Ireland’s new generics and biosimilars framework agreement

Home/Policies & Legislation | Posted 04/03/2022 post-comment0 Post your comment

In December 2021, Medicines for Ireland (MFI) signed a new framework agreement on the supply and pricing of non-originator, generic, biosimilar and hybrid medicines to be implemented between 2021‒2025.

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The agreement between MFI and the Department of Health, the Department of Public Expenditure and Reform, and with the Health Service Executive (HSE), hopes to deliver improved access to new and innovative medicines, reductions in the cost of existing medicines, increased security of supply, and an overall easing of financial pressure on the health services across Ireland into the future.

The new framework agreement outlines aspects of general pricing related to reimbursement schemes, the proposed pricing of new medicines, and pricing procedures for generic, biosimilar and hybrid medicines which include setting maximum prices. It also outlines aspects of the supply to HSE and related agencies and ensuring continuity of supply.

It is estimated that the agreement will reduce Irish state spending on medicines by up to €700 million, while dramatically improving access to innovative new medicines for patients nationwide.

A parallel agreement has also been set up between the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) for the same time period.

The use of generic medicines in Ireland has been encouraged since the 2013 bill delivered by MFI [1] and switching to biosimilars has also been actively encouraged in hospitals since 2019 [2]. In addition, this new framework agreement follows the publication of MFI’s ‘Reductions in the Cost of Medicines – Ireland’s Patients First 2020–2022’ report [3].

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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1. GaBI Online - Generics and Biosimilars Initiative. Ireland passes bill to encourage generics use []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Irish hospitals to get incentives to switch patients to biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Generics and biosimilars can save Ireland Euros 1 billion in five years []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from:

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