Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

The Minister has met the patients affected and their families.

He has committed to giving the Deputy an update on the status of approval for Kuvan specifically and also to give an update on funding for the rare diseases office.

As a broader issue, the Government acknowledges we have a problem here in that the process by which we approve drugs generally may be inappropriate for orphan drugs because it is the only one available; that is the nature of an orphan drug. However, the pharmaceutical industry takes advantage of the situation. When a number of medicines are available for a particular condition, pharmaceutical companies cannot overcharge for them. However, a sole producer of the only medicine can charge whatever it likes. That is an enormous problem that we and other countries are facing.

The process we have for assessing new medicines is robust and good. It is scientific and independent. However, I am concerned when I see medicines available in Britain that are not available here. The NHS is not renowned for approving new medicines quickly - for example, it has not approved Orkambi for patients with cystic fibrosis. I am concerned when I see medicines available in Britain but not available here. I find it very hard to justify. The Minister, Deputy Harris, and I are in conversation with the Minister for Finance as to how we might improve that in the near future.

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