Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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I am glad that this issue was selected, which is important to the people of Kilkenny. I mean no disrespect to the Minister of State but I was hoping that the Minister for Health would be present because it is relevant to his brief. The first thing I want to do is obtain a commitment from the Minister of State that he will bring this matter to the Minister's attention.

This issue relates to pembrolizumab, a drug that is available for the treatment of patients with certain cancers in this country. Patients with a particular type of cancer are not able to access the drug, making this another example of the two-tier health system with which, unfortunately, we are all too familiar. Deputy McGuinness and I want to refer specifically to John Holmes, a Kilkenny man who has had to resort to having friends and family establish a fundraising committee in order that he can access the drug pembrolizumab. There are regular fundraisers throughout Kilkenny to try to fund his treatment. It is not nice for anyone to be diagnosed with any type of illness, not to mention having then to go out and fundraise in order to pay for one's medication. Ironically, pembrolizumab is manufactured in Carlow, one of the counties bordering Kilkenny. The drug is not available to Mr. Holmes but it is available to certain other patients. We are seeking a firm commitment from the Minister that he will meet Mr. Holmes and his fundraising committee to discuss the matter, that he will examine the position and that he will not offer some sort of watery reply whereby he states that he will come back to the matter and then kicks the can down the road.

Time is of the essence. We need a definite commitment that he will meet the fundraising committee and that he will consider the matter and come up with a solution in order that John Holmes can get access to this vital drug because it is working and, thankfully, he has seen results from it. Obviously, it costs approximately €5,000 per session so treatment is out of the reach of most people.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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John Holmes began to have investigations into his health in 2010 when it was established that he had cancer. From 2010 to today, he has been battling cancer. He has had chemotherapy and he has had various invasive surgeries. Professor John Crown has recommended that he undergo an aggressive form of chemotherapy. That has all happened and now it is being recommended that he be treated with pembrolizumab. The local community and John have been out begging for funds to fund the 30 infusions of pembrolizumab he needs at a cost of €5,111 each. Nobody can afford this. This man will die if he does not receive the treatment needed to give him an extension of his time. The Government can provide the answer by assisting Mr. Holmes in accessing the pembrolizumab.

I have asked the Minister to meet the family and to meet John Holmes. We tabled this matter in the belief that the Minister would come to the House and provide an answer. It is a sad reflection on the Government that the Minister is not here to answer the question being put to him by Deputy Funchion and me. That is a disgraceful way to treat the family. I ask that the Minister of State request an immediate meeting between John Holmes and the Minister, that he take immediate steps to remove VAT from this drug and that he ensure that the drug is made available to John, who has a unique type of cancer and who requires this drug immediately.

I have asked the Minister to meet the family and to meet John Holmes. We tabled this matter in the belief that the Minister would come to the House and provide an answer. It is a sad reflection on the Government that the Minister is not in here answering the queries that are being put to him by Deputy Funchion and me. That is a disgraceful way to treat the family. I ask that the Minister of State request an immediate meeting between John Holmes and the Minister, that he take immediate steps to remove VAT from this drug and that he ene sure that the drug is made available to John, who has a unique type of cancer where he requires this drug immediately.

Finian McGrath (Dublin Bay North, Independent)
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I thank Deputies Funchion and McGuinness for raising this very important and serious issue. The Deputies described in great detail the sad case of John Holmes.

I wish to inform the Deputies that pembrolizumab is available to public cancer patients in Ireland for a number of licensed indications and is included on the HSE reimbursement list for some of those indications. Furthermore, pembrolizumab is currently being assessed by the HSE, using the criteria as set out in the Health (Pricing and Supply of Medical Goods) Act 2013, for a number of other indications for which it has received marketing authorisation.

The Deputies will be aware that the Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE.

In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must first submit an application to have the new medicine added to the reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE conducts health technology assessments, HTAs, for the HSE and makes recommendations on reimbursement to assist decisions. It uses a decision framework to assess systematically whether a drug is cost effective as a health intervention. Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received by the HSE.

The Deputies will be aware that as an exceptional measure, the Government made a decision in May 2018 to put in place a package of support measures for women and families affected by issues related to CervicalCheck. These measures included medicines which might not be approved for reimbursement, including pembrolizumab, once they are prescribed by the treating clinician. The establishment of such a comprehensive support package reflected the impact of the lack of disclosure of the result of clinical audit and the ensuing controversy on individual women and their families. In January 2019, after careful consideration of the situation which had arisen in respect of patients with cervical cancer who were not encompassed by the terms of the support package agreed by the Government for those affected by the CervicalCheck clinical audit non-disclosure issue, it was agreed the HSE would put in place arrangements to facilitate access to pembrolizumab for cervical cancer patients on a case-by-case basis in public hospitals when a treating clinician determined this to be in the patient’s best interests. The Minister for Health has no role in how doctors manage or the care of individual patients. All prescribing decisions are entirely a mailer for the treating clinician, in line with patient safety protocols and the Medical Council guide to professional conduct and ethics.

Additional information not given on the floor of the House

The Deputies may also be aware that on 29 March 2019, the VHI sent a circular to oncologists advising them that it was extending cover to a number of new cancer medicines, including pembrolizumab. This decision by the VHI applies only to private care for VHI private patients in private hospitals and will have no impact on the provision of care in public hospitals. The effect of the VHI decision will be that VHI private patients in private hospitals may have access to a medicine not yet available in the public hospital system. A number of the medicines or indications which the VHI has now decided to cover are at various stages of the HSE assessment and reimbursement process in accordance with the provisions laid down in the 2013 Act.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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It was not worth including in the record the additional information not given on the floor of the House. The Minister of State did not address the question.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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So be it.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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Not so be it.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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I should have said earlier that Deputy Aylward has sent his apologies for his absence. With respect, the Minister of State's reply is a load of nonsense. We know about the women with cervical cancer. We are all well aware the medicine is not one on trial or that has not been approved by the HSE. It is available for a number of types of cancer but not for the cancer John Holmes has, which has been diagnosed as a metastatic neo-endocrine tumour. He has been forced to fundraise for the drug and the HSE can see that the drug is working. Providing access to the drug makes sense. It is available through the HSE for other cancer patients and has been clinically shown to work. What is preventing John Holmes from accessing it?

We need an urgent meeting with the Minister. Common sense is needed but it is utterly lacking. All the scripts and paperwork being presented to deal with the matter do not do so. The campaign group has been in contact with the Minister and has requested a meeting, as has Deputy McGuinness on our behalf. It is important the matter is not kicked down the road. I know how the House operates, where in two months we will be speaking about the same issue. The man in question does not have that time and we need a commitment this week that we will have a meeting with the Minister.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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What the Minister of State has outlined has nothing to do with the question that was asked. He should be ashamed of himself. He was asked a specific question about supporting Mr. Holmes in the context of a cost of €5,111 for 30 treatments of the drug. All the Minister of State did, however, was give us a history lesson. The Government is cold and callous if it can stand back and watch the likes of John Holmes die when all he needs is the Government's permission to allow what Professor Crown has said Mr. Holmes needs, namely, to be given pembrolizumab. That is a simple instruction to the Minister to follow the medical need of Mr. Holmes, but the Government has refused to do that. Not only that, but the Minister of State has put this waffle on the record.

Will the Minister meet Mr. Holmes? Will the Government remove VAT from the drug? Will it assist the man to live or will it let him die? That is the question. The Government did the same in the case of young Isaac Brennan and Spinraza. The same argument was made in the Chamber, where the Government stated it would wait and see. Last week, the HSE made the decision to push out again the date for the final decision.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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The Deputy's time is up.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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On a point of order, a Cheann Comhairle, it is a disgrace that a Minister of State would use that script in the Chamber and fail to address a question about a man who is seriously ill. The Government can be described as cold and callous.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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With respect, Deputy McGuinness-----

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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The Government is being seriously disrespectful to Mr. Holmes by not responding properly or adequately to the requests made of it.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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I fully accept this is an inordinately difficult problem for two representatives of someone in a gravely ill condition. Nevertheless, I do not see the name of any patient on the notes before me.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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Mr. Holmes met the Minister. I sent a text message to the Minister and asked him to meet. I sent him a note in Deputy Funchion's presence but he ignored it. How will people build respect and trust for politicians when this nonsense is put on the record and when the real issues of Mr. Holmes and Isaac Brennan are not addressed in the Parliament?

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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To be clear, I reiterate that the name of Mr. Holmes or of anybody else does not appear on the subject matter before us.

John McGuinness (Carlow-Kilkenny, Fianna Fail)
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Nor does any of the nonsense the Minister of State has outlined.

Finian McGrath (Dublin Bay North, Independent)
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I reject many of the allegations that Deputy McGuinness has made. The House knows my position on the issue. It is important that pembrolizumab is available to public cancer patients in Ireland for a number of licensed indications which have been assessed in line with the 2013 Act. Clinical trials are ongoing globally for a range of other possible uses which may receive marketing authorisation in the EU over the next number of years. Each of those treatments will be considered for reimbursement as the market authorisations are granted and applications are submitted to the HSE for decisions.

Of course I will convey the Deputies' message to the Minister for whom I am stepping in today. I reject Deputy McGuinness's personal allegations against me. I always convey the views of Deputies to the Minister. Deputy McGuinness should show some respect. I hope that as a result of the process, pembrolizumab will become available for more indications in the years ahead. I will convey the other points raised by Deputies, in respect of Mr. Holmes and the VAT issue, to the Minister, which is as much as I can currently do.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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I had also requested a meeting with the Minister.

Finian McGrath (Dublin Bay North, Independent)
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I will convey that message to the Minister. There is no problem in that regard.

Seán Ó Fearghaíl (Kildare South, Ceann Comhairle)
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In the light of the extreme urgency of the case the Deputies describe, will the Minister of State request an urgent response from the Minister? It would be appreciated by all concerned.

Finian McGrath (Dublin Bay North, Independent)
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There is no problem in that regard.