The Online Pharmacy Regulation 2021 constitutes Nigeria’s first attempt at directly legislating in respect of telemedicine, with a focus on pharmaceutical service providers who leverage the internet to deliver their services.
The Regulation casts a wide net to capture manufacturers, wholesalers, distributors, retailers, and dispensers, in so far as they use the internet to sell pharmaceutical products. In this review, the regulatory authority here is the Pharmaceutical Council of Nigeria (PCN, referred to as ‘the Council’).
The Regulation is subsidiary legislation issued by the Minister of Health, under his powers under the PCN Act. It is set to come into force by January 1st, 2022, having already been gazetted.
Interplay with other laws
Because the Regulation is a first of its kind, it does not amend or repeal any previous law in the space. It, however, refers to existing regulations broadly. For instance, it requires online pharmacies to comply with relevant telecoms regulations but fails to state those regulations, considering the gulf between the telecoms space and healthcare, lack of common regulator, and also the fact that most telecoms regulations expressly refer to licensees of the Nigerian Communications Commission (NCC) and those offering communication services.
Registration of online pharmacies – Registration of an online pharmacy can only be done by its superintendent pharmacist, who will also be held responsible for services offered by the online pharmacy.
Shutting down operations – Where an online pharmacy wishes to shut down operations, it must notify the Council at least 14 days to the date of ceasing operations. However, if the shutting down is only temporary, it must not exceed 12 months, and the online pharmacy will still have to pay annual renewal fees for its license, which expires December 31st of every year.
Inspection of online pharmacies – introduces an inspection, monitoring, and heavy-handed enforcement framework, empowering inspectors to use ‘force and technology as is necessary’ to enter premises hosting the online pharmacy and its website. Inspectors can access any online or physical record and the backend of the website concerning their services and where there is a suspected breach of the Regulations. They can also make copies and retrieve information from the site. The operator refuses to grant access, the website can be shut down, and the online pharmacy premises are sealed. The same also applies to unregistered online pharmacies.
Telecoms regulation – Online pharmacies must comply with best practices and relevant regulations in the telecoms industry.
UI/UX Optimisation – Online pharmacies should optimise their sites to provide consultancy services, patient education, provide feedback where there is a delay in delivering prescriptions, and report adverse drug reactions.
Prescription-only medication – Online pharmacies cannot dispense prescription-only medication based on online or telephone-based consultation. Such medication can only be dispensed upon presenting a prescription obtained from a physical consultation.
Audit trail – Online pharmacies must develop a full audit trail to track medication delivery, which must involve signature upon delivery.
Registered emblem – Online pharmacies, once registered, are required to display the Council Registered Online Pharmacy Sites Emblem (ROPSE) on their website. Registered online pharmacies can only display the emblem. Where a pharmacy is not registered and displays it, risks a fine of not less than N250,000 and the shutting down of the site
Vague restriction in Rule 21(5) – This provision is poorly worded and seems to restrict online pharmacies to either one website or one physical premise. It is unclear, but attempting to register more than one site may shut down the website or premises.
Categories of applicants – The second Schedule lists the categories of applicants to include manufacturers, importers, wholesalers, distributors, retailers, and dispensers.
Suggested Action Items