On 15 December, the Irish Pharmaceutical Healthcare Association (IPHA) announced a new four-year Framework Agreement on the Supply and Pricing of Medicines with the HSE (Agreement), which will improve patients’ access to innovative new treatments.

The Agreement will take effect from 1 January 2022, allowing for medicines to be available to patients through the improved funding framework. The Agreement is available here.

The Agreement with IPHA is in relation to the pricing and supply of on-patent and originator medicines. (A separate agreement has also been secured by the HSE with Medicines for Ireland (MFI) who represent the generic and biosimilar industry in Ireland but this article deals only with the IPHA Agreement).

The Government announced €30 million for new medicines in Budget 2022, which will help give patients access to new treatments for a range of medical conditions. IPHA announced that over 170 innovative new medicines will be proposed over the four years of the Agreement. It is expected that 35 new medicines will be made available next year, offering new treatments to around 17,500 patients.

Rebates

The Agreement provides for staged increases in rebates to the HSE on sales of on and off-patent unique medicines. The rebate to the HSE on all sales is increased from 5.5% under the current agreement to 7.75% in 2022, 8.25% in 2023, 8.5% in 2024 and 9% in 2025. 

Improved timeline for processing of reimbursement applications 

One key objective for IPHA is improving the timeline for the processing of reimbursement applications, noting that its research has showed that it can take more than three years to reimburse some innovative new medicines in Ireland and that Ireland is one of the slowest countries in Europe in making new medicines available to patients. It is noted in the Agreement that the State intends that sufficient administrative resources are in place to ensure timely processing of pricing and reimbursement applications for new products, subject to compliance with the pricing framework and IPHA have stated that the State has committed to increasing the number of HSE Drug Group reimbursement decision-makings slots (by between 35% and 62% over 2020) in order to improve this timeline. 

Conclusions 

The research-based biopharmaceutical industry has indicated that the Agreement will improve the appetite for adopting innovative new medicines in Ireland. As one of Ireland’s strongest performing industries, the renewed commitment to research-based biopharmaceutical innovation is a reminder of the importance of innovation for both patients and economic players. 

Please contact Laura Scott, Charleen O’Keeffe, Colette Brady or your usual William Fry contact if you would like further advice or insight.

Contributed by Colette Brady, Aisling Casey & Sinéad Cullen