Health Products Regulatory Authority v Rossi
| Jurisdiction | Ireland |
| Judge | Mr. Justice MacGrath |
| Judgment Date | 04 November 2019 |
| Neutral Citation | [2019] IEHC 723 |
| Docket Number | [2018 No. 262 SS] |
| Court | High Court |
| Date | 04 November 2019 |
[2019] IEHC 723
THE HIGH COURT
MacGrath
[2018 No. 262 SS]
IN THE MATTER OF SECTION 52 OF THE COURTS (SUPPLEMENTAL PROVISIONS) ACT 1961
Consultative case stated – Prosecution – Irish Medicines Board Act 1995 – District Judge seeking the opinion of the High Court – Are the admissions made by the defendant during a voluntary cautioned interview admissible in evidence in circumstances where the District Judge is satisfied that the admissions were voluntary, but no statutory provision was invoked to interview the defendant?
Facts: This was a consultative case stated made pursuant to s. 52(1) of the Courts (Supplemental Provisions) Act 1961 for the opinion of the High Court on two questions posed by Judge Brennan of the Dublin Metropolitan District Court on 30th June, 2017. The court had been informed that the case was stated on the application of the defendant, Ms Rossi. It concerned the prosecution of the defendant in respect of offences alleged to have been committed contrary to certain regulations made under the provisions of the Irish Medicines Board Act 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006. The prosecutor was the Health Products Regulatory Authority (previously known as the Irish Medicines Board). The 1995 Act makes provision for the appointment of authorised officers upon whom certain powers are conferred, including powers of entry, search and to require information and assistance. The questions posed by the District Judge were as follows: (i) In the absence of a report as contemplated by s. 32D(1) of the 1995 Act can the statutory offences in this case be proven by the Ipsen Report and other evidence? (ii) Are the admissions made by the defendant during a voluntary cautioned interview admissible in evidence in circumstances where the District Judge is satisfied that the admissions were voluntary, but no statutory provision was invoked to interview the defendant? It was confirmed at hearing that reference to the word “report” in the first question meant and was intended to mean a “certificate” as described in s. 32 D(1).
Held by MacGrath J that should an issue arise as to whether the officer, by the tone of the questioning or by the trappings of office, led a person under investigation to believe, despite the administration of a warning or caution, that he or she was nevertheless obliged to answer the question, then it would also be open to the trial judge to conclude that the statement was not truly voluntary, or the caution not effective. MacGrath J held that these will be dependent on the assessment of the evidence, but that did not arise in this case; it was accepted by the defendant, and found by the District Judge, that a caution was administered and the statement voluntary. MacGrath J held that the wording of s. 32C(2)(c) is instructive as it provides for the forwarding of the sealed container “for test, examination or analysis ... by a person mentioned in s. 32D(1)(a),(b) or (c)”; it does not mandate that testing can only be done in that manner where reliance is not sought to be placed on a certificate as provided for in s. 32D. Therefore, MacGrath J was unable to conclude that only persons referred to in s. 32D(1)(a), (b) or (c) may give evidence of testing procedures, analysis and results. In the circumstances, MacGrath J did not believe that it follows that a failure to comply with the provisions of the 1995 Act in this specific regard necessarily results in the invalidation of the process.
MacGrath J held that, in all the circumstances, he was satisfied that the answers to the questions posed by the District Judge were as follows: (i) Yes; (ii) Yes.
Consultative case stated.
This is a consultative case stated made pursuant to s. 52(1) of the Courts (Supplemental Provisions) Act, 1961 for the opinion of this court on two questions posed by Judge John Brennan of the Dublin Metropolitan District Court on 30th June, 2017. The court has been informed that the case was stated on the application of the defendant. It concerns the prosecution of the defendant in respect of offences alleged to have been committed contrary to certain regulations made under the provisions the Irish Medicines Board Act, 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act, 2006 (referred to herein as “the Act”). The prosecutor is the Health Products Regulatory Authority (previously known as the Irish Medicines Board and hereafter referred to as “the Authority”). The Act makes provision for the appointment of authorised officers upon whom certain powers are conferred, including powers of entry, search and to require information and assistance.
The offences are alleged to have occurred on various dates between 20th November, 2014 and 19th February, 2015. It is alleged that the defendant supplied a prescription only product and placed a medicinal product on the market without a necessary prescription. The product is Dysport, which is manufactured in Wales by Ipsen. It contains Botulinum Toxin A and is commonly known as Botox, a prescription only drug. It is used to treat certain muscular conditions but, in a more purified form, is used cosmetically by blocking certain nerves that contract muscles, thus softening the skin and reducing the appearance of wrinkles.
The defendant is a state registered nurse who conducts business as a beautician at her premises known as the Anne Rossi Clinic (“the Clinic”), Clontarf, Dublin. The Authority alleges, inter alia, that the defendant provided Botox treatments as part of her service without having necessary prescriptions from doctors. A number of witnesses have given evidence to the District Court regarding treatments which they received. Medical evidence has also been given. It is claimed that her registration does not authorise her to administer Botox.
The prosecution originated from a statement taken from a client of the defendant who claims that she received Botox treatment at the Clinic. On the 19th February, 2015, authorised officers employed by the Authority seized a quantity of Dysport during a search of the Clinic. It is alleged that an offence was committed on the date of the search and on dates when customers attended and availed of Botox treatments. The authorised officers took a cautioned statement from the defendant when they were on the business premises.
The defendant maintains that the prosecution is not in a position to offer any direct evidence to prove the allegations that she was in possession of a product containing the said substance on any of the dates particularised save only on the 19th February, 2015, being the date of the search. Consequently, it is submitted that the issues that arise concern the powers purportedly exercised by the Authority's employees including, inter alia, the interview conducted during the search and the handling and testing of the samples.
Counsel for the defendant, Mr. Bradley S.C., submits that central to understanding the objections taken by the defendant is that the regulatory authority has exceeded its powers and seeks to rely upon a form of nonspecific authority which is claimed to be found in the general body of the criminal law and criminal procedure. Fundamentally, the Authority is a creature of statute and is obliged to act within its statutory powers. To this end, it is argued that the Authority is engaged in a form of reprobation and approbation, essentially choosing to rely on its statutory powers when it suits and abandoning the statutory framework when it does not. He suggests that there is a long-standing distinction between regulatory and criminal codes and refers to the Law Reform Commission Issue Paper, 2016 entitled “Regulator Enforcement and Corporate Offences”, which addressed the issue of standardising regulatory powers. Counsel observes that the Authority joined in submissions with other regulatory bodies and argued that the lack of a standard set of procedures for regulators has led to the absence of a reliable set of precedents that can apply to enforcement powers exercised by all agencies.
The District Judge made the following findings of fact.
i) The Authorised Officers entered the defendant's home on foot of a valid search warrant.
ii) No issue was made in respect of items seized from the house (or the admissions made by the defendant in the house).
iii) The Authorised Officers entered the defendant's business premises pursuant to statutory powers.
iv) While present on the premises they took possession of a box of Dysport and three vials (one of which was empty).
v) While present on the premises, the defendant was Interviewed under caution on a voluntary basis and no statutory power was invoked to question her.
vi) The products were not sent to the State Chemist for analysis because it was not possible to have it analysed in the State Laboratory.
vii) In those circumstances, a decision was made to send the products to the manufacturer, Ipsen, for analysis.
viii) There is no issue in respect of the chain of evidence save and except issues relating to the handling of the sample. In this regard the following submissions are recorded at para. 19(b) of the case stated. The product was not handled in accordance with the sealing requirements of s. 32C(1) and s. 32C(4) of the Act. The prosecutor could not have complied with the provisions of s. 32C(4) as there was an intervening act between the sealing and marking of the container as required by s. 32C(4)(b) and the requirements of s. 32C(4)(c). In October, 2015 the sealed container was opened or unsealed by Mr. McCarthy. He removed items and placed them into another bag. The removed items were then brought to...
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