Navigating the regulatory labyrinth of online prescribing

The Covid-19 pandemic has had a profound impact upon the delivery of healthcare over the last two years, not least in the enhanced accessibility of health services via remote means. The initial need to minimise personal contact has paved the way for an increase in assessing and treating patients by way of virtual consultations, including by way of video calls and online platforms. An internet search for the words ‘online doctor service’ throws up numerous results for private providers who can connect patients and doctors. This has, inevitably, led to an upsurge in prescribing to patients remotely. In addition, there has been a general rise in the availability of medication which can be ordered over the internet, sometimes by members of the public directly without a prescription.

Obtaining and supplying medication online is easy and convenient, however, it is a regulated activity and, whilst the benefits are significant, it is not without risk. Healthcare regulation helps to ensure safety for patients and that providers meet required standards. The substantial rise in remote medicine has been recognised by regulatory bodies who have tried to keep pace and ensure that sufficient safeguards are in place, with organisations such as the General Medical Council (‘GMC’) and the Care Quality Commission (‘CQC’) tightening regulation and publishing specific guidance on remote prescribing. The GMC guidance clarifies the expected standards surrounding remote prescribing by doctors, including that doctors should not prescribe controlled drugs unless they have access to patient records and should ensure that they have sufficient information to prescribe safely. The CQC has outlined key lines of enquiry (‘KLOEs’) specific to online primary healthcare providers which will be used to direct CQC regulatory inspections of the service provided.

Some online healthcare providers are based outside of the UK and fall outside of the UK regulatory system. Others would be properly captured by the relevant UK regulators but are not appropriately registered, meaning they are effectively operating illegally. The regulatory system across the UK and abroad is complex and nuanced and, in this still relatively new and developing area of healthcare, regulation is still adapting and becoming more rigorous. This can be confusing for legitimate healthcare providers who, understandably, will want to ensure that they are fully compliant. Non-compliance with requirements or breaches of obligations, including being incorrectly registered, can lead to regulatory action being taken against healthcare providers, which can be seriously detrimental to business operations or prevent the service from operating at all. Some of the potential sanctions include limiting the activities that a provider is permitted to undertake, suspending or cancelling a providers’ regulatory registration, issuing a caution or a fixed penalty notice, or prosecution. Prosecution can result in convictions, fines or, at the more serious end of the scale, custodial sentences. In addition to the practical effects of such sanctions, providers will also be concerned about the reputational damage incurred.

As a recent practical example, last month the CQC prosecuted an online doctor’s service in England for providing a regulated activity without holding CQC registration. The service, Pharmacorp Ltd (also known as Medicine Direct), was using GMC registered doctors based in Romania to prescribe controlled drugs to patients. Patients were asked to complete an online questionnaire, which the doctors used to prescribe medication to patients without access to their GP records. The medication was then sent to the patients from Pharmacorp’s premises in Stockport by post. Alongside not holding CQC registration, it was found that Pharmacorp’s website was misleading as it suggested that the doctors were based in the UK. In addition, the lack of available medical records to cross check the patients’ responses to the questionnaire carried a real risk of misdiagnosis and exposed patients to a significant risk of harm. Pharmacorp was fined £3,500 and ordered to pay £10,000 costs and a £170 victim surcharge.

So when it comes to regulatory registration, what are the requirements for providers who intend to prescribe medication online? In England, prescribing medication falls within the CQC regulated activity of ‘Treatment of disease, disorder or injury’. This means that any provider who wishes to engage in this regulated activity must register with the CQC to do so. The provider must ensure any healthcare professionals who they engage to prescribe the medication are appropriately qualified and hold the relevant professional registration. This will normally be a doctor, who must have GMC registration, but other professionals such as nurses and pharmacists may also be qualified prescribers. If the provider intends to dispense medicines, they must ensure that they are registered with the General Pharmaceutical Council too. Each regulator will have a range of regulatory obligations and requirements with which the provider must comply and compliance will normally be checked via a process of regular monitoring and inspection.

The type of regulatory registration that is required differs throughout the UK, depending on which jurisdiction the provider, healthcare professionals and patients are based in. It also differs according to the specific activity that will be undertaken by the provider. The scope of registration is somewhat fluid as regulation evolves to keep up with emerging trends and legislation. If you require advice or guidance on any aspect of healthcare regulation within the UK, please contact our Professional Discipline and Regulation team and we will be happy to assist you.

Research undertaken by Heather Flaherty, Solicitor Apprentice at CMS.