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

As Deputies will know, this is not a political decision; it is made in line with a statutory process under the Health (Pricing and Supply of Medical Goods) Act 2013. I understand that the committee met to consider a number of new medicines, including Kuvan, Spinraza and Translarna. The committee must consider the evidence as to whether a drug is effective; if so, how effective; and whether the price charged by the company is fair and in line with charges in other countries. Under the statutory process, the HSE must issue a letter to the company this week formally notifying it of the HSE's proposal. After this, the company has another 28 days to respond and, as is the case with all medicines, has the opportunity to submit revised data on either efficacy or cost.

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