Global Operation PANGEA Targeting Falsified Medicines

News Category: Regulatory news

Date: 09/06/2016

Over 60,000 units of illegal prescription medicines worth €350,000 detained in Ireland

Globally 11.1 million units seized worth $53 million

The Health Products Regulatory Authority (HPRA), in partnership with Revenue’s Customs Service, An Garda Síochána and regulatory and law enforcement agencies worldwide, today revealed that they have detained, in Ireland, 60,000 falsified/counterfeit and other illegal medicines worth €350,000 as part of the Interpol coordinated Operation Pangea IX. Actions included reporting of 67 offending websites that illegally supplied prescription only and other unauthorised and illicit medicines via the internet.

Working alongside 193 enforcement agencies across 103 countries, the operation targeted the supply of falsified/counterfeit and other illegal medicines and medical devices, primarily via illicit online sales. The HPRA, Revenue’s Customs Service and An Garda Síochána jointly led the operation in Ireland.

The Irish operation detained 60,000 dosage units comprising tablets, capsules and ampoules which included anabolic steroids, sedatives, painkillers (analgesics), stimulants, illegal injectible tanning products (Melanotan II),  botulinum toxin, weight loss products as well medicines indicated for oncology and erectile dysfunction.  The main countries of origin for these falsified, counterfeit or illegal products detained in Ireland were India, USA, UK, Romania, Switzerland, Singapore and Poland.

The breakdown of medicines detained includes (figures rounded):

  • Anabolic Steroids: 33,000 units
  • Sedatives: 6,500 units
  • Analgesics (painkillers): 1,600 units
  • Erectile Dysfunction: 9,000 units
  • Slimming: Weight loss (Sibutramine) 1,200 units
  • Other: 8,000 units, including -
  • Stimulants:1,300 units
  • Corticosteroids: 1,000 units
  • Antibiotics: 970 units
  • Melanotan II:230 vials
  • Misoprostol & Mifepristone: 78 units
  • Botulinum Toxin: 80 vials

 

Over the course of the operation, 425 individual packages of medicines were detained by Revenue’s Customs Service at its Mail Hubs nationwide. A total of eight search warrants were executed which led to two arrests being carried out.  67 websites, and three advertisements on separate websites in Ireland, were investigated. Five of these have already amended their sites.

Commenting, Lorraine Nolan, Chief Executive, HPRA, said “It’s important for the public to realise that falsified medicines and medical devices pose a very significant risk to their health.  From tests on some products detained in recent years, many of these medicines contain too much or too little or no active ingredient at all – there are simply no guarantees as to what is contained in the products. We urge members of the public not to use unverified and unregulated sources to buy prescription only and illegal medicines, including over the internet”

“No online pharmacy is authorised to supply prescription medicines into Ireland and members of the public are reminded that, under the law, the supply of prescription medicines by mail order (including the internet) is prohibited. They are putting their health at risk”, she continued.

The Interpol coordinated operation resulted in 318 arrests worldwide with some 4,938 illegal websites being closed down through removal of online payment facilities or domain name registry.  Across participating agencies worldwide, packages were inspected by regulators and customs resulting in the detention of 11.1 million illicit and counterfeit medicines. The total value of illicit medicines seized and detained during Operation Pangea IX is estimated at USD$53 million approximately.  The participation of social media, technology companies and the electronic payments industry, as well as the pharmaceutical industry highlighted the importance of collaboration between the health product regulators, law enforcement agencies and the private sector in combating online pharmaceutical crime.

Operation PANGEA has grown extensively since it first took place in 2008 involving, at that time, just eight countries, including Ireland. It is the largest internet based action of its kind and this year’s operation is the largest since its inception. Operation Pangea IX was coordinated by Interpol, together with the World Customs Organisation (WCO), the Permanent Forum on International Pharmaceutical Crime (PFIPC), the European Heads of Medicines Agencies Working Group of Enforcement Officers (WGEO), the Pharmaceutical Security Institute (PSI), Europol, and was supported by the Center for Safe Internet Pharmacies (CSIP) and private sector companies including LegitScript, G2 Webservices, Google, Twitter, Facebook, Mastercard, Visa, American Express, Discovery, Union Pay, Western Union and PayPal. 

ENDS

FOR FURTHER INFORMATION:

Orla Molloy/Siobhan Molloy                   Tel: (01) 679 8600

Weber Shandwick PR                            087 770 5108 /086 817 5066

 

ABOUT THE HEALTH PRODUCTS REGULATORY AUTHORITY:

The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics. Formerly known as the Irish Medicines Board (IMB), it became the Health Products Regulatory Authority on 1 July 2014.

Notes to Editor:

  1. Counterfeit medicinal products are now known as ‘falsified medicinal products’ in accordance with amendments to the EU legislation on medicines for human use ((Directive 2001/83/EC) that came into force in 2013.
  2. 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 supply a person in Ireland. Further, any offer by an online supply outlet of a prescription medicine without the need for a prescription is not a legitimate pharmacy in any EU Member State, or if it so supplies,, it will be acting outside of Irish legislation.
  3. Since June 2015, the sale of non-prescription medicines authorised for supply in Ireland is permitted by Irish legislation. The Pharmaceutical Society of Ireland (PSI) regulates this area.

 



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