Gino Kenny (Dublin Mid West, People Before Profit Alliance) | Oireachtas source

I have found the discussion extremely insightful and very informative, so far. Access to orphan drugs is a very topical issue in Ireland at present and I wish to ask a couple of specific questions. Can the HSE overturn a decision made by the NCPE? If so, where has it happened and for which drug?

Mr. Hennessy referred to the assessment of orphan drugs. In my view the process is largely flawed, particularly for one drug called Kuvan, which is used in the treatment of phenylketonuria, PKU. Kuvan was approved by the FDA seven years ago, it was approved by the European regulator in 2009, it has been approved for use in 20 European countries and Ireland has one of the highest rates of PKU in the world. More bizarre is the fact that Kuvan is made here in Ireland in County Cork. I have outlined all of the mitigating circumstances for Kuvan to be approved as a drug to treat PKU. Mr. Hennessy has said that the HSE will meet to discuss Kuvan in the coming months. The meeting is imperative.

I wish raise the perennial issue whereby pharmaceutical companies ask Governments to pay extortionate amounts of money for drugs. It is all done at a time when they have countries and patients over a barrel. I do not know whether Mr. Hennessy can comment on the matter. The scenario is profiteering at its worst. It is the jungle mentality of capitalism. I would go so far as to say that huge pharmaceutical companies, and there are a lot of them in this country, are killing people. The companies have priced people out of their health and countries out of their wealth. I know Professor Barry because I have watched him speak a few times on television. I have a great deal of respect for him because he said that pharmaceutical companies have flexed their power over countries where drugs should be available to people. I ask the witnesses to comment on my questions, particularly my queries about Kuvan.