High Court Considers First Application to Cancel Decision of Pharmacy Regulator

Pharmacist Colin Lannon was the subject of a fitness to practise investigation by the Pharmaceutical Society of Ireland (PSI). The complaint against Mr Lannon related to the dispensing of Kalydeco, used as a treatment for cystic fibrosis, in the absence of a prescription. Mr Lannon dispensed the medication personally only once, as the supervising pharmacist in Lannon’s Late Night Pharmacy, Sligo. However, he was legally responsible for all dispensings, whether made by him or while he was on the premises.

Mr Lannon applied to the High Court to cancel the decision of the PSI which sought to suspend him for a period of two months following a hearing before the PSI’s Professional Conduct Committee (PCC).

At the Inquiry hearing, the PCC accepted evidence from an expert that Mr Lannon’s actions were at, or very close to, the most serious end of the spectrum and considered that protection of the public required that he be suspended. The PCC’s decision was ultimately adopted by the Council of the PSI.

Before the High Court, Mr Lannon argued that neither the PCC nor the Council had appropriately considered previous decisions made by the regulator which he contended closely mirrored his situation. Mr Lannon also said that they failed to give proper weight to the insight which he said he had demonstrated since the time of the alleged incidents, which he ultimately admitted.

Precedent

In her judgment, Ms Justice Egan held that, while consistency is important in administrative decision-making, regulatory committees and bodies should not feel constrained by earlier decisions. These should be “a guide, but not a straightjacket”. Regulatory bodies must ensure that they give appropriate consideration to sanctioning principles and guidance. However, this judgment reiterates that it is regulators which are best placed to consider similarities and distinctions between cases and the weight which should be given to a previous decision in considering a current one.

Ms Justice Egan emphasised the deference which is to be paid to each regulator within their areas of expertise. The Pharmacy Act 2007 (Act) permits the High Court to look behind the decision made by the Council. The Act also states that the regulator must provide sufficient justification for its decision, both regarding sanction and more generally. However, it is incumbent on a registrant seeking to cancel such a decision to identify an error in the regulator’s approach or a specific reason for altering a sanction which the regulatory committee considered justifiable.

Insight

The Court also focused on the weight to be attached to the registrant’s insight at different stages of the matter. Ms Justice Egan considered that, while a registrant is entitled to defend themselves as they see fit, the regulator is also entitled to conclude that the position they have adopted is untenable. The Court found that “[f]ailure by a practitioner to accept allegations made at an inquiry is not an aggravating factor, but it might reduce the level of mitigation available on foot of a later acceptance of responsibility”.

The emphasis placed on insight by regulatory bodies cannot be overstated and is considered the best protection against the repetition of prior conduct. However, in the absence of such insight, the primary consideration for the regulator must be the protection of public health and safety which “exceeds the regrettable misfortune that may be visited upon [a] practitioner” in appropriate cases.

Conclusion

While appeals of the decisions of regulatory bodies are relatively rare, the availability of this avenue to registrants is an important check on the exercise of regulatory decision-making. Regulators should always ensure that decisions made at Committee, and Board or Council level, articulate the reasoning on which they are based. It should also be clear from all decisions that the position advanced by the registrant has been taken into consideration.

This judgment provides a clear and succinct summary of the matters which regulators must have regard to when considering and imposing sanction. The case reiterates and underlines these principles, but also plainly articulates that it is the regulators which are the arbiters of their own professions, and that court oversight will only be exercised in limited circumstances.

For more information on the impact of this judgment, contact a member of our Public, Regulatory & Investigations team.

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