R (Actegy Ltd) v The Advertising Standards Authority Ltd [2019] EWHC 2374 (Admin)

R (Actegy Ltd) v The Advertising Standards Authority Ltd [2019] EWHC 2374 (Admin) concerned a judicial review challenge, heard in the Administrative Court by Charles Bourne QC (sitting as a deputy High Court judge), to decisions by the Advertising Standards Authority and the Independent Reviewer upholding complaints that an advertisement for a medical device contained unsubstantiated efficacy claims. The claim was dismissed.

The claimant, Actegy Ltd, manufactured and distributed the Revitive Circulation Booster, a range of devices applying neuromuscular electrical stimulation to the feet. The advertisement in issue, published in the Daily Mail on 21 April 2017, concerned the “DX” model. It was headlined “Revitive boosts your second heart for fast relief from aching legs & swollen feet!” and claimed the device would improve circulation, reduce swelling and alleviate pain and discomfort in the lower limbs. The Advertising Standards Authority investigated following a public complaint. The claimant provided evidence including a Clinical Evaluation Report prepared under the supervision of Professor Tim Watson and studies by Ravikumar et al, Babber et al and Varatharajan et al. The claimant held a CE certificate for the device as a Class IIa medical device issued on 23 November 2016 by the British Standards Institution following an audit under Council Directive 93/42/EEC concerning medical devices. On 11 April 2018 the ASA published its ruling that the advertisement breached the UK Code of Non‑broadcast Advertising and Direct & Promotional Marketing, section 3.1 (misleading advertising) and section 12.1 (substantiation of claims for medical devices). The ASA concluded that the available evidence did not sufficiently support the efficacy claims made. On 29 April 2018 the claimant requested the Independent Reviewer to review the ruling. By letter dated 7 July 2018 Sir Hayden Phillips, the IR, refused to find a substantial flaw in the ASA’s decision and did not invite reconsideration.

The claimant challenged the decisions on three grounds. First, it alleged that the ASA maintained an unlawful test or approach for assessing substantiation of efficacy claims for medical devices that was not required by the CAP Code and was disproportionate and/or unreasonable. Second, the ASA applied a disproportionate, irrational and/or unfair approach when assessing the adequacy of substantiation in this case. Third, the conclusion that the efficacy claims were not adequately substantiated was irrational. The claimant contended that the ASA’s approach exceeded what was permitted by Directive 2005/29/EC concerning unfair business‑to‑consumer commercial practices (the Unfair Commercial Practices Directive) and interfered with its right to free movement of goods under EU law. It argued that the ASA impermissibly required high‑quality studies such as fully blinded randomised control trials relating to all patient groups and failed to consider whether the totality of available evidence provided sufficient substantiation notwithstanding the limitations of individual studies. It placed particular reliance on the expertise of Professor Watson, who prepared an expert report stating that the CER had concluded that sufficient evidence supported the proposed claims and that the ASA applied unreasonably exacting standards. The claimant also submitted that the ASA failed to attach proper weight to the fact that the device had obtained CE certification. It further argued that the ASA had made factual errors, namely initially stating that the CE certificate did not cover the advertised device (later corrected) and incorrectly stating that the CER did not identify specific models when it did refer to the DX model by its stock control code “RLV”.

The defendants submitted that the ASA’s general approach and its specific decision were lawful. They emphasised that CE certification alone could not substantiate advertising claims, the MDD regime governing marketing authorisation being separate from the UCPD regime governing advertising. They contended that the ASA was entitled to assess the quality of evidence and to find the evidence insufficient in light of genuine issues including equivalence of devices, mode of use, consumer groups targeted, and methodological weaknesses such as small sample sizes and absence of control groups. They relied on expert evidence from Dr Ben Heller, who took the view that the ASA adopted an appropriate approach consistent with that of the general scientific community and reached reasonable conclusions.

Charles Bourne QC held that the EU law ground of proportionality could only succeed if the claimant showed that the ASA’s approach departed from the requirements of the UCPD in a manner interfering with its EU law rights. He found that the UCPD both permitted and required advertising controls and that Article 12 contemplated that traders must furnish evidence as to the accuracy of factual claims. He observed that it was self‑evidently necessary in the public interest for there to be assessment of the quality of evidence regardless of its quantity and that neither the UCPD nor free movement principles were inconsistent with a requirement for evidence consisting of rigorous and relevant studies. He held that since the ASA’s approach did not go beyond what was contemplated by the UCPD, no separate question of proportionality arose. He rejected the argument based on competition law, finding that the claimant had not identified an association of undertakings engaged in economic activity rather than regulatory or public interest activity. He noted that the claimant expressly did not challenge the lawfulness of the CAP Code itself, which required objective claims to be backed by evidence including trials conducted on people where relevant.

Charles Bourne QC considered the alleged factual errors. He found that the initial error concerning the CE certificate was immaterial because the ASA’s decision was ultimately based on its review of the evidence concerning effectiveness rather than on absence of certification. He found that the statement that the CER did not identify specific models was factually incorrect but not material because none of the studies relied upon by the claimant involved the DX model and the different models had different technical specifications relevant to effectiveness. He noted that the claimant’s own website had stated that the DX had a more limited intensity range and was suitable only for those with very mild symptoms. He noted that the claimant had not raised this objection in response to the draft recommendations or in the review request to the IR.

On the substantive assessment, Charles Bourne QC held that it was common ground that the evidence used to substantiate the claims was subject to significant limitations. He declined to decide which of the competing expert views was the better view, commenting that the expert evidence was of limited assistance without cross‑examination and that the court had to be alert to the danger of allowing parties to supplement either the reasoning in the decision under challenge or the material before the decision maker. He held that the claimant had failed by a wide margin to demonstrate that the ASA’s approach was inconsistent with accepted scientific practice or that the ASA did not properly understand the CER. He found that the ASA assessed the totality of the evidence and did not simply base its decision on the absence of a single high‑quality randomised controlled trial study. He held that the ASA’s reading was properly interpreted as a survey of the evidence as a whole with reference to particular issues leading to a cumulative conclusion. He found that the issues identified by the ASA – equivalence of devices, mode of use and consumer groups targeted, and methodological issues including blinding and sample sizes – were genuine issues acknowledged by both experts. He held that Dr Heller’s evidence at least showed expert support for the ASA’s conclusions and therefore those conclusions were rational in the Wednesbury sense. He saw no unfairness in the way they were reached. He held that even if a proportionality test were applied, the ASA’s analysis was in pursuit of the legitimate objective of consumer protection, was a suitable or appropriate means of pursuing that objective and was necessary in that it was not more restrictive than any alternative, no other such alternative having been identified. He emphasised that it was common ground that CE certification for the purposes of the MDD did not automatically satisfy the requirements of the UCPD because of considerable differences in how evidence was assessed under the two regimes, and therefore it was lawful for the ASA to carry out its own assessment.

Charles Bourne QC addressed separately the claim against the IR. He noted that the claimant had made the IR a defendant in case he was properly to be treated as a person separate from the ASA but that discrete grounds of challenge to the IR’s decision had not been advanced. He rejected the submission that the scope of the judicial review claim was limited by what had been put to the IR, distinguishing R (Sainsbury’s Supermarkets Ltd) v Independent Reviewer [2014] EWHC 3680 (Admin) where the judicial review claim was directed against the IR’s decision only. He found that the absence of discrete arguments aimed at the IR’s reasoning did not necessarily lead to failure of the claim against him but that if the claim against the ASA failed the claim against the IR would also fail because of the lack of discrete grounds and because such claim would in any event be academic.

In short, the ASA’s general approach to substantiation of efficacy claims for medical devices and its specific decision in this case were held to be lawful, neither departing from the requirements of the UCPD nor interfering disproportionately with the claimant’s EU law rights, and the claim against both defendants was dismissed.

Trading v Tobyward Ltd [1989] 1 WLR 517
R v ASA ex p The Insurance Service plc [1990] Tr LR 169
Sainsbury’s Supermarkets Ltd v The Independent Reviewer of ASA Adjudications [2014] EWHC 3680 (Admin)
SAT Fluggesellschaft v Eurocontrol [1994] 5 CMLR 208
R (on the application of Cityfibre Ltd) v The Advertising Standards Authority Ltd [2019] EWHC 950 (Admin)