Dáil debates

Tuesday, 31 May 2016

Leaders' Questions

 

4:45 pm

Photo of Micheál MartinMicheál Martin (Cork South Central, Fianna Fail) | Oireachtas source

I want to raise the unacceptable situation regarding the approval of life-saving drugs. This has come into the public domain again in the past week, in particular in the case of three drugs, namely, Pembro, Nivo and Ibrutinib. Pembro has had an astonishing impact in the treatment of melanomas and the prospects for its impact on lung and kidney cancer are also exciting, something to which most oncologists will testify. Pembro and Nivo deal with melanomas and Ibrutinib deals with CLL, a type of blood cancer. They all have significantly improved survival rates and all are in use in most of the EU25 countries. They have been approved by the FDA and the European pharmaceutical agency, as they have by our own pharmacoeconomic unit, which is normally the area of contention when disagreements arise. It suggested, for example, that with Ibrutinib there was a 90% survival rate, which is quite dramatic, while up to 50% of those treated with Pembro can expect to have significant survival rates.

There has been an unacceptable delay in approving these drugs, because the pharmacoeconomic unit approved them in February. My understanding is that the relevant group within the HSE is not due to meet until June. To be fair to the Minister for Health, he has brought forward that meeting to Wednesday. The compassionate access programme has been closed and it now only applies to existing patients.

No new patient can access these vital drugs. I met a family over the weekend. Other Deputies have met families also. The prospect facing families is having to find up to €10,000 to start paying for a drug that has been approved by the pharmacoeconomics unit. What is going on is scandalous. It speaks to the lack of an overarching policy in this area. I ask the Taoiseach to take every step to ensure the approval process is sorted out as quickly as possible. My understanding is that after the approval of the HSE committee has been secured, the matter has to be referred to to the Government.

I suggest we consider the establishment of a ring-fenced fund that could be top-sliced from overall Government expenditure. If 0.4% were taken from it, approximately €200 million could be put into a separate fund every year. The fund that builds up during the years could be used to deal with new technologies and new drugs. Such an approach would have a real impact from a policy perspective. Alternatively, the proposed sugar tax could be used to finance such a fund. We need to do something that differs from the current ad hocapproach, which involves pushing the can down the road and hoping the issue will not come up straightaway. That is what is going on because of the current budgeting process and lives are being lost as a result. It is just not good enough.

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