By: Yuen Wai Hung1, Oladunni Lawal1, Remi Adeseun1, Mara Hansen Staples1, Elijah Nurudeen A. Mohammed2 (Lead Writers)
Affiliations: Salient Advisory, Canada/Nigeria; Pharmacists Council of Nigeria, Nigeria.
The COVID-19 pandemic triggered an extraordinary demand for innovations that enabled the remote access of medicines, creating a unique opportunity to transform healthcare delivery systems using more decentralised approaches, supported by technology.
Technological innovation in health has impacted the processes and practices of health services, including diagnostic and pharmaceutical services. It has helped improve access, choice, and affordability for consumers unable to access traditional diagnostic and pharmaceutical services, especially during the COVID-19 lockdown and self-isolation period, for those requiring medicines for chronic conditions.
The online pharmacy model
Online pharmacies act as intermediaries or retailers to facilitate the sales of medicine. The first online sale of medicine occurred in the late 1990s and it has since become an increasingly popular, globally accepted, means of purchasing medical products and services. The COVID-19 pandemic intensified demand for remote access of medicine, and online sales of medical supplies spiked during lockdowns and enforcement of other social distancing measures.
Patients are now able to access medicines and prescriptions online instead of standing in line at the pharmacist or visiting a doctor in overflowing waiting rooms. The online pharmacy model, which offers privacy, convenience, and increased access to medical products, is also growing in many low- and middle-income countries. This trend is becoming quite popular in sub-Saharan Africa, where recent market research suggests that 70% of online pharmacies began operations within the last 5 years. This model is being looked upon to expand access to products like contraceptives and pre-exposure prophylaxis for HIV.
Regulating online pharmacies
Although purchasing medicines online can be convenient, countries are not prepared for its rapid expansion therefore the practice has been mostly unregulated, and activities such as the sale of prescription-only medications without a prescription, the sale of sub-standard medication, consumer fraud, and lack of data privacy from cyber-crimes, has raised public health concerns. The Center for Safe Internet Medicine reports that about 96% of pharmacies online worldwide, do not adhere to the laws set up within the countries they operate.
Whereas regulatory authorities in many EU and North American countries have enabled remote pharmacy services such as e-prescriptions, home delivery of medicines, and remote consultation by pharmacists, such regulation is lacking in much of sub-Saharan Africa.
Without equivalent policies in sub-Saharan Africa, online pharmacies’ ability to safely and effectively expand operations and contribute to health system goals will be severely limited.
Through a joint discussion with pharmacy regulators in Nigeria, Ghana, Uganda, and Kenya, and a review of online publications, we identified key developments and challenges in the application of the online pharmacy model in those countries and presented recommendations to improve the process.
Emerging regulations in key countries
In most sub-Saharan countries, regulations stipulate that online pharmacies must be owned and operated by a licensed traditional/physical pharmacy. While this favours physical pharmacies, it limits digital-first companies who must resort to opening or acquiring licensed physical pharmacies. A range of online pharmacy providers have emerged independently, and regulators have introduced frameworks to ensure consumer safety.
At least two countries — South Africa and Rwanda — have implemented regulations to monitor the activities of online pharmacies, and regulators in four key countries confirm that they are currently under development. Ghana developed and recently published an electronic pharmacy policy and guideline. Kenya and Uganda have also developed guidelines for online pharmacies that are anchored to existing laws.
In 2021, the Pharmacists Council of Nigeria (PCN) released the Online Pharmacy Regulations Policy. This policy ensures that pharmacists can register only one internet-based platform and the site must be user-friendly and provide a mechanism for consultancy, patients education, and reporting medium for drug reactions and medication errors. The regulations also prohibit the sale of controlled medications such as narcotics, while prescription-only medicines shall be dispensed based on good pharmacy practice. PCN announced that they would commence the registration and licensing of all online providers of pharmaceutical services in the country from January 2022.
Ghana is the first country in sub-Saharan Africa to have a National Scale E-Pharmacy platform which is run by the government and oversees all online pharmacy transactions. This requires that all independent online pharmacies be linked to the national scale E-pharmacy platform where all orders shall be placed from.
Enabling online pharmacies to integrate with other health system actors is an important step in the continuum of care. In Ghana, regulations permit online pharmacies to fulfill prescriptions electronically from healthcare providers, this however is not the case in Nigeria.
Challenges regulators encounter in advocating for safe innovations
It appears regulation for online pharmacies has not kept pace with their rapidly evolving, dynamic markets as they appear to operate with ease across national boundaries. The implementation and enforcement of regulations will require resources, supporting technology and relevant skills. Unfortunately, today’s regulators are often stretched thin as most of them lack the know-how and or resources to effectively carry out their duties.
Countries have identified the need to include key stakeholders including health care providers, national data protection agencies, and academics as part of the regulatory process. This would help to ensure patient safety, promote access, and encourage innovation.
Currently, each country’s individual market needs, and legislative structures predominate. However, a synchronised or common method of regulating structures across the continent would aid the expansion of online pharmacy companies across country borders. The sharing of best practices and lessons learned across countries can aid in laying the foundation for such harmonisation.
In Nigeria, the regulatory agency does not have control over the internet service provider that enables online pharmacies. This would imply that any breach of regulations by online pharmacies that would require site closure would be difficult to regulate.
In addition, countries with poor pharmaceutical manufacturing capacity can’t compete against better quality medicines that can be sourced online. They would have to improve their capacity or risk losing their place in the market. This might pose a serious economic challenge to underdeveloped countries with limited resources in Africa, particularly the sub-Saharan region.
Recommendations for better regulation
Online pharmacies have the potential to improve product delivery at scale across the continent — but not without regulatory support. Here are five ways in which we think countries can support this process:
1. Adopt a holistic approach towards health tech innovation governance including systems adjacent to online pharmacies such as ePrescription and telemedicine. This should be based on a validated dynamic list of authorised prescribers and a comprehensive database of uniquely identified producers, providers, payers and patients/users.
2. Prioritise technical assistance to build the capacity of regulators and provide tools required for effective contemporary regulation of online pharmacies.
3. Improve key stakeholder engagement in regulatory development through early, systematic, and continuous consultation.
4. Deploy resources to build digital infrastructure for seamless online pharmacy operations and extend financial assistance to the supply chain actors, especially retailers.
5. Formalise a multi-country working group for regulators so that sharing approaches, lessons learned, and best practices can improve regulatory efficiency and effectiveness as we enter a new era of digitally enabled care.
Under-regulated online pharmacy markets pose serious threats to public health through misuse of medicines; yet the opportunities they provide to increase access and quality should not be overlooked. The online pharmacy sector is still an emerging market in sub-Saharan Africa and countries must harness this opportunity to use regulation to shape the sector and encourage its expansion.