Case Comment: Professional Standards Authority for Health and Social Care v (1) General Pharmaceutical Council (2) R2 [2024] EWHC 3005 (Admin)

Background

This case arises from a decision by the Fitness to Practise Committee (“the Committee”) of the General Pharmaceutical Council (“GPhC”) to impose a stay on proceedings against a registered pharmacist, referred to here as R2. The proceedings concerned allegations of R2’s involvement in a fraudulent scheme related to the sale of high-value, short-supply medications overseas. The scheme allegedly involved falsified prescriptions and dishonestly wholesaling medicines intended for patient use, with the aim of arbitraging medicine prices within the EU.

The allegations against R2 were uncovered during an investigation into his co-director, Mr Amier, who admitted to engaging in the fraudulent activities but claimed R2 was uninvolved. Despite R2’s denial of any wrongdoing, the Medicines and Healthcare products Regulatory Agency (“MHRA”) found evidence suggesting that R2’s name appeared on documents related to the fraudulent orders.

Initially, the GPhC decided in 2022 to close the case against R2, citing insufficient evidence to meet its threshold for referral. However, this decision was later revisited, with the GPhC claiming the closure had been made in error. The closure of the case was later described by the Court as more of an ‘administrative’ act rather than a true final decision, which significantly impacted the Court’s analysis. R2 was informed nearly a year later that the case would be reopened. The delay and procedural irregularities led R2 to argue that the reopening was improper and unfair.

The Committee ultimately granted R2’s application to stay the proceedings, citing three serious irregularities in the GPhC’s handling of the case and R2’s legitimate expectation that the matter would not be revisited. This decision prompted an appeal by the Professional Standards Authority (“PSA”), which argued that the stay was wrong in law and insufficient for the protection of the public. The appeal was brought on three grounds, namely; 

Ground 1: The Committee wrongly concluded that the closure of R2’s case was not a fundamental mistake of fact, misapplying the legal principles governing when a case can be reopened.

Ground 2: The Committee erred in finding that the allegations against R2 were not capable of being referred under rule 6 of the General Pharmaceutical Council (Fitness to Practise Rules) 2010.

Ground 3: The Committee misapplied the legal test for imposing a stay of proceedings for abuse of process, failing to appropriately weigh the public interest in determining the allegations.

Decision

The Court allowed the Professional Standards Authority’s (“PSA”) appeal on grounds 1 and 3,  quashed the Committee’s decision to stay the proceedings, and remitted the case for reconsideration by a fresh panel. The Court found that the Committee erred in its assessment of both the alleged mistake of fact and the justification for the stay.

Mistake of Fact

The PSA argued that the initial closure of R2’s case was based on a fundamental mistake of fact, entitling the GPhC to reopen the matter. The Court held that the Committee had failed to properly apply the principles governing whether a fundamental mistake of fact had occurred.

In paragraph 105 of the Committee’s decision, it noted that the GPhC had claimed the closure letter sent to R2 had been issued in error. However, the Committee concluded that this error did not amount to a “fundamental mistake of fact” but rather reflected differing judgments between the PRM and the senior lawyer. The Court disagreed with this conclusion, finding that the closure was not a proper final decision but rather an administrative act that failed to resolve the allegations substantively. This distinction was critical in determining that the GPhC could revisit the case under the principle established in Chaudhuri. The Court highlighted that reopening the case required more than a difference of opinion—it required demonstrating a genuine mistake in the underlying facts, which the GPhC successfully did by showing that the initial closure stemmed from a procedural error.

The Court found that the GPhC had acted within its authority in reopening R2’s case and found that the Committee had erred in treating the closure as definitive.

Stay of Proceedings

The Court also addressed the Committee’s decision to stay the proceedings as an abuse of process. The Committee had identified three procedural irregularities under the General Pharmaceutical Council (Fitness to Practise and Disqualification etc. Rules) Order of Council 2010 (“the 2010 Rules”):

• Misuse of urgency provisions: The GPhC had improperly referred the case under rule 6(5)(b), which allows urgent referrals, despite the circumstances not meeting the urgency requirement.
• Delay in notification: The GPhC breached rule 11(1) by failing to notify R2 of the reopening of his case within the requisite 10 days, instead delaying notification for six months.
• Failure to provide reasons: The GPhC violated rule 11(3) by not providing R2 with reasons for bypassing the Investigating Committee until the fourth day of the hearing.

The Committee concluded that these irregularities, coupled with R2’s legitimate expectation that the case would not be reopened, made it unfair to continue proceedings. 

The Court acknowledged the procedural irregularities identified by the Committee, including the misuse of urgency provisions under Rule 6(5)(b). However, it emphasised that a stay is an exceptional remedy, only justified when continuation of proceedings would irreparably undermine fairness or the integrity of the regulatory process. In this case, the Court found that the irregularities, while serious, did not meet this high threshold. Public confidence in the regulatory system required the allegations against R2 to be heard, and a fresh panel could fairly adjudicate the case without prejudice stemming from the earlier errors.

Comment

This case clarifies the circumstances in which a when a regulatory decision can be revisited and when a stay of proceedings may be justified. Both issues are of particular relevance to healthcare professionals and regulatory bodies alike, as they underscore the delicate balance between procedural fairness and public protection.

The Court’s decision reinforces the principle that regulatory decisions can be revisited only in exceptional circumstances, such as when an administrative act has been mischaracterised as a final decision. This aligns with the principle in Chaudhuri, where public bodies were held to have an implied power to correct errors arising from fundamental mistakes of fact. Here, the Court distinguished between a procedural closure and a substantive resolution, allowing the GPhC to revisit the case. Reopening a case requires more than a mere difference of opinion or judgment. The regulatory body must demonstrate a genuine mistake in the underlying facts, as was done here. This serves as a reminder to registrants that closure decisions, while appearing final, may still be subject to scrutiny if procedural errors are later identified.

The Court also clarified that a stay of proceedings should only be granted when no other remedy can sufficiently address the unfairness caused by procedural irregularities. The threshold for a stay is exceptionally high, requiring proof that the continuation of proceedings would irreparably undermine fairness or public confidence. While the procedural errors in this case were significant, the Court found that they did not irreparably prejudice R2’s ability to have a fair hearing, particularly given the possibility of a fresh panel addressing the matter impartially.

The decision underscores the importance of balancing procedural fairness with public interest. While regulatory bodies must adhere to robust procedural standards, their overarching duty to protect public confidence in professional regulation can justify continuing proceedings despite procedural missteps.

The full judgment can be accessed here: https://www.bailii.org/ew/cases/EWHC/Admin/2024/3005.html