News Category: Regulatory news
The Health Products Regulatory Authority (HPRA) today stated that the volume of detained illegal medicines in 2021 remained at a near record high, with its enforcement section detaining 1,604,589 million dosage units of falsified and other illegal products in 2021. Announcing its annual detention figures, the HPRA once again stressed the health dangers associated with sourcing prescription medicines online and advised the general public to only seek medicines from authorised sources. The HPRA states that the online supply of prescription products into and within Ireland is illegal and stresses that consumers can have no guarantee of the safety or quality of medicines they are seeking to buy outside of the regulated pharmacy supply chain.
In the 12 months of 2021, the most significant categories of illegal products detained included sedatives (46%), anabolic steroids (13%), analgesics (10%) and erectile dysfunction medicines (6%). The breakdown is:
- Sedative medicines – 741,492 units detained (583,805 units detained in 2020)
- Anabolic steroids – 204,843 units detained (101,683 units detained in 2020)
- Analgesic medicines – 161,670 units detained (145,921 units detained in 2020)
- Erectile dysfunction – 103,816 units were detained (484,846 in 2020 which included one detention of over 370,000 tablets)
- 56,385 units of Covid-19 medicines were detained, including 28,302 units of Ivermectin
- 461 websites, e-commerce listings and/or social media pages amended or shutdown
- 5 prosecution cases initiated, and seven voluntary formal cautions issued
According to Grainne Power, Director of Compliance with the HPRA, the high number of illicit medicines detected in 2021 is very concerning and when combined with the 2020 figures means that over 3.2 million units were detained over a two-year period.
“It’s so important that members of the public are aware of the health risks associated with buying prescription only products from unverified and unregulated sources. When you obtain your medicines through recognised and regulated sources you will know you are getting products that can be both relied upon to contain the right ingredients and that are tailored to your specific needs under the supervision of a doctor or pharmacist. So, it isn’t just about people wasting their money on falsified or counterfeit product, it is potentially far more serious than that. As well as the risk of significant side effects or medicine interactions, for some there is also the very real risk their condition may go untreated or it could be made worse. The HPRA has over many years identified that a significant proportion of detained products are falsely labelled, do not contain accurate information on the strength of active ingredient they contain, or have been found to contain a different ingredient altogether. When you consider also that these products are often delivered without a leaflet, instructions for use or information on the correct dose, the illegal supply of unregulated and potentially fake medicines clearly presents a significant risk to public health,” says Ms Power.
“Every single one of the tablets, capsules and vials intercepted during 2021 was important. Our detentions disrupt the illicit market and we continue with our ongoing work in this area to disrupt the flow of counterfeit and falsified medicines into Ireland. We know that those who seek to profit from illegal medicines have little regard for the health of the end users they are supplying. Our goal, with a focus on impacting both supply and demand, is to protect the public from the risks associated with products for which there are no guarantees as to what they contain or under what conditions they have been manufactured,” concludes Ms Power.
The HPRA works in close co-operation with colleagues from An Garda Síochána and Revenue’s Customs Service with whom there is significant inter-agency collaboration to combat the illegal supply of health products into and within Ireland. It also co-operates and shares intelligence with other regulatory and law enforcement agencies worldwide to prevent the illegal manufacture, importation and distribution of medicines, medical devices, and cosmetics.
The HPRA is responsible for prosecuting cases where it considers that there is a significant risk to public health or where there are persistent non-compliances. Five prosecution cases were initiated in 2021. Three prosecutions related to the unauthorised supply of anabolic steroids, one related to the unauthorised supply of sildenafil citrate and one related to the unauthorised supply of medicinal products from a market stall. The HPRA also supports prosecutions brought by the Director of Public Prosecutions in relation to the illegal supply of medicines.
- To inform members of the public about the dangers associated with buying prescription medicines online, the HPRA has published an advice leaflet which is available freely on its website.
- For more information on the HPRA’s specific campaign to highlight the specific dangers of anabolic steroid use please visit www.zerogains.ie.
- The public can report suspicious activities around the supply of medicines and other health products to the HPRA, in confidence, at reportacase@hpra.ie or at 01 6343436.
For Further Information:
Káno Communications Tel: (01) 679 8600
Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438
*HPRA Annual Detentions
- 2018: 619,213 dosage units
- 2019: 1,018,678 dosage units
- 2020: 1,610,295 dosage units
- 2021: 1,604,589 dosage units
Dosage units = individual tablets, capsules, vials, etc.