Dáil Éireann Debate, Wednesday - 6 May 2026
1129. Deputy Ken O'Flynn asked the Minister for Health whether any statutory, contractual, policy or administrative time limits apply where a marketing authorisation holder has been invited to submit a commercial proposal for a medicine but has not yet done so. [32779/26]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines.
During the pricing and reimbursement process where a marketing authorisation holder (MAH) is invited by the HSE to submit a commercial proposal in respect of a medicine, there are no statutory or contractual time limits specified in legislation that require the MAH to submit such a proposal within a defined period.
There are also no formal policy or administrative deadlines that compel a company to engage in, or conclude, commercially confidential discussions once an invitation to submit a proposal has issued. Engagement in pricing and reimbursement negotiations is a matter for the company, and the timing of any submission is at the discretion of the company. In the absence of a commercial proposal from the MAH, a pricing and reimbursement application cannot proceed.
The Department of Health and the HSE continue to encourage early and constructive engagement in the process by companies to facilitate timely access to new and innovative medicines for patients.
