My Department has completed a tender process for a review of the HSE reimbursement and pricing decision-making process and is currently appointing a consultancy firm to complete this review.
The terms of reference, which form the basis for the conduct of the review, are as follows. The review is expected to be completed within three months of commencement.
Although not included in the terms of reference, consideration will be given to consultation with relevant stakeholders.
Terms of Reference
Having regard to the introduction of the Health (Pricing and Supply of Medical Goods) Act 2013 and the 2016 Framework Agreement on the Supply and Pricing of Medicines, the Department of Health considers it opportune to commission a review of the governance arrangement, and resources in place in the HSE supporting decisions on applications from drug companies for a medicine to be reimbursed pursuant to the community drug schemes or as a hospital medicine.
In particular, the review will examine governance arrangements (including the systems, structures, processes) and the resources which support the decision-making process for the consideration of an application including:
- the use of expert advice throughout the assessment process (including clinical, pharmacoeconomic, commercial, financial, procurement and legal expertise);
- the approach to securing the best value and terms to the HSE through commercial negotiations and procurement policies and procedure;
- the procedures for detailing agreements by means of written contracts;
- the arrangements and supports in place to facilitate the HSE Directorate in making reimbursement decisions in line with the criteria set out in Schedule 3, Part 3 of the 2013 Act.
This review should have regard to the policy, legal and institutional framework within which the HSE operates, in particular the requirements set out in the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Act 2004 and the processes described in Schedule 1 of the 2016 Framework Agreement.
The review will make recommendations as considered appropriate in respect of any required improvements to the HSE’s systems, structures, processes, governance arrangements or use of specialist resources in respect of the review.
In making its recommendations, the review will have regard to best practice regarding the procurement of medicines, the conduct of high-value commercial negotiations, governance, organisational structures, skill-mix and oversight.
The review will complete its work and report to the Department of Health within three months.
