In an important decision for all UK advertisers, but especially those advertising medical devices, the High Court has found that Clearcast is not amenable to judicial review because it is not a public body.

Clearcast

Clearcast is an organisation owned by the four largest UK broadcasters, which clears broadcast advertising for compliance with advertising law and the CAP Codes before it is shown. Importantly, Clearcast has no statutory foundation or authority. It operates entirely through industry co-operation. Without Clearcast approval, it is almost impossible to air a broadcast advertisement. Clearcast therefore acts as a gatekeeper to broadcast advertising.

The dispute

According to a Clearcast press release, Diomed Direct Limited submitted for clearance an ad for Prevasore Everyday Lip Therapy, a Class IIb medical device. Diomed argued that as they had received EC certification for Prevasore, which cleared certain claims for use on packaging, they should be able to include the claim in TV advertising without further substantiation. Clearcast refused clearance and Diomed applied for judicial review of that decision.

Judicial review

On the question of whether Clearcast decisions are judicially reviewable at all, the court found that Clearcast does not exercise any statutory or public law powers and does not perform “functions of a public nature”. The court also emphasised that the fact that private arrangements were used to secure public law objectives was insufficient to create that function. Accordingly, Clearcast was not amenable to Judicial Review.

Medical device claims

In comments which it is assumed, in light of the fact that the judgment is not yet available, areobiter dicta, the court also addressed a number of specific challenges Diomed made to Clearcast’s decision. 

Among other things, Diomed argued that the effect of the Medical Devices Directive was to harmonise regulation of the performance of medical devices and that EU law does not permit medical device claims to be subjected to further regulatory approval. However, the court held that Clearcast was not bound by the Medical Devices Directive, and that Clearcast only provides advice on the ASA’s likely position. Diomed also argued that Clearcast’s policy discriminated between certified medical devices (for which substantiation is required in the clearance process) and certified medicines and foods or food supplements in respect of which health or nutrition claims are made, but the court found that the differences in the laws governing the respective certification regimes justified different treatment. The court also found that, because it was not an “Emanation of the State”, Clearcast was not bound by the obligation in Article 4 of the Medical Devices Directive not to create any obstacle to the placing on the market of devices bearing CE marks, and that in any event it had not created any such obstacle. Finally, the court found that Clearcast’s decision was not disproportionate or irrational; and nor did it materially interfere with Diomed’s right to commercial free speech.

Comment

It has often been suggested that Clearcast decisions might be amenable to judicial review – mainly by disgruntled advertisers – but until this decision no advertiser had placed this question before a court. Now that Diomed has done so, and failed, then (unless there is a successful appeal) the option of raising the possibility of judicial review proceedings in support of a negotiating position is no longer available. An alternative route of challenge may be available in competition law for abuse of a dominant position, but this is far from certain.

The decision also clarifies that the Medical Devices Directive, on the one hand, and UK advertising law and the CAP Codes, on the other, are distinct regimes with different requirements, and that the Medical Devices Directive did not harmonise the law in relation to the advertising of medical devices. This decision vindicates the position taken by the ASA in a previous adjudication (Enzymatica AB, 27 January 2016), and confirms that obtaining certification for a claim under the Directive does not mean that the requirements of UK advertising law and the CAP Codes are met.