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Dáil
‹ Ceisteanna ó Cheannairí - Leaders' Questions

Pembrolizumab access for cervical cancer

Summary

Brendan Howlin argued that women affected by CervicalCheck should not face unequal access to pembrolizumab and sought talks with the HSE and drug company. The Taoiseach said exceptional measures were already in place, contact had been made with the manufacturer, and possible funding or risk-sharing options would be pursued.

The cancer treatment drug pembrolizumab has received much public attention because of the Government's decision to make it available to survivors of the CervicalCheck scandal, the 221 group, people like Vicky Phelan.

Vicky Phelan has spoken publicly about how pembrolizumab has had a significant effect on her tumours and has given her a much better quality of life. The drug has been shown to have a significant impact on tumours in some cases. The Government owes a duty of care to those women who have been failed by our health services, but this decision risks setting a dangerous precedent if the Government does not make the same drug available to all cervical cancer patients.

Article 40 of the Constitution holds that all citizens shall be held equal before the law. The State cannot unjustifiably or arbitrarily discriminate between citizens. However, that is what is happening in this instance because the Government has decided to provide a treatment to some patients but not to others on the basis of dubious legal grounds. It is not for the Government to determine who does and does not deserve the hope of a longer life and a better quality of life than others who are suffering from same fatal illness. How can the Government decide that Vicky Phelan from Limerick should have a chance to prolong her life, but not Áine Morgan from Galway as we saw on last night's "Claire Byrne Live"? Either a treatment is so prohibitively expensive that it cannot be provided or else it must be made available to all; there is no middle ground.

My colleague, Deputy Kelly, has raised this issue repeatedly. Many patients and their family members have contacted us. Some of them are paying privately to access pembrolizumab. It is unsustainable for them to continue to pay privately. In some cases, the drug may be all that is keeping people alive. Leading oncologists, Dr. Fennelly and Professor Crown, have contacted the Minister for Health with a proposal that pembrolizumab be made available on a trial basis. Surely the Government can come up with some arrangement with the Irish-based drug company that is making this drug in Carlow to provide it to those who could materially benefit from it now. We need to have a plan in place to ensure equity in accessing this drug for all who need it and time is not on the side of the many people dependent on this treatment. My question is very simple. Will the Taoiseach, as head of the Government, provide legal clarity on the availability of pembrolizumab? Will he give a timeline as to when the drug will be available to all cancer patients who can benefit from it?

Comment on this
Leo Varadkar The Taoiseach Fine Gael

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.

Comment on this

I welcome the Taoiseach's response and I thank him for it but he and I both know that the current position where women suffering from the same form of cervical cancer are treated differently is not sustainable. It is only a matter of time before they or their legal representatives will go into the court to demand that the constitutional requirement for equal treatment be vindicated. Will the Taoiseach tell the House today that he will sit down with the Minister, Deputy Harris, to instruct the HSE to begin to negotiate with the drug company mentioned to ensure all women who suffer from cervical cancer and whose clinicians determine that pembrolizumab would be of benefit to them will have that drug made available to them? If there is a knock-on from that in respect of other cancers, that is something we can deal with. However, this is a form of cancer and the Taoiseach cannot look two women suffering from the same disease in the eye and say that the State will provide potentially life-saving treatment for one of them and not the other. He knows we cannot do that.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

I have sat down with the Minister, Deputy Harris, about this issue. As the Deputy can imagine, he is very aware of it. We have had contact with the manufacturer about it in the past couple of months. It will be a difficult one to resolve but the ideas the Deputy put forward, either the Government funding a clinical trial or a cost-sharing or risk-sharing arrangement with the company, could provide a solution. However, we would need to have the company, and the clinicians, on board to do that. That is something we will pursue in the next couple of weeks.

Comment on this