A Review of the Online Pharmacy Regulations 2021
January 7, 2022

by Akintunde Agunbiade

Introduction

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.

 

Scope and Regulator

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’).

Status

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.

Key Provisions

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.

Definition – Online pharmacies are defined to be internet-dependent pharmaceutical services

Categories of applicants – The second Schedule lists the categories of applicants to include manufacturers, importers, wholesalers, distributors, retailers, and dispensers.

Top-line Impact

  • Where non-pharmacists own an online pharmacy, they will have to appoint a qualified pharmacist into superintendent pharmacist. For both new and existing online pharmacies, the superintendent will be responsible for carrying out the registration with the Council.
  • Online pharmacies are essentially at the mercy of the Council when it comes to inspection and may have to walk a tightrope between maintaining the confidentiality of patients records’ confidentiality and complying with access requests from inspectors. In addition, web hosting providers for online pharmacies may also find themselves dragged into the net of the Regulation for access to the backend of websites and to shut down, if necessary.
  • Online pharmacies may need to seek advice on relevant telecoms regulations to comply.
  • The UI/UX of online pharmacy websites will have to be improved or designed to offer additional services such as online consultancy and feedback for drug delivery or adverse reactions.
  • If an online pharmacy already offers prescription-only medication based on patients requests or online consultation, such services will have to be discontinued or modified. The online pharmacy can continue dispensing prescription-only medication by modification but must require the patient to present the prescription as received from a physical consultation.
  • Online pharmacies may need to set up their own logistics platform or partner with logistics companies to ensure good storage of drugs and secure signature upon delivery, preferably through digital means. This also presents an opportunity for logistics companies to offer niched services to online pharmacies.
  • The use of the designated emblem will help online pharmacies win customers’ trust and serve as a mark of quality in a market proliferated by counterfeit drug sellers.
  • Online pharmacies may be unable to register more than one website, thus preventing them from offering niche-focused websites to specific customers, depending on the correct interpretation of Rule 21(5)

 Suggested Action Items

  • Online pharmacies should review their terms of use to disclose the possibility of sharing confidential information in compliance with inspection requests from the Council
  • Specific advice should be sought on the telecoms regulations relevant to online pharmacies.
  • To mitigate the potential revenue loss from being unable to deliver prescription-only medication from online consultancy, online pharmacies may seek to partner with hospitals, clinics or equip their physical offices to offer diagnostic services and consultation.
  • Overall, online pharmacies would be advised to collectively lobby for the review of Regulations, reduce its restrictions on their business model, and support greater compliance with data subject rights.