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At the 4 May meeting of the HPRA Management Committee, minutes of which have been seen by the Medical Independent (MI) following a Freedom of Information request, there was a discussion regarding the internal risk register. The register is compiled as part of the Authority’s risk management system and is a requirement of the Code of Practice for the Governance of State Bodies.
“As is normal practice in risk management systems, risks are reviewed on a regular basis. This was one of those regular reviews,” a HPRA spokesperson told MI.
Brexit’s impact on fee income was raised at the meeting and this issue was added to the risk register.
“The HPRA is charged to be a self-financing State body under Irish law and like similar regulatory authorities worldwide, it levies a range of charges to the healthcare industry for the range of services, inspections and licence assessments,” the HPRA’s spokesperson told MI.
“With Brexit, there is the potential for changes to our fee income. This may include a reduction in income if medicines are withdrawn from our market as a result of the UK leaving the EU or alternatively, an increase in income if the HPRA takes on additional work which would have otherwise been conducted by the UK’s medicines agencies.
“Given our close existing ties with the UK, including a shared marketplace, Brexit is already recognised as a risk in terms of its potential impact on public health and is included in the risk register. The HPRA is actively planning Brexit contingencies and some additional detail was added as per the discussion.”
Meanwhile, the meeting discussed the implications of a judicial review regarding the labelling and packaging of veterinary medicinal products in Irish. This issue was also added to the risk register.
A survey conducted by the HPRA on the matter last September found that 92 per cent of respondents felt such a requirement would have a negative or significantly negative impact on their company.