Enforcement

Illegal activity involving the manufacture, supply and sale of medicines can potentially have consequences for public health. It is the role of the HPRA to investigate potential breaches of human medicines legislation and, where necessary, we will take the appropriate corrective action, up to and including legal proceeding

Enforcement Cases and Detained Medicines

During 2016, 4,054 enforcement cases were initiated, compared to 3,677 in the previous year. There were a total of 673,906 dosage units detained, down from 1.1 million units in 2015. While the year-on-year decrease in products detained can be partly attributed to the ongoing inter-agency approach, both nationally and internationally, to combating the illegal supply of sedative products onto the Irish market, these products still accounted for 40% of all detentions. Anabolic steroids and erectile dysfunction medicines accounted for 16% and 14% of detentions, respectively.

Inter-Agency Co-operation

The HPRA continues to liaise and work closely with other enforcement agencies both nationally and internationally, in preventing, detecting and combating the unauthorised supply of medicines. The co-ordinated approach by the HPRA with the Revenue’s Customs Service and An Garda Síochána was clearly evident during Operation Pangea IX. This operation, which is co-ordinated globally by INTERPOL, targets the criminal networks behind the sale of falsified and illegal medicines via illicit websites. The inter-agency approach employed nationally during this operation resulted in 60,000 tablets and capsules worth over €350,000 being detained. Of note, anabolic steroids accounted for over 50% of the products detained in Ireland.

The HPRA also actively co-operates with Sport Ireland in combating the use of doping substances and with the Department of Agriculture, Food and the Marine, the Pharmaceutical Society of Ireland (PSI), the FSAI and the HSE to address specific offending behaviours on the market.