Marc MacSharry (Sligo-Leitrim, Fianna Fail) | Oireachtas source

The programme for Government refers to breakthrough treatments, the availability of new drugs and their cost. The previous Deputy mentioned that Kuvan is the only treatment for PKU, a disease that is prevalent in Ireland. Ireland has the highest incidence in the world at one in 4,500. Many countries throughout Europe have already approved this drug for supply. We have not done it here because it has failed the NCPE test on two occasions, in 2009 and 2017. This is largely because for orphan drugs and rare diseases our system is in effect, or would appear to be, designed to fail and such drugs have no chance.

Will the Government approve the provision of Kuvan for sufferers of PKU? Will the Government immediately reform the approach taken by the State to rare diseases? Will the Government amend the current assessment processes? They would appear to be designed to fail and do not take adequate cognisance of the benefits of these important treatments for patients.

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