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‘Delays in approval’ preventing prescription of life-saving cancer drugs

Doctors cannot prescribe appropriate treatments to one-in-four cancer patients due to delays in a...
Ellen Kenny
Ellen Kenny

09.01 21 Aug 2023


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‘Delays in approval’ preventin...

‘Delays in approval’ preventing prescription of life-saving cancer drugs

Ellen Kenny
Ellen Kenny

09.01 21 Aug 2023


Share this article


Doctors cannot prescribe appropriate treatments to one-in-four cancer patients due to delays in approving new cancer drugs.

That’s according to oncologist Dr Michael McCarthy following reports there is an “ongoing frustration” among doctors and cancer patients alike. 

At a presentation this weekend, doctors warned they cannot prescribe drugs to 25% of cancer patients due to flaws in the system for approving new medicines from Europe in Ireland.

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“I cannot just prescribe the medications,” he told Newstalk Breakfast. “They have to be approved for reimbursement by the HSE.” 

Pharmaceutical companies must get approval from the European Medicines Agency (EMA) before seeking reimbursement from the HSE. 

The unavailable drugs are high-cost treatments used when chemotherapy is unavailable.  

They typically cost €50,000 to €100,000 per patient per year, according to Dr McCarthy. 

Currently the HSE is dependent on the EMA licence holder or the pharma company to apply to the HSE for reimbursement for each cancer patient,” he explained. 

While some companies work closely with the HSE, it might be six, 12, 18 months after the EMA licence is issued that the pharma company will approach the HSE to ask it provides reimbursement.” 

'Greater transparency'

Dr McCarthy said the “pace of change and innovation” in Ireland needs to be changed to treat these vulnerable patients. 

“It takes on average two years from EMA approval to availability for cancer patients in Ireland compared to approximately one year in comparable countries,” he said. 

“[We need] greater transparency with indicative timelines so patients and applicants can know exactly where a drug is in the reimbursement process. 

“Also, improved resources of key organisations such as national cancer control programme and National Centre for Pharmacoeconomics which deliver the reimbursement process. 

“It is very frustrating and it’s an ongoing frustration for not only oncologists, but cancer patients too.” 


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