Talks have yet to start on a new medicines pricing agreement less than a month before the existing accord expires.
Industry sources say they have little interest in any new agreement unless guarantees can be provided that new medicines will be assessed within the 180-day time frame set down in legislation as far back as the 2013 Health Act.
The current four-year agreement expires on September 30th.
The Government needs to issue a mandate before direct negotiations can take place between industry and the Department of Health. That has not yet happened, although preliminary discussions have been under way in recent months.
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Price and access to medicines have been the core issues in successive agreements. However, there is concern on the industry side that the Government has focused too heavily on the cost benefits.
“For all the promises made over the past two agreements, we have seen little if any improvement in the system for approving new medicines,” one industry sources said.
“Any new agreement really has to be focused on faster access.”
[ Pricing of medicines needs to be reformed, says IPHA presidentOpens in new window ]
For their part, the Government will be looking for further savings as it comes under pressure to find budgetary capacity for new, and quite often expensive, therapies.
Pharmaceutical companies say that it is taking, on average, two years to secure a decision of an application, making Ireland one of the slowest countries in western Europe to approve new medicines for use in patients.
Why is the delivery of vital infrastructure so slow in Ireland?
A survey publish by the Irish Pharmaceutical Health Association – the industry body for drug developers – last year found that it was taking 729 days, or two years on average, to get from application for reimbursement to the medicine being available in Ireland.
The report noted that the Irish reimbursement system could have between 20 to 30 separate steps an application had to work through, depending on the type of medicine.
The Government has doubled the size of the team dealing with medicine reimbursement over the past year but, as yet, industry says that it has not seen any impact on reimbursement times.
The most recent agreement, which was signed in December 2021, but ran from the start of October that year, promised savings of between €700 million and €800 million on State spending on for medicines that had already been approved. Both sides accept that target has been exceeded.
It also increased the rebate available to the Health Service Executive on all sales from 5.5 per cent when the agreement was signed in stages to 9 per cent this year. The State spends around €2.7 billion annually on medication.
Under the 2021 agreement, both sides undertook to begin negotiations on a successor agreement no later than March of this year. However, the Government has yet to sanction the start of those talks.
The new agreement comes against a backdrop of geopolitical uncertainty for the pharmaceuticals sector. The threat of tariffs and strong US pressure to reshore manufacturing capacity has meant big pharmaceutical companies are paying close attention to framework agreements on access and price, with Ireland’s accord one of the first up for review since the new 15 per cent tariff was confirmed.
It also comes amid sustained shortages of certain medications, especially certain types of hormone replacement therapy over recent years.
Other once common medicines are no longer available on the Irish market, having been withdrawn because companies can no longer see sufficient economic case for continuing supply.
