News Category: Regulatory news
Additional 103,000 dosage units for Operation Pangea 2021 alone
The Health Products Regulatory Authority (HPRA) today expressed its concern at an increase in detentions of illegal medicines during 2020. It announced today that its enforcement section detained some 1,610,295 dosage units* of falsified and other illegal medicines in 2020, an increase of 58% on 2019*. The HPRA states that the supply of these products into and within Ireland is illegal and stresses 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 reminds the public for their own safety to only purchase medicines from authorised Irish sources. The national health products regulator also announced today it detained a further 103,000 dosage units of illegal prescription medicines this past 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 ecommerce platforms.
In the 12 months of 2020, the most significant categories of illegal products included sedatives (36%), erectile dysfunction medicines (30%), analgesics (9%) and anabolic steroids (6%). The 2020 HPRA figures include:
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Sedative medicines - 583,805 units (344,758 units detained in 2019)
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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.
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Anabolic steroids - 101,683 units detained (121,581 units detained in 2019)
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Analgesic medicines -145,921 units detained (81,672 units detained in 2019)
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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.
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482 websites, e-commerce listings and/or social media pages amended or shutdown.
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3 prosecution cases initiated related to the importation or distribution of anabolic steroid products and eleven voluntary formal cautions issued.
According to Dr Lorraine Nolan, Chief Executive of the 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. 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. While, in many cases, those who buy online at best may be simply wasting their money on falsified (including counterfeit) product, at worst, they may be taking very serious health risks.
“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 says.
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.
“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 concludes.
To inform members of the public about the dangers associated with buying prescription medicines online, the HPRA has published an advice leaflet on its website.
ENDS
Further Information
Káno Communications
Barry Dunning 083 167 4871
Siobhan Molloy 086 817 5066
Notes to Editor
Dosage units = tablets, capsules, vials, etc
* HPRA Annual Detentions
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2018: 619,213 dosage units
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2019: 1,018,678 dosage units
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2020: 1,610,295 dosage units
Operation Pangea Detentions Ireland 2021
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Sedatives:61,698 units
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Erectile Dysfunction:6,985 units
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Analgesic:4,154 units
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Anabolic Steroids:2,830 units
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The global Operation Pangea XIV resulted in over 9 million dosage units of illegal medicines and medical devices, with an estimated value of $23,414,483 being detained.
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'Falsified medicinal products' (including counterfeits) are defined in amendments to the EU legislation on medicines for human use (Directive 2001/83/EC) that came into force in 2013.
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The Mail Order of prescription medicines, including internet supply, is prohibited in Ireland. No internet pharmacy authorised in another country is permitted to supply prescription medicines to consumers in Ireland. Consequently, any legitimate online pharmacy that may be authorised to act as such in another country may not legally supply a person in Ireland. Furthermore, any online outlet offering to supply a prescription medicine without the need for a prescription is not a legitimate pharmacy in any EU Member State, and if it so supplies, it will be acting in breach of Irish legislation.
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Since June 2015, anyone who wishes to sell non-prescription medicines over the internet in Ireland must register with the Pharmaceutical Society of Ireland and be entered on to the approved Internet Supply List.
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New EU-wide measures were introduced from February 2019 that further protect patients from falsified medicines. A special new barcode is displayed on the majority of prescription medicine packs which, when scanned by the pharmacist at point of dispensing, enable them to check that the individual pack is legitimate. The barcode on the pack links to a central database of barcodes managed by European and national bodies. In Ireland, this is the Irish Medicines Verification Organisation (IMVO) (www.imvo.ie). When the scanned barcode details are validated with the database, the pharmacist is assured that the pack of medicine is authentic. Further information can be obtained from the IMVO.