Challenging Pandemic Law: From Vaccine Mandates to Judicial Review of Vaccine Approvals.

Over recent years, dozens of legal challenges have been instituted in response to government action during the COVID-19 pandemic. While public health orders have been challenged on several grounds, few cases have succeeded. Fewer cases still have called into question decisions made by the Therapeutic Goods Administration (TGA) to approve the COVID-19 vaccines.

Sexual Boundary Violations by Doctors - Context, Regulatory Consequences and Preventive Strategies.

While sexual boundary violations by doctors (SBVs) are viewed with utmost seriousness by disciplinary bodies and tribunals, complaints of SBVs in Australia continue to increase. In 2023, the Australian Health Practitioner Regulation Agency (Ahpra) outlined a "blueprint" to protect patients better from sexual misconduct in healthcare: reform being considered in 2024, by Australian health ministers. Few analyses or studies have offered an overview of the prevalence, effects, and causes of SBVs, nor the duties, liabilities, possible disciplinary action against, and potential treatment of, doctors who commit them.

Promoting the personal importation of therapeutic goods: recent legislative amendments to advertising regulations may impact consumer access and understanding.

Objective The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme's interaction with the communications of health professionals and buyer's clubs.

Throwing a Cat among the Pridgeon(s): The New South Wales Court of Appeal and the Public Interest Test under the Health Practitioner Regulation National Law.

This section examines the 2022 decision of Pridgeon v Medical Council of New South Wales in the New South Wales Court of Appeal that has taken a fundamentally different view of the public interest test employed in immediate action hearings under the Health Practitioner Regulation National Law. The section starts by examining the case and then looks at the approach taken by subsequent decisions. It will argue that the decision is substantially at odds with earlier authorities from all around Australia and fails to understand properly the meaning and purpose of the test.

A New Priority Pathway for Biologicals in Australia: Contextualising and Evaluating the Proposed Reforms.

This section examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

Made by cells for cells - extracellular vesicles as next-generation mainstream medicines.

Current medicine has only taken us so far in reducing disease and tissue damage. Extracellular vesicles (EVs), which are membranous nanostructures produced naturally by cells, have been hailed as a next-generation medicine. EVs deliver various biomolecules, including proteins, lipids and nucleic acids, which can influence the behaviour of specific target cells.

The Public Interest Test in Immediate Action Hearings under the Health Practitioner Regulation National Law.

This paper examines the public interest test and how it is employed in immediate action hearings under the Health Practitioner Regulation National Law. It examines the history of the test in New South Wales and its eventual adoption by other States and Territories. The paper then examines recent cases from across Australia to highlight differences of approach in the formulation and application of public interest in immediate action hearings.

Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions.

Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources.

Unconventional Practice, "Innovative" Interventions and the National Law.

This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved "innovative" practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner's registration. This column looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine.

Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.

In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.

Impact of Gestational Diabetes Mellitus on Sexual Function: A Case-Control Study.

The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide, and this condition may be compromising female sexual function. However, there are controversial findings regarding the impact of GDM diagnosis and proposed treatments on sexual function during pregnancy. Therefore, this study seeks to elucidate the impact of GDM on sexual function in pregnant women by making a comparison between GDM and non-GDM groups using pregnancy sexual response inventory (PSRI).

Score Establishment and Brazilian Portuguese version of the Pregnancy Sexual Response Inventory (PSRI).

Objective:  To establish the Pregnancy Sexual Response Inventory (PSRI) scores for each domain before and during pregnancy, and to publish the Brazilian Portuguese version of the PSRI.

Methods:  Pregnant women were recruited during antenatal care; the PSRI was administered to 244 women prenatally at Faculdade de Medicina de Botucatu, at Universidade do Estado de São Paulo (UNESP, in the Portuguese acronym). The PSRI scores were estimated based on the Kings Health Questionnaire (KHQ) and the Medical Outcomes Study 36-item short form survey (SF-36).

Contamination index. A novel parameter for metal and pesticide analyses in maternal blood and umbilical cord.

Purpose: To evaluate the contamination index of metals and pesticides in pregnant women, and to relate this to perinatal outcomes.

Methods: Descriptive, retrospective, exploratory study, developed from existing secondary data analyses at Level III maternity center. A total of 40 mothers with their newborns (NB), living in a rural area in Botucatu- Brazil and surrounding region.

Ethical, legal, and societal issues and recommendations for controlled and uncontrolled DCD.

This report deals with organ retrieval procedures in both controlled and uncontrolled DCD, looking at the ethical, legal, and psychosocial aspects during the different phases of the process. A recently published report by the UK Donation Ethics Committee (UKDEC) has served as an important reference document to outline the steps in the controlled DCD patient-donor pathway (Academy of Medical Royal Colleges. UK Donation Ethics Committee.

Prevalence of urinary incontinence and pelvic floor muscle dysfunction in primiparae two years after cesarean section: cross-sectional study.

Context And Objective: There is uncertainty in the literature regarding the theory that obstetric events and pelvic floor injuries give rise to lower risk of subsequent urinary incontinence among women delivering via cesarean section than among women delivering vaginally. The objective of this study was to assess the two-year postpartum prevalence of urinary incontinence and pelvic floor muscle dysfunction and the factors responsible for them.

Design And Setting: Cross-sectional study, conducted in a public university.

International practices of organ donation.

Organ donation and transplant rates vary widely across the globe, but there remains an almost universal shortage of deceased donors. The unmet need for transplants has resulted in many systematic approaches to increase donor rates, but there have also been practices that have crossed the boundaries of legal and ethical acceptability. Recent years have seen intense interest from international political organizations, led by the World Health Organization, and professional bodies, led by The Transplantation Society.

The safe motherhood referral system to reduce cesarean sections and perinatal mortality - a cross-sectional study [1995-2006].

Background: In 2000, the eight Millennium Development Goals (MDGs) set targets for reducing child mortality and improving maternal health by 2015.

Objective: To evaluate the results of a new education and referral system for antenatal/intrapartum care as a strategy to reduce the rates of Cesarean sections (C-sections) and maternal/perinatal mortality.

Design: Cross-sectional study.

How to increase organ donation: does opting out have a role?

Every country needs to increase the number of deceased organ donors and the potential impact of a change to opting-out legislation remains unproven, despite the apparent association between opting out and higher donor rates. However, the Spanish model--so successful in Spain and many other countries--is not based on a requirement for opting out, and, in the UK, deceased organ donation has increased by 25% in 3 years through implementation of a series of recommendations that have transformed the infrastructure of donation. A major review of opting out concluded that it is not appropriate for the UK at this time.

Histopathological placental lesions in mild gestational hyperglycemic and diabetic women.

Objective: To investigate and compare the incidence of histopathological placental lesions in mild gestational hyperglycemia, gestational diabetes and overt diabetes at term and preterm gestation.

Research Design And Methods: One-hundred-and-thirty-one placental samples were collected from Diabetes mellitus (DM) positive screened patients. Two diagnostic tests, glycemic profile and 100 g oral glucose tolerance test (OGTT) in parallel identified 4 groups normoglycemic, mild gestational hyperglycemia (MGH), gestational DM (GDM) or overt DM (DM).

Levels of selected persistent organic pollutants in blood from delivering women in seven selected areas of São Paulo State, Brazil.

Persistent organic pollutants (POPs) present in the living environment are thought to have detrimental health effects on the population, with pregnant women and the developing foetus being at highest risk. We report on the levels of selected POPs in maternal blood of 155 delivering women residing in seven regions within the São Paulo State, Brazil. The following selected POPs were measured in the maternal whole blood: 12 polychlorinated biphenyls (PCBs) congeners (IUPAC Nos.

Toxic and essential elements in blood from delivering women in selected areas of São Paulo State, Brazil.

This study was designed to evaluate the degree of environmental contamination and possible exposure of pregnant women to toxic elements in seven selected areas of São Paulo State, Brazil. The overall median concentration of Mo in maternal blood was 0.53 μg L⁻¹, highly significant differences found between sites (p < 0.