New Medicines Waited Almost 2.5 Years For Reimbursement Decisions, says IPHA

Posted on March, 07 - 2019

New figures show 10 innovative treatments approved by the HSE for use by patients spent 890 days awaiting decisions

The 10 new innovative medicines recently approved by the Health Service Executive for use by patients spent on average almost two-and-a-half years waiting for a reimbursement decision, according to the Irish Pharmaceutical Healthcare Association (IPHA), the body representing the research-based pharmaceutical industry.

The 10 products were approved for reimbursement over the coming months so it will be July before some of them will be available to Irish patients.

The products spent, on average, 890 days waiting for a reimbursement decision - almost two-and-a-half years. The time-to-decision calculation is made from the point at which the products were licensed by the European Medicines Agency.

The lengthy delay contravenes the letter and the spirit of the EU Transparency Directive (add ref) which sets a strict time limit of 180 days for decisions on pricing and reimbursement  to ensure that bureaucracy does not get in the way for patients who are seeking newer and better treatments.

IPHA welcomed the go-ahead for the reimbursement of the 10 medicines - but said the time they spent awaiting a decision was “unacceptably long”.

Oliver O’Connor, Chief Executive of IPHA, said it is vital that industry and policymakers urgently begin a formal dialogue to agree steps that can eliminate the ongoing delays getting medicines reimbursed for patients with serious illness and conditions, something that was promised to us by the Minister in November 2017. 

“No one is arguing that every medicine can - or should - be reimbursed. But it is clear that the approvals system for new medicines doesn’t work and funding is neither predictable nor adequate. It’s up to all of us to build planned innovation into our health services, treating the discovery, development and delivery of new medicines as one integrated loop.

“The industry has set a simple goal: to place Ireland in the top quartile in the EU28 for speed of access to new medicines. This is consistent with the Government’s own ambitions for outcomes as part of the National Cancer Strategy. We urgently want to work with politicians and policymakers to realise that goal. If we do not Irish patients will be left waiting,” said Mr. O'Connor.

IPHA has argued that the process in Ireland is not that different to many other European countries where the State determines the added value of new products through the  Health Technology Assessment (HTA) process  and then companies negotiate the price based on that value assessment.  Prices in Ireland are not that different to those in our peer countries in Europe, so the delay not due to price but rather due to inadequate funding. The HSE only provided €10m in funding for new medicines in 2019 which is roughly 0.4% of the Drugs budget. Most other Western European countries allow for a minimum of 2-3% growth to allow for demographic pressures and to provide for medical innovation.

“Three years ago, we chose to do a deal with the State precisely to set certain controls on the price public payers would be charged for our medicines. That deal has delivered hundreds of millions in savings. But there has been no improvement in speed of access for medicines. If anything, things have worsened. We must get this right. Otherwise, industry and policy leaders will continue to find ourselves in a zero-sum game, endlessly at odds with each other over what constitutes affordable innovation. The losers will be patients,” Mr. O’Connor ended.


Editors’ Note

The table shows the number of products, made by originator companies, that awaited reimbursement and the number of days it took the HSE to reach their decision. The average number of days is 890 days. These numbers are from the most recent HSE Senior Leadership Team meeting on February 12, 2019.


Number of Days Waiting






Number of Products Waiting