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Dáil

Written answer

Medicinal Products

899. Deputy Joe Neville asked the Minister for Health to update Dáil Éireann on the 10 June 2026 statement of the Beneluxa countries on a unified approach to access to and affordability of medicines; her Department’s engagement in 2026 with Beneluxa countries on this initiative; the possible advancements in pharmaceutical procurement across the Beneluxa countries in 2026 and 2027; and if she will make a statement on the matter. [47854/26]

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The BeNeLuxA initiative is a major collaborative step towards sustainable access to, and appropriate use of, medicines in the participating countries.

Ireland became a member of the BeNeLuxA Initiative in June 2018, alongside existing members Belgium, the Netherlands, Luxembourg and Austria. BeNeLuxA Member States cooperate in the fields of horizon scanning, information sharing and policy exchange, and Health Technology Assessment. Several pilot joint pricing and reimbursement processes have also been conducted.

Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Collaboration with Beneluxa partners provides a larger market which may be more appealing to suppliers of medicines, encouraging more timely pricing and reimbursement applications. This has been successful and has led to the reimbursement of new and innovative orphan medicines in Ireland for patients such as Libmeldy® for metachromatic leukodystrophy and Zolgensma® for Spinal Muscular Atrophy. Overall, Beneluxa enhances Ireland’s ability to provide high-quality, affordable healthcare to its patients.

Notwithstanding Ireland’s engagement with its BeNeLuxA partners, ultimately decisions on the pricing and reimbursement of medicines is a national competence. The legislation detailing how these decisions are made in Ireland is the Health (Pricing and Supply of Medical Goods) Act 2013, which includes nine factors which much be considered in reaching a decision. National legislation governing this process, including in our BeNeLuxa partners, varies by country.

The BeNeLuxA Initiative provides a valuable forum for discussion of and collaboration on contemporary policy issues faced by European countries seeking to safeguard access to medicines for their patients. It is important to reflect that BeNeLuxA collaboration is not just in respect of pricing and reimbursement but across a broader range of medicine policies and processes, all of which support domestic reimbursement. This includes for example:

• Horizon Scanning - where we work together to find out which innovative – often extremely expensive – medicines are about to become available in the near future.

• Information sharing and policy exchange - where we exchange information on our medicine policies. We believe that sharing information and collaboration between countries, over an extended period of time, will benefit policy initiatives on pricing and reimbursement of medicines.

• Health Technology Assessment - where we cooperate on Health Technology Assessments. By using expertise acquired domestically and across European networks, we have a strong base for performing joint assessments.

As in the Initiative’s statement of the 10th June 2026, Ireland appreciates the value of collaboration and encourages European partners to jointly seek solutions to the challenges with which the Union is now faced. The BeNeLuxA Initiative will continue to contribute to this discussion.

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