Michael McGrath (Cork South Central, Fianna Fail)
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188. To ask the Minister for Health if the governance review of the drugs approval process as set out under Sláintecare work stream 2 has commenced; if so, the date on which it commenced; if not, the date on which it will commence; and if he will make a statement on the matter. [40528/19]

Michael McGrath (Cork South Central, Fianna Fail)
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189. To ask the Minister for Health if there is a process for relevant stakeholders to feed into the drugs approval process review; if so, the nature of the process; and if he will make a statement on the matter. [40529/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 188 and 189 together.

Work on the review of the HSE reimbursement and pricing decision-making process is ongoing. The review, conducted by Mazars, is progressing and on completion my officials will consider its findings.

The agreement which was signed with Mazars, sets out the relevant stakeholders to be consulted, including patient representatives.

The review will make recommendations in respect of any required improvements to the HSE’s systems, structures, processes, governance arrangements or use of specialist resources.