News Category: Regulatory news
RTÉ’s research, and the HPRA's related and 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 advises anyone considering a cosmetic procedure involving medicines that contain botulinum toxin to:
- Ensure that the procedure offered by a clinic, salon, or individual will be carried out by a:
- Registered medical doctor or dentist.
- Registered nurse under the direction of a medical doctor/dentist.
- Request a consultation with a medical doctor or dentist to ensure the treatment is suitable for them.
Medicines that contain botulinum toxin are prescription-only medicines. It is illegal to supply these without a prescription.
The examples encountered during RTÉ’s research are similar to cases investigated by the HPRA over several years. The specific scenarios highlighted by RTE mirror a number of active enforcement cases currently under our investigation. The HPRA regrets that it is not in a position to participate in this broadcast as commenting directly on the scenarios outlined may prejudice our open cases.
The scale and extent of our recent enforcement activities are reflected below:
- In the past three years alone, the HPRA has detained more than 10,000 dosage units of medicines containing botulinum toxin, hyaluronidase or lidocaine as part of its enforcement activities in monitoring the supply chain. In 2023 specifically, the HPRA increased its detentions of botulinum toxin products by more than 400%.
- Since 2018, the HPRAs enforcement unit has initiated 88 investigation cases linked to the suspected illegal sale, supply or administration of medicines containing botulinum toxin. In 41 cases, either compliance with the regulations was successfully achieved or it was deemed no further investigation was required. In a further 16 cases, cautions were issued by the HPRA for minor breaches of the regulations. The remaining 31 investigation cases are currently ongoing (the majority relating to 2023).
- Since 2022, the HPRA has instructed 135 clinics advertising botulinum toxin online to remove unlawful content; the vast majority acted swiftly.
- In 2023 alone, some 2,350 individual webpages or social media posts in breach of the laws relating to the promotion of prescription-only medicines were removed by social media platforms following intervention by the HPRA. Many of these sites were involved in the promotion of medicines used in aesthetic procedures.
- The HPRA has initiated 54 prosecutions in the past 10 years resulting in 52 convictions. During this period, we have taken four successful prosecutions for breaches of legislation pertaining to the administering, distributing, selling or advertising of prescription medicines containing botulinum toxin. Prosecutions are progressed where it is considered that the illegal activity poses significant risk to public health or where there are persistent non-compliances. Prosecutions relating to medicines containing botulinum toxin have accounted for approximately 7.5% of all prosecutions taken over the last decade. For context, over 4,000 medicines are authorised for supply to the Irish market and there are eight medicines containing botulinum toxin representing less than 0.2% of the total.
- The decision to prosecute is carefully considered by the HPRA in consultation with legal advisors and, as appropriate, the DPP. For lower-risk situations, before initiating a prosecution, we will typically engage with the offender, caution them and ensure the legal activity is ended. This results in the desired public health outcome without placing a burden on the resources of the State. In total, over the past decade, 24 cases of illegal activity linked to medicines containing botulinum toxin, hyaluronidase or lidocaine have been addressed in this way.
- The HPRA has over many years consistently advised members of the public of the dangers of sourcing prescription medicines online and outside of the legal supply chain. This includes medicines used in aesthetic procedures. The HPRA also advises anyone seeking such treatments should engage with registered medical practitioners or registered dentists. This is because of the dangers posed by people who are not appropriately qualified to administer them.
As demonstrated, to protect consumer health, we have taken enforcement action in hundreds of individual situations to disrupt the illegal supply and promotion of medicines that contain botulinum toxin. This has included taking successful prosecutions against individuals involved in illegal activities that posed a significant risk to public health.
Prescription, supply, administration, and advertising of medicines containing botulinum toxin, hyaluronidase and lidocaine are subject to the laws governing both health products and professional practice. The HPRA's legal remit relates to health products only. It does not regulate clinical practice including aesthetic or cosmetic procedures. All scenarios involving a potential breach of regulations need careful consideration and detailed legal review. This is to establish, based on the individual circumstances of the case, whether the breach relates to the health product, the clinical practice or both.
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.
For further information
Káno Communications: (01) 679 8600
Siobhán Molloy / Kathryn Moley: (086) 817 5066 / (086) 733 4438