Government decision on tougher online pharmacy regulation expected ‘shortly’

Exclusive: The Department of Health and Social Care has said it hopes to publish a review of the Care Quality Commission's functions "shortly", which will inform its decision on whether the regulator's proposals for legislative changes around online prescribing are needed.
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The government is considering proposals from the Care Quality Commission (CQC) to close regulatory gaps in online prescribing, following a legislative review, the Department of Health and Social Care (DHSC) has said.

In April 2021, the CQC said it submitted proposals to the DHSC for legislative changes that would address “safety gaps” in online prescribing, including the loophole that allows online providers based abroad to evade UK regulation.

The CQC proposals came after extensive efforts with other regulators, including the General Pharmaceutical Council, to share intelligence about online providers to improve regulatory coverage.

The proposals recommended changes that would “improve CQC’s ability to take action against independent providers of online primary care services that are putting people’s lives at risk”, in an effort to address the “limited jurisdictional ability for UK regulators to take action in response to harmful prescribing by providers or registered persons based outside the UK”.

An investigation by The Pharmaceutical Journal revealed in April 2022 that online pharmacies are eight times more likely than high street pharmacies to fail regulatory standards, with a third of failing online pharmacies using prescribers based outside the UK, enabling them to avoid CQC regulation.

When asked for an update on the DHSC’s progress in considering the CQC’s proposals, a government spokesperson told The Pharmaceutical Journal on 12 October 2022 that it “hopes to publish the results of a review into the CQC’s functions shortly, which will be used to inform whether any further changes regarding the CQC — including these proposals — are needed”.

The spokesperson clarified that the government is currently carrying out a ‘post-implementation review’ of three sets of regulations associated with the CQC’s functions: the Care Quality Commission (Registration) Regulations 2009; the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014; and the Care Quality Commission (Reviews and Performance Assessments) Regulations 2018.

As part of the review, the DHSC opened a consultation in June 2022 seeking feedback on the three sets of regulations from all providers registered with the CQC.

While the consultation did not specifically ask about online prescribing, respondents were asked whether there are “activities not currently defined as ‘regulated activities’ in the 2014 Regulations where there is a possible risk to patient safety or service users”.

“The UK’s medicines regulator, the [Medicines and Healthcare products Regulatory Agency], has been cracking down on the illegal sale of medicines by bringing offenders to justice to protect public health,” the DHSC spokesperson continued.

“We strongly recommend people only use registered pharmacies, which apply the same high safety standards for the online supply of medicines as they do in store.”

Elen Jones, acting director for England at the Royal Pharmaceutical Society (RPS), said: “The RPS recognises there is a gap in the regulation of pharmacist-led online prescribing services and supports proposals for these to be appropriately regulated.

“Proportionate regulation is really important and underpins patient safety.”

A spokesperson for the General Pharmaceutical Council said it is “supportive of the CQC taking on the regulation of pharmacist-run online services outside of a registered pharmacy”.

“We look forward to reading the DHSC’s report once published,” they said.

  • This article was updated on 25 October 2022 to clarify that the legislative changes would be around online prescribing, not online pharmacies
Last updated
The Pharmaceutical Journal, PJ, October 2022, Vol 309, No 7966;309(7966)::DOI:10.1211/PJ.2022.1.162225

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