The recent deployment of digital platforms, such as online pharmacies, in Nigeria, which was accelerated by the COVID-19 pandemic, creates a new channel that has the potential to expand access to many essential health commodities and services.
Despite the growth in the number of online pharmacies in Nigeria, the regulations and guidelines that govern such platforms are new and inadvertently include some potential barriers to scaling key health products, including but not limited to, newer contraceptive products like DMPA-SC.
Under the leadership of the Pharmacy Council of Nigeria (PCN), we supported a review and revision of Nigeria’s Online Pharmacy Regulations 2021 to refine and strengthen its framework to enable the distribution of essential medicines like DMPA-SC via digital channels. This project was conducted over 5 months from July to November 2023.
The revision covered four broad categories, namely:
- Structural changes to enhance overall clarity and ease of reference by disaggregating and regrouping several sections.
- Clarification of definitions for regulated activities (online consultations, online prescriptions) and entities (e.g., online pharmaceutical service providers and online pharmacy aggregators).
- Addition, modification, or deletion of several sections and/or clauses to address specific barriers (such as clarifying and easing registration and licensing requirements for online pharmacies and online pharmacy aggregators, clarifying data protection requirements, clarifying restrictions regarding dispensation of POM drugs that have OTC waivers, clarifying rules around advertisement of OTCs online, and more).
- Addition of additional regulatory considerations in line with global best practices that are not covered in the existing regulations (such as returns, requirements to identify and prevent abuse of online pharmacies, and cross-border sales).
The assessment identified several opportunities for enhancing regulations to improve the distribution of health products, including DMPA-SC, such as:
- expanding and refining the definition of online pharmacy operations,
- clarifying the role of physical premises requirements for aggregators,
- establishing a feedback and redress mechanism for license revocation appeals,
- creating exceptions for approved products like DMPA-SC,
- allowing the advertisement of family planning products authorized for self-administration,
- and updating the regulations to restrict the registration of multiple online pharmacies.
The draft revised regulation was vetted by key stakeholders including the leadership of the PCN, the Food and Drug Services department of the Federal Ministry of Health (FMOH), civil society organizations, non-governmental organizations, online pharmacy innovators, as well as pharmacy regulatory technical experts, and legal consultants.
The revised online pharmacy regulations is now set for final stakeholder engagements by the PCN, to be followed by ministerial approval. Stay tuned!
Project team
Salient Advisory managed the project, with guidance from the Pharmacy Council of Nigeria (under the leadership of the Registrar, Pharm. Ibrahim Babashehu Ahmed, FPSN and Pharm. Dr, Amina Shekarau Omar, Ph.D, FPCPharm, Director, Inspection, Monitoring, and Quality Assurance) and legal consulting advice by Health Ethics & Law Consulting (led by Prof. Cheluchi Onyemelukwe). Regulatory technical advice was provided by Dr. Elijah Mohammed, former Registrar of the Council.
The Salient team comprised Abdullah Yusuf, Joshua Uka, and Zillah Waminaje – all of whom have public health and consulting backgrounds, with Pharm. Remi Adeseun FPSN providing oversight.
We are grateful to our partners at the Clinton Health Access Initiative for funding this work, via the DMPA-SC Catalytic Opportunity Fund.
Click here, here, and here for more information about Salient’s work in advancing regulations for online pharmacies in Africa.
