Seán Fleming (Laois-Offaly, Fianna Fail) | Oireachtas source

I thank the Deputy for his reference to the note I circulated before I spoke, which deals with the HSE having sufficient scope from the legislation to consider the unique circumstances surrounding orphan drugs, such as small patient numbers. The evidence suggests these expensive orphan drugs are getting reimbursed even, in many cases, when they far exceed the National Centre for Pharmacoeconomics QALI of €45,000 the Deputy already mentioned in this contribution.

The pipeline for new medicines coming to market remains strong in Ireland and we are committed to funding access to new and innovative therapies, including those for rare diseases. Increasingly, products within the orphan drug designation have extremely high prices and budget impact. At this stage, one lesson we have learned from Covid is the importance of countries within the EU working together on the pricing, sourcing, contracting and placing of orders for these. Once they get regulatory approval in the different countries we have seen the value of this with respect to the delivery of drugs. It is something I have long called for and something we have learned from the pandemic. That principle should be extended into these areas as well.

On the Mazars report on the drug reimbursement process, this work stream was suspended to reallocate resources to support the pandemic response so I do not have a date for when it can be completed. The Deputy has previously mentioned online publication of the rare disease technology review committee meeting minutes and the HSE and Department support such publication with a view to improving transparency with respect to the committee.

On the issue of guaranteed weighting, which the Deputy has raised before, I understand the Department view is it is not possible at this time to commit to the assigning of guaranteed weighting for rare disease technology review committee recommendation in the assessment process.

I thank the Deputy. I will take the additional points he has raised directly back to the Minister at the first available opportunity.

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