Mattie McGrath (Tipperary, Independent)
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714. To ask the Minister for Health the amount of counterfeit medication estimated to be in circulation here; and if he will make a statement on the matter. [35864/18]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is responsible for supervision of the authorisation, manufacture, wholesaling and placing on the market of medicines for human use in Ireland. The Authority has not, to date, found any falsified (including counterfeit) medicine within the legitimate supply chain that has reached patient level. It has identified and investigated falsified medicines transacted through a small number of wholesalers and, in each case, the medicines concerned were not subsequently sold into the Irish market.  The HPRA does not have any remit under intellectual property enforcement legislation and does not keep records under the heading ‘counterfeit medications’.

In co-operation with Revenue’s Customs Service and An Garda Síochána, the HPRA detains significant quantities of illegally supplied medicines. An amount of these are known to be falsified. In 2017, the HPRA initiated six prosecutions that included falsified medicines, only one of which involved a wholesaler that was authorised when the activity took place, and the remainder were supplies that took place outside the legitimate supply chain. Since 2015, the HPRA has initiated a total of 15 prosecutions that involved falsified medicines.

The HPRA also works with other regulatory and law enforcement agencies worldwide in relation to the illegal manufacture, importation and distribution of medicines, medical devices, cosmetics and other health products. This includes participation in Operation Pangea, an Interpol-coordinated international operation against illegal supply, including trafficking, of unauthorised prescription medicines and medical devices via online and social media channels.