R Actegy Ltd v The Advertising Standards Authority Ltd
| Jurisdiction | England & Wales |
| Judge | Charles Bourne |
| Judgment Date | 09 September 2019 |
| Neutral Citation | [2019] EWHC 2374 (Admin) |
| Court | Queen's Bench Division (Administrative Court) |
| Docket Number | Case No: CO/4162/2018 |
| Date | 09 September 2019 |
[2019] EWHC 2374 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Charles Bourne QC
(SITTING AS A DEPUTY HIGH COURT JUDGE)
Case No: CO/4162/2018
Alan Bates and Will Perry (instructed by Lewis Silkin LLP) for the Claimant
Catherine Callaghan QC (instructed by Bates Wells & Braithwaite London LLP) for the Defendant
Hearing dates: 16 and 17 July 2019
Approved Judgment
If this draft Judgment has been emailed to you it is to be treated as ‘read-only’. You should send any suggested amendments as a separate Word document.
Charles Bourne QC:
Introduction
The Claimant applies for judicial review of a decision by the First Defendant (“the ASA”) and/or a decision by the Second Defendant (“the IR”), upholding complaints against a newspaper advertisement placed by the Claimant for a medical device, the “Revitive Circulation Booster” which it manufactures and distributes.
The Revitive Circulation Booster is the name given by the Claimant to a range of devices which apply neuromuscular electrical stimulation (“NMES”) to the soles of the feet, via gel footpads, with electrical stimulation. This case concerns an advertisement for a specific model known as the “DX” (“the device”). The stated purpose of the device is to use NMES to achieve a number of potential therapeutic benefits including improving circulation, reducing swelling in the lower limbs and reducing pain and discomfort in the lower limbs.
The device was advertised in the Daily Mail on 7 January 2017 and in The Times on 24 February 2017. Those advertisements made a number of claims for the efficacy of the device. A member of the public complained to the ASA that these claims were misleading. There was a further complaint relating to a claim that the device was being offered at “£50 off” in an advertisement in the Daily Mail on 21 April 2017, but this pricing complaint has no relevance to these proceedings and I therefore make no further reference to it. The advertisement of 21 April 2017 contained the same efficacy claims as the previous advertisements. For that reason it was that advertisement (“the advertisement”) which the ASA decided to investigate.
Before setting out the facts, it is necessary to explain the regulatory background concerning, first, medical devices and, second, advertisements.
Medical devices
Council Directive 93/42/EEC concerning medical devices (“the Medical Devices Directive” or “MDD”) harmonises the requirements for placing medical devices on the market in the EU.
Medical devices are defined by Article 1 of the MDD as including any apparatus or appliance intended to be used by humans for, inter alia, the treatment or alleviation of an injury or handicap which achieves its principal intended effect otherwise than by pharmacological, immunological or metabolic means.
Devices are divided into four classes based on risk to the user where class I is the highest risk, classes IIa and IIb are medium risk and class III is low risk. The device with which this case is concerned has been classified IIa.
Article 2 requires Member States to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements of the MDD. Article 3 requires devices to meet “essential requirements” set out in Annex I. These include safety requirements specified in paragraph 1 of Annex I, design requirements specified in paragraph 2 and, by paragraph 3:
“The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of [their intended uses] …”
Paragraph 6a of Annex I further states: “Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.” I return to the topic of clinical evaluation below.
Article 17 requires relevant devices which meet those essential requirements to bear “the CE marking of conformity” when placed on the market.
Article 11 prescribes procedures which must be followed by the manufacturer in order to affix the CE marking to a relevant device. For class IIa devices the manufacturer may choose between a number of procedures. In the present case the Claimant chose the conformity assessment procedure under Annex II of the MDD, excluding section 4.
Under that procedure (by section 3 of Annex II), the manufacturer “must lodge an application for assessment of his quality system with a notified body”. Article 16 provides for Member States to designate “notified bodies” to carry out such tasks. Section 3.2 of Annex II requires that the manufacturer's quality system must be fully documented, and the documents must meet a number of specific requirements. By Section 3.2(c) the system must include “the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular” several items of information of which one is “the clinical evaluation referred to in Annex X” (as referred to in paragraph 9 of this judgment, above).
Annex X in turn describes the clinical evaluation as:
“… a defined and methodologically sound procedure based on:
1.1.1 Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
— there is demonstration of equivalence of the device to the device to which the data relates, and
— the data adequately demonstrate compliance with the relevant essential requirements.
1.1.2 Or a critical evaluation of the results of all clinical investigations made.
1.1.3 Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.”
It is therefore for the manufacturer to obtain and collate the necessary materials including the clinical evaluation. These are then provided to the notified body for assessment.
Section 3.3 of Annex II further provides:
“The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonised standards conform to these requirements.
The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.
The decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.”
Section 7.2 further provides:
“For devices in class IIa, the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.”
So, the notified body does not carry out a clinical evaluation of the device itself, that being a task for the manufacturer. Instead, the notified body carries out an “audit” of the manufacturer's quality system as a whole. As Section 7.2 makes clear, this involves considering samples of the documentation, as opposed to considering all of the documentation.
The requirements of the MDD are implemented in the UK by the Medical Devices Regulations 2002 (SI 2002/618). Regulation 45 empowers the Secretary of State to designate “notified bodies”, and this function is discharged on his or her behalf by the Medicines and Healthcare Products Regulatory Agency (“MHRA”). Manufacturers are permitted by regulation 46 to choose any notified body to carry out the conformity assessment procedure. The MHRA does not itself carry out such procedures.
It should be noted that this regime is concerned with authorising manufacturers to place products on the market, and not with the way in which such products are advertised once on the market.
Advertisements
Business-to-consumer advertising in the EU is regulated by Directive 2005/29/EC concerning unfair business-to-consumer commercial practices (“the Unfair Commercial Practices Directive” or “UCPD”). Recital (6) explains that the UCPD seeks to harmonise the laws of Member States in relation to:
“… unfair commercial practices, including unfair advertising, which directly harm consumers' economic interests and thereby indirectly harm the economic interests of legitimate competitors. In line with the principle of proportionality, this Directive protects consumers from the consequences of such unfair commercial practices where they are material but recognises that in some cases the impact on consumers may be negligible.”
Other recitals emphasize that the UCPD helps to guarantee fair competition and seeks to achieve the proper functioning of the internal market and eliminate obstacles to the free movement of services and goods which could arise from a lack of uniform rules at EU level.
The aims of the UCPD are further clarified by recital (14) which states:
“It is desirable that misleading commercial practices cover those practices, including misleading advertising, which by deceiving the consumer prevent him from making an informed and thus efficient choice.”
Recital (20) makes clear that self-regulation is to be encouraged:
“It is appropriate to provide a role for codes of conduct, which enable traders...
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