HPRA statement – Ruling of Justice O’Brien against Anne Rossi in case involving the unauthorised supply of the medicinal product botulinum toxin (brand name Dysport)

News Category: Regulatory news

Date: 29/02/2024

The HPRA notes today's significant ruling by Justice O'Brien against Anne Rossi in a case involving the unauthorised supply of the medicinal product botulinum toxin, commonly referred to as 'Botox'.

Justice O'Brien found Anne Rossi guilty on four charges of keeping for supply and four charges of placing on the market the unauthorised medical product Dysport from her business premises on dates in 2014 and 2015, contrary to the Medicinal Product Regulations.

Justice O'Brien dismissed the Circuit Court appeal and affirmed the earlier decision of the District Court. Having risen and reviewed the matter, she decided that the Probation Act or Section 100 of the Criminal Justice Act did not apply in this case which was a serious matter.

Justice O'Brien convicted Anne Rossi on all charges fining her €1000 on each charge with six months to pay. She noted the agreement of costs totalling €5170 which must be paid within eight months.

Commenting on today's ruling, Dr Lorraine Nolan, Chief Executive, the HPRA, said “As demonstrated by this case, to protect consumer health, the HPRA will diligently pursue those involved in the illegal supply and promotion of medicines including those medicines that contain botulinum toxin. Prosecutions are progressed where it is considered that the illegal activity poses significant risk to public health. Medicines that contain botulinum toxin are prescription-only medicines. It is illegal to supply these without a prescription.

"The HPRA’s ongoing enforcement activities reflect a growing trend where certain individuals offering aesthetic services may be operating outside the law by providing prescription medicines without a prescription. In such cases, they aim to take commercial advantage of consumers. Their primary concern is financial gain - not the health of consumers availing of these services.

"The HPRA welcomes any information relating to the potential illegal supply, administration and advertising of prescription-only medicines. All information shared is treated in strictest confidence. Members of the public can report any suspicions in this regard to enforcement@hpra.ie or by phone on (01) 634 3871." she concluded.

For further information

Káno Communications Tel: (01) 6798 600         

Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438

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