When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries

Abstract

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation—through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Patients Access to Medicines – A Critical Review of the Healthcare System in Kenya

“…So far there is no study conducted to understand the quantity and quality of the medicines sourced by patients via the internet in Kenya. Though the sale of medicines over the internet may offer some benefits such as improved patient access to medicines convenience, cost savings, 88 and facilitating traceability and transparency of medicines, 89 the current CAP 244 does not have a provision to facilitate proper regulatory oversight of online pharmacies. This is because online pharmacies provide a convenient and easy way to access medicines by patients who may obtain SF medicines from criminals 88 , 90–92 and sale of medicines without a valid prescription.…”

“…This is because online pharmacies provide a convenient and easy way to access medicines by patients who may obtain SF medicines from criminals 88 , 90–92 and sale of medicines without a valid prescription. 89 PPB needs to strengthen a system to regulate online pharmacies that can facilitate verification of trusted online pharmacy websites. 90 , 93 …”

Analysis of the Medicinal Assortment as a Factor of Increasing the Competitiveness of Organizations in the Pharmacy Market of the Region

“…Pharmacies should use not only and not so much the organizational and economic mechanisms of doing this business, but take into account the social significance of the product they sell, increase the level of trust and loyalty of customers, and also use government support measures for organized support of socially vulnerable groups of the population [18][19][20][21][22].…”

Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

“…While online pharmacies were initially available only in highincome countries, they have been increasing in many low-and middle-income countries (1). The scope of online pharmacies may include direct-to-client distribution of health products through online and mobile channels, digital health information, and remote consultations with health providers.…”