Current lethal combinations and doses of drugs used in physician-assisted dying/suicide are untested, unlicensed and unregulated, with little pharmacological understanding of efficacy and safety at high doses. Despite this, the proposed legislation would bypass regulatory safeguards, licensing, adverse event reporting and coroner referral. In any other area of medicine, such practices would be unacceptable. Before legalisation, we recommend that a formal, prospective clinical trial should be undertaken to establish the safety, efficacy and acceptability of different practices in end-of-life care including any use of lethal drug combinations. We also suggest that prescribing, licensing and monitoring gaps should be addressed.