A recent High Court decision in Health Products Regulatory Authority v Anne Rossi has confirmed that regulatory authorities can interview suspects on a voluntary cautioned basis, without being required to invoke any specific statutory powers.

While the result is not surprising, a number of points from the decision are worth noting, given the increasing number of regulatory bodies empowered to investigate regulatory offences and to bring summary prosecutions.

This bulletin provides an overview of the decision. The key takeaway is that if you engage in a voluntary interview with a regulatory authority, it is likely that evidence rendered at that interview will be admissible.


The case involved a prosecution brought by the Health Services Regulatory Authority (HPRA) against Ms Rossi, a registered nurse and owner of a beautician business, for supplying a Botox product at her business premises without a prescription. It was also alleged she was not authorised to administer Botox under her registration.

HPRA officers have specific statutory powers under the Irish Medicines Board Act, 1995 (as amended) to enter premises and to require any person present to provide assistance, information and documents/records.

Two HPRA enforcement officers had searched Ms Rossi's clinic and taken possession of a box that appeared to be a Botox product and three vials. During the search, at which Ms Rossi was present, the officers took a statement from her in a detailed question and answer format. Ms Rossi was cautioned in advance – i.e. it was explained to her that she wasn't obliged to say anything, but that if she did it would be taken down in writing and could be given in evidence.

The District Court found that a caution was administered to Ms Rossi; her statement was voluntary; and that no statutory power was invoked to question her. However, before deciding the case, the District Court Judge put two questions to the High Court by way of a case stated. One of these was whether "admissions made by the defendant during a voluntary cautioned interview [are] admissible in evidence in circumstances where […] no statutory provision was invoked to interview the defendant."

The Defendant's Case

Ms Rossi argued that the HPRA officers were required to invoke the relevant statutory provisions before interviewing her, and were not entitled to elicit information in a voluntary manner outside the scope of their specific powers. Had they exercised these powers, the statement made by Ms Rossi would have been inadmissible against her, as provided for elsewhere in the Act.

The HPRA's Case

The HPRA disputed this, arguing that its authorised officers are not required to invoke a statutory power before interviewing an individual under caution. Counsel for the HPRA noted that the law encourages investigative agencies and An Garda Síochána to seek voluntary co-operation from citizens before exercising potentially draconian powers which may affect their legal and constitutional rights.

The HPRA argued that the real issue to be addressed was whether the defendant's statement was voluntary, and not whether a statutory power has been invoked. If a defendant's constitutional rights had been infringed, then the Court could address the issue of admissibility at a later stage, as there is no absolute exclusionary rule in Irish law.

The High Court's Decision

The High Court found in favour of the HPRA. Rejecting the contention that HPRA officers were only entitled to obtain information in the particular manner provided for in the Act, it accepted the HPRA's submission that the admissibility of evidence lay at the heart of the case.

In this regard, the Court noted that where information is obtained in a solicited manner by a person in authority, the caution takes on some significance. If no caution had been administered, it may have been open to the District Judge to conclude that the statement obtained was not voluntary in the true sense of the term. Likewise, if the defendant was under the impression that he/she was obliged to answer questions because the authorised officers had entered the premises in accordance with a warrant, it may be open to a trial judge to conclude that such statement was not truly voluntary.


The ultimate outcome of the case is unlikely to have raised many legal eyebrows. However, the decision demonstrates the complex issues at play when engaging with regulatory authorities exercising their investigative powers. Key takeaways include the following:

  • A regulator is not necessarily limited by statute in terms of the questions it may ask
  • It is important to clarify with a regulator the basis upon which any interview is being carried out
  • Where a regulator is invoking statutory powers to compel a suspect to answer questions, then those answers are unlikely to be admissible against them in any future legal proceedings (subject to certain statutory exceptions)
  • If, however, an interview is voluntary, and provided the interviewee is cautioned, any incriminating statements or admissions they make are likely to be admissible as evidence in any future criminal proceedings against them
  • Assessing the true voluntariness of admissions will be important
  • The privilege against self-incrimination may generally be asserted in refusing to answer any question
  • Be aware however that many regulatory statutes provide for a criminal penalty to be imposed for failure to answer questions where a statutory power is invoked. This should be explained by the regulator

The assessment of these various issues in practice is rarely straightforward. Persons or entities caught up in a regulatory investigation or enforcement action should seek legal advice at an early stage to properly understand their rights and obligations.