State slower to ‘adopt new drugs’ than most of western Europe

Medicines regularly not worth approving at asking price

Ireland continues to trail most of western Europe in sanctioning use of new medicines for patients, according to an industry survey.

The study examined how quickly countries across Europe agreed access to 152 new drugs that came to market between 2016 and 2019. Access generally means that agreement has been reached on reimbursement for the medicine.

The study shows that only 54 of the 152 drugs were approved at all in Ireland – the lowest among all western European countries. And, for those drugs approved, the process took, on average, 477 days.

The pharmaceuticals sector states that Ireland, like other EU states, is supposed to aim to deliver a decision on drug access within 180 days.


The report notes that some drug approvals in the period took as long as 1,600 days – close to 4½ years – though others were done in just a couple of months.

The figures were collated by data analytics group Iqvia for the European Federation of Pharmaceutical Industries and Associations. It is a Brussels-based lobby group representing the research-based pharma industry, including the Irish Pharmaceutical Healthcare Association (IPHA).

The data come as the Government and industry prepare to hammer out an agreement on the pricing and supply of drugs over the next few years. The new agreement has already been deferred a number of times because of Covid-19 but is supposed now to be tied down over the summer.

The issue with drug approval in Ireland remains cost. Assessments of new drugs regularly determine that they are not worth using at the price being sought by pharma companies. What generally follows is an extended period of negotiation over price in the context of the annual HSE medicines budget.

The survey says Ireland ranked 18th out of 34 countries across Europe – including eastern European states where the drug approval process appears to be even more protracted. Only France and Portugal among western European states are slower in approving medicines, according to the report.

Cancer medicines

On cancer medicines Ireland fares worse, according to the study, ranking just 21st with an average 606 days to approval. And it ranks 24th, with a lag of more than two years, in terms of approval for drugs for orphan diseases – rare diseases or ones for which no effective treatment is available.

The industry hopes that a supply agreement and an associated announcement on budgetary funding for new therapies can address the issue.

IPHA chief executive Oliver O’Connor said the Government deserved credit for providing an extra €50 million in last year’s budget for new medicines, releasing a backlog that followed what he said was a funding freeze imposed in 2019.

“But data shows Ireland still has a major problem with speed of access to new medicines, compared with peer countries in western Europe,” he said. “It is not because all these countries’ assessment processes are somehow less stringent than ours. Our processes are not organised to deliver fast access for patients.

“A funding shortfall in previous years has meant medicines were left unfunded, even when they were deemed cost-effective after price negotiations. We need to fix these problems, together, through a new supply agreement and in Budget 2022.”

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times