Regulating e-pharmacy: challenges and opportunities for access and quality of care in LMIC health systems

Access to essential medicines is a critical building block of the health system, but many low and middle-income countries (LMICs) continue to face substantial challenges in ensuring medicine accessibility, affordability and quality. The recent growth of medicine sales online represents a major disruption to pharmacy provision, presenting both challenges and opportunities across the globe. Whilst e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in LMICs, and have gained attention due to public health concerns, including the sale of prescription-only medicines without a prescription; the sale of substandard and falsified medicines; inadequate provision of information to patients; and erosion of the doctor-pharmacist-patient relationship. Further non-health-related risks include consumer fraud and lack of data privacy. The COVID-19 pandemic is encouraging a further surge in online sales, and an associated rise in cybercrime. However, e-pharmacy also presents opportunities for enhancing access to medicines, particularly for those with problems accessing traditional pharmacy services, or requiring regular medication. Regulatory systems are crucial in managing these risks and opportunities, but are hampered by lack of consensus on appropriate approaches, lack of skills and capacity among regulators, and difficulties in using national regulatory frameworks to control markets operating across country boundaries. However, analysis of LMIC e-pharmacy markets from a health systems perspective remains very limited.

We will address this knowledge gap by assessing the performance of e-pharmacies in India and Kenya, and analysing the systems that regulate them. We will characterize the e-pharmacy market in each setting in terms of its market structure and business models. We will then assess e-pharmacy performance in terms of the quality, safety and affordability of medicine provision, using online standardised patients. The quality of a sub-set of medicines obtained will be tested. We will critically appraise e-pharmacy regulation by mapping existing regulatory frameworks and accountability mechanisms, and explore implementation in practice and views on regulatory alternatives with a wide range of national and international stakeholders. Finally, reflecting the hotly contested nature of debates around e-pharmacy, we will study the policy processes that influence the design and implementation of its regulation, documenting the stakeholders involved and the institutions, interests, ideas and networks that influence them.

The research will guide policy makers, regulators and other stakeholders on approaches for strengthening regulation of e-pharmacy and improving the quality, safety and accessibility of medicine provision.

E-pharmacy is a growing phenomenon in low and middle-income countries. It has the potential to improve accessibility, reduce prices, and enhance quality assurance, yet public health concerns abound. Inappropriate use of prescription-only medicines purchased online is argued to lead to increased morbidity and mortality, antibiotic resistance and controlled prescription drug use disorders, with cyber-security threats also a significant risk. Regulation of the sector has not kept pace with these rapidly evolving, dynamic markets which operate with ease across national boundaries. This study will provide new evidence on the performance and regulation of e-pharmacies in Kenya and India- two countries at very different stages of e-pharmacy development and with contrasting political and regulatory settings.

We will characterise the e-pharmacy markets in both countries in terms of their scale, scope, business models and website regulatory compliance, using a mix of internet scraping, website review and in-depth interviews. The performance of e-pharmacies will be assessed using standardised patients (online mystery clients) to measure the proportion of cases managed in line with recommended care and government regulations, and prices charged. A sub-set of medicines purchased will be tested for quality through package inspection, and analysis of available active pharmaceutical ingredient and dissolution. We will conduct a critical appraisal of e-pharmacy regulation in each country, and assess options for amendments, drawing on document review and in-depth interviews with staff from regulatory, professional, industry and patient bodies. Finally, we will study the policy processes influencing the design and implementation of the regulatory environment, drawing on the '3I+N' framework of interests, ideas, institutions and networks.