Prosecution of woman for alleged provision of Botox can continue

A High Court judge has cleared the way for continuation of a woman’s prosecution for allegedly providing Botox treatments without having the necessary doctors’ prescriptions.

The District Court had asked the High Court to decide legal issues concerning the prosecution of Anne Rossi, a State-registered nurse who conducts business as a beautician at the Anne Rossi Clinic in Clontarf, Dublin.

In his judgment on Monday, Mr Justice Michael McGrath said Ms Rossi is charged with various offences on dates between November 20th, 2014 and February 19th, 2015. It is alleged by the Health Products Regulatory Authority that she supplied a prescription only product – Dysport, which contains Botox, and is manufactured by Ipsen in Wales — and placed that on the market without the necessary prescription.

The authority claims Ms Rossi’s registration does not allow her to administer Botox. The prosecution arose from a woman’s claim she had received Botox treatment at Ms Rossi’s business premises.

On February 19th, 2015, authorised officers from the authority seized a quantity of Dysport during a search of the Clontarf clinic and took a cautioned statement from Ms Rossi.

It was not possible to have the seized products analysed in the State laboratory so they were sent to the manufacturer, Ipsen, for analysis. Ipsen then provided a report.

Repackaged

The sealed containers in which the seized products had been placed were opened and the relevant items repackaged for the purpose of sending them to Ipsen in Wales.

Ms Rossi’s lawyers argued that the authority could not prove she was in possession of a substance containing Botox on any date except the search date of February 19th, 2015.

The District Court granted their request to ask the High Court to address legal issues concerning the exercise of the authority’s powers concerning that search. It was argued, for reasons including the seized product was not handled in line with the relevant provisions of the Irish Medicines Board Act 1995, as amended, the authorised officers exceeded their powers under that Act.

Mr Justice McGrath said the admissibility of evidence – Ms Rossi’s statement and the Ipsen report – was at the heart of the case. He held that admissions by Ms Rossi during a voluntary cautioned interview with an officer of the authority are admissible in evidence despite no statutory provision being invoked for that interview.

Voluntary

Ms Rossi had accepted, and the District Judge had found, her statement was voluntary, he said. He also said there was nothing to suggest the samples of Dysport were unlawfully taken.

The absence of a report compiled in line with the relevant section of the Act did not mean the offences could not be proven by a report by Ipsen, plus other evidence, he said. While the samples were not forwarded for analysis in the manner envisaged by the Act, that did not necessarily result in an invalidation of the process, he ruled.

He did not accept that only persons referred to in the Act may give evidence of testing procedures, analysis and results. If there was any breach of a legal right arising from failure to follow the statutory process for testing by designated persons under the Act, the District Judge can exercise his discretion as to whether the evidence should be admitted.

The District Judge must also be satisfied beyond reasonable doubt the prosecution has established its case, including any issue about the chain and integrity of the samples taken and their testing and analysis, he said.