More than a third of all new drug approvals take longer than two years to complete

More than one-third of all new drug approvals take more than two years to complete, according to a report published by the Department of Health.

The Health Service Executive completes just 36 per cent of all applications for drug reimbursement within a year, despite a legal requirement allowing 180 days for the process, unless additional information is required from an applicant.

The timelines for approving new medicines are “not in line” with the spirit of the 2013 Act that gives the HSE the power to reimburse certain drug, according to the report by consultants Mazars into the governance of the process.

Greater transparency and better communications with patients is needed in the drug approval process, the report recommends.

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On foot of specific recommendations in the report, Minister for Health Stephen Donnelly has asked the HSE to introduce an application tracker on its 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 and approval process. A working group will report on this within six months.

The report was commissioned on foot of concerns around possible delays and a lack of transparency in the process for approving new treatments. Patient groups, especially those for rare diseases, say Irish patients struggle to gain early access to innovative new treatments, compared to other countries.

The report has been gathering dust since it was submitted to the Department in 2020, and the Department refused to release it under a freedom of information application from The Irish Times last year.

Lack of transparency

The Department explained on Friday it was not “progressed” in 2020 as resources were diverted to responding to the Covid-19 pandemic.

Aside from specific areas where improvements are recommended, the report says the HSE process is operating in line with the legislation and delivering results in keeping with international norms.

Mr Donnelly said he has asked the HSE to bring forward proposals to improve overall transparency in the process. “Greater engagement with stakeholders, including patient groups, will ensure that patients are aware of the process and have sight of various steps and timelines”.

“I want to ensure we have a process that provides timely access to new medicines and maximum value for money for all taxpayers,” said Mr Donnelly, who pointed out that the Government has provided €100 million in the last three budgets for over 130 new medicines to be reimbursed.

According to the report, there is a lack of transparency regarding the number of reimbursement applications being received and how these applications progress through the process. The process is not adequately documented or communicated to the public.

Welcoming publication of the report, the Irish Pharmaceutical Healthcare Association said it would engage with the working group by making the case for increased staffing and resources in the HSE and to explore ways for early reimbursement for treatments for certain conditions.