Irish Framework Agreements in principle on supply and pricing of medicinal products
The Irish Minister of Health has announced the conclusion of two Framework Agreements in principle with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicinal products. The Agreements, which will apply until 31 December 2029, are intended to strengthen security of supply of medicinal products and reduce the risk of shortages of medicinal products to patients.
The purpose of the Framework Agreement with IPHA is to enhance the current pricing and reimbursement process for new medicinal products, including in relation to Health Technology Assessment (HTA). The Agreement include a commitment and a structured process intended to have a 180-day timeline for completion of HTAs and reimbursement decisions. Starting in 2026, the capacity of the HSE Drugs Group will be enhanced to facilitate a greater capacity to process applications, including those currently under consideration. Measures to be established include predictable pricing structures, lifecycle management of medicinal products, and mechanisms to manage financial risk that are intended to achieve a balance between innovation and affordability, ensuring the health service operates within budgetary constraints agreement throughout the life of the Agreement.
Through the mechanism of tiered-pricing, review of current processes and rewarding of incremental technological improvements in the context of value-added medicinal products, the Agreement with MFI is intended to encourage companies to launch generic and biosimilar products as quickly as possible into the Irish market upon lapse of patents for reference products. Following engagement with MFI, the State will also review the current Best-Value Biologics (BVB) process and adapt it to ensure that best-value medicinal products, such as biosimilars, are introduced as early as possible. To enhance security of supply of medicinal products, the Agreement encourages MFI companies to apply for licensing and reimbursement in Ireland to reduce the use of high cost Exempt Medicinal Products (EMPs). It is hoped that this will secure greater diversity of supply in markets where patient access is at risk of disruption by decreasing the dependency of healthcare service on EMPs.