1. prevented BSI from suspending the UKCA certificate applicable to the portable defibrillator (Cell AED®) manufactured by the Respondent ("RRR"); and
2. requested the BSI to renew the Respondent's UKCA certificate at a future date despite BSI's concerns as to the safety and effectiveness of the device.

The interim relief ruling

BSI is an approved body appointed by the Medicines and Healthcare Products Regulatory Authority ("MHRA"). It has the power to award, suspend and revoke "UKCA" (previously "CE") certificates under the Medical Devices Regulations 2002.

In March 2024 RRR applied for judicial review of BSI's decision to suspend their certificate after a BSI technical surveillance review concluded that there was not enough clinical evidence to show that the device was safe and effective, or that it was clinically equivalent to other certified devices.  RRR also applied for an injunction to prevent BSI from suspending the device's UKCA certificate.

At an expedited interim relief hearing held on 21 March 2024 before the Administrative Court, Mrs Justice Lang DBE ruled – applying the known principles in American Cyanamid Co v Ethicon Limited [1975] AC 396 modified as appropriate for public law cases – that the balance of convenience lay in favour of maintaining the status quo until the conclusion of the Judicial Review.

The Judge noted that whilst "public health and safety is obviously of paramount concern" there was no evidence that the device was "a current risk on health and safety grounds" on the basis that BSI had not identified "direct evidence" that the device was "unsafe" and that the device had been previously certified elsewhere. BSI was also ordered to pay RRR's costs of the application for interim relief.

The Appeal

BSI appealed the interim relief decision on three grounds:

1. Ground 1 was that the Judge misunderstood both the burden of proof under the relevant statutory framework, and what it was that had to be proved;

2. Ground 2 was that the Judge had been wrong to issue a mandatory order forcing BSI to renew the UKCA certificate at a future date in circumstances where BSI was not satisfied that the device was safe;

3. Ground 3 was that costs should have been reserved until the outcome of the application was known, as the costs order against the BSI pre-empted the outcome of the JR proceedings.

The Court of Appeal Judgment

In a judgment that will be of interest to all public authorities and regulatory bodies, and particularly to those making decisions in the context of public health and safety, the Court of Appeal judgement re-asserted a number of fundamental principles applicable to interim relief applications issued in the context of judicial review proceedings:

1. When a Court grants an injunction in the course of an application for judicial review, it does not exercise a freestanding equitable jurisdiction, but it does so by reference to the powers described in section 31 of the Senior Courts Act 1981. Accordingly, in determining the application the Judge was bound to approach all relevant questions in the context of the regulatory framework applicable to the sale and certification of medical devices. This included "whether there was a serious legal issue to be tried in that framework", and if so, as part of the balance of convenience, "the strength of RRR’s legal arguments, again, in that framework."

2. The courts will not readily restrain a public authority from exercising its powers in good faith. Even if a claim passes the threshold test of raising a serious issue to be tried, if there is not a strong prima facie case on the merits, this will be a significant factor in the balance of convenience against the grant of an injunction.

3. In the context of the applicable regulatory framework, which was designed to ensure a high level of protection of health and safety:
   1. By asking whether BSI had positively shown that the device was "a current risk on health and safety grounds" the Judge wrongly reversed the burden of proof. The lack of existence of direct evidence showing that the device was dangerous should have been given "little or no weight", particularly in light of the availability of alternative devices on the market.
   2. The underlying principles which should have been applied to the facts of the case were:
      1. That great weight must be given to the protection of public health;
      2. That the manufacturer must satisfy the approved body that a device is safe and effective; and
      3. That the court should also give great weight to the assessment of the relevant material by the expert regulator.

4. On ground 2, the judgement confirmed that De Falco v Crawley Borough Council [1980] QB (CA) 460 remains good law. The courts will accordingly be slow to grant a mandatory order to compel a public authority to act in a way which it considers to be contrary to public interest. The threshold test, separate from the balance of convenience, is that a strong prima facie case must be shown for the grant of a mandatory order against a public authority.

5. The judgment goes as far as suggesting that in the context of an interim relief application in judicial review proceedings, there are no circumstances in which it would be lawful for a court to issue a mandatory order requiring a public authority to make a future decision in a particular way without having first determined that the decision under challenge is unlawful.

6. On ground 3 the Court established that for the purposes of costs a successful application for interim relief cannot be equated with success overall in an application for judicial review. The usual position in circumstances where a Claimant successfully applies for interim relief in judicial review proceedings is that the costs of the application should be reserved until the outcome of the application for judicial review.

Conclusion

This judgment reinforces some well-established principles applicable to interim relief applications against public authorities, namely that in the absence of a strong prima facie case, the courts will be slow in exercising their interim relief powers to restrain decisions made by public authorities in good faith, and that that significant weight will be given to the protection of public health and safety. 

The judgment breaks new ground in establishing that in no circumstances should a public authority be subject to a mandatory order requiring a future decision to be made before a decision has been made on the legality of the decision under challenge. 

In the absence of any precedents in the context of Judicial Review applications, the clarification of the costs position following a successful application for interim relief is welcome, and should be considered carefully by Claimants seeking to use judicial review proceedings primarily for the purpose of obtaining interim relief.

Darryn Hale (Partner) and Nico Tilche (Senior Associate) of DAC Beachcroft LLP instructed Tim Johnston of Brick Court Chambers for the Defendant / Appellant.