Variation and gaps in online pharmacy regulation: a comparative review of regulations across 12 countries

E-pharmacies carry enormous potential to improve access to medicines but also introduce significant regulatory concerns. This research maps the regulatory approaches governing e-pharmacies across 12 countries and identifies gaps in their scope and comprehensiveness.

Comparative review of regulatory documents.

Publicly accessible documents from governments, regulatory authorities and relevant national, subnational and supranational sources.

Countries (Brazil, Germany, Ghana, Indonesia, Ireland, Japan, Kenya, Singapore, South Africa, UAE, UK and USA) were purposively selected to capture geographic and regulatory diversity.

We extracted e-pharmacy-related regulatory text using a piloted tool, categorising identified requirements across 10 domains: licensure, accreditation, medicine sale, website content, data privacy, quality, operational oversight, advertising, penalties and other technological aspects. We also developed a 15-item subset of basic requirements and assessed regulatory comprehensiveness.

From 41 documents, we identified 43 regulatory requirements, with substantial country and regional variation in whether each was mandated, permitted, prohibited or unaddressed. Online sale of prescription medicines was explicitly permitted in 8 of 12 countries, but prohibited in Ireland, Japan and UAE. Most countries (n=9) required e-pharmacies to be linked to a brick-and-mortar pharmacy. Four countries prohibited online sale of narcotics. Approaches for verifying website authenticity included displaying licence numbers (n=5) and using a 'common logo' (n=5). Fewer regulations addressed newer technological developments, including mobile apps (n=2) and social media (n=1). Kenya and the UK met all requirements on our 15-item checklist, indicating higher comprehensiveness.

We identified substantial variation in how e-pharmacy regulations addressed the 10 regulatory domains, particularly licensure, medicine sale and website authenticity. Gaps in regulatory coverage were most evident for accreditation, penalties and integration with broader digital health systems. This review offers a practical checklist of basic regulatory requirements to help policymakers strengthen e-pharmacy governance and ensure safe access to medicines online.