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

We all appreciate the reasons the Government took exceptional actions and put in place exceptional measures for the 221 women and their families who were affected by the CervicalCheck audit scandal. Those measures included, for example, the provision of medical cards regardless of income, counselling and a refund of out-of-pocket medical expenses. While pembrolizumab is not specifically referenced in that package, it is counted as an out-of-pocket medical expense if a consultant prescribes it for a woman who is affected. While this medicine is licensed for some conditions in the European Union, it is not licensed for the treatment of cervical cancer and that creates a difficulty for us. It is licensed for other cancers, but not for cancer of the cervix.

The Deputy is correct that this has created an anomaly - an inequity - in that women who are part of the group of 221 can have that particular medicine refunded through the out-of-pocket expenses system, whereas others whose doctors may wish to recommend it for them and prescribe it for them cannot. I accept that we need to try to resolve that anomaly. The Deputy's suggestions are helpful. This could be done by means of a trial or perhaps as is done in other countries but is often resisted by pharmaceutical companies here, namely, by means of a payment-by-result system whereby the reimbursement happens if the medicine actually works. This does not happen much in Ireland but it has been done in other countries through a risk-sharing system. We have made contact with Merck Sharp & Dohme about this in the past. We will renew our contacts in that regard.

In resolving one anomaly or inequity, we need to be careful not to create another. Often we do these things with the best intentions of resolving one issue but, as a result, create a new inequity.

If it is the case that we will reimburse the cost of medicine that is not licensed for the treatment of one cancer, will the same issue then not arise for other cancers? There are many cancers other than cervical cancer and there are many unlicensed medicines that we do not reimburse. In resolving this inequity, as the Deputy describes it, we have to be careful that we do not create a new one. That is part of the dilemma.

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