Patients waiting over two years for access to EU- approved medicines

Irish approvals process delays mean public patients forced to wait for new therapies already available to private patients

Ireland remains slow in granting patients access to new cutting edge medicines, according to new data compiled by the industry.

The Irish Pharmaceutical Healthcare Association (Ipha), which represents drug developers, said that it took an average of 759 days – or just over two years – to win approval for the 23 medicines developed by its member companies that were made available for the first to public patients last year.

Medicines that required a health technology assessment were further delayed, taking, on average, more than 1,000 days to become available to patients.

The report comes as Ipha holds its annual conference in Dublin on Thursday, with both Minister for Health Stephen Donnelly and Sinn Féin health spokesman David Cullinane due to address delegates.


“Patients deserve to know that they can, through their clinicians, access the best medicines available to treat cancers, obesity, rare diseases and many others,” the industry group said. “Ipha believes timelines can, and must be, improved significantly.”

While the industry says it accepts that a robust clinical and economic evaluation is needed, it said the Irish reimbursement system can have approximately 20 to 30 separate steps, depending on the medicine concerned.

“Reducing the lengthy timelines to reimbursement will improve standards of care and outcomes for patients in Ireland,” Ipha chief executive Oliver O’Connor said.

Ipha said one consequence of the increasingly long approval timelines is that some private patients can avail of cancer treatments under their private health insurance as soon as the therapy secures a European Medicines Agency licence while public patients, typically wait two years after this point before accessing the same medicine.

“The specialist staff operating the [approvals] system have faced much-increased workloads from new medicines developments and applications; they’ve been under-resourced for the challenges,” Mr O’Connor said. “We hope the Minister will follow up on his funding announcements with the approval of much needed staff in the pricing and reimbursement system. These highly specialised experts are as important to the health of the nation as frontline workers.”

Speaking in advance of the conference, Ipha president Michael O’Connell said: “Patients need the system to work better; they deserve fundamental reform of the process. We stand ready to collaborate with all stakeholders to ensure that meaningful reform is achieved.”

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times