BY OLUWASEUN AFUYE, REMI ADESEUN & MARA HANSEN STAPLES
Despite global recognition of the importance of access to essential medicines, for millions in Africa, access to essential medicines of the right quality, and at the right price and place remains a problem. [1],[2],[3] Traditional supply chain mechanisms on the continent are plagued by fragmented distribution networks, inadequate logistics infrastructure, and weak regulatory systems.[4],[5]
Consequently, many Africans grapple with unavailability and un-affordability of medicines, a situation that perpetuates poor health outcomes and worsens the continent’s socio-economic challenges.
The COVID-19 pandemic further highlighted these deficiencies. As borders were shut due to “lockdowns”, and the demand for essential supplies soared, disparities in the availability of logistics infrastructure and data between urban and suburban/rural areas resulted in worse cases of stockouts and price gouging in underserved areas.[6]
The Power of Online Pharmacies
However, in the wake of the pandemic, there was an increase in the adoption of innovations that enable convenient, remote access to health products and services.[7] These ‘online pharmacies’ act as intermediaries, distributors, or retailers, leveraging digital technology to streamline the distribution of health supplies. They also serve as a bridge to connect remote and underserved populations to essential medicines. Patients no longer need to wait long hours or endure long lines to access medicines, but can privately and conveniently, access prescriptions and essential medicines from the comfort of their homes and offices, ultimately improving health outcomes and reducing healthcare disparities. This model is growing rapidly in many low-and-middle-income countries, including in Africa, where steadily rising smartphone adoption and internet penetration rates will drive healthcare’s digital renaissance. At present, research suggests over 160 innovators offer online pharmacy solutions.[8],[9]
One significant advantage of online pharmacies is the democratization of access in traditionally excluded regions. For instance, mPharma facilitates access to affordable, high-quality medicines for more than 2 million Africans across Ghana, Nigeria, Kenya, Zambia, and Zimbabwe; MyDawa, Kenya’s first registered online pharmacy, provides a direct-to-consumer web platform with quality controls along the entire supply chain, enabling consumers, including those in remote, underserved communities, to conveniently access and receive deliveries of health supplies at affordable prices.
Traditional retail pharmacies are also adopting this model. HealthPlus, an established pharmacy chain with 62 locations across Nigeria has launched an integrated digital platform, leveraging its existing retail operations to provide online pharmacy, telemedicine, and diagnostics services to patients.
These online pharmacies offer several benefits including convenience, accessibility, even for the most remote locations; cost efficiency gained by minimizing physical infrastructure and middlemen, and visibility of supply chain data for inventory management, regulatory planning, and policy formulation.
The need for robust, innovation-friendly regulations
Despite their many benefits, these online pharmacies, if unregulated, amplify existing risks in pharmaceutical supply chains, namely, the proliferation of substandard, falsified, or unlicensed medicines, prescription misuse, and data protection – in this case, health records – concerns.
Generally, technological advancements precede regulations. However, as innovations mature, and potential risks become evident, regulatory frameworks are gradually developed to ensure safety, security, and ethical use. This sequence allows innovators to push boundaries and explore novel solutions, but also protects the public from misuse of untested and potentially unsafe technology. Striking the right balance between fostering innovation and safeguarding public interests remains an ongoing concern for regulators in fast-evolving technological landscapes. To address this, regulators may adopt either liberal approaches, emphasising flexibility, innovation, ease of entry and growth, or restrictive approaches, prioritising consumer safety, stability, and ethical considerations. An efficient regulatory framework seeks to strike a balance between these two paradigms.
Learning from Early Adopters in Africa
As adoption of online pharmacies has soared globally, many regions and countries, including the European Union, United States of America, Canada, among others have established regulatory guidance to enable and govern the operations of these innovators.
Despite the rapid growth of online pharmacies in Africa over the past three years, however, regulatory guidance for their operations has lagged. Nevertheless, some progress can be observed, particularly in Anglophone Africa. For instance, Ghana developed and published its electronic pharmacy policy and guideline in 2021, and became the first African country to establish a government-operated, national-scale electronic pharmacy platform (NEPP) in 2022. Nigeria, home to one of the most evolved online pharmacy ecosystems in Africa, has established a full complement of laws and policies for the regulation of online pharmacy. The Pharmacy Council of Nigeria (Establishment) Act, 2022, recognizes the practice of online pharmacies and the Online Pharmacy Regulations (2021) lays out the requirements for the licensure and operation of these digital pharmacies.
In Rwanda, the Regulations Governing Online Pharmacy (2020) articulates the stipulations for the licensure and operations of online pharmacies, while guidance for online pharmacies in Kenya is embedded into the Guidelines for Internet Pharmacy Services in Kenya and Guidelines for Good Distribution Practices for Medical Products and Health Technologies in Kenya. However, despite the progress seen in these early adopter countries, published regulations and implementation processes require refinement.
Figure: Regulatory ecosystems indicators in assessed countries
Fostering Innovation and Collaboration:
Over the past year, Salient Advisory, with support from the Bill and Melinda Gates Foundation, convened a regulatory learning group, involving representatives of drug regulatory agencies, pharmacy councils and poisons boards from 13 African countries. The regulatory group identified key opportunities to advance regulatory action for online pharmacy in Africa, including but not limited to:
- In countries without online pharmacy regulations,
- Strengthen regulatory capacity through knowledge transfer and technical assistance by developing a joint learning program to boost advocacy and engagement processes across countries.
- Initiate pilot projects to evaluate the feasibility and impact of online pharmacies
- In countries where online pharmacy regulations exist or are in development,
- Strengthen the regulatory framework for online pharmacies where they exist. To achieve this, regulators need to create mechanisms to accredit online pharmacies, authenticate customers, and implement sanctions to stop the operation of unlicensed pharmacies.
- Pilot national-scale online pharmacy platforms
- Promote consumer awareness and education campaigns to help individuals make informed choices when purchasing medicines online.
- Collaborate with international organisations and neighbouring countries to harmonise regulatory standards and share best practices.
- Enact comprehensive data protection laws to safeguard patients’ personal health information and establish penalties for breaches.
An Urgent Call to Action
In conclusion, online pharmacy platforms have the potential to transform access to medicines in Africa, bridging existing gaps in traditional supply chains. The growth and effectiveness of these online pharmacies is dependent on the establishment of robust regulatory frameworks that balance consumer protection with enabling innovation. African pharmaceutical regulators must adopt holistic approaches to regulating these innovations, learning from early adopters such as Ghana, Kenya, Nigeria, and Rwanda, and deploy resources to create enabling infrastructure for online pharmacy operations.
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