The Court of Appeal (in R (RRR Manufacturing Pty Ltd) v British Standards Institution [2024] EWCA Civ 530) recently considered an appeal from an approved body - appointed (under the applicable regulatory regime for medical devices) by the Medicines and Healthcare Products Regulatory Agency (the MHRA) – against an order of the lower court which restrained it from withdrawing or suspending a certificate (given by it in respect of a medical device) and requiring it to extend or renew the certificate upon its expiry, until the conclusion of an associated judicial review claim.

The appeal was upheld on all grounds, for the reasons outlined below.

Background

British Standards Institution (BSI) is an approved body, appointed by the MHRA, responsible for assessing whether or not medical devices conform with the Medical Devices Regulations 2002 (the Regulations).

RRR Manufacturing Pty Ltd (RRR) manufactures and markets a small, portable defibrillator device (the device). In order to be able to sell the device in the UK it needs to hold an approved body certificate, which in essence certifies that the device meets all 'essential requirements' (namely relating to the safety of the device) under the Regulations.

RRR's device was certified by BSI in 2022 on the basis that it was equivalent to another approved defibrillator. However, following concerns expressed by third parties, including that there was a 'lack of available clinical data to confirm safe and effective use', BSI conducted a review of the certification.

On identification of various non-conformities, and a request for corrective action plans (which RRR had failed to provide), BSI decided to suspend the certification in February 2024.

In March, RRR sought judicial review of this decision, and applied for interim relief to prevent BSI from suspending or removing the certification until the conclusion of the judicial review.

Interim Relief

The relevant principles for interim relief are laid down under American Cyanamid Co v Ethicon Limited [1975] AC 396 – modified as appropriate for public law cases.

It was common ground that the 'balance of convenience' test was to be applied and that the court was required to balance 'the harm to the claimant and to any public interest which would be caused if interim relief is not granted and the claim later succeeds, against the harm which would be caused to the defendant, any third party and the public interest if interim relief if granted'.

Interim relief was granted by the High Court on the basis that there was no "direct evidence" that the device was "unsafe" or a "current risk on health and safety grounds", and the device had been previously certified in the UK and elsewhere. The court also recognised the significant commercial implications that such a suspension would have for RRR, even for just a few months.

The lower court judge accordingly gave an order which prevented BSI from suspending the certification, required to extend it on renewal (as it was in any event due to expire on 26 May 2024) and to pay RRR's costs of the interim application.

BSI appealed the lower court's decision on the grounds that the Judge had –

  1. As part of the balance of convenience considerations, failed to approach the questions in the context of the applicable statutory framework.
  2. Erred in issuing a mandatory order which required BSI to renew the certificate in circumstances where it was not satisfied that the device met the essential requirements.
  3. Erred in making a costs order in circumstances where the judicial review had not yet been determined.

The Court of Appeal (CA) held that the High Court had erred in law on all of the grounds cited in the appeal. In particular (in respect of the substantive matters) the CA held that the lower court –

  • Wrongly gave decisive weight to the commercial damage which the suspension of certification would have on RRR and wrongly balanced, against that commercial damage, BSI's power to prevent RRR from operating in the UK (based on the scope of evidence available and the fact of its previous certification), rather than against BSI's concern that RRR had not shown that it met the essential requirements.

     

  • Was wrong to grant a mandatory order compelling BSI to grant any future renewal application. No example could be provided in which a court has required a public authority to exercise a power on a future occasion in a particular way without having first decided that the decision under challenge is unlawful.

     

  • Was wrong in principle to order BSI to pay the costs of the interim relief hearing. These costs should have been reserved until the outcome of the application for judicial review.

The CA observed that, on the contrary, great weight must be given to the protection of public health, and to the assessment of relevant material by the approved body as the expert body in respect of these matters. It is for the manufacturer of a device to satisfy the approved body that the device is safe and effective. RRR had to show that BSI acted unfairly or irrationally in not being satisfied that the essential requirements are met. It was not for BSI to prove the device is unsafe or ineffective.

The CA concluded that any commercial damage was "obviously outweighed by BSI's concern that RRR had not provided it with material to satisfy it that the device was safe and effective and that another relevant device was available".

Concluding remarks

The application of the American Cyanamid balance of convenience test in public law cases is not surprising but the judgment makes it clear that the safety of pharmaceutical products and the governing statutory framework are key factors for consideration in the application of the test in such cases.

The ruling also serves as a reminder to pharmaceutical manufacturers that the burden of proof is on them to satisfy an approved body of the safety and effectiveness of their pharmaceutical product.

It is relevant to note here that, in these appeal proceedings, BSI reserved its position on whether it was a body amenable to judicial review on the basis that its relationship with the certificate holder is purely contractual. It will be interesting to see what the court makes of any such arguments should BSI run with them in the substantive judicial review proceedings.