The precautionary principle (“the Principle”) has been widely embraced as the new paradigm for contending with biological and environmental risk in the context of emerging technologies. Increasingly, it is being incorporated into domestic, supranational, and international legal regimes as part of a general overhaul of health and environmental regulation.1 Codifications of the Principle typically are vague, with their content intentionally left for scholars to debate, decision makers to interpret, and the courts to flesh out through case law. Generally speaking, the (...) Principle holds that scientific uncertainty will not be a bar to preventive regulatory action, and that decision makers should err on the side of .. (shrink)

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to (...) show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed. (shrink)

The COVID-19 pandemic has led a number of countries to introduce restrictive ‘lockdown’ policies on their citizens in order to control infection spread. Immunity passports have been proposed as a way of easing the harms of such policies, and could be used in conjunction with other strategies for infection control. These passports would permit those who test positive for COVID-19 antibodies to return to some of their normal behaviours, such as travelling more freely and returning to work. The introduction of (...) immunity passports raises a number of practical and ethical challenges. In this paper, we seek to review the challenges relating to various practical considerations, fairness issues, the risk to social cooperation and the impact on people’s civil liberties. We make tentative recommendations for the ethical introduction of immunity passports. (shrink)