Urgent: Medicine Pricing Talks Stalled as Deadline Approaches

UPDATE: Time is running out for a new medicines pricing agreement as talks have yet to commence, just weeks before the current deal expires on September 30, 2023. Industry insiders reveal a lack of interest in renewing the accord without guarantees that new medicines will be assessed within the 180-day timeframe mandated by the 2013 Health Act.

The current four-year agreement is set to end soon, and the Government has not yet issued a mandate needed for direct negotiations between the pharmaceutical industry and the Department of Health. Preliminary discussions have been happening, but they have not yielded significant progress. According to a source from the industry, “For all the promises made over the past two agreements, we have seen little if any improvement in the system for approving new medicines. Any new agreement really has to be focused on faster access.”

As pressures mount on the Government to find budgetary capacity for new therapies, it is clear that price and access to medicines remain the core issues. Pharmaceutical companies report that it is currently taking an average of 729 days—about two years—to secure a reimbursement decision, making Ireland one of the slowest countries in Western Europe for new medicine approvals.

The Irish Pharmaceutical Health Association, the industry body for drug developers, highlighted last year that the reimbursement process can involve up to 30 separate steps, depending on the type of medicine. Although the Government has doubled the size of the reimbursement team over the past year, industry representatives claim that no tangible improvements have been observed in the reimbursement timelines.

The last pricing agreement, signed in December 2021, promised savings of between €700 million and €800 million on already approved medications. Both parties acknowledge that the savings target has been exceeded. The deal also increased the rebate available to the Health Service Executive on all sales from 5.5% to 9% this year.

The urgency for a new agreement comes amid geopolitical uncertainty affecting the pharmaceutical sector. The imposition of a new 15% tariff and increased pressure from the U.S. to reshore manufacturing have put Ireland’s pricing accord under scrutiny. This is one of the first agreements up for review, posing significant implications for access and pricing structures.

Moreover, Irish patients are facing sustained shortages of essential medications, particularly certain hormone replacement therapies. Many once-common medicines have disappeared from the market due to companies withdrawing them, citing insufficient economic incentives to continue supply.

As the deadline looms and negotiations remain stalled, the urgency for a resolution grows. Stakeholders are anxiously awaiting the Government’s next steps. Will they prioritize faster access to new medicines, or will cost savings take precedence? The health and well-being of countless patients in Ireland may hinge on the outcome of these discussions.

Stay tuned for more updates as this critical situation develops.