Injuncting a UK Approved Body

Our Life Sciences team reviews the case of British Standards Institution v RRR Manufacturing PTY Ltd. This judgment clarifies the principles for interim relief applications against public authorities. They also examine why the decision emphasises the importance of public health and safety.

In a significant judgment for public authorities and regulatory bodies, the Court of Appeal of England and Wales allowed the appeal in British Standards Institution v RRR Manufacturing PTY Ltd. The Court considered the principles applicable to interim relief applications against public authorities. While this is a decision of the English and Welsh courts, it is still important and of potential persuasive authority in Ireland. This is due to the shared common law tradition with England and Wales. The judicial review application was taken by the British Standards Institution (BSI) to challenge interim relief obtained against it by RRR Manufacturing PTY Ltd (RRR). By prohibitory and mandatory orders, BSI was (a) prevented from suspending the UKCA certification for RRR’s small portable defibrillator medical device (the device) and (b) required to renew the UKCA certificate at a later date, irrespective of its concerns about the device’s safety and performance.

The facts

BSI is an ‘approved body’ in the UK appointed by the Medicines and Health Regulatory Agency (MHRA). It has the power to award, suspend and revoke UKCA certificates under the UK Medical Devices Regulations 2002.[1]

The device had both CE and UKCA certification permitting it to be sold in both the EU and UK markets. However, following concerns raised by the MHRA regarding the device’s safety, BSI initiated a technical surveillance review of the device’s UKCA certificate. In its subsequent decision, BSI identified a number of major and minor non-conformities with the device to be addressed through corrective action plans (CAPs). RRR exercised a right of internal appeal to BSI. This appeal was dismissed. Subsequently, BSI issued a further decision justifying its conclusion. Based on these two decisions, BSI decided to suspend the device’s UKCA certification. RRR applied for judicial review challenging BSI’s decisions. It sought an expedited hearing to prevent BSI from withdrawing its UKCA certificate. The grounds for its application for interim relief were that suspending the device’s certificate, on the basis of allegedly unlawful decisions, would cause serious and potentially irreversible harm to RRR, both in the UK and in other jurisdictions.

The judgment

RRR’s four grounds of claim were:

• Illegality
• Procedural unfairness
• Irrationality, and
• Fettering of discretion

In considering the balance of convenience, the judge applied the principles governing the grant of interim relief in judicial review proceedings as set out in American Cyanamid Co v Ethicon Limited[2] modified as appropriate for public law cases. In doing so, she concluded that the balance of convenience favoured maintaining the status quo. She directed that BSI be restrained from suspending or withdrawing the device’s UKCA certificate until after a decision on the substantive claim. She also directed that BSI maintain the device’s certification, which was shortly due to expire and for which renewal was not automatic, pending determination of the claim.

In reaching her decision, the judge acknowledged that public health and safety is of paramount concern. However, she found no evidence that the device was a current risk on health and safety grounds. She also noted that the MHRA had the power to investigate the device if it was shown to be a risk to public health and safety. The judge further noted that news of the suspension would spread quickly and that RRR would suffer considerable commercial and reputational harm as a result. The judge refused BSI’s permission to appeal.

Grounds of Appeal

BSI appealed the decision on the following three
grounds:

• The judge misunderstood both the burden of proof under the relevant regulations, and what it was that had to be proved. BSI argued, amongst other things, that the judge was wrong to decide that there was no evidence that the device was a current risk on health and safety grounds. It further argued that it was not for BSI to satisfy the court that the device was unsafe. Rather, it was for RRR to satisfy BSI that the device was safe and met all the essential requirements
• The judge was wrong to grant a mandatory injunction requiring BSI to renew the device’s UKCA certification at a future date. BSI argued, amongst other things, that a public authority should not be restrained from discharging its functions in good faith. This was particularly relevant in the context of a mandatory order. BSI contended that such an order would require it to act in a way it considers unsafe and contrary to the public interest
• The judge should have reserved the costs of the interim application until the outcome of the claim was known

Court of Appeal judgment

The Court of Appeal held that all three grounds of appeal should be allowed. Accordingly, the Court of Appeal set aside the prohibitory order restraining suspension of the UKCA certificate. The Court of Appeal also set aside the mandatory order requiring BSI to renew the UKCA certificate at a later date. Additionally, the costs order was set aside. In her leading judgment, Lady Justice Laing outlined the underlying principles which should have been applied to the facts of the case as follows:

• First, that great weight must be given to the protection of public health
• Second, in accordance with the medical device regulatory framework, the manufacturer must satisfy the approved body that a device is safe and effective
• Third, the court should also give great weight to the assessment of the relevant material by the expert regulator

In light of those considerations, the Court of Appeal affirmed that, in determining where the balance of convenience lies in a public law case, two important factors are that:

• The court 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
• Maintenance of public health is a very important objective and must carry great weight in the balancing exercise

Conclusion

This judgment reaffirms the principles to be applied in interim relief applications against public authorities. It confirms that, in the absence of a strong prima facie case, the courts should be slow to grant interim relief against a public authority that is exercising its powers in good faith. It also confirms that the courts should afford significant weight to the protection of public health and safety in determining the balance of convenience. While this is a decision of the Court of Appeal of England and Wales, it is still important and of potential persuasive value in Ireland as a common law EU jurisdiction. This is particularly so given that the underlying principles and legal tests applied in this instance are largely the same as those that would be applied in an Irish law context. The judgment can be found online.

For more information, contact a member of our Product Regulation & Consumer team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1] Whereas the EU Medical Devices Regulation (2017/745) (MDR) is now applicable in EU Member States and Northern Ireland, the UKCA requirements for medical devices regulated under the UK Medical Device Regulations 2002 are based on requirements derived from the MDR’s predecessor, Directive 93/42/EEC on medical devices (MDD).

[2] [1975] AC 396