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. Since EVs not only mirror composition of their parent cells but also modify the recipient cells, they can be used in three key areas of medicine: regenerative medicine, disease detection and drug delivery. In this Review, we discuss the transformational and translational progress witnessed in EV-based medicine to date, focusing on two key elements: the mechanisms by which EVs aid tissue repair (for example, skin and bone tissue regeneration) and the potential of EVs to detect diseases at an early stage with high sensitivity and specificity (for example, detection of glioblastoma). Furthermore, we describe the progress and results of clinical trials of EVs and demonstrate the benefits of EVs when compared with traditional medicine, including cell therapy in regenerative medicine and solid biopsy in disease detection. Finally, we present the challenges, opportunities and regulatory framework confronting the clinical application of EV-based products.

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.

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In response to the COVID-19 pandemic, governments worldwide introduced vaccine mandates and ‘passports’, creating tension between individual liberties and public health. This article provides an overview of the history of vaccine mandates in Australia and the United Kingdom, before examining the COVID-19 period, when Australian states introduced various conditional mandates while the United Kingdom largely avoided doing so. This article considers several medico-legal and human rights arguments for and against the imposition of conditional mandates. Although this article concludes that vaccine coercion is both legally and morally justified, it acknowledges the right to refuse medical treatment, freedom of thought, conscience, and opinion, and the right to bodily integrity as important precepts deserving serious consideration. In many cases, alternatives to coercion are preferable. This article has ongoing relevance, both for COVID-19 (as new variants and treatments emerge) and beyond, including for the use of coercion in childhood vaccination and future pandemics.