Review of governance arrangements to support HSE drug reimbursement process


The Minister for Health has published a Report prepared by Mazars which examines the governance arrangements around the HSE’s drug reimbursement process.

The Report found that the HSE process was operating in line with the legislation and that it was delivering results in keeping with international norms.

The Report concluded that there was scope for improvements in a number of areas, including:

  • Transparency of the process
  • Communications with, and the availability of, information to patients
  • Tracking the progression of medicines through the process

The Minister for Health said he fully supported any recommendations contained in the Report that improved the process, provided easier access, and supported value for money.

Minister Donnelly said: 

“I want to see improvements in the overall transparency of the process, and I have asked the HSE to bring forward proposals in that regard as a matter of urgency. Greater engagement with stakeholders, including patient groups, will ensure that patients are aware of the process and have sight of various steps and timelines”.

In that respect the Minister has asked the HSE to introduce an application tracker on the HSE’s website, detailing how applications progress through the process. He has also asked the HSE to introduce indicative timelines for a medicine to complete the application/approval process. That work is now progressing. 

The Minister continued: 

“This Government has provided substantial funds for new medicines, €100 million in the last three Budgets, which to-date has enabled over 130 new medicines to be added to the reimbursement list for patients. Our mission is Universal Healthcare and one of the pillars of that is timely access and I want to ensure we have a process that provides timely access to new medicines and maximum value for money for all taxpayers.”

An Implementation Plan is being published and an Implementation Working Group is being established between the Department of Health and the HSE. This Group will consider and progress the various recommendations contained in the Report as well as other options to improve the process.

The Working Group will 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 existing processes described in Framework Agreements with industry on the supply and pricing of medicines. The Group will engage with all stakeholders, including patient groups and industry, in seeking to bring about further improvements to the reimbursement process. The Working Group is due to report to the Minister in six months.