Irish government strikes new deal with pharmaceutical bodies

The new agreements in principle that the government has reached with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) will replace the existing framework agreements which have been in place since 2021.

The Irish government said the new agreements would run until 31 December 2029, with the final terms expected to be agreed in February, following further discussions between IPHA, MFI and the administration.

Under the terms of the framework, the new agreement with the IPHA will see a commitment towards achieving a 180-day timeline for completing health technology assessments and reimbursement decisions, with the capacity of the HSE Drugs Group to be enhanced in order to facilitate more applications.

It will also include predictable price structures and mechanisms to manage financial risk, and provide for monitoring and oversight of delivery of the new commitments. IPHA members will also agree to move more quickly on reimbursement applications to align with European Medicines Agency recommendations: that is, within six months of authorisation by the European Commission.

The new framework agreement with MFI will introduce measures to ensure diversity of supply of medicinal products into Ireland and reduce the risk of medicine shortage, encourage early launch of generic and biosimilar products in Ireland when patents lapse, reward technical improvements by way of value add medicines, and include a commitment to review the best value biologics process to ensure better value medicines, such as biosimilars, are introduced as quickly as possible to the country’s market.

Karen Gallagher, an IP and medicines regulation expert with Pinsent Masons in Dublin, said the new provisions would be welcomed by both patients and the pharmaceutical bodies.

“These updated framework agreements seek to address some of the concerns raised by the pharmaceutical sector in recent years in relation to market access, continuity of supply and the pricing and reimbursement process in Ireland.

“The IPHA agreement will include provisions aimed at delivering faster access to medicines by improving the reimbursement process, including by increasing capacity at the HSE Drugs Group, which is the body that makes recommendations on the reimbursement of medicines.

“This will be welcomed by IPHA members and patients - the IPHA has long lobbied for improvements in the reimbursement timeline for innovative medicines.”

Ireland currently lags behind the EU average in the time it takes for new therapies to be introduced according to industry data (70-page / 1.74MB PDF), with the new agreement looking to shorten that, following last year’s Programme for Government announcement.

“Both agreements address the financial sustainability of medicines for the state,” added Gallagher.

“Reference is made to ‘predicable pricing structures’, ‘lifecycle management’ and ‘tiered pricing’ in the context of both agreements. It will be interesting to see the final terms of the agreements and whether there will be a significant move away from the current model of 45-60% price reductions for medicines upon biosimilar/generic entry.

“A phased or tiered approach will have to balance the need to encourage originator companies to continue to make new therapies available to Irish patients, whilst also ensuring that generics and biosimilars companies have sufficient incentive to continue to supply affordable medicines to the state.”