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Judicial review is the legal procedure by which the decisions, including acts and omissions, of bodies exercising public functions can be challenged and reviewed before the courts. In the Life Sciences sector, this could involve decisions made by regulatory authorities, such as the Health Products Regulatory Authority (HPRA). As a statutory body established to regulate medicines and devices, decisions of the HPRA are subject to judicial review, and several judicial review challenges have been taken against it previously.

Judicial review is generally not concerned with the merits of the decision, ie whether the decision was right or wrong. Rather, the courts will consider whether the decision-making process was lawful or unlawful. In this article, we outline some key considerations in relation to judicial review challenges.

Grounds for judicial review

If a person believes that a decision of a public body, like the HPRA, has strayed outside of the law or has been made without lawful authority, then that person can seek a review by the courts. An application for judicial review can be made on the following grounds:

  • The decision is outside of the legal powers of the public body. This is often referred to as being “ultra vires”. Either the public body did not have the legal power to act at all, or it exercised the power in a manner that amounts to an abuse, or mis-use, of the power.
  • The public body has not adhered to fair procedures, or has not followed prescribed procedures, in reaching its decision. Often the argument is that the public body (1) was biased, prejudiced, or had prejudged matters; or (2) did not afford notice and/or a fair opportunity to be heard.
  • The decision is irrational, unreasonable, or disproportionate. The court will examine if the decision and conclusion of the public body was so unreasonable or irrational that no reasonable body could have come to it.

Application requirements

Two key requirements to bring a judicial review challenge relate to the timeline and the two-step application process to the High Court.

Timelines

In judicial review, it is important for the person or group bringing the challenge (the applicant) to act without delay. An application for judicial review must be made, at the latest, within three months of the date on which grounds for judicial review first arose.

Generally, the date on which grounds arise for judicial review is the date the relevant decision is made. In Arthropharm (Europe) Ltd v HPRA,1 the date on which the decision of the HPRA to grant a marketing authorisation for a veterinary product was made was determined to be the date the decision was
published on the regulator’s website. This was so despite the fact that the applicant did not become aware of the decision until a later date.

While there is generally a three-month time limit for judicial review applications, specific statutes can impose shorter time limits or introduce other modifications and restrictions. For example, planning and procurement legislation set specific time limits for certain judicial review challenges. Applicants can also apply for an extension of time, in limited circumstances, and only with good and sufficient reason.

Process

An application for judicial review involves a twostep process:

1. Leave application

First, an applicant must bring an application seeking “leave” or permission to bring the judicial review proceedings.

The application for leave is usually made ex parte, ie without notifying the other party and without that party being present in court to oppose the application.

The threshold to obtain leave is relatively low. The applicant must establish that:

  • They have ‘standing’, which means that they have a sufficient interest in the matter at issue
  • The decision is amenable to judicial review, ie it is a decision on a matter of public law, and
  • They have an arguable or stateable case

If the Court decides to grant leave to bring the proceedings, it also has discretion to order a stay on the decision of the public body. A stay may prevent the decision from coming into effect pending the hearing and determination of the proceedings.

2. The substantive hearing

Once leave is granted, the proceedings must be served on the respondent public body and any other persons affected. The case then moves forward with the exchange of evidence and legal submissions. This process culminates in
the substantive hearing of the case. Evidence is generally given on affidavit, rather than by way of oral evidence.

Limitations

The court can make a range of orders. These include, in particular, an order to set aside or quash the impugned decision of the relevant public body, such as the HPRA.

However, it is important to note that judicial review is not an appeal. The court will not substitute its own decision for that of the public body. Often, the court will remit (ie send the matter back) to the public body to reconsider its decision in accordance with law, as determined by the court.

In addition, judicial review remedies are discretionary in nature. This means that, even if a court finds in favour of an applicant, it may decide not to grant certain reliefs, based on the circumstances at issue in the case.

Also, while judicial review is a generally available remedy, it will usually not be available if there are adequate alternative remedies available to the applicant. Alternative remedies can include an entitlement to a statutory appeal, for example, which should be exhausted in the first instance.

Comments

The timelines and procedural requirements for bringing judicial review proceedings are stringent and the proceedings themselves, especially in specialised regulatory sectors like Life Sciences, can be complex.

Our Public, Regulatory & Investigations team can provide expert guidance and advice to those considering or involved in judicial review proceedings.

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

1. [2020] IEHC 16; [2022] IECA 109



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