Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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975. To ask the Minister for Health his plans to establish the facts behind the increase in registration fees set by the Health Products Regulatory Authority that came into effect as of 1 January 2017; the consultation that took place in advance of these increases; the persons or groups consulted and the date of same; and if he will make a statement on the matter. [35966/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland.

Fees relating to activities and services provided by the Health Products Regulatory Authority are set out on a legislative basis and are subject to annual public consultation. Statutory Instrument No. 602 of 2016 details fees applicable for 2017.

I understand that the ‘increase in registration fees’ referred to in the Deputy’s question relates to the introduction of a new fee model to cover the cost of the HPRA’s regulatory activities for medical devices. This fee model, which is incorporated in S.I. No. 602 of 2016, was subject to a specific public consultation during July and August of 2015 to allow affected stakeholders to provide comments and proposals on the model. All of the details and the outcome of this consultation is publicly available on the HPRA’s website.

The HPRA have been engaging with industry, trade associations and others on the introduction of medical device fees since 2013 and on the basis of responses to the 2015 consultation. During 2016 the fee model was amended and clarified based on the consultation responses and ongoing dialogue with stakeholders who engaged in the process.

The HPRA has committed to review the fee model on an annual basis. Further engagement is possible through a public consultation on this process where all stakeholders are encouraged to engage in the consultation and submit feedback.