Alan Kelly (Tipperary, Labour) | Oireachtas source

It is very disappointing that the Minister for Health is not here to deal with this and other issues. This is a particularly important issue. I want to know why a drug, pembrolizumab, is not being made available to cancer patients who require it. The issue has received a great deal of publicity in the context of the case of Vicky Phelan, to whom I spoke before I came into the Chamber for this debate. Pembrolizumab is produced by a drug company here in Ireland - in County Carlow - and is at least two years away from being approved. It has had very significant effects on Vicky Phelan's tumours and on her cancer and has given her a much better quality of life. Like many others, Vicky Phelan has been inundated with requests from people who want to know how they can access this drug. It is not a drug that is on a clinical trial. It is off licence. It is a unique drug because it has been shown to have a significant impact on tumours in many of the cases of those affected. Two leading oncologists in this country, Professor Crown and Dr. Fennelly, have written to the Minister and the Department to ask for this drug to be trialled, or for some method to be found so that it can be provided to cancer patients. These patients need this drug.

Pembrolizumab is unique because patients can be tested in advance to determine their potential responses to it. This makes it cost-effective. The test in question, which is known as the PD-L1 test, costs approximately €2,000. In order to show that one is suitable for this drug and that it will have an impact on one's life, one must score over 55% in that test. Vicky Phelan scored up to 75% in it. Even though this drug is very expensive, it is cost-effective when compared with all the ancillary costs of other treatments, including potential hospital stays. Given that this drug has been trialled in the US, and in light of the US Food and Drug Administration's call for it to be released and approved immediately, I would like to know why a programme has not been put in place in this country to allow it to be used on a trial basis. The Government and the company could work together or some other method could be used to that end.

It is not acceptable that the 221 women affected by the CervicalCheck scandal have access to this drug, but others do not. It is morally right that the State is paying for the 221 women in question to access this drug, as a result of a Cabinet decision. While that decision is morally the right one, what distinguishes those women from people who are not in the group of 221? Why are they not entitled to access the drug in the same way? How is it legally possible for this country to say that a cohort of women who are absolutely devastated by what has happened - I know about this because I am fighting for the women in question - should have access to a drug, and have it paid for by the State, but women outside that cohort should not have the same entitlement? I do not even think that is legal. I think it is illegal. I do not think a Government decision can distinguish between two categories of people in this way. We need to have a plan in place to ensure there is equity in access to this drug for those who need it. We need to put a plan in place quickly because time is not on the side of many of these people. This point also applies to forms of cancer other than cervical cancer and to drugs other than pembrolizumab.

I encourage the Minister of State, Deputy Catherine Byrne, to go back to the Department. I am very disappointed that the Minister is not here. I have raised this issue with him directly. He knew I was probably going to bring it up soon. We need an answer to this. I am speaking with the support of Vicky Phelan and others who have raised the need to get wider access to this drug in a fair and compassionate way.

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