Varadkar welcomes success of global operation against falsified medicines

Operation Pangea Illegal medicines Minister Varadkar HPRA-9
Over 142,000 units of illegal prescription medicines worth €430,000 detained in Ireland

The Health Products Regulatory Authority (HPRA), with Revenue’s Customs Service and An Garda Síochána joined Health Minister Leo Varadkar to confirm that they have detained over 142,000 tablets and capsules worth over €430,000 in Ireland as part of Operation Pangea VIII.    This Operation is an international week of action (9 -16 June) targeting the online sale of falsified (counterfeit and illegal) medicines where the HPRA, Revenue’s Customs Service and An Garda Síochána, along with 236 enforcement agencies across 115 countries, target criminal networks behind the sale of counterfeit and illegal medicines via illicit online sales.
Locally, the concerted interagency operation with Revenue’s Customs Service, Gardaí and the HPRA detained 142,000 units comprising tablets, capsules and liquids which included sedatives, painkillers (analgesics), weight loss products as well as anabolic steroids and medicines indicated for erectile dysfunction.  The main countries of origin for these falsified, counterfeit or illegal products detained in Ireland were Singapore, USA, India and the UK.

Operation Pangea Illegal medicines Minister Varadkar HPRA-6

The breakdown of medicines detained includes:

•    Sedatives: 104,000 units
•    Erectile Dysfunction: 8,000 units
•    Anabolic Steroids: 12,000 units
•    Slimming: Weight loss (Sibutramine) 2,000 units
•    Other 16,000 units

Over the course of the operation, 496 individual packages of medicines were detained by Revenue’s Customs Service at its Mail Hubs nationwide. A total of four search warrants were executed which led to two arrests being carried out. Eight websites, including five that were Irish based, and one advertisement on a separate website were investigated. Four of these have either amended their sites or are no longer active. While one site was compliant the supplier is still under investigation. The other four websites are based outside of Ireland and are also still under active investigation. These sites supplied anabolic steroids, erectile dysfunction and weight loss prescription medicines.

Minister Varadkar said: “50% of the medicine sold by unregulated online retailers is estimated to be unreliable and potentially harmful.  Consumers are taking a significant risk with their health.  Often the medicine doesn’t contain the active ingredient or has the wrong dose. Sometimes the substances used to bulk up the medicines are harmful. People also need to be cautious about buying herbal and alternative medicine products online, many of which may include strong pharmaceutical substances. The criminal networks behind many of the illicit websites are passing themselves off as legitimate pharmacies. I hope that when the public see the photographs of these seized products, they will pause and think about what they are buying online and who they are buying from.  From June 24th next week, a new EU logo for legitimate websites selling medicines will come into effect across Europe.  Consumers should make sure they know what they are buying. In the meantime, I commend everyone involved in operation PANGEA for their excellent work.”

Operation Pangea Illegal medicines Minister Varadkar HPRA-7

Commenting, Pat O’Mahony, Chief Executive, HPRA, said “This is an important public health message from the regulator for health products: counterfeit and illegal medicines pose a serious health risk. Members of the public are urged not to use the internet to source prescription medicines. Bogus websites can be very sophisticated and appear to be legitimate. However, in reality they can be supplying unsafe and harmful products. Laboratory analysis of products detained has shown that medicines being sold through illicit websites will often contain too little or too much of the active ingredient or may contain undeclared and harmful substances. So not only are people wasting their money but more importantly they are putting their health at risk.”

“No online pharmacy is authorised to supply prescription medicines into Ireland and members of the public are urged not to place their health at risk by purchasing such products from online sources”, he concluded.

Operation Pangea Illegal medicines Minister Varadkar HPRA-3

Speaking about Operation Pangea, Marie-Claire Maney, Head of Revenue’s Investigations & Prosecutions Division said: “Today’s results demonstrate the importance of national and international cooperation between enforcement agencies in combating this illegal trade and stopping dangerous medicines from reaching unsuspecting customers. Members of the public need to be aware of the risks associated with buying illegal medicines online.”
Detective Chief Superintendent Michael O’Sullivan, Drugs and Organised Crime Bureau in relation to Operation Pangea, “An Garda Síochána is committed to working together with Customs and the Health Products Regulatory Authority in combating pharmaceutical crime in this country. The Drugs and Organised Crime Bureau will maintain a focus on tackling organised crime groups involved in the importation, sale and distribution of counterfeit and illicit medicines. The success of this operation is reflective of the positive cooperation of various enforcement agencies to reduce the harm caused by illicit pharmaceutical drugs in our society.”
Under Irish law, the sale of prescription only medicines by mail order is prohibited.  This includes internet supplies of prescription only medicines.  State agencies, including the HPRA, Revenue’s Customs Service and An Garda Síochána, continually monitor and investigate instances of illegal supply of medicines via the internet and actively enforce suspected breaches of the law.

The INTERPOL coordinated initiative from 09-16 June resulted in 156 arrests worldwide with some 2,414 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 20,709,037 illicit and counterfeit medicines. The total value of illicit medicines seized and detained during Operation Pangea VIII is valued at USD$81,060,037 approximately.  The participation of Google, one of the world’s largest Internet companies, highlighted the importance of collaboration between law enforcement and the private sector in combating online pharmaceutical crime.

Operation Pangea Illegal medicines Minister Varadkar HPRA-5
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 is the largest such operation since its inception. Operation Pangea VIII was coordinated by INTERPOL, together with the World Customs Organization (WCO), the Permanent Forum of International Pharmaceutical Crime (PFIPC), the European Heads of Medicines Agencies Working Group of Enforcement Officers (WGEO), the Pharmaceutical Security Institute (PSI), Europol, and supported by the Center for Safe Internet Pharmacies (CSIP) and private sector companies including LegitScript, Google, Mastercard, Visa, American Express and PayPal.

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.
Counterfeit medicinal products are now known as falsified medicinal products in accordance with the EU legislation (known as the Falsified Medicines Directive – Directive 2011/62/EU) that came into force in Ireland in 2013.
The Mail Order of prescription-only medicines, including internet supply, is prohibited in Ireland. No internet pharmacy authorised in another country is permitted to supply prescription only 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 is, it will be acting outside of Irish legislation.