HPRA ‘concerned’ about data that show a major increase in amount of illegal medicines

The Health Products Regulatory Authority (HPRA) has expressed its concern at an increase in detentions of illegal medicines during 2020. It made the announcement recently that its enforcement section detained some 1,610,295 dosage units of falsified and other illegal medicines in 2020, an increase of 58 per cent on 2019. The HPRA stressed that the supply of these products into and within Ireland is illegal and stated to the public that consumers can have no guarantees about the safety or quality of prescription medicines they are seeking to buy outside of the regulated pharmacy setting. 

It reminded the public for their own safety to only purchase medicines from authorised Irish sources. The national health products regulator also announced it detained a further 103,000 dosage units of illegal prescription medicines in one week alone as part of its Operation Pangea actions in partnership with Revenue’s Customs Service and An Garda Síochána. Operation Pangea is an annual Interpol-coordinated international week of action targeting the online sale of falsified and illegal medicines via illicit online suppliers and/or e-commerce platforms.

Categories

In the 12 months of 2020, the most significant categories of illegal products included sedatives (36 per cent), erectile dysfunction medicines (30 per cent), analgesics (9 per cent), and anabolic steroids (6 per cent). The 2020 HPRA figures include:

  • Sedative medicines — 583,805 units (344,758 units detained in 2019).
  • Erectile dysfunction — 484,846 units were detained (283,989 in 2019). While the 2020 figure is the highest ever detention in a single year, it includes one detention of over 370,000 tablets.
  • Anabolic steroids — 101,683 units detained (121,581 units detained in 2019).
  • Analgesic medicines — 145,921 units detained (81,672 units detained in 2019).
  • 56,876 units of Covid-19 medicines were detained, the majority of which related to traditional Chinese medicine not approved or authorised for use in Ireland.
  • 482 websites, e-commerce listings and/or social media pages amended or shut down.
  • Three prosecution cases initiated related to the importation or distribution of anabolic steroid products and 11 voluntary formal cautions were issued.

According to Dr Lorraine Nolan, Chief Executive, HPRA, the year-on-year increase in illicit medicines being detected and detained is very concerning. 

“The Internet is a major outlet for legitimate purchases such as food, clothing and electronics, and people may not realise that sourcing prescription medicines online is illegal and that the sources behind these sites can be bogus, or worse, criminal networks,” she said. “The monitoring of websites, online marketplace advertisements and social media sites throughout the year to identity illegal sales of illicit medicines is a key part of our work to protect consumers. 

“We are also seriously concerned that an escalating number of people are not conscious of the potentially significant health risks they are taking by purchasing potent prescription medicines online without medical supervision, rather than under the care of their doctor or pharmacist,” she continued. “While in many cases, those who buy online at best may be simply wasting their money on falsified (including counterfeit) products, at worst, they may be taking very serious health risks.

Falsely labelled

“We know from our investigations and prosecutions that those who seek to profit from illegal medicines have little regard for the health of the end-users of the medicines they are supplying. Our detentions over many years have identified that a significant proportion of these products are falsely labelled and do not contain the type or quantity of active ingredient as stated on the product information. Worryingly, they have also been found to contain harmful substances,” Dr Nolan said.

Under the law, the unauthorised supply of prescription medicines (including via mail order and the Internet) is prohibited. The HPRA’s focus on detaining illegal prescription medicines is part of its ongoing efforts to protect public health and prevent illegal and potentially falsified medicines reaching Irish consumers, said the Authority.
“There is a significant inter-agency approach, nationally, working with our colleagues from the Revenue Customs Service and An Garda Síochána, and internationally with the Interpol co-ordinated Operation Pangea.

I would particularly like to acknowledge the significant support and work of customs officers in 2020 at a time when Brexit would have presented additional challenges and the requirement for additional resources. We continue to work closely with our national and international partners to combat illegal supply through intelligence-sharing and working on joint detention and prevention efforts. We are grateful for their co-operation and assistance where we work together with one objective, to safeguard public health,” Dr Nolan concluded.