The challenge was on the basis that that Actegy had complied with the process for putting devices on the market provided for in the EU Medical Devices Directive, including a clinical evaluation report (CER) on the evidence for safety and performance by an external expert, and an audit of Actegy’s quality assurance process by the British Standards Institute; and that it was disproportionate, anti-competitive, unreasonable, irrational and unfair for the ASA to insist on rigorous studies of the efficacy of the device advertised (or any clearly equivalent devices).
The Judge (Charles Bourne QC sitting as a deputy High Court judge) held that the consumer protection regime for the advertising of medical devices (along with other consumer products) is to be found in the EU Unfair Commercial Practices Directive (UCPD) as implemented in UK law, for the enforcement of which the ASA, in applying the CAP Code, is regarded as the “established means”. UCPD required the prohibition of misleading advertising, and for advertisers to be required to furnish sufficient evidence of the accuracy of factual claims. The Judge stated that “It is self-evidently necessary, in the public interest, for there to be assessment of the quality of evidence, regardless of its quantity. Where claims for the efficacy of medical devices are concerned, neither the terms of the UCPD nor the principles of free movement more generally are inconsistent with a requirement for evidence consisting of studies which are both rigorous, in respect of study methodology, and relevant, in respect of equivalence of devices and correspondence between the test parameters and the types of user and types of use contemplated by an advertisement”. It was not disproportionate, anti-competitive or irrational for the ASA to follow such an approach.
Actegy also made a more detailed attack on the ASA’s reasoning, their expert contending for example that the ASA’s insistence on randomised controlled trials of sufficient size and relevance went beyond what was necessary, practicable or generally accepted. Having also considered the evidence of the ASA’s own expert, Dr Ben Heller of Sheffield Hallam University, the Judge concluded that “the Claimant has 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”. The Judge found that there was no meritorious ground of challenge and awarded the ASA its costs.
All content on this page is correct as of September 9, 2019.