Pharma firms call to speed up process for approving new medicines
The pharmacy body called on political parties to commit to funding the HSE to meet six-month target times as set out under legislation. File photo
The next Government needs to change how medicines are approved in Ireland with patients facing delays of up to two years compared to other EU countries, the Irish Pharmaceutical Healthcare Association (IPHA) has said.
It called on political parties to commit to funding the HSE to meet six-month target times as set out under legislation, warning the very first step in the process can take longer than six months now.
Once a company has submitted a new drug for approval, the HSE National Centre for Pharmacoeonomics (NCPE) typically sends back preliminary review questions as the first step. Analysis by the IPHA shows the average number of days for this stage is now 192 days.
For cancer drugs only, it found it is taking on average 232 days or over seven-and-a-half months just for this stage. It identified five cancer medications where the wait for those questions has come to over seven months already.
One company submitted a new treatment for reducing the risk of heart disease in adults taking statin medication in November last year. It received its first questions in September after 322 days.
Another new treatment for kidney transplant patients was submitted in April. The first questions came back in September after 147 days.
New cancer drugs also face delays, including one for adults with a type of lymphoma. This was submitted in September last year with the first questions coming in March after 177 days.
One cancer drug for adults who cannot have chemotherapy was submitted in January but by November 20 the company had not yet received these questions, coming to 279 days.
The IPHA warned delays can come to as much as two years across the various parts of the process. This is despite limits set in place under the Health Act 2013 to ensure timely processing.
“Other EU countries comply with this law but the 180-day timeline is simply not being met in Ireland,” the IPHA said. “The HSE is not being resourced to meet it. The process is not designed to achieve it. There are no performance indicators. There is no visibility or reporting on it.”
It said analysis shows it took on average six months for the NCPE to even respond to applications from companies so far this year.
IPHA Chief Executive, Oliver O’Connor said:
“We believe this will spur on both industry and State authorities to fulfil their roles efficiently and responsibly in the best interest of advancing patient care.”
In July, Health Minister Stephen Donnelly defended the process based on a review report.
“(The Mazars report) found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms,” he said.
