Pharmaceuticals

Dublin launches formal talks with pharma industry on new drug pricing framework

The Irish government has initiated formal negotiations with the pharmaceutical industry to establish a new multi-year agreement on the supply and pricing of medicines, aiming to strike a balance between fiscal discipline and enhanced patient access to innovative treatments.

Talks have begun between the Department of Health and the Irish Pharmaceutical Healthcare Association (IPHA), following months of preparatory engagement involving the Department of Public Expenditure, Infrastructure, Public Service Reform and Digitalisation, the Health Service Executive (HSE), and IPHA.

“I am pleased that these formal talks have commenced,” said Minister for Health Jennifer Carroll MacNeill TD. “This longstanding relationship has been an important one, particularly for patients in Ireland, contributing towards a sustainable supply of innovative medicines.”

Branded medicines

The negotiations are intended to replace the current 2021–2025 Framework Agreement, signed in December 2021, which governs pricing and reimbursement mechanisms for branded medicines. A separate agreement with Medicines for Ireland (MFI), representing generic and biosimilar manufacturers, is expected to be renegotiated in the coming weeks.

Between 2021 and 2025, the Irish government allocated €158 million for new medicines, supplementing annual pharmaceutical spending that now exceeds €3 billion. Over the same period, the HSE approved 238 new medicines for Irish patients.

“We remain committed to supporting timely access to new and innovative medicines,” Carroll MacNeill said. “This is underpinned by the continued collaboration between the State and the pharmaceutical industry on our shared objectives of reaching decisions on applications within the context of existing legislation for the benefit of patients.”

Achieving binding timelines

IPHA welcomed the launch of formal negotiations, describing it as a “significant confirmation” that could accelerate access to new therapies. They also underscored the importance of the statutory 180-day timeline for reimbursement decisions, as outlined in the Health Act 2013. “We believe this is the first time a Minister for Health has confirmed a policy to achieve the timelines in the 2013 legislation,” the association said.

Meeting the 180-day target, IPHA added, “requires a shared understanding of the role played by all actors in achieving this and where necessary appropriately targeted interventions, including evidence-based capacity investments.”

Commercial sensitivity

The Department of Health confirmed to Euractiv that negotiations with IPHA had commenced, and that talks with MFI would begin in the coming weeks. “These discussions will support the development of new multiannual agreements that promote the financial sustainability of medicines, enhance patient access to new treatments and access to new medicines for patients,” the Department said. It declined to comment further, citing the commercial nature of the talks.

Colm Burke TD, a member of the Oireachtas, welcomed the negotiations. He told Euractiv he has made representations to the Minister on this matter and has also engaged with the pharmaceutical industry.

Burke noted the historical significance of such agreements, which date back to the 1970s. “These agreements… provide stability and certainty in the area of the supply and pricing of medicines. This is particularly important given the global trade environment, where the US has now imposed 15% tariffs on the pharmaceutical industry,” he said.

He added: “While the Government believes that tariffs are ultimately a negative policy tool, the deal struck by the EU also provides a much-needed layer of certainty. I believe that it was important to have this certainty at the onset of negotiations.”

Access and value for money

Burke emphasised the importance of timely access and value for money: “Any agreement should ensure that we commit to a process which will enable new medicines to be assessed for reimbursement by the HSE within the 180-day time frame as set out in legislation under the 2013 Health Act. If the agreement adheres to these principles, then it will be a very positive outcome for all.”

“Budgets 2021 to 2025 provided €158 million for new medicines; this is in addition to annual funding for medicines, which stands at €3 billion,” he said. “While these figures are substantial and it is hugely positive that funding has been increased for new and innovative medicines, we can always do more.”

“Ultimately, these negotiations are about delivering positive outcomes for patients. I am confident that by working together, the Government and the IPHA can achieve this.”

Both the HSE and IPHA declined to comment further on the ongoing discussions.

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