“We recognize how crucial it is to have the necessary tools to manage and monitor the distribution of medicines through digital channels. Our goal is to leverage the experience of countries who have gone ahead on this journey and avoid the challenges they have faced.” – Dr Yossounon Chabi, D.G. Agence Béninoise du Médicament et des autres produits de santé (ABMed) / Chairman, African Medicines Agency
Online pharmacies are working to enhance access to high-quality medicines for over 19 million customers across Africa. These innovations are growing rapidly, with revenues tripling from $190M USD in 2019 to over $560M USD by 2022.[i] Furthermore, online pharmacies captured 38% of all healthtech funding in Africa in 2023.[ii] Online pharmacies can address critical issues of availability, accessibility, and health product quality. However, innovators and investors face challenges due to the nascent stage of regulatory and policy guidance, which exists in only a few countries and needs to be more innovation-friendly.[iii]
Since 2023, Salient Advisory has convened a Regulatory Learning Group (RLG) of 13 countries representing FDAs and pharmacy councils across Africa, focused on facilitating cross-learning, identifying and implementing opportunities to advance online pharmacy regulations in their respective countries.[iv]
In June, Salient and 24 regulators from across Africa co-hosted a RLG event with the International Pharmaceutical Federation (FIP) and the National Association of Boards of Pharmacy (NABP) of the United States, focused on sharing experiences to advance the implementation of online pharmacy regulation across Africa.
What we are learning.
Challenges with online pharmacy regulations are universal. While the United States and Europe have a significant head start in regulating the online distribution of health products compared to most African countries, regulators globally face similar challenges. These challenges include setting specifications for the registration of online pharmacies, authentication of registered online pharmacies, identifying and sanctioning illegitimate or unregistered entities, and ensuring the quality of both products and pharmacy practices via online channels.
The spectrum of regulatory models for online pharmacies varies widely. On the more liberal end, the United States allows relative parity between the authorized operation of online pharmacies and brick-and-mortar retail pharmacies, while the United Kingdom permits pharmacies to prescribe and dispense medicines via asynchronous communication. On the more restrictive end, some geographies discourage or even prohibit the online distribution of health products as can be seen in some European countries such as Norway and France, where online pharmacies are limited to the distribution of over-the-counter medicines only.
Fundamentally, the primary objective of regulators is to ensure optimal product and practice standards across all channels, and to guard patient safety. As African regulators seek to advance frameworks governing online pharmacy, they must strive for a delicate balance between patient protection and enabling channels that could advance access for millions of Africans. Five key considerations for effective regulations of online pharmacies were discussed during the meeting:
- Licensing and registration: Regulatory experts suggest that successful licensing requirements ensure consistent standards of delivery of both health products and professional pharmacy services, without being too restrictive for new entrants.
- Authentication/ verification of licensed providers: Regulators agree that the uptake of online pharmacies by the wider population will depend on the ability to rapidly build trust. Effective mechanisms for validating the credentials of online pharmacies and pharmacists are essential. Geographies such as the E.U and UK utilize logos and seals for the identification of licensed pharmacies, however, these seals are limited in efficiency as they can be easily falsified. An alternative, as adopted in the U.S., is the dotPharmacy (.pharmacy) top-level domain, which retains a greater level of control of the authentication tool within the regulator and approved third-parties.
- Tools for validating prescriptions: Regulatory experts suggest that the development and use of secure means of generating, sharing and validating electronic prescriptions are integral to regulating online pharmacies. This may require integration into provider databases and standardization of prescription formats. In addition, some African regulators are exploring the centralized approach of the National Electronic Pharmacy Platform in Ghana, which ensures seamless integrations between hospitals, clinics and pharmacies, keeping prescriptions in a closed loop.
- Product quality and visibility: Regulators discussed the need for stringent quality standards for products distributed online, preventing operators from distributing unlicensed products, and ensuring sufficient information about product origin, manufacturer, expiration, side effects, etc.
- Enforcement and regulatory compliance: Experience from the US and Europe highlights the need for a robust plan for the enforcement of regulatory guidance. This may involve continuous tracking of operating entities; for example, the NABP constantly tracks the emergence of unregistered providers of pharmacy services and at present maintains a “Not Recommended List” of 43,000+ websites for consumers to verify the legitimacy of providers. In addition, clear processes for patients / consumers to report suspicious operators and extensive collaboration with law enforcement agencies will be important.
“The current process of regulatory development presents a lack of uniformity in regulations across different African countries, hindering progress and potentially leaving some countries behind. We should focus on facilitating collaboration across countries at various stages of development, exploring the adoption of a common scope within regions” – Julius Kaluai, Head, Good Distribution Practices, Pharmacy and Poisons Board, Kenya
As regulators across Africa work to incorporate these key elements, continued engagement with global experts and regulators from other countries will be crucial in shaping the future of online pharmacy regulations in Africa.
Special thanks to Ronald Guse and Justin Macy from the NABP, and Carola van der Hoeff, Dr Zuzana Kusynova and Ali Burak Salman from the FIP.
Stay tuned!
[i] Statista, Online Pharmacy Market Insights, April 2023.
[ii] 2023 Round Up: Investments in African Healthtech. A Review of 2023 Funding Activity. Salient Advisory. February 2024.
[iii] Advancing Access to Essential Health Products via Online Pharmacies in Africa: Regulatory Landscaping Report. Salient Advisory. September 2023
[iv] The Online Pharmacy in Africa Regulatory Group (RLG) comprises representatives from Benin (Agence Béninoise du Médicament et des autres produits de santé), Burkina Faso (Agence Nationale de la Régulation Pharmaceutique, Burkina Faso), Cote d’Ivoire (Autorité Ivoirienne de Régulation Pharmaceutique, Côte d’Ivoire), Ghana (Pharmacy Council of Ghana), Guinea (National de la Pharmacie et du Médicament Ministère de la Santé et de l’Hygiène Publique, Guinea), Kenya (Pharmacy and Poisons Board, Kenya), Mali (Direction de la Pharmacie et du Medicament du Mali (DPM)), Mauritania (Pharmacies, Laboratoires et Equipements Techniques, Mauritania), Niger (Agence Nigérienne de Régulation du Secteur Pharmaceutique), Nigeria (Pharmacy Council of Nigeria), Rwanda (Rwanda Foods and Drugs Authority), Senegal (Agence de Réglementation Pharmaceutique du Sénégal) and Togo (Direction de la Pharmacie du Medicament et des Laboratoires).
