The role of the Health Products Regulatory Authority (HPRA) is to protect and enhance public and animal health by regulating medicines, medical devices and other health products.

Following commencement of the Misuse of Drugs (Amendment) Act 2016 on 4 May 2017, changes were made to the requirements for controlled drug import and export licences. All necessary adjustments to HPRA procedures and forms were subsequently implemented. Prior to the commencement of the new legislation, we communicated with relevant stakeholders to remind them that a number of substances that were not previously controlled would now fall under the scope of the Misuse of Drugs framework. We published the relevant details in the HPRA’s Medicinal Products Newsletter in January and this was followed by the dissemination of an e-mail update in April. Companies were advised to review products handled to ascertain any impact of the proposed changes and to update procedures and authorisations where necessary.

P.18 Under our enforcement programme:
– The HPRA detained 948,915 dosage units (including tablets, capsules and vials) of falsified and other illegal medicines last year compared to 673,906 units in 2016 – an increase of more than 40%. The products detained, through both ongoing surveillance and targeted intelligence based operations, included anabolic steroids (47%), sedatives (23%) and erectile dysfunction medicines (13%). There was a significant rise in the number of anabolic steroids detained rising from 109,006 in 2016 to 449,411 dosage units in 2017. The HPRA also took possession of 336,200 dosage units of expired medicines in order to arrange for their destruction in accordance with national waste legislation. Separately, a total of 3,866 enforcement cases were initiated, compared to 4,054 in the previous year.
– In one operation of particular significance, over 60,000 vials labelled as containing anabolic steroids were detained as part of a joint operation carried out with An Garda Síochána and Revenue’s Customs Service at a number of locations in County Donegal. Other medicines, including human growth hormone and products indicated for erectile dysfunction, were also found. The total value of illegal medicines detained was estimated to be in excess of €2 million.
– We initiated six prosecution cases and issued six voluntary formal cautions. Prosecutions are taken where the HPRA considers that there is a significant risk to public health. The 2017 prosecutions related to the unauthorised supply of prescription medicines, including anabolic steroids and erectile dysfunction products. The HPRA also supports prosecutions brought by the Director of Public Prosecutions in relation to the illegal supply of medicines.
– The HPRA, in partnership with Revenue’s Customs Service and An Garda Síochána, detained over 200,000 units of illegal prescription medicines in Ireland, valued at over €850,000, as part of the Interpol-coordinated Operation Pangea X. The products detained included significant volumes of anabolic steroids, sedatives and erectile dysfunction medicines. Nationally, the week-long operation also resulted in two arrests, the investigation of 38 websites and eight social media pages being taken offline. Operation Pangea X was an international week of action across 123 countries to tackle the online sale of counterfeit and illicit medicines and highlight the dangers of buying medicines online.