HPRA statement - RTÉ Investigates report on illegally supplied GLP-1 medicines promoted as weight loss products

The HPRA actively monitors the Irish market for counterfeit and illegal medicines which pose serious health risks to Irish consumers. Working closely with An Garda Síochána and Revenue’s Customs Service, the HPRA employs various enforcement powers to combat this issue, including product detentions and prosecutions aimed at disrupting illegal supply.

The HPRA repeatedly warns of the health risks associated with the use of glucagon-like peptide-1 (GLP-1) receptor agonists that have been obtained outside of the legitimate pharmacy setting and without a prescription supplied by a doctor providing professional oversight. GLP-1 products include medicines that contain semaglutide, liraglutide and tirzepatide. Criminals are drawn to the illegal trade in these new medicines because it presents a lucrative opportunity to exploit high demand and limited supply. Driven solely by financial gain, criminals will always seek to bypass the law and regulatory safeguards to maximise their profits showing no regard for the health and safety of those who use these substances. The HPRA’s focus on this emerging illegal practice is reflected in both the level of our enforcement activities since 2022 and the proactive public warnings we have issued during this time.

The HPRA's most recent public health warning linked to GLP-1 products was issued as recently as 26 November 2024: HPRA warns of health risks of semaglutide type products sold illegally online.

Our message to consumers is that there is no way of knowing what substances these products actually contain and taking them poses a real and significant risk to their health. The supply of these illegal products by criminal elements via unregulated supply chains into Ireland is illegal and highly concerning, and the HPRA’s enforcement division is consistently taking action to stem this activity. Anyone who wishes to report suspicious activities linked to the illegal supply and promotion of GLP-1 products or any other prescription medicines can contact the HPRA directly. Email us at reportacase@hpra.ie or call us on 01 634 3871. This information, which will be managed in strictest confidence, will be carefully considered as part of our ongoing investigations linked to these products.

The demand for these medicines is being driven by their global promotion as products for weight loss, typically via social and other online media. The criminals behind the production of falsified and counterfeit versions of these medicines are also using social and online media to target individuals who are seeking the product for cosmetic rather than medical use. The medicines purchased online or from other unregulated sources may be falsified, counterfeit and contaminated as well as being improperly stored and transported. This poses a significant risk to the health of those who use them. We urge the public to protect their health and to only use prescription medicines under the supervision of a trusted prescriber and to obtain product authorised for the Irish market from a registered pharmacy.

When sourced appropriately and used in line with the product licence, the benefits of these medicines outweigh the risks for patients. However, this benefit-risk balance is positive only for those patients within the approved indications for weight management or type 2 diabetes as described in the product information. GLP-1 products are not authorised for short-term use and, as with all medicines, there are known side effects. Therefore, our clear and repeated advice is that anyone wanting to use these medicines should only do so after consulting with their doctor or healthcare professional.

Using the legal powers available to the HPRA under medicines legislation, we are taking direct action against those illegally supplying and promoting GLP-1 products in Ireland and carrying out related investigations:

• In 2024, up to 30 November, 456 URLs linked to GLP-1 products were removed or amended. This is more than double the 172 URLs removed or amended in 2023.
• This year, the HPRA has detained 1,469 units of GLP-1 products, close to three-times the volume detained in 2023.
• There are several active investigations in progress and one investigation is currently before the courts.

Among the more than 2,000 GLP-1 products detained by the HPRA since 2022 are unauthorised tablets and pens as well as vials containing powder or clear liquid. These presentations are all illegal prescription medicines. There is limited if any information about their sources, manufacturing conditions, or safety. There are no GLP-1 products authorised in Europe supplied in vials regardless of whether they contain powder or liquid. There are also no authorised generic versions of GLP-1 medicines. Any such products promoted online are likely falsified and potentially dangerous to those who take them.

These illegally supplied products have also been found and detained by HPRA enforcement officers in non-healthcare settings. They pose significant health risks as their contents are unknown and are subject to on-going investigations.

The HPRA will continue to commit resources and collaborate with An Garda Síochána and Revenue’s Customs Service, as well as its international partners, to tackle criminal activity and combat illegal health product supply.

ENDS

For further information

Káno Communications: (01) 679 8600

Siobhán Molloy / Sinead Brassil: (086) 817 5066 / (086) 057 9298