British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of)

[2024] EWCA Civ 530

Case details

Case citations
[2024] EWCA Civ 530
Court
Court of Appeal (Civil Division)
Judgment date
15 May 2024
Judgment text

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Subjects
Administrative law Judicial review Interim remedies
Keywords
interim relief balance of convenience mandatory injunction public authority public health medical devices regulatory decision strong prima facie case costs of interim application
Outcome
appeal allowed
Judicial consideration

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Summary

Interim relief in judicial review is granted under the court’s public law jurisdiction, with private law injunction principles applied by analogy. When assessing the balance of convenience, the court must consider the strength of the claim and give substantial weight to the public interest in permitting a public body to perform its functions. Protection of public health and the expert regulator’s assessment may outweigh commercial harm.

A mandatory order against a public authority requires a strong prima facie case. The court cannot ordinarily direct the outcome of a future decision before unlawfulness has been established. Success on an interim application is not success in the judicial review as a whole. The interim costs should usually be reserved while the merits remain undecided.

Factual background

RRR Manufacturing Pty Ltd marketed a portable defibrillator under a certificate issued by the British Standards Institution, an approved body under the medical-device regulatory regime. Following a technical review, BSI identified non-conformities and decided to suspend the certificate.

RRR sought judicial review and interim relief. Lang J restrained suspension or withdrawal of the certificate, required BSI to extend or renew it when it expired, and ordered BSI to pay RRR’s costs. Her decision was reported at [2024] EWHC 709 (Admin).

At an expedited rolled-up hearing, the Court of Appeal considered the public law test for prohibitory interim relief, the power to compel a public authority to make a future decision, and the proper costs order where interim relief has been obtained but the judicial review remains undecided.

Held

  1. Appeal allowed on all three grounds. The prohibitory and mandatory relief could not stand, and the costs of the interim application should have been reserved.

  2. The jurisdiction to grant interim relief in judicial review derives from section 31 of the Senior Courts Act 1981. The principles in American Cyanamid are applied by analogy. The court does not thereby exercise a free-standing equitable jurisdiction. The legal merits and the balance of convenience must be assessed within the statutory and regulatory framework governing the challenged decision: per Elisabeth Laing LJ at [76]–[77], with Nugee LJ agreeing.

  3. The judge failed to bring the strength of RRR’s claim into the balance of convenience and failed to give proper weight to the public interest in BSI continuing to perform its functions. Under the relevant medical-device regime, the manufacturer had to satisfy BSI that the device met the essential requirements. BSI did not have to prove that the device was unsafe. Great weight was due to public health, the expert regulator’s assessment, and the availability of an alternative certified device. The feared commercial harm was outweighed by the absence of material satisfying BSI that the device was safe and effective: [80]–[85]. Snowden LJ and Nugee LJ agreed that effectiveness was itself an important public-health consideration: [96]–[102], [104]–[110].

  4. De Falco remained good law. A mandatory order against a public authority requires a strong prima facie case as a threshold requirement, not merely as an aspect of the balance of convenience. The judge had found only a serious question to be tried: [87], [112]. The majority agreed that the order compelling renewal was unlawful because no future decision had yet been made and no unlawfulness had been established. Elisabeth Laing LJ considered that no such order could lawfully have been made; Nugee LJ agreed that it was inappropriate here while reserving whether an exceptional case might exist: [89], [111].

  5. A successful interim application is not equivalent to success in the judicial review overall. Because the merits and even permission remained undecided, the judge erred in ordering BSI to pay the interim costs in any event. Those costs should have been reserved: [90]–[93], [113].

The court’s approach to earlier authorities

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Appellate history

  1. Court of Appeal (Civil Division): In [2024] EWCA Civ 530, permission to appeal was granted and the appeal was allowed on all three grounds. The prohibitory injunction, mandatory renewal requirement and immediate costs order were set aside.
  2. High Court, Administrative Court: Lang J, in [2024] EWHC 709 (Admin), restrained BSI from suspending or withdrawing the certificate, required its extension or renewal pending determination of the judicial review, and ordered BSI to pay RRR’s costs of the interim application.

Lower court decision

Judgment appealed:
Outcome:
appeal allowed

Key cases cited

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Cases citing this case

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