A Dublin beautician has been fined €10,000 for unlawfully giving Botox-like treatments to clients at her salon.
Anne Rossi, who runs the Anne Rossi Clinic, at Vernon Avenue, Clontarf, Dublin 3, was prosecuted by the Health Products Regulatory Authority (HPRA) for offences under the Irish Medicines Board Act. The HPRA is the regulatory body for prescription medicines in Ireland.
She pleaded not guilty to all the charges.
The trial before Judge John Brennan at Dublin District Court began in 2017 but ran into legal arguments about admissibility of an alleged admission into evidence. Prosecutions and defence lawyers then sought clarification from the High Court in a procedure known as a consultative case stated.
The District Court prosecution resumed on Wednesday, and Brian Gageby BL, for the HPRA, said eight charges could be withdrawn.
Judge Brennan finalised the matter by imposing fines on the 10 remaining charges, totalling €10,000, with eight months to pay. He also set recognisance at €300 in the event of an appeal of the conviction.
Generic Botox
The trial had heard that the term Botox was a brand and trademarked but not a product featured in the charges; however, it was used as a generic term for similar products with the same active ingredient Botulinum Toxin A.
HPRA inspector Niall McCarthy has told the trial he was granted a search warrant and went to Ms Rossi's home on Howth Road in Raheny, Dublin.
Invoices from a health products supplier for Dysport were found. She told him that there was Dysport at her business premises.
The Anne Rossi Clinic at Vernon Avenue was also inspected. Dysport was found in a fridge, and Ms Rossi, a former psychiatric nurse, was interviewed under caution, the trial heard.
Mr McCarthy said that during the interview, she admitted she had administered Botox-like treatments using Dysport and had been doing so for the previous year.
In her statement, she said she injected customers after showing them areas which needed Botox treatment, costing about €250 to €300, the trial heard.
He said Ms Rossi told him, "I knew I was on a sticky wicket for the last year or so". He said she knew that the product was subject to prescription control.
The HPRA inspector said she claimed that she had been trying to find a doctor to administer the treatment at her clinic but could not get one.
Dysport contains the prescription-only substance Botulinum Toxin A.
It was the prosecution's case that it was unlawfully imported into the State without permission and administered to customers by injection at Ms Rossi's clinic. The prosecution submitted that a doctor or a pharmacist must do it.
Three women had told the court that they had received the Botox treatments in 2014 and 2015 at the beauty clinic from Ms Rossi, and no doctor was present.
'One brow lower than other'
Dr Muckesh Lalloo, a skin surgeon specialist who works out of an HSE clinic at Blanchardstown Primary Care Centre in Dublin, told the court he reported the Anne Rossi clinic to the HPRA after a patient came to him with "one brow lower than the other". He said it was consistent with the "inexpert administration" of Botulinum Toxin A, which has a freezing effect.
Dr Katherine Mulrooney had told the court she had an arrangement with the Anne Rossi Clinic from 2008 to 2012. She would see several patients on a given day and administer Botulinum Toxin A in either Dysport or Botox. The doctor brought the products with her, and she said they must be administered by a medicinal practitioner such as a doctor.
She also provided after-care, if necessary, at her main clinic.
Dr Mulrooney was shown six copies of orders allegedly emailed from the Anne Rossi Clinic in 2014 to a UK-based supplier of healthcare cosmetic products with orders for boxes of Dysport.
She agreed they had her medical registration number and her name. However, she said it was not her signature and she had not done any work for the Anne Rossi Clinic since 2012.
Dr Mulrooney said she had not permitted the use of her medical registration number.
It was alleged that from November 20th, 2014, until January 27th, 2015, while not a pharmacist Ms Rossi supplied a medicinal product without a prescription. It was also alleged she unlawfully imported and placed the product on the market without authorisation.
Dysport is a Botox-like product used in various treatments, but is most famous for its anti-wrinkle and anti-ageing signs effects.
A district court conviction for the charges can result in a fine or jail sentence of up to one year.
