2023-01-03 16:11:43
Applications for permission to apply for judicial review are usually not fully reported because the judge does not decide whether or not the applicant’s arguments are correct; but only whether the applicant has an arguable case to be heard at a later date. However, R (on the application of Hexpress Healthcare Ltd v Care Quality Commission [2022] EWHC 2943 (Admin) sheds light on the policing of online pharmacy services by the Care Quality Commission (CQC) and addresses the question of whether a provider (Hexpress in this case) could prevent the CQC from publishing a report that would be highly damaging to Hexpress and which Hexpress considered was factually incorrect.
Under the Health and Social Care Act 2008, anyone who provides a regulated activity must be registered with the CQC. Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, regulated activities are defined as including “the provision of services by medical practitioners, and the term “undertaking” in this definition includes any business or profession”.
Hexpress, typically of online pharmacy businesses, has a website that offers treatment for treatments including erectile dysfunction, weight loss and STIs. Patients seeking treatment are asked to make a payment and fill in an online questionnaire which is referred to a medical practitioner who may prescribe. What is prescribed is then supplied by Hexpress. Hexpress was duly registered with the CQC.
The CQC has a statutory obligation to conduct reviews of regulated activities by service providers (including carrying out inspections), assess their performance following each such review; and it must publish the reports of its assessments. The provider must be sent the report before publication. Providers are offered the opportunity to correct factual inaccuracies. Services are given a rating which the provider must display conspicuously and legibly in every place where the regulated activity is carried out and on its website.
Between 28 April 2021 and 14 August 2021, five concerning incidents took place concerning patients who had received medication from Hexpress. One patient suffered from a non-fatal overuse of Saxenda, a weight loss injection pen. Two suffered from non-fatal overdoses, and two from fatal overdoses, of the beta-blocker propranolol.Hexpress, in response, changed its systems before suspending propranolol prescriptions entirely. These five incidents were brought to the CQC’s attention. On 17 May 2022 an announced, fully comprehensive inspection took place. Its remit was the fundamental standards of care and the safety of the service of the provider as a whole. Out of 60,000 medical records available, the CQC randomly selected 9 to review. However, 3 of those were for technical reasons unreviewable, producing no evidence. Therefore, the sample size was 6, representing 0.01% of all patient records. Out of these 6 records, 5 raised concerns.
The CQC treated its findings in relation to five out of six records as representative of the whole and sent Hexpress a draft report. Solicitors for Hexpress made representations. On 20 October 2022, the CQC provided the Hexpress with the final inspection report together with confirmation that the report and its response to the factual accuracy comments would be published on 25 October 2022.
Hexpress applied for permission to apply for judicial review to quash the report and for an injunction to prevent the report being published before a final hearing. The application came before Mr Justice Mostyn in late November 2022. Hexpress argued that the CQC acted disproportionately, and thereby breached its obligations in the 2008 Act, by using only six medical records as its sample. The CQC’s case was that this approach to the records was reasonable firstly because it only had one day to inspect and did not have easy access through the system and secondly because “while the sample was relatively small, a very worryingly high proportion of the records examined contained issues”
Without deciding whether the report was based on unlawfulness, the judge granted Hexpress permission to apply for judicial review because it was arguable whether a sample size of 6 out of 60,000 was statistically significant and whether, in using such a small sample, the CQC failed to conduct a fair analysis or whether the principle of fairness had been sacrificed on the altar of CQC’s limited resources.
The judge refused to grant an injunction to restrain publication of the CQC report prior to the final hearing of the judicial review application. He held that when a public body had a statutory duty to publish a report, there would have to be the most compelling reasons to prohibit publication, such as a report that was manifestly untrue or riddled with error. There was nothing of this kind to justify granting an injunction.