judges have become more receptive to protecting patient rights through the law of negligence, engaging in the expanding discourse concerning judicial deference to medical decision-making. It is argued that judges should sometimes show a greater propensity to question expert medical testimony in support of GPs, because some of the issues GPs typically face are less complex than in other clinical negligence cases involving technical areas of medicine, and that causation does not appear to be such a key factor in defeating patient claims. The work also provides useful guidance for GPs and their advisers in respect of where liability is most likely to be founded and how behaviour can be modified accordingly to reduce the chances of being sued.

Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic.

Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.

Learning the law: practical proposals for UK medical education.

Ongoing serious breaches in medical professionalism might be avoided if UK doctors rethink their approach to law. UK medical education has a role in creating a climate of change by re-examining how law is taught to medical students. Adopting a more insightful approach in the UK to the impact of The Human Rights Act and learning to manipulate legal concepts, such as conflict of interest, need to be taught to medical students now if UK doctors are to manage complex decision-making in the NHS of the future. The literature is reviewed from a unique personal perspective of a doctor and lawyer, and practical proposals for developing medical education in law in the UK are suggested.

Reflexiones nerviosas. Los fantasmas / Reflections nerve. The ghosts

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Making sense of assessment in medical ethics and law.

Are curricula in medical ethics and law effective in producing ethical doctors? Assessment is central to this question, both in setting the standards that students are expected to meet and in establishing the extent to which learning correlates with these. Medical ethics and law: a practical guide to the assessment of the core content of learning from the Education Steering Group of the Institute of Medical Ethics is an excellent guide for educators in approaching this curriculum task. If the teaching moment is temporally antecedent to assessment, it is not logically prior to assessment decisions as if these were simply retrospective, and we cannot speak meaningfully of assessment without also speaking of intended learning. The IME assessment guide places emphasis on the alignment of learning, teaching and assessment in curriculum design; on specifying in advance the learning opportunities available to students; on delivering these via appropriate forms of learning; and on matching suitable methods for testing this learning in both summative and formative modes. Variety in assessment is essential across the cognitive, the affective and the psychomotor domains of learning, and the IME assessment guide provides illustrative examples of, and templates for, types of assessment that are relevant to these. The practical advice offered is as applicable in schools of nursing and in dental schools as it is in medical education.

Medical ethics and law: assessing the core curriculum.

The Institute of Medical Ethics (IME) has produced a guide to the assessment of medical ethics and law (MEL) in UK medical schools which is available on-line. It complements the work which was carried out in 2010 to up-date the MEL consensus statement on what should be considered core content. The guide aims to provide practical help for teachers on what, when and how to assess medical students' learning. The briefing paper gives a background introduction to the guide, outlines its purpose and plans for future work.

Effects of MHRA drug safety advice on time trends in prescribing volume and indices of clinical toxicity for quinine.

AIMS: To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. METHODS: We analysed quarterly primary care total and quinine prescribing data for England and quinine prescribing volume for individual Primary Care Trusts in the North East of England from 2007/8 to 2011/12 obtained from the ePACT.net database. We also analysed quinine toxicity enquiries to the National Poisons Information Service (NPIS) via Toxbase(®) and by telephone between 2004/5 and 2011/12. Joinpoint regression and Pearson's correlation tests were used to ascertain changes in trends in prescribing and indices of toxicity and associations between prescribing and indices of toxicity, respectively. RESULTS: Total prescribing continued to increase, but annual growth in quinine prescribing in England declined from 6.0 to -0.6% following the MHRA update [difference -0.04 (95% confidence interval -0.07 to -0.01) quinine prescriptions per 100 patients per quarter, P = 0.0111]. Much larger reductions were observed in Primary Care Trusts that introduced comprehensive prescribing reviews. The previously increasing trend in Toxbase(®) quinine searches was reversed [difference -19.76 (95% confidence interval -39.28 to -9.20) user sessions per quarter, P = 0.0575]. Telephone enquiries to NPIS for quinine have declined, with stabilization of the proportion of moderate to severe cases of quinine poisoning since the update. CONCLUSIONS: The MHRA advice was followed by limited reductions in the growth in quinine prescribing and in indicators of quinine overdose and toxicity. Quinine prescribing, however, remains common, and further efforts are needed to reduce availability and use.