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High Court: Prosecution of woman accused of providing Botox treatments without prescription can continue

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The prosecution of a registered nurse who allegedly provided Botox treatments without a prescription can proceed after the High Court ruled that evidence central to the case against her is admissible.

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About this case:

  • Citation:
    [2019] IEHC 723
  • Judgment:
  • Court:
    High Court
  • Judge:
    Mr Justice Michael MacGrath

Satisfied that the samples of Botox had not been seized illegally, Mr Justice Michael MacGrath did not accept that the process of sending the samples to the manufacturer for testing made the resultant report inadmissible.

Search of premises and seizure of Botox

In February 2015, authorised officers of the Health Products Regulatory Authority (HPRA) searched the Anne Rossi Clinic in Clontarf after receiving information from someone who claimed that she received Botox treatment at the clinic without the necessary prescription.

Under section 32B(3)(a) of the Irish Medicines Board Act 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006, an authorised officer may:

“…enter (if necessary, by the use of reasonable force), at all reasonable times, any premises at which he or she has reasonable grounds for believing that:

  1. any trade, business or activity connected with the manufacture, processing, disposal, export, import, distribution, sales, supply, storage, packaging or labelling of any relevant thing is or has been carried on, or
  2. books, records or other documents (including documents stored in non- legible form) relating to such trade, business or activity are kept….”

Furthermore, section 32B(3)(e) provides that an authorised officer may:

“…require any person at the premises or the owner or person in charge of the premises and any person employed there to give to him or her such assistance and information and produce to him or her such books, records or other documents (and in the case of documents or records stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under this Act.”

During the search, the authorised officers seized a quantity of Dysport, which is a product containing Botox manufactured by Ipsen in Wales. While on the premises, the authorised officers also took a voluntary cautioned statement from the proprietor of the clinic, Anne Rossi.

The District Court

The HPRA decided to prosecute Ms Rossi in respect of offences alleged to have been committed contrary to certain regulations made under the Irish Medicines Board Act 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006.

In Dublin Metropolitan District Court, the HPRA alleged, inter alia, that between November 2014 and February 2015, Ms Rossi supplied a prescription-only product and placed a medicinal product on the market without a necessary prescription.

In addition to being a beautician, Ms Rossi is a State-registered nurse; however, it is claimed that her registration does not authorise her to administer Botox.

The District Court heard that the sample of Dysport seized from the Clinic could not be analysed in the State Laboratory, and was therefore repackaged and sent to the manufacturer in Wales. Judge John Brennan found that the sample was not handled in accordance with the sealing requirements of sections 32C(1) and 32C(4) of the 2006 Act.

On the application of Ms Rossi, Judge Brennan stated a case to the High Court pursuant to s. 52(1) of the Courts (Supplemental Provisions) Act 1961.

High Court

In the High Court, Mr Justice MacGrath considered the following questions:

  1. In the absence of a report as contemplated by s. 32D(1) of the 2006 Act, can the statutory offences in this case be proven by the Ipsen Report and other evidence? (the word “Report” was intended to mean a “certificate” as described in s. 32 D(1) of the Act).
  2. 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?”

Considering the admissibility of the Ipsen Report, Mr Justice MacGrath emphasised that there was nothing to suggest that the samples had been taken illegally, but that it was what happened to the samples thereafter that was in issue.

Mr Justice MacGrath said that the wording of section 32C(2)(c) of the 2006 Act was 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)” – and that it did 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 section 32D. Mr Justice MacGrath also said that the failure to comply with sealing requirements of the samples did not automatically lead to the exclusion of the evidence.

In those circumstances, Mr Justice MacGrath answered the first question in the affirmative.

Considering the voluntary cautioned interview, Mr Justice MacGrath said that there was nothing in the 2006 Act to suggest that if information is elicited, it can only be done in one way.

Satisfied that the information was obtained in a solicited manner by a person in authority, and to that extent the caution assumes some significance on the facts, Mr Justice MacGrath said that if “a caution had not 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 that term”. In the circumstances of the present case, Ms Rossi accepted that the caution was administered, and the statement was voluntary – as such, Mr Justice MacGrath answered the second question in the affirmative.

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