John Brassil (Kerry, Fianna Fail)
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I welcome the opportunity to once again raise this very important issue. I understand that Deputy Sherlock put it down as a Topical Issue yesterday and it was not selected. He cannot be here today so I want to acknowledge that. Since we last spoke about this issue on which we hoped we would make some progress, unfortunately, we have regressed somewhat in that the HSE decided during the summer not to reimburse the drug for various reasons, to which I will return in a second. CSL Behring has been providing the drug as part of a compassionate access programme to 21 patients. I understand that 17 of them are in this jurisdiction. This will be withdrawn at the end of September.

I, along with Deputies Micheál Martin and Kelleher, have written to the Minister for Health on foot of this decision and the reply we got was interesting. The Minister outlined that the HSE suggested the drug has not proved itself to be clinically efficient. This is where the big problem lies. I have met the patients who are getting this drug. I have met most of the 21 patients who are getting it and they have made presentations to Members in the AV room. I ask the Minister to talk to John Hannon in Mallow who has been receiving the drug. That man was breathing with the aid of an oxygen tank before he got the drug. He had to retire early from this job as an engineer, a job he was very good at but where, unfortunately, he could no longer function. Since he has been taking that drug, he has been functioning as a normal human being. I ask the Minister to speak to James Coffey in Killorglin who has the combined condition of Alpha-1 antitrypsin deficiency and panniculitis, which basically rendered him bedridden for two out of every four weeks and put him in hospital for months upon months of each year. Seven years ago, he received the Respreeza double dose, which deals with the issue, and has been living a normal life ever since.

I might revert back to that particular situation because there are two other individuals in the country who suffer from the condition of combined alpha-1 deficiency and panniculitis and they are receiving a sister drug of Respreeza called Prolastin. They receive it from the HSE and get on with their lives and I think we have to do the same for James. We are caught in a dilemma. CSL Behring is providing the information. The HSE is saying, in good faith, I am sure, that the information is not sufficient. The cost of the drug is another issue that we have to come to terms with. In the meantime, there are 21 people, 17 of them in our jurisdiction, whose lives are being affected. Those are the people I represent and for whom I am trying to get reimbursement for the drug over the line, to let these people get on with their lives.

There seems to be more confusion in that the HSE has not been formally informed. The drug has been provided to the Alpha One Foundation which Professor McElvaney is involved with. The Alpha One Foundation administers and distributes the drug, and it has been informed that the compassionate access programme has come to an end. Lest there be any ambiguity, I have asked the Alpha One Foundation to contact the Minister's office directly and confirm to him and the HSE that this drug is no longer available as of 30 September, so we really have only one week to try to sort something out, in particular for the 21 people, of whom 17 are in our jurisdiction.

Simon Harris (Wicklow, Fine Gael)
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I thank Deputy John Brassil for raising this issue. I appreciate the sincerity with which he approaches it. I think we can all agree in this House that medicines clearly play a vital role in improving the overall health and well-being of patients. The pipeline for new medicines is very strong and it is estimated that in the region of 45 new molecules are due to receive market authorisation in Europe each year over the next five years. It is vital that all new medicines are thoroughly assessed to determine both their clinical and cost effective value to ensure that resources are committed to medicines that deliver a high clinical and cost effective return. The HSE has carefully considered the pricing and reimbursement of Respreeza through its decision-making process which was aligned with the statutory criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013.

I would like to highlight the importance of that Act. That was an Act that this House passed to give powers to the HSE, and not the Minister for Health, to decide which drugs to reimburse or not to reimburse. I do not mean this in relation to Deputy Brassil directly, but if Deputies in this House have a difficulty with that, they should come forward with an alternative. That is the law of the land. It is the law that was passed by this House. The HSE has the statutory power, not the Minister of the day, to decide to reimburse or not reimburse. It is important that, as legislators, we accept the responsibility that we have in that regard and the legal reality.

Following an extensive review process over the past 18 months, the HSE has written to CSL Behring, the manufacturer of Respreeza, advising it that the HSE will not support reimbursement at this time. The HSE informed me that it was unable to recommend Respreeza as there is not enough evidence to suggest that patients will derive a clinically meaningful benefit from augmentation therapy with the human inhibitor. It is not my view but the clinical view put forward by the HSE. The HSE also considered its cost-effectiveness and deemed that the current price was not a cost-effective use of resources. I appreciate Deputy Brassil's point in this regard. Many in this House have heard that this drug is being provided at a much cheaper cost to other countries and it is despicable that any drug company would try to exploit our patients or our taxpayers for a higher price than it is demanding in other countries.

I am aware that there are a number of patients on a compassionate access scheme for Respreeza which is operated by the drug company. Following recent media reports, it appears that the company could be considering terminating this scheme. However, no formal notification has been received by the HSE from the manufacturer of its intention to discontinue access to this scheme. I take the point Deputy Brassil makes about the Alpha One Foundation but I suggest that this company should come out and make a statement on this and on why, if it intends to do so, it would behave in such an unethical way. As I have stated previously, and I hope it is something that all politicians in this House would agree on, there should be no link between compassionate access schemes and reimbursement decisions. That is not just my view. The World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects indicates that, in medical research involving people, informed consent requires that these subjects are adequately informed of a range of criteria including post-study provisions and that post-study provisions should be provided for in advance of a clinical trial.

In fairness to our own Irish Pharmaceutical Healthcare Association, it is clear publicly, in its view, that there should be no link between clinical trials and reimbursement. There is no reason this patient should not receive the drug. While rightly raising it in this House, I would hope that we would all call on the company to comply with what is normal ethical practice with regard to decoupling clinical trials. It should be decoupling clinical trials from the reimbursement process. I have requested and directed the HSE to seek assurances from the relevant hospital, Beaumont Hospital in this case, that appropriate care arrangements are in place in the event that any access programme is discontinued in an unethical fashion, and that appropriate guidelines have been and continue to be followed in relation to all aspects of the clinical trial and access programme. It is the responsibility of both the company and what is known as the investigator, in other words, the clinician, to ensure that they have considered and made arrangements for their patients, including in circumstances where the product is not reimbursed by the HSE.

It is completely inappropriate and unethical for any company to link reimbursement decisions to compassionate access schemes. When I attend round table meetings with other EU Health Ministers, drug companies and the drugs industry, they are at pains to tell us that there is no link between reimbursement and clinical trials. I do not want a situation where they are using as leverage human beings who are concerned about their health and well-being. I genuinely appreciate the Deputy's issue of concern. I hope that in the next week, we can all work together to ask this company to behave in a normal ethical way. I do not think that is too much to expect.

John Brassil (Kerry, Fianna Fail)
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I have no issue with the methodology by which Professor Barry operates. I have met him specifically on this issue and he has told me specifically that if the company comes forward with more detailed clinical information, he will look at it. The problem I have, as I stated in my earlier contribution, is that I can see the obvious clinical benefit by meeting the patients who are getting the drug. Something is falling between the stools here. Is the company not submitting enough data? Is it not presenting them in such away that it allows Professor Barry to get it over the line? We have mentioned reimbursement. We are led to believe that the costs of reimbursement offered to some countries is much lower than what is offered in Ireland. All those are issues but next week, and I have absolutely no doubt about this, regardless of how poorly the company may have informed or not informed as the case may be, those patients are going to lose their drug.

I ask the Minister, Professor Barry, John Hennessy, who heads up primary care in the HSE, Professor McElvaney in the Alpha One Foundation and CSL Behring to sit around the table and thrash out a solution, if not the long-term solution over the provision of the drug to the general population, then specifically for those who are on the compassionate access programme. We need to do something for those patients. I mentioned an individual who has the double condition of alpha-1 and panniculitis. That is critical for that particular individual. He will be in a hospital bed in a week's time if his drug is withdrawn from him. The likes of John Hannon and his colleagues who I met have had their lives changed. I feel it is my responsibility to ensure they continue to get the medication they need.

I ask the Minister to keep this issue live. The next week is critical. I ask the Minister to call all the relevant parties together and get a resolution. It does not matter to me that CSL is a company with a €1.2 billion profit per year. It does not matter to me that it has endless resources. It matters to me that the patients in our jurisdiction, who I represent, get the drug that allows them to live a normal life. I trust in the Minister and his Department to make sure that heads are knocked together to allow these people the access that they need to live a normal life.

Simon Harris (Wicklow, Fine Gael)
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The well-being of patients and citizens is something the Deputy and I share a desire to work together on. It is something all of us in this House want to see. What we cannot see is a drug company behave in an unethical fashion and blackmail the taxpayer and effectively, therefore, blackmail patients. As Minister for Health, each week I see more drugs become available.

This is good. These are drugs that can save patients' lives and make their ' lives better. However, we cannot have a situation where a drug company is breaking all the normal rules. The Irish Pharmaceutical Healthcare Association, the representative body for drug companies, does not behave or believe in behaving in this way. There is not meant to be, internationally or nationally, a link between clinical trials, compassionate access programmes which a company puts in place and the HSE reimbursement process. I have directed the HSE to make contact with the hospital and the clinician responsible to ensure that individual care plans are put in place for each of the patients. My concern is for 17 patients in this jurisdiction, and 21 patients on the island of Ireland.

I suggest, as the Deputy has done, that the company in this case should come forward with more information. It should reflect on the price it is seeking in this jurisdiction versus others. While that is happening, patients should not be used as pawns. The Deputy makes the point that while it might not be particularly relevant to the patients, it is important for the record of this House to state that, according to its annual report, CSL is a $45 billion company, with sales in 2016 of $6 billion and net profits in that year after tax of $1.2 billion. Its CEO was paid salary and bonus of $8.1 million and the nine other directors of the management team were paid amounts ranging from $1.5 million to $3.2 million each in 2016. That is all in its annual report. Surely to God it can continue a clinical trial for 17 of our patients. I ask for cross-party support in sending out that very clear message from this House while at the same time expecting the HSE to engage in respect of any further information presented to it. That is very important and I will certainly keep in touch with the Deputy on the matter.