Denise Mitchell (Dublin Bay North, Sinn Fein)
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823. To ask the Minister for Health the enforcement cost for the Health Products Regulatory Authority since 2014 and to date in 2017; the number of premises that have been visited under its enforcement powers; the average cost per enforcement action at premises; the number of enforcement powers; the average cost per enforcement action at premises; the number of enforcement actions that have been undertaken since 2014; and the number of enforcement actions at which gardaí were present at premises, in tabular form. [19334/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) has confirmed the direct costs of the Agency's enforcement unit as follows:

2014€911,970

2015€989,093

2016€961,369

2017€204,458 (January to March 2017).

All HPRA visits to premises are conducted under the provisions of the Irish Medicines Board Acts 1995 and 2006 and under regulations relating to health products. The HPRA does not record enforcement activity by premises visited, as enforcement activity can be office based (e.g. online investigations) or a single case may involve multiple visits to premises. Enforcement activity is recorded by enforcement cases opened and product detained.

The HPRA does not record the cost of specific enforcement activities. It prioritises enforcement cases on the basis of the perceived risk to public health; application of an average cost would not be representative as visits vary considerably according to the issue being investigated, the time spent on the premises, the number of personnel involved and the depth of investigation required at the particular time.

Section 32 (b) of the Irish Medicines Board Acts 1995 and 2006 provides powers for the enforcement officers at HPRA. These powers are extended in regulations relating to medical devices and other health products, including regulations on the quality and safety of human blood and blood components; the quality and safety of human tissues and cells; the quality and safety of human organs intended for transplantation; clinical trials on medicinal products for human use; cosmetic products; and the protection of animals used for scientific purposes.

The powers of "authorised officers" (as provided under the Irish Medicines Board Acts 1995 and 2006), include but are not limited to entering any premises at which an officer has reasonable grounds for believing that any trade, business or activity connected with the manufacture, processing, disposal, export, import, distribution, sale, supply, storage, packaging or labelling of any relevant thing is or has been carried out; powers to inspect, copy or remove records; and powers to take samples or remove any relevant thing found at the premises for the purposes of any test, examination or analysis. However, it should be noted that authorised officers of the HPRA do not have powers to arrest or detain people.

HPRA enforcement activity is recorded by enforcement cases. The total number of cases recorded since January 2014 is as follows:

2014 - 3,703

2015 - 3,677

2016 - 4,054

2017 - 841 (January to March)

Total: 12,275.

The HPRA does not record statistics on the number of attendances by An Garda Síochána at premises being visited by the HPRA; the agency cooperates with An Garda Síochána on an ongoing basis. In general, where the HPRA visits a premises where it is anticipated that there could be a public order issue, a Garda presence may be requested. In addition, HPRA staff assist with Garda investigations, at the request of the Gardaí, when An Garda Síochána believes that HPRA knowledge and experience may be beneficial.