Mr. Jim Breslin:

I can give the Deputy a summary of the terms of reference, if it is useful. It does not involve a review of the Act; we would not give that to Mazars to do as it is a policy piece. However, it does touch on more than the Act. The terms of reference include examination of the governance arrangements, including systems, structures and processes; and the resources that support the decision-making process for pricing reimbursement applications such as the use of expert advice in the assessment process, including clinical, pharmacoeconomic, commercial, financial, procurement and legal expertise. The review will examine the approach to securing the best value in terms to the HSE through commercial negotiations and procurement policies and procedures. It will examine procedures for detailing agreements in written contracts. Finally, it will examine arrangements and supports for the HSE directorate in making reimbursement decisions in line with the 2013 Act. It is about the resources that are brought to bear on the problem, the expertise and skills that are brought to bear on it, how knowledge is brought into the dialogue between firms and the HSE, how cost effectiveness is assessed, how pricing is arrived at and, ultimately, the function of the HSE leadership to sign off on those decisions.