HPRA Prosecution of Nurse to Proceed after High Court Ruling

Author: Aisling Ray and Zoe Richardson

November 21, 2019

The High Court has recently provided a useful clarification in respect of the admissibility of evidence, including admissions made under caution during voluntary interview. Mr Justice Michael McGrath recently gave his decision in respect of a case stated to the High Court in a prosecution brought by the Health Products Regulatory Authority (“HPRA”) against a nurse for alleged provision of Botox treatments in the absence of a valid prescription.

HPRA Investigation

Anne Rossi, a registered nurse, operates a beautician’s clinic in Clontarf. The clinic was searched by Authorised Officers of the HPRA in February 2015. Samples of Dysport, a type of botulinum toxin injection, were collected and detained during the search. The Authorised Officers also took a voluntary cautioned statement from Ms Rossi in which she made various admissions relating to the alleged offences.

Authorised Officers of the HPRA have statutory powers under the Medicines Board Act 1995 (“the Act”) to enter premises and to require persons at the premises, or the owner, or an employee, to furnish them with information or documentation that may be required by them to carry out their functions under the act.

District Court Prosecution

On foot of the search, the HPRA brought a District Court prosecution against Ms Rossi for offences including that Ms Rossi had supplied a prescription only product and placed a medicinal product on the market without a prescription.

During the course of the prosecution, the Court was informed that the sample of Dysport seized by the HPRA had to be sent to the manufacturer, Ipsen, based in Wales, to be analysed as the State Laboratory could not analyse the samples. Judge John Brennan found that in repackaging the samples for sending to the manufacturer, the samples had not been handled in accordance with the requirements for sealing as set out in Sections 32C(1) and 32C(4) of the Act and that a certificate as provided for in Section 32D(1) of the Act was not obtained.

Judge Brennan acceded to the application of Ms Rossi to state a case to the High Court to consider the following two questions;

  1. “In the absence of a report as contemplated by s. 32D(1) of the Act, can the statutory offences in this case be proven by the Ipsen Report and other evidence? (“Report” was intended to mean a “certificate” as described in s. 32 D(1) of the Act)

Are the admissions made by Ms Rossi during a voluntary cautioned interview admissible in evidence in circumstances where I am satisfied that the admissions were voluntary, but no statutory provision was invoked to interview the Defendant?”

High Court Ruling

In considering the first question, Mr Justice McGrath stated that there was nothing to suggest that the samples had been collected unlawfully by the Authorised Officers of the HPRA.

Mr Justice McGrath considered the wording of Section 32C(2)(c) of the Act, and stated that it was instructive. This was because it provided for the furnishing of a sealed sample for testing by a person mentioned in Section 32D(1) of the Act but did not mandate that testing could only be conducted in this way where reliance was not being placed on a certificate. He found that the absence of a report compiled by the specified persons in line with Section 32D(1) of the Act did not mean that the offences could not be proven by a report by Ipsen and other evidence.

He also stated that the failure to comply with the sealing requirements did not automatically lead to the exclusion of the evidence and, further, he did not accept that only persons referred to in the Act may give evidence of testing procedures, analysis and results.

In relation to the admissions made by Ms Rossi in the voluntary cautioned interview, Mr Justice McGrath was satisfied, and it was accepted by Ms Rossi, that the admissions made by Ms Rossi were made voluntarily and after the administration of a caution. The Judge confirmed that simply because the Act provided for information to be elicited through compelled, there was nothing in the Act to suggest that this was the only way that information could be elicited. The Court did note that the District Court may have been in a position to find that the admissions made were not made voluntarily, if a caution had not been administered.

The decision of the High Court clears the way for the prosecution against Ms Rossi to proceed and in a broader context provides useful support for prosecutors who may rely on voluntary admissions made under caution in support of charges for statutory breaches.

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