Objective To evaluate the regulation of unapproved medicines and its impact on paramedic practice in out-of-hospital settings by comparing regulatory frameworks in New Zealand, the United Kingdom, and Australia. The objective was to propose actionable policy recommendations to improve New Zealand's current regulatory approach. Methods A comparative analysis was conducted using theoretical frameworks including regulatory theory, public health law, institutionalism, comparative policy analysis, and health crisis management. A technical comparison was also undertaken. Data were collected from legislative texts, policy documents, and secondary sources. The analysis focused on prescribing and administration authority, administrative requirements, flexibility in emergency situations, and the impact on patient care. Results New Zealand's Section 29 of the Medicines Act 1981 imposes comprehensive reporting requirements and restricts unapproved medicine use to registered medical practitioners, hindering timely interventions by paramedics. The administrative burden and lack of flexibility in emergency situations compromise patient care. In contrast, the UK's Human Medicines Regulations 2012 and Australia's Therapeutic Goods Act 1989 provide structured and adaptable pathways. Discussion New Zealand's framework of Section 29 is ill-suited for pre-hospital emergency care, creating ethical and practical dilemmas for paramedics. Comparative insights reveal that more flexible legal frameworks in the UK and Australia better support paramedics' ability to provide timely care. Ethical considerations emphasise the need to balance regulatory oversight with patient care imperatives. Conclusions Legislative reforms in New Zealand are urgently needed to enable the lawful administration of unapproved medicines by paramedics, reduce administrative burdens, and align its framework with international best practices.

The authors have declared no competing interest.

This study did not receive any funding.

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