O'Sullivan welcomes "long overdue" publication of Mazars report on HSE's drugs reimbursement process

Published on: 24 February 2023

Fianna Fáil TD Pádraig O’Sullivan has welcomed the “long overdue” publication of an independent review into the HSE’s drug reimbursement process.  
The Cork North-Central TD has repeatedly called for a new structure for Irish health authorities to assess, approve and reimburse what are known as orphan drugs for rare diseases.  
Health Minister Stephen Donnelly published the Mazars Report on drugs reimbursement and pricing decision-making on Friday.    
Mazars was tasked in 2019 with conducting a review of the governance structures around the HSE’s drug reimbursement process.  
The report makes a number of recommendations around the HSE’s systems, structures, process surround the drug reimbursement process.  
It recommends more patient involvement, the establishment of a patient liaison team, and for patient submissions to go to the Corporate Pharmaceutical Unit (CPU) not the National Centre for Pharmacoeconomics (NCPE).  
Deputy O’Sullivan said: “I very much welcome the publication of this Mazars Report. It is long overdue.  
“The reimbursement process needs reform to avoid pricing disputes and ensure people can access drugs used to treat rare diseases.
“The current process is not fit for purpose as the Irish system does not distinguish between orphan drugs and other drugs when assessing their pharmacoeconomic value, resulting in lengthy delays for their approval.
“I am heartened that the report recommends more patient involvement. Patients suffering from rare diseases need to have their voices heard.
“It is also very timely given it is being published in advance of National Rare Disease Day on February 28.  
Deputy O’Sullivan’s Private Member’s Bill (PMB), the Orphan Drugs and the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021, making its way through the Oireachtas at present.  
This will establish a new process for assessing orphan drugs, allowing them to be streamlined and to be assessed on their individual merit and not on the same criteria as drugs not on the same criteria as drugs for more common conditions.
“I will continue to pursue my Private Member’s Bill (PMB) on the matter which should go to third stage in the Oireachtas shortly, as well as work with the Oireachtas cross-party group on rare diseases," he added.
The aim of the group, which was established with his Fianna Fáil colleague John Lahart, is to highlight the issues and blockages patients in Ireland face trying to access orphan drugs.