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Seanad Éireann debate -
Wednesday, 11 Jul 2012

Vol. 216 No. 11

Access to Cancer Treatment Bill 2012: Second Stage

I move: "That the Bill be now read a Second Time."

I welcome the Minister of State to the House and thank her for yet again making herself available. She has given great commitment to this House over the last two years. I am proposing this Bill and it is co-sponsored by my friend and colleague, Senator John Crown, who is not short of expertise in this particular department. I proposed on the Order of Business that this Bill be accepted by the Government in the interests of a number of actors but primarily in the interests of patients. It is not political in nature as it is a non-adversarial Bill. I know that it has been the norm to vote down such Bills in the past, purely on political grounds. I appeal, in this instance, that it be seen for what it is, namely, the simplification of a process which heretofore has been complex and which has not put the patient in the centre of the debate on the provision of cancer drugs. It is a short Bill, but it is necessary in our view.

Recent controversies in this area have included decisions on drugs such as ipilimumab, or IPI as it is known, and decisions taken by the National Centre for Pharmacoeconomics not to provide particular drugs, apparently for purely cost considerations. This Bill provides a process which puts the patient at the centre while still protecting the Government's necessary right to refuse the availability of a drug on particular grounds, such as the balance between patient outcomes and costs. The Bill would effectively create a scenario where the Government would have to opt out of the provision of a particular drug rather than the current scenario, which is effectively a situation where the Government must opt into the provision. Once approved by the European Medicines Agency, this Bill would ensure that the HSE would have to provide a drug for a patient. A drug is approved by the EMA in the normal way, but nobody knows the process through which it then goes. It is certainly a very lengthy process. It is unclear who pays for it and how much it is going to cost. Individual hospitals may require a particular drug, based on the views of the oncologist and the haematologist. The pharmacist may wish to prescribe the drug, but the management of the hospital may not allow its purchase because the National Centre for Pharmacoeconomics has informed the management that it should not be available because the cost per year per life saved does not justify it.

What is the cost per year per life saved? What is the cost per year per life saved of having three junior Ministers, with all due respect to the Minister of State? What is the cost per year per life saved of Mr. Mark Costigan advising the Minister for Health? What is the cost per year per life saved in having gardeners prepare Leinster Lawn behind us? What is the cost per year per life saved of the provision of €3,000 per year to meat inspectors who must put up with the smell of meat to work in meat factories? The criteria used to determine whether a drug is specifically value for money or not are too crude. I am sure Senator Crown will go into more detail on this issue.

The reality and the message is that one size does not fit all. Drug A may not add a single day to my life and, therefore, it may not be beneficial for it to be prescribed to me. However, to Senator Darragh O'Brien, for example, it may give an extended period of remission or even cure.

What this Bill will do is simplify the process. All American Medical Association, AMA, approved drugs will be made available by the HSE, and the Minister of the day, be it the Minister of State, Deputy Kathleen Lynch, the Minister, Deputy Reilly, or whatever Minister of whatever party or future Government, must affirm or deny the access to such drug and, in doing so, can deliberate and consult the Irish Society of Medical Oncologists, the Haematology Association of Ireland, the National Centre for Pharmacoeconomics, the National Cancer Control Programme and the HSE.

Of course, the Minister of the day would not look forward to having to take a difficult decision and having to say at times that a drug would not be made available, but it would be based on very good grounds and on consultations with professionals who have the expertise to help the Minister make that determination. However, it would be up to the Minister to opt out of providing that drug rather than just opting in.

We have seen the ipilimumab, or Ipi, scenario and other scenarios, where the only recourse for vulnerable cancer patients was to resort, as I said in my press statement, to the Joe Duffy approach to obtaining cancer treatments which would prolong their lives or perhaps lead towards cure. This is an unacceptable scenario and one that is not becoming of any Government interested in representative politics and in putting the patient first.

It is time the patient was put first. We on this side of the House are very honoured and proud of the fact Senator Crown has endorsed the Bill. We believe this is legislation that puts the patient first. It certainly acknowledges that difficult decisions will have to be made by the Government of the day, but that is the responsibility of any Government. It is not about making it politically easier to lead the country. It is a difficult job and the buck must stop somewhere. The responsibility, ultimately, is to the people and, in medicine, the patient.

This simple legislation assures the patient of guaranteed access to drugs that are going to help them in the context of outcome. Of course, there are certain scenarios where a drug will be too expensive given the expected outcome or given the expected extension of life. Professor Crown will give examples of such drugs in regard to breast cancer, where consultants, because the extended period given is so small and the cost so high, understand that these issues have to be balanced. However, we cannot have a criteria based solely on cost. As I said, the criterion of cost per life saved is far too crude a methodology on which to make that assessment, for the reasons I highlighted.

I very much hope the Government can accept the Bill on Second Stage. If there are additional suggestions or improvements that can be made in areas I have missed or that Senator Crown may have missed in his consideration of these proposals, let us deal with those on Committee Stage. Let it also be a victory for the Seanad. We have had other legislation initiated here in the past that has made very worthwhile improvements, and this Bill is another such example. I appeal to colleagues, the Minister of State and the Whips to allow this legislation to be accepted today on Second Stage. It is a Bill that is patient focused and puts the patient at the centre while still preserving the very important role of the Government to take, at times, the decision not to provide a particular drug.

As we have seen with the high profile cases involving Ipi in recent times, the current situation cannot be allowed to continue and, for that reason, I commend the Bill to the House. I look forward to Members' contributions during the debate. I very much hope the Seanad can unite behind this Bill, which, as I said at the outset, is non-adversarial and non-political, and has been put forward simply in the best interests of the patient. I hope the Minister of State and Members will agree with that.

I second the proposal. I welcome the Minister of State, Deputy Kathleen Lynch, to the House on this occasion and thank her for her contributions to the discourse in Seanad Éireann over the past year or so. I commend the Bill across the House as one which was wholly thought of by Senator MacSharry. I acknowledge it as very innovative potential legislation and I acknowledge the fact he has been the inspiration and driver for it.

I am not a starry eyed idealist. I know we live in a real world. I know that every penny I prescribe is a penny that is not available for some other part of the health service or some other part of essential social and educational services. I am well aware there is an opportunity cost to every penny that is spent by every person, in particular those spent by the Government. I am aware we have children on waiting lists for spinal surgery and cardiac surgery, and we have older citizens waiting to have their sight restored from simple cataract surgery or their mobility restored from simple hip operations. There are children who cannot hear their teachers in school who are waiting to get their hearing tested and to get hearing aids fitted, if they need them. There are people in some parts of the country waiting one and two years to see specialists in the areas of rheumatology, diabetes and so on.

I know there is not an endless pot of money and that it is not as simple as pulling a financial rabbit out of the hat and making every drug available. I know somebody has to make hard decisions and I am very respectful of that fact. However, I believe there is a sort of deal implicit in this legislation being accepted, which is that we have to grit our teeth and also be part of the hard decisions which are made by the Minister, even if they are ones which we wish had gone a different way.

The reality is we have lost our sovereignty, we are broke, our tax take is down, our spend on social welfare is up and we cannot pay for every treatment for every patient all of the time. In general, in our public but not in our socialised private health system — I have said this on many occasions over 20 years and it is becoming truer than ever — the way we deal with financial constraint is to put people onto waiting lists. We close the ward, close the operating theatre, do not make the extra appointment, do not replace the people and we let the waiting list lengthen, because the person on the waiting list is a patient who costs the health service nothing whereas the patient who is in the hospital is not a revenue source but a cost source.

This is why I have and continue to be extremely supportive of the plan of the current Government to introduce a fundamental revolution in the way the health system is run, organised, managed and financed. What do we do in the meantime, however? Cancer patients cannot readily go on a waiting list because they have a life expectancy that has to be dealt with. This is why issues, such as that which arose with Ipilimumab, become so emotional in that they become fired up by the urgency of individual patients. Hard cases make bad policy but it is difficult to ignore them at the same time.

We need to look at some of the precedents. Historically, in this country, we had good access to cancer drugs and we were one of the more liberal environments for cancer drugs, certainly when compared with Her Majesty's United Kingdom National Health Service, which by every measure is the worst of the developed countries and also has the worst cancer survivals of any major country.

As we have only just mended that fence, please do not——

I love them dearly but one of the better arguments for independence was not being in their health system, to be honest. They have historically had extremely bad access. I am 55 and have been doing oncology for 30 years. Thank God I lived long enough to see the day when the kind of drugs we dreamt about when all we had was chemotherapy are now becoming available, as they are.

Let me give one example involving a drug called herceptin, the development of which I had a lot of involvement in. A very brilliant man called Dr. Dennis Slamon in Los Angeles, who has been a very good friend to Ireland, the Irish health service and Irish cancer medicine, was the brains behind this. I managed to get involved at a relatively early stage, making sure that Irish patients had access to it and that we had some input into the clinical trials. In 1998, I saw a very nice lady from Leitrim who was supposed to be one of the first patients in Ireland to get herceptin. She had extensive secondary breast cancer in her liver, was in liver failure and was deeply jaundiced. In fact, she was so jaundiced we actually could not put her on the research study with herceptin because she did not meet the eligibility criteria. None the less, we got permission by begging and saying she was all psyched up to join the study and there was a little delay getting the drug sent across the Atlantic. We asked whether we could, please, give it to her, they said "Okay, this once." Therefore, we gave it to her. That was 14 years ago. She was on the treatment for five years and in the end we were raising our eyes and asking what we would do, and whether to continue it or stop it. We stopped it, and she has never relapsed. I believe she is cured. This month in the Annals of Oncology, Europe’s leading cancer journal, a joint paper from St. Vincent’s University Hospital, Dublin, a Health Service Executive institution, and the Istituto Clinico Humanitas, Milan, is for the first time demonstrating, with long-term follow-up results, how we believe herceptin is curing some patients with metastatic breast cancer who would have been considered incurable. When this drug was available across Europe and rolled out to earlier stage patients, Her Majesty’s National Health Service rejected it because the NHS bureaucracy was so well developed for approving and rejecting drugs. Accordingly, a generation of British cancer patients missed it. They now receive it. We are told by our colleagues in the Health Information and Quality Authority not to worry, that we do not follow the British model but the Australian one. In Australia the authorities rejected the drug. The Australian Parliament had to bypass its own national drugs approval process and set up a Commonwealth fund to make the drug available to Australian women such was the appropriate political outcry over the bureaucratic decision not to make it available.

Kidney cancer is rare, with only several hundred cases a year in Ireland. In my young career I saw some of the worst tragedies because there was no good treatment for this disease. We now have four drugs that work. While none of them cures it, the average person with kidney cancer lives for two or three years as opposed to several months. Each one of these four drugs was rejected in the United Kingdom by the NICE, National Institute for Health and Clinical Excellence. After a huge outcry, as we had here over the ipilimumab story, the NICE rolled back a little and some of the drugs are now being made available, although sparingly. Those officials and their health economic analyses do it get right but too late. It is similar to the British slur on Americans that they usually come to the right decision, having tried everything else first. In oncology the British are dead wrong, while the Americans tend to get it right. For all the problems with its health service, America has the best cancer survival rate of any country in the western world.

What happens here now? A drug is subject to trials which look good. The data will prove to the regulatory agency if it can be sold. The European Medicines Agency does it on a pan-European basis and then it is up to individual health systems, jurisdictions and insurance companies to decide if the approved drug will be made available. In the past this was a liberal and smooth process. For obvious reasons, it is now the subject of greater scrutiny and there is greater potential for delay. We have a more formal health economic analysis performed. As Senator Mark MacSharry pointed out, such an analysis works out on average how much longer an average patient lives with a good quality of life because of a drug, divides it into one year and then multiplies the number by how much the drug costs a year. Accordingly, a drug which helps a patient to live four months longer but costs €100,000 has a €300,000 cost per year of life saved. For some drugs, that is bad and just not worth it.

I used to give one drug which I will not name to breast cancer patients. The more I looked at the data as they became available, it looked like on average people lived four to six weeks longer. The drug cost €100,000 to achieve this, which was not worth it. I am not saying the patient's life is not worth it, but that is €100,000 that could be spent on other drugs that might help to prolong someone's life for longer, providing hearing aids, cataract or hip surgery. We are not being unreasonable about this, as we understand there needs to be an economic analysis undertaken. However, the tools used are too crude.

In the case of ipilimumab, the health economic analysis component of the overall analysis — I accept there was more to the analysis — was facile. The catch with some drugs is that on average some patients will live a little longer. There are within that group some patients who will have a spectacularly better result. A crude analysis in which all cancer types and drugs are measured by the same yardstick is never to going to pick up that subtlety.

The fundamental principle of management and leadership is the marriage of authority with responsibility. Accordingly, the people with authority to make the decision are the ones responsible for the decision, something which is systematically disconnected. In view of the complexity of this process and driven by humanitarian concerns which are shared across the House, wedded with responsibility, pragmatism and the desire to conform to what is the fundamental principle of management and leadership, in the future we believe a drug which has satisfied the expert regulatory agency should be approved and that there should be an opt-out clause which may be frequently used in the coming years as larger numbers of expensive drugs with marginal benefit become effective.

The alternative is what happened with two high profile drugs in recent years. The HPV vaccine, given to young girls to prevent them from getting cervical cancer, was a phenomenal and extraordinary breakthrough and rightly won the Nobel Prize for Dr. Harald zur Hausen. It could effectively eliminate this disease by reducing it by 80% to 90% over time. The Minister in the previous Government made the correct decision to introduce it. However, when times got tough, we were told the decision was being rolled back on. When it was finally introduced, we were told there had been years of negotiations to bring down the price. I must say in the sacred confines of this House that there are no data to show that those negotiations took place. There had been no calls for tenders with that drug in the first instance.

More recently with ipilimumab, we were told that as a result of the five or six month delay during which time several patients could not receive it, there had been robust negotiations to bring down the price. I have to say again that I am not certain those negotiations tookplace because the price finally quoted was the same as that quoted internationally for any health service that bought it in bulk. The original price quoted was the notional price for one person going into a drug store to buy one vial of it. That is not the way health economic systems work.

I am not here to look at the mistakes of the past but to look forward. I commend Senator Mark MacSharry for having a good insight into this area. If this legislation was to be passed, we would all have to acknowledge there was collective responsibility in this area. We sometimes receive a letter from a constituent asking why he or she cannot receive a touted drug for his or her son suffering from cancer who has a short life expectancy, yet we have to say it is not available, because on the basis of analysis, the modest benefit it would give him is not worth it. That is a decision in which we should be all prepared to join. If the legislation is passed, we will not have the current situation where a nebulous and year-long gap appears between a drug being approved and it being made available. Fingers are being pointed in all directions as to what is happening with various cancer drugs. This legislation would have the effect of concentrating the minds of the health economists, health officials and the cancer bureaucracy to tell the Minister the meter was running on and we must make a decision on making a drug available. I hope we can have cross-party support for this innovative Bill.

I thank Senators Mark MacSharry and John Crown for their contributions. Senator Mark MacSharry opened the debate by acknowledging the work done at the coalface of cancer treatment by Senator John Crown and others. I am not sure everyone has such a capacity and it must be readily acknowledged. There are ongoing negotiations on new drugs and budgets are being put in place to ensure benefits can be gained from new developments. However, the Senators will acknowledge that there are new drugs which come on the market which are of no greater benefit than older drugs.

I am taking this debate on behalf of the Minister for Health, Deputy James Reilly. The Government does not intend to accept the Access to Cancer Treatment Bill 2012. However, I congratulate both Senators for raising this important subject which is worth debating. Debates such as this bring us a step forward.

The Bill would give responsibility for decisions on the availability of cancer drugs to the EMA, an external agency. Apart from the fact that this could be construed as the State abdicating its responsibility for making difficult decisions on resource allocation, it should be noted that the EMA conducts a scientific evaluation of a drug with a view to providing a licence for its sale in the European Union. Decisions on making a particular drug or intervention available to citizens should remain within the remit of the State. Approaches to priority setting require consideration of effectiveness and efficiency, as well as equity and fairness. Adopting the position suggested in the Bill, that is, that products for cancer treatment approved by the EMA be made available, fails to take account of the wide range of factors and constraints that may influence national priority setting. I do not doubt that, in the context of his research work, Senator John Crown is well aware of the other factors taken into account. In fact, he set out a number of them. Many factors shape decisions on access to therapeutic interventions. They include the benefit to patients, quality of evidence, the existence of alternatives, treatment duration, the potential to save or prolong lives, the total population of patients affected and the cost to the system. These factors are not part of the EMA evaluation.

A significant ethical concern in the context of the proposed legislation is that it prioritises cancer treatment over other drugs, interventions and services. As Senator John Crown indicated, there are other areas of the health service which are of equal importance. The prioritisation of cancer treatment would pose a serious challenge to the fundamental concept of equity in the provision of health care. Requiring a drug to be assessed and a decision made by comparing it with existing services and other potential competing service developments is considered to be a fairer method of allocating resources. Drugs and new technologies will always hold greater appeal than, for example, preventive medicine which may well offer larger population benefits. Allowing special decision-making for cancer treatments is ethically problematic because it would mean the system would make provision for a subset of funding decisions to be taken on a different basis. It is highly unlikely that such an approach would conform to the accountability for reasonableness framework which seeks to ensure fair and legitimate allocation of resources in health care. One would have to be made of stone not to understand that when it is a question of an immediate threat to life, people can very reasonably make an argument in this regard.

The Senators claim that the Bill would improve the access of cancer patients to much needed drugs. The Minister for Health would strongly disagree and argue that the current system of care under the national cancer control programme, NCCP, particularly the medical oncology programme, provides cancer patients with access to optimum modalities of treatment along their cancer journey, including excellent access to effective cancer drugs. Furthermore, a Bill on the pricing and supply of medicines will shortly be brought before the House. The health (pricing and supply of medical goods) Bill 2012 will not only provide for an important change with the introduction of a system of reference pricing and generic substitution, it will also provide a statutory basis for decisions relating to approval for funding of medicines and pricing decisions. The legislation sets out clear criteria for the HSE in making pricing and reimbursement decisions, including clinical need, cost-effectiveness and security of supply. The HSE will, as necessary, require detailed assessments of drug efficacy and cost-effectiveness through the use of health technology assessments conducted, as appropriate, by the National Centre for Pharmoeconomics.

The mission of my Department and the health system is to improve the health and well-being of the people in a manner that promotes better health for everyone, fair access, responsive and appropriate care delivery and high performance. In keeping with this, the aim of the NCCP is to ensure patients are diagnosed and begin their cancer journey in a designated cancer centre, with access to multidisciplinary teams during their treatment. The objectives of the Bill before the House are contrary to this mission and its enactment would lead to an inequitable and, in some cases, unsafe system of health care. I am not certain that is the intention, nor do I believe it would happen. I fully accept that the Bill is clearly aimed at improving the situation for patients.

It is important to note that the administration of cancer drugs, including chemotherapy, biological and immunotherapy is a complex process fraught with the potential for patient harm. Many cancer drugs have serious side effects and risks to patient safety grow as the number of multi-drug regimens expands and oral chemotherapy becomes commonplace. Under the NCCP, clinicians with appropriate expertise and skills, in conjunction with colleagues in multidisciplinary teams, have access to effective medicinal products necessary for the treatment of cancer in line with international best practice. There is no need for legislation to improve access. The enactment of a Bill which would allow medical practitioners to single-handedly prescribe these complex drugs without the benefit of multidisciplinary assessment and support and, in the longer term, the implementation of national treatment policies and guidelines would be wrong.

On a point of information, nowhere in the legislation is there a such proposal. With respect, the Minister of State is reading from a script which was written, I am sure, by officials who are not experts and which is full of inaccuracies. I am not trying to be personal about this.

I co-sponsored the Bill in a spirit of bipartisanship. I am not a member of a party and, on a personal basis, I am hugely offended by some of the imputations made in the Minister of State's script.

I was just about to say that I did not believe the Bill was intended to achieve what was stated in my script.

Then the Minister of State should throw it away and speak from her conscience.

My conscience tells me that there is much in the prepared script by which we must abide. Equally, it also informs me that there is a great deal of common sense in some of the points raised in the script. We cannot simply abdicate our responsibility in respect of drugs. It is not just about the economics. As the Senator outlined, there are other matters which arise. I agree that there is nothing malicious about the Bill, the intention behind which is to ensure the best possible service would be available.

Each country must retain the responsibility for constraining or discontinuing the use of a drug if safety concerns arise, if off-label use is not in line with best clinical practice or if a more cost-effective therapy enters the market. It should be remembered that only a few weeks ago a major pharmaceutical company in the United States was fined almost $3 billion for its business practices in the context of how it marketed its products.

When the HSE's NCCP was established in 2007, it aimed to ensure people with cancer would be treated in designated cancer centres where they would be managed by multidisciplinary teams with expertise in surgery, radiation oncology and medical oncology in order to optimise diagnosis and treatment. International evidence shows that such a programme provides the best outcomes. The regime of treatment for complex cancers involves careful assessment of all options and continued monitoring of patients throughout their cancer journey. I am sure the Senator is aware of that fact.

On another point of information, nowhere in the Bill is there a suggestion patients should not be monitored or should not have access to multidisciplinary care. All of the multidisciplinary planning and consultation in the world is of no good if the recommendation of the multidisciplinary team is that a drug which is not yet available be used in treatment.

Nowhere in what I have just said is it suggested what the Senator says is untrue. We both need to have a little respect for each other.

On a point of order, the text of the Bill is not inconsistent with what the Minister of State is saying. If the intent of what the proposers say is not clear in the text of the Bill——

That is not a point of order. Does the Senator intend to make a contribution on the Bill?

I certainly do.

Then he will have the opportunity to make his point at that stage. The Minister of State to continue, without interruption.

The Acting Chairman has given Senator John Crown a great deal of latitude in his contradicting of the Minister of State. That is rather unfair.

The Senator will have the opportunity to make his contribution later.

The priorities for the NCCP under its medical oncology programme are development of national multidisciplinary clinical practice guidelines which are under way for breast, lung, gastrointestinal, prostate and gynaecological cancer; a review of medical oncology services from a quality assurance and safety perspective, commencing in September 2012; continual assessment of new drugs and related predictive laboratory tests through a health technology review committee in order that these may be presented to the HSE management team for approval; recruitment of a pharmacist to lead, in conjunction with Irish medical oncologists and nurses, the development of more than 300 national treatment protocols and to advise on drug utilisation costs and pharmacy ICT — this recruitment is nearing completion; development of national protocols for drug usage and standardisation of practice nationally, based on best clinical evidence; assisting in the development of mechanisms for the management of the cancer budget within the HSE's community drug scheme. With regard to the latter, the new melanoma drug, ipilumimab, or Ipi, is the first intravenous drug administered in hospitals in respect of which reimbursement is available under the primary care reimbursement scheme on a demand-led basis. This is an example of money following the patient.

The HSE examines a range of important inputs, including input from clinicians before making a recommendation regarding funding approval for a particular drug, including oncology drugs. Pharmaceutical companies make applications to the HSE seeking pricing and reimbursement of new medicines. The HSE considers a range of factors prior to making an initial recommendation on pricing and reimbursement. These factors include but are not limited to clinical effectiveness, cost-effectiveness, unmet needs, availability of other treatments, sub-group response and budget impacts. Recommendations from these processes are forwarded to the HSE drugs group which has been tasked by the HSE with prioritising those medicines which should be processed first. In addition, the group also considers how any prioritised medicine might best be introduced in the HSE clinical care pathways.

The HSE seeks to provide the best access possible to new services and new technologies within its resources. In any health system with a fixed budget, each decision to fund a new service and technology has implications in relation to availability of resources for other services or technologies. Unfortunately, that is a challenge faced by all health systems, even in a good economic climate.

In the specific area of pharmaceuticals, individual pharmaceutical companies hold patents for a new medicine and are the sole supplier of such medicine to health services, that is, they are monopoly suppliers. These companies decide the initial price at which they seek to provide medicines, but the health systems do not have access to an alternative supplier of the medicine. There is always a danger that monopoly suppliers might seek to achieve the highest possible price. If health systems do not challenge such demands, pharmaceutical costs could rise exponentially.

The Secretary General of the Department of Health has requested the HSE to examine further the approval system for new drugs to ensure the robust system is put in place to support decision-making in relation to drugs and to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.

Internationally, the cost of cancer drugs has risen by 15% year on year, of which 5% is related to the rising incidence of cancer and the prevalence of patents remaining on ongoing treatment. Some 10% of growth is related to the cost of new drugs. Drug costs reported from the acute hospitals for 2011 and the most up-to-date figures on cancer expenditure from the primary care reimbursement scheme indicate that the annualised expenditure on oncology drugs is currently in the region of €150 million. There are now more than 700 new drugs in clinical trials around the world and the nature of cancer treatment is being transformed with the discovery of targeted molecular therapies and immunotherapies.

In the wider context within the national cancer control programme, NCCP, a range of initiatives have been introduced to support the ongoing growth in demand for medical oncology services. This includes the establishment of the NCCP technology review committee which is responsible for reviewing proposals received from industry or expert groups in Ireland for funding of new cancer drugs or expanded indications for existing cancer drugs or related predictive laboratory tests. The NCCP technology review committee takes account of national clinical practice guidelines from the Irish Society of Medical Oncology, the Irish Haematology Association and other relevant bodies.

The aim of the NCCP medical oncology patient safety and quality review is to conduct the baseline assessment of medical oncology services from a quality assurance and safety perspective across 25 hospitals. The review will enable the NCCP to establish a broad understanding of existing medical oncology policies and practices nationally. These data will help to develop national quality and safety guidelines for the safe handling of cytotoxic biological and immune therapy drugs.

It is not necessary to legislate for optimum access and treatment for cancer patients. To do so would be inequitable for other patients in need of effective treatments and would introduce risks for patients in this era of increasing complex treatments.

The NCCP is developing a comprehensive oncology drug management system comprising evidence-based treatment protocols, technology review and a national oncology drugs budget, including a national register of patients. Money will follow the patient when the system is implemented in 2013. The overarching plan will ensure access to effective drugs and best value for investment of very scarce resources and the means to ensure compliance with national standards of care.

I welcome the Minister of State, Deputy Kathleen Lynch, to the House, even though I am very disappointed with her response to the Bill. It is a problem for the Government that it has been absorbed by the permanent government. Today, another Minister of State abolished voting rights in Gaeltacht areas because the civil servants told him to do it and it was to save money as well.

That is inaccurate.

I think that is what has happened here.

How can Senator Barrett say that? Does he have an insight into this?

We asked the Minister of State at the Department of Arts, Heritage and the Gaeltacht, Deputy Dinny McGinley, to justify how he changed his mind in two years from being pro-democracy.

Let us turn to this matter. There is always a committee and the Department of Health claims it is in favour of fairness. However, if one looks at the size of the waiting list as well as the extension of the medical card scheme to those over 70 years, even though it was known this would be regressive in the absence of a means test, one will see the Department of Health has no record of acting fairly. It is wrong that it behaves like it did just now.

I regret that the Bill proposed by Senators MacSharry, Crown and Darragh O'Brien has been received so unfavourably. There is evidence that drugs are an effective way of treating cancer. I think the Senators should get that fact on the record. In September 2004, an article in The Lancet by Nick Bosanquet and Karol Sikora stated that in the 1980s, 66% to 69% of spending in the United States on cancer treatment was on hospital care and only 3% to 6% was on drug treatment. Since 1990 there has been a shift away from hospitals towards treatments in the physician’s office and drug-based treatments. The amount of money mentioned as being spent on drugs is a fraction of the total health budget.

There should be more open-mindedness in the Department of Health because when one looks at the Milliman report on costs in VHI, it shows that treatments which internationally should take 3.7 days take 11.6 here. They put that down as the major reason for VHI's problems with high costs. These costs include €1,000 a bed per night, and the nights seem to glide by. I understand the Department has Milliman back to advise it. Given the high cost of hospitalisation in Ireland, to say we will not use drugs because they would cost too much money seems to be a false economy. It is not where much of the money is spent and it goes against the trends I mentioned.

It was estimated by the Lancet Oncology Commission in September-October 2011 that from 1980 to 2010, anti-cancer medicines increased life expectancy of the average patient with cancer by almost one year at a mean cost in the USA of $6,500, a sum of money which would not keep an Irish patient in a hospital bed for three nights. When the Minister of State threw away the prepared script, she referred to the high cost of institutionalisation when she spoke on the treatment of old people. One must have an open mind to what Senators MacSharry and Crown have said about these drug treatments. One must also look at the very high cost of institutionalising a patient in Ireland, as outlined in the Milliman report. We need to open our minds. The Minister of State referred to the monopoly suppliers of drugs, but how does that compare with a health service that doubled the number of staff from 55,000 to 110,000 since the mid-1980s and has extremely high costs? It has always protected an attempt to have a monopoly health insurance company in the country. The issues raised by the two Senators relate to drug treatments for patients, who we are always supposed to put first and I hope that we always will do. They deserve more consideration than the Department has given them.

I welcome the Minister of State to the House and the initiative taken by Senators MacSharry and Crown in introducing the Bill. It is important that we debate the issue but I am concerned about the Bill. Section 3 states: "The Health Service Executive shall ensure that all prescribed medicinal products necessary for the treatment of cancer, as approved by the European Medicines Agency, are supplied to all persons who are cancer sufferers who require cancer treatment as certified by a registered medical practitioner." I know that the idea for the legislation by both Senators is very much on the side of the patient but the section will, if enacted, cause problems for the Department and the HSE. Litigation will follow from the Bill because it simply does not give any room for negotiation by the Department or the Minister on issues related to drugs. A drug manufacturing company could set its price for a drug because the legislation clearly states that once a drug is approved by the European Medicines Agency and is prescribed by one person then it must be provided. My problem is that the Bill removes all negotiating powers from the Minister and the Department when they deal with the drug manufacturers and distributors. The legislation would pass power to the manufacturers and distributors. The idea behind the legislation is welcome but my concern is that its format would create a legal problem.

I am always concerned about legislation that refers to regulation as is done in section 4. I have debated regulation here when a Member tried to introduce legislation to give a Minister the power to introduce a regulation on nursing homes. A lack of legislation led to the Department of Health having to pay back over €400 million between 2004 and 2008. Today I am worried about section 4.

Cancer care is an extremely important issue. We must be extremely proactive and give every possible support to the medical practitioners concerned. Over the past 20 years major progress has been made through their initiatives. They have taken on challenges and crossed the line when no-one expected them too. They provide a great level of care and support and have developed new drugs and treatment methods. That progress came as a result of dedicated and committed staff.

The HSE and the Department of Health have been proactive in making sure that we develop a far more comprehensive way of dealing with cancer. For instance, in 2007 services were re-organised in order to achieve better outcomes. Four designated cancer control networks and eight cancer centres with multidisciplinary teams were established. Before that only one or two people provided treatment in smaller hospitals but they did not have the necessary backup. There were a lot of complaints about the introduction of a new system in 2007 but it was the correct step forward and we have moved on. The bulk of the 2007 proposals have been put in place and have achieved the results that the programme was developed for.

The HSE's plan for the future has been clearly set out and will provide a continual assessment of new drugs as they become available. The Minister of State referred to the recruitment of a pharmacist that will lead to the development of more than 300 national treatment protocols and that is extremely important. There will be a development of national protocols for drug usage and to assist budget planning for the HSE in order to ensure that we get value for money. That too is extremely important. We have a large number of people to care for in this country and it is important that everyone can access care. With cancer care, time is of the essence and it is important that we have the facilities, personnel and can give support. We also need to be conscious of the careful use of available budgets and that funding is used efficiently. The problem with the legislation is that it does not give the discretion to the Minister to deal with drug manufacturers and distributors. Interestingly, over the next few years the patent for quite a number of drugs will expire and the Minister will be in a stronger position to negotiate. The Department will publish the health (pricing and supply of medical goods) Bill in 2012 within the next few weeks that will ensure that we reduce the cost of drugs used for medical treatment. At the same it will ensure that we get the best possible medication available for patients that require it. I am on the same side as the Minister of State on this occasion and I oppose the Bill.

I thank the Minister of State for her attendance and Senators MacSharry and Crown for the work that they have put into the Bill. I would love to know who wrote her script and I know her well enough to know that she did not. I also know the Minister well enough to know that he probably did or had an input. I find the congratulatory tone at the start of the script that the Minister of State read — I do not believe it to be her words — nothing short of condescending. Two Senators have worked exceptionally hard to put together good legislation but her script is littered with insults. It sounded like she was reading to a group of seven year old children and not to a group of Senators, a professor who is a leading oncologist in the country or to Senator MacSharry, our health spokesperson. I shall explain why.

At least at the start of her presentation she said that she rejected the Bill and that is fine. Later she said: "The objectives of this Bill are contrary to this mission and its enactment would lead to an inequitable, and in some cases unsafe, system of healthcare." She also stated the obvious that: "Many cancer drugs have serious side effects and risks to patient safety grow as the number of multidrug regimens expands and oral chemotherapy becomes commonplace." What is the EMA for? Fianna Fáil proposed, in conjunction with Senator Crown, that the EMA will be the licensing authority and it will not grant a licence for a drug that is unsafe. The Minister of State basically said that the Bill and the Senators' proposals will lead to an inequitable health service. That is absolute rubbish.

Section 5 gives the Minister firm powers. Senator Colm Burke referred to sections 3 and 4 but handily forgot to mention section 5 which states: "The Minister shall affirm or deny the provision of a medicinal product if he or she deems it to be the appropriate decision and while the Minister's decision is final". The Minister does not even have to tell us why.

I mentioned section 3.

The Senator mentioned sections 3 and 4 but he did not refer to section 5.

I was trying to assist the Senator.

Ar aon nós, I did not interrupt the Senator. This is quite serious. This is well thought out legislation but not necessarily without imperfections. We ask that the Bill go to Committee Stage and that amendments be allowed. Time and again, any legislation introduced by the Opposition, regardless of how good, is rejected. I was surprised not to see one phrase——

Senator John Crown got the last Bill through.

Senator Darragh O'Brien to continue, without interruption.

If the Senator does not like what I am saying, tough, but this is the reality. The one phrase that is missing is "unconstitutional", which is the usual response from Ministers to this side of the House. I have immense regard for the Minister of State but I know she did not write the script. I doubt if she believes much of what she has said. If people were to examine the Bill with a cold eye, they may see imperfections in it, but why not allow it go to Committee Stage? It does not seek to set up in any shape or form an inequitable treatment for cancer sufferers above and beyond that provided for others. It simply tries to legislate for speedier access to drugs approved by the European Medicines Agency for those suffering from cancer, which is one of the most prevalent diseases and affects every family. As Senator MacSharry said in regard to skin cancer drugs, it removes the public outcry element where people have to fight tooth and nail to get drugs they know are available in other EU countries. This is not rocket science and it leaves the final decision with the Minister. The Minister of State said, "Furthermore, a Bill on the pricing and supply of medicines will shortly be brought before the House." When? Do we have a date for it?

What does "shortly" mean? Perhaps the Minister of State's official can inform her.

That is excellent. That Bill is on pricing but what we are talking about is the licensing and availability of drugs. The Minister of State said there was no need for legislation to improve access. Does she believe that? Perhaps her officials believe that. I do not believe it.

I do believe it.

It could well be that the Fine Gael press office believes there is no need for legislation to improve the process. I would ask cancer suffers and listen to what Senator John Crown said in regard to Ipi and what happened there.

It is now available. There is no problem with that.

It would not be available without a public outcry.

That is for sure.

It is simple, because in the Department of Health and the HSE the Minister acted only when the issue was raised on the public airways day after day. Please do not tell me the Department was planning to introduce the drug. As the Minister of State said at the beginning of her contribution that she is rejecting the Bill, there is no point in making a plea for her to accept it. The manner in which it is being rejected is extremely disappointing. I ask the Minister of State to convey that message to the Minister, Deputy James Reilly. When Senator MacSharry comes back in I am sure he will raise some points. The Bill seeks access to cancer treatment. Some of the points made by the Minister of State are obvious such as that many drugs have serious side effects. Of course they do, we know that. Let us examine the case of how drugs are assessed already and when they can go out on the market. Some patients are different than others.

Senator MacSharry asked that the Bill be allowed go to Committee Stage and that amendments be made but it was rejected flat out. The view of my party is that it is rejected on erroneous terms. The Government's approach is, frankly, insulting. I ask Members who have not read the Minister of State's script to read it. I do not blame the Minister of State. I ask Members opposite to take off the party cap and read it and then read the Bill and what it seeks to achieve.

The Senator has less than one minute remaining.

That is good for the Senator.

How can the Minister of State make this response to the Bill? The response is very disappointing. Is that Bill being brought to the other House next week?

It is being brought here next week.

When will it be enacted?

It has to be adopted first.

That is a simple question. The Minister of State said, "Furthermore, a Bill on the pricing and supply of medicines will shortly be brought before the House." When?

I ask the Senator to conclude.

The Minister of State's approach and that of the Department of Health is nothing short of disgraceful.

I welcome the Minister of State. I welcome Senator MacSharry's call that the Bill be debated in a non-party political and calm manner. I will be led by the Senator in that regard. I am quite certain that Senators Darragh O'Brien, Crown and Barrett do not intend to disrespect their colleagues in the House by suggesting that the Minister of State's contribution has been spoon-fed to her by some faceless bureaucrat, and Senator Colm Burke's contribution likewise.

Get a life, John.

Senator Gilroy to continue, without interruption.

The script has been proofed by one Dr. Susan O'Reilly of the NCCP over whose credentials Senator John Crown might stand. Before the Senator gets on his high horse and insults the Minister of State, Senator Colm Burke and me for being spoon-fed, the well thought out element of the Bill is not all on the one side. I suggest the Bill is not too well thought out at all. Section 3 seeks to provide for a statutory obligation to access certain drugs and section 5 contradicts that by allowing the Minister to overrule it. What do we have? Do we have a statutory obligation or not? Perhaps the Bill is not thought out as well as its proponents say.

The text of any Bill must stand on its own. If the text allows ambiguity to creep in, the fault lies with the text of the Bill. The interpretation of any Act by the courts will be, in the first instance, interpreted by the text and, second, by the intention. We need to be very careful about the text of the Bill. That is the point I tried to make when the Leas-Chathaoirleach cut me off. I welcome the Bill as it draws public attention to a topic that is of very great importance and certainly its aims are such that it would be difficult to disagree with them. We know the number of deaths from cancer each year and the number of people affected by it. We agree that everything possible and practicable should be done to provide treatment and support for people thus affected. I commend the proposers of the Bill for making that point.

The aims of the Bill are commendable but the drafting raises concerns in some areas. It is difficult to argue that all possible steps should not be taken in support of cancer treatment but one immediately obvious concern is that, if passed, the Bill would place a potential cost on the State that may prevent the fair use of limited resources across the totality of the health service provision. If adopted it would charge the Minister to provide an almost unlimited access to treatment which, in the context of limited resources, within the health service may cause limits to be placed on sectors in other areas. This cannot by any measure be seen to be an equitable use of resources. When we have limited resources we must use them as efficiently and as fairly as possible and by definition these limited resources must be spread across all medical specialties. In a world with unlimited resources we could do that. Unfortunately, in this case it is not possible. What I am saying is that — Senator John Crown referred to it — a policy of unlimited funding for certain cancer drugs, however desirable, at the discretion of individual providers protects one sector of health programmes at an opportunity cost to other sectors. Everybody will agree this is not equitable. If we were to spend X plus €1 in one specialty that means, in our limited world, we must spend X minus €1 in another specialty.

Is the health budget split equally across every area?

Is the health budget limited if we spend X plus €1 in one area we must spend X minus €1 in another area? The other area could equally be as life threatening as the first. There is a responsibility on the Government, the Department of Health and the HSE to set appropriate priorities and make decisions in the interest of the entire population. This Bill undermines that responsibility. It must be noted that our research, which I conducted along with our research team, has failed to uncover any other national precedent for this Bill elsewhere in the world. We cannot find one. Section 3 seems to allow the prescription of all "medicinal products necessary for the treatment of cancer", as approved by the——

On a point of information, can the Senator clarify precisely what his research failed to uncover?

The Senator has spoken already.

I am sorry. I could not hear Senator Gilroy.

The record will show what he said.

He said that provision like this has not been made anywhere in the world.

I did not say there is no example anywhere in the world.

I said my research has failed to identify such an example.

That is a different thing.

I am not saying it has not ever been done.

This is pioneering legislation. We do not have to look to other jurisdictions.

Senator Gilroy to continue, without interruption.

I appreciate the protection the Chair is giving me from the unreasonable heckling from the other side of the House, which seems to possess the totality of knowledge on this matter. Section 3 seems to allow all "medicinal products necessary for the treatment of cancer, as approved by the European Medicines Agency" to be prescribed by a "registered medical practitioner". I suggest this is at variance with best practice. It is likely that it would be done without the benefit of multidisciplinary assessment and support. Therefore, it would probably not be in the best interests of patients. Section 3 refers to the approval by the European Medicines Agency of "products necessary for the treatment of cancer". The agency approves new drugs for sale but it does not——

The Senator has one minute remaining.

How come I only have one minute remaining?

I apologise. I had forgotten that the Senator is his party's spokesperson in this area.

I thank the Chair. The European Medicines Agency approves new drugs for sale but it does not play a role in deciding the most effective——

I understood that everybody has six minutes, with the exception of those who have proposed this legislation.

Yes. Senator Gilroy has one minute left.

I thought the Leader of the House said on the Order of Business this morning that spokespersons would have eight minutes.

According to the advice I was given when I was in the Chair, everybody has six minutes apart from the proposer of the Bill.

Everybody has six minutes on Private Members' business.

Will there be some added time at the end of this speech?

I suggest that if we agree to this proposal, we might build a cost into certain drugs and products, as providers will be conscious of the statutory obligation on the health service to provide these products. Therefore, the effect of this Bill could be exact opposite of its intent. When a new drug is introduced, its price generally falls when it is widely produced. If there is a statutory obligation on the State to provide these drugs, it might perversely incentivise drug companies to keep their costs high. That would be contrary to the intention behind this legislation. I would be open to accepting this well intentioned and well meaning Bill if it had not been drafted wrongly. Sections 3 and 5, at least, need to be redrafted because they are contradictory.

A little more thought needs to be put into it.

I am not an expert in the health area. Any time Senator Crown speaks in this House on one of his areas of expertise, his word is good enough for me. As the Minister of State, Deputy Kathleen Lynch, said, he is working at the coalface. His remarks this evening seem to be at variance with the written script provided by the Department of Health. The Minister of State is always welcome in this House. She is a long-standing friend and colleague of mine. I have rarely seen her so uncomfortable when reading a script. She departed from it on a number of occasions. She almost distanced herself from it.

That is not true.

That is not true.

I know the Minister of State can speak for herself. I am merely outlining the perception I had. I would like to nail a few canards that have come up during this debate.

I am just uncomfortable about being disrespected.

I am absolving the Minister of State totally of responsibility for her script.

I am just uncomfortable about the manner in which I was disrespected and heckled by Senator Crown.

The Minister of State interrupted me. No one is disrespecting her.

I was not trying to offend the Minister of State. What did she say?

I ask the Senator not to invite trouble.

I did not hear what she said.

I said the only reason I was uncomfortable was that I was being heckled in a disrespectful way by Senator Crown.

I did not expect that.

I would like to speak about the European Medicines Agency. My understanding is that all drugs that are approved in this country come through European sources. The European Medicines Agency is the primary association or institution for that. I take some offence at the part of the Minister of State's speech that referred to "many factors" shaping decisions, including "benefit to patients, quality of evidence, existence of alternatives, treatment duration [and] potential to save lives". The Minister of State said "these factors are not part of the EMA evaluation", but I understand that is not the case. As a layman, I have to wonder what the agency is for if such issues do not come before it. The script refers to "scientific evaluation".

That is the drug.

I am just saying that I question whether the script, as written——

The licence is for the drug.

Perhaps the Minister of State will have an opportunity to reply to that. If the European Medicines Agency is not involved in assessments of this type, what is it for? The Minister of State also said "drugs and new technologies will always hold greater appeal than, for example, preventative medicine". I think Senator Crown took offence at that statement because it seemed to suggest there is something wrong with drugs and new technologies. In fairness to him, he pointed out on two occasions that some drugs and new technologies extend the lives of unfortunate cancer patients by a short period only, which would not be cost-effective. That is why I am questioning the presumption in the Minister of State's speech. She said that "Senators MacSharry and Crown claim that this Bill will improve access of cancer patients to much needed drugs". She also said that the "mission of my Department and the health system is to improve the health and well-being of people in Ireland in a manner that promotes better health for everyone, fair access, responsive and appropriate care delivery, and high performance" and went on to say that the "objectives of this Bill are contrary to this mission". Was that not a gratuitous insult? Have the proposer and seconder of this legislation not already stated plainly that this is about improving the health and well-being of people in Ireland and promoting better health?

Where is that in the text of the Bill?

We have been told that the objectives of the Bill are contrary to this mission.

The Minister of State also said that the enactment of this legislation "would allow single handed medical practitioners prescribe these complex drugs". Senator Darragh O'Brien has already pointed out that Senator Colm Burke did not mention section 5, which provides that "the Minister shall affirm or deny the provision of a medicinal product if he or she deems it to be the appropriate decision".

Section 3 says the opposite.

Senator Mooney to continue, without interruption.

Section 3 refers to products being "prescribed". Section 5 makes it quite clear that the decision ultimately rests with the Minister of the day. If "he or she deems it to be the appropriate decision"——

Sections 3 and 5 are contradictory.

I do not want to be interrupted by a man who came in here with a written script.

On a point of order——

It was party propaganda.

On a point of order——

There will be no point of order. I am entitled to make a political point.

I will take the point of order.

All the Senator is interested in doing is hindering this debate.

Let us hear the point of order.

The Senator has been doing nothing other than intervening since he came into the Chamber.

Senator Mooney, please.

Please allow me to finish.

Senator Gilroy has a point of order.

I want Senator Mooney to withdraw the comment that I came in here with a written script.

I will not withdraw that comment. The Senator had a written script.

I wrote the script myself before I came into the Chamber.

I said the Senator came in with a written script.

The Senator is somehow——

It is not a point of order.

It is not a point of order. Senator Gilroy is trying to eat into Senator Mooney's time. That is all he is doing.

I think Senator Mooney should withdraw the comment.

If the Senator is looking for a point of order, I will point out that Standing Orders refer to the convention in this House that Members do not read scripts.

I will not take lectures from the Senator about the protocol in this House.

If the Senator wants to make a point of order, that is my point of order. I am not giving a lecture. I am advising the Senator to read Standing Orders.

I ask Senator Gilroy to resume his seat.

Section 5 makes it quite clear that the Minister of the day "shall affirm or deny the provision of a medicinal product if he or she deems it to be the appropriate decision and while the Minister's decision is final [irrespective of what is in section 3] he or she may, during deliberations, consult" a variety of other organisations.

The Senator has one minute remaining.

As always, you are ensuring we keep on the right of things.

On a point of order——

What is the point of order?

I would like to raise an issue.

My final point is that every country needs to retain responsibility——

Senator Mooney, please. There is a point of order.

Senator Mooney is referring to section 5 of the Bill. There is no cross-reference——

That is not a point of order.

That is not a point of order.

I ask Senator Burke to resume his seat.

Senator Mooney is giving incorrect information.

I am surprised that a Senator who has sat in the European Parliament would stand up to make a nonsense point of order.

I ask the Senator to conclude.

The Minister of State said that "each country needs to retain the responsibility for constraining or discontinuing the use of a drug if safety concerns arise". At the risk of sounding boring at this stage, section 5 makes it perfectly clear that "the Minister shall affirm or deny"——

There is no reference to section 3.

Section 5 is part of the proposed Bill. The Senator can make his argument about the other section all he wants.

Section 5 contradicts section 3.

Section 5 makes it clear. I will leave it at that. I commend the Bill to the House.

I commend the Senators for introducing this Bill. It is important we have a reasoned discussion on this topic. We do not live in a Utopian society. We have to deal with many issues in this House. The references to the Minister of State reading a script were most insulting.

I have known the Minister of State for some years.

I knew her before she was a Minister of State. She was never a puppet on a string.

What does that have to do with anything?

On a point of order——

What is the point of order?

Will Senator Keane concede for one moment?

Senator Keane should resume her seat.

My point of order is that I never impugned the integrity of the Minister of State. She has been a long-standing friend and colleague of mine and I have tremendous admiration and respect for her——

That is not a point of order. I ask the Senator to resume his seat.

It is most unfair of Senator Keane to be implying that when it was not the intention.

Does the Senator know that I was referring to him? I was not. The speaker before Senator Mooney said the Minister of State was reading from a script that she did not agree with and that it was written by civil servants or some other body.

That is not what I said.

We will have to get Ursula Halligan to ask her.

To say that any Minister of State would be led into this House with a noose around her neck to jump through hoops is a total insult. She is an opinionated Minister of State and I admire her.

The record of the House will speak for itself.

I ask the Senator to check the record of the House. That is not what I said. I said she was reading a script. She was, she is and she did not agree with most of it.

Senator O'Brien, please.

Can we get back to debating the Bill, not the Minister of State?

The record of the House will speak for itself.

We will reread it into the record of the House tomorrow. I admire Senator Crown and his expertise in the field is second to none. Mine is not but mine is in the field of politics and reasoned debate.

The fifth point refers to consultation with the Minister and recommends that the medical oncologist, the national cancer control programme, the National Centre for Pharmaeconomics and the Haematology Association of Ireland are all consulted by the Minister. The Bill leaves out one body. We do not have an infinite amount of money so we should include the body that deals with the accountability for a reasonable framework when making a judgment. People should use their own reason and ensure it is fair, legitimate and allocates expenses, although expense never comes into——

We will be pleased to accept that amendment.

Can we allow Senator Keane to speak without interruption, please?

I am surprised Senator Crown admitted there was a tiny flaw in the Bill.

We have not yet reached Committee Stage.

I listened to Senator Mary Ann O'Brien and my heart went out to the idea of having money available for disabled children and everyone else. I want to have every modern medicine for cancer made available but I also want to ensure modern medicine is available to disabled children, the needy and the poor. One cannot be totally unreasonable and expect that, no matter what manna comes from Heaven, it is there with the click of a finger. One must use different yardsticks.

The statement of the Minister of State refers to a Bill that will include all variations. I want to wait until the Bill is before us. The Minister of State said that the health (pricing and supply of medical goods) Bill will be brought before the House shortly. It will involve a statutory basis for decisions on decision-making on medicines. Who is charged with statutory decision-making? We are not doctors, although Dr. Crown is. I am not a doctor but I am charged with statutory legislative responsibility and I cannot agree only with my soft side, which wants to agree with Senator Crown and make it all available now. The other side is that I am also charged with statutory legislative responsibility. I must also take that side into account.

In cancer treatment, medicine is one aspect but cancer care is another. In the case of a patient I know, a consultant failed to follow up after markers were raised. The person was suffering, knew she was not in remission but was told by the consultant that she was in remission. The people involved were not on the east coast but on the west coast. She had to ensure the scan was read properly. The diagnosis was made in 2007 on another issue and it was noted as urgent but not acted on until 2012. That was not a failure of money or a failure to get the patient into the system. The person was in the system and there were medical flaws in the system. It is not only medicine into which money must go. The Minister of State has an important statement on the national register of patients. I have chapter and verse of people who have been neglected because of issues other than the non-availability of drugs. It is a major issue but not the only one. I want to ensure private patients are not treated better than public patients. Everyone should treat public patients.

I thank the Fianna Fáil Senators and Senator Crown for bringing forward an important item of legislation. It is not without flaws but it is useful and could be amended if the Government so wished. It is regrettable that we had unnecessary rancour associated with the discussion today. The petty political point scoring I witnessed in respect of scripted speeches did this debate no justice but it is a matter for those who made comments.

Cancer affects all of us and there is not a single Member who has not been affected by the scourge of cancer. We should all be committed to doing what we can to improve cancer services, access to treatment and access to medicine. It is also important to have access to infrastructure, which is necessary in some parts of the country in order to deliver the cancer services many people need.

This is a topical issue because it has been in the public domain for the past few months. One man in Ashbourne, County Meath, is suffering from advanced malignant melanoma and he used the medium of national radio to make a plea for the life-saving cancer drug, IPI. It would have made a major difference to him, his health and his long-term prospects but he had to try to raise the money to get treatment in the US. This added trauma to the illness he has but, thanks to his efforts and those of Senator Crown, the Government's hand was forced. I was very pleased that the Taoiseach announced the drug would be made available to cancer patients with a very aggressive form of malignant melanoma. At the time, Senator Crown said the €4 million investment required to provide the drug to patients was money well spent and worth the cost. I agree with that point.

I agree with the Government that we must weigh up the value of the cost of various treatments but we must put it in the context of the money wasted in our public health service. That must be taken into account. The previous Government must take responsibility for that. It is uncomfortable for some to hear that private consultants are still carrying out private practices in public hospitals and availing of taxpayers' money to do so. That practice should end. The Government laboured this point when it was in opposition but it is one of the sacred cows in the health service that needs to be taken on. That would save money that could be used towards drugs. The blunt instrument of the recruitment embargo leads to unnecessary expenditure on agency workers. The Minister has done some work in this area but much more needs to be done. The chief executive officer of the Health Service Executive, Mr. Cathal Magee, recently acknowledged that its auditing structures are not up to scratch. That has cost us money. We heard in recent days of the incidence of significant fraud at Cork University Hospital, which was only belatedly identified. The Health Information and Quality Authority has an annual budget of some €20 million. The Health Service Executive spends huge amounts of money on communications consultants. We are all agreed that the cost of drugs is far too high. While the Government has gone some way towards encouraging the use of generic medicines, we are still spending far too much in that area. All of these issues require urgent attention. The Government's time would be far better spent in seeking to achieve appreciable savings in those areas where savings can be made, which would free up resources for the provision of drugs and treatments that patients require.

It is a cause of serious concern that the National Centre for Pharmacoeconomics, which advises the HSE, has apparently blocked the reimbursement of a number of key drugs, such as ipilimumab, thus preventing their availability across the entire health service. Many people in the health care sector are of the view that the centre's criteria for assessing new drugs have become much more stringent in recent months. Even where medicines are approved for reimbursement, the necessary funding is not being provided to allow them to be prescribed for patients. The pharmaceutical and insurance industries cannot be allowed to hold people to ransom, as happened in the case of ipilimumab.

That is what this Bill does.

Senator Cullinane should be allowed to continue without interruption.

The intent is different.

I accept that it is a difficult issue to deal with, but the Government must do so.

Apart from the availability of medicines, another key issue for health service delivery is the provision of infrastructure. My county of Waterford — the south east as a whole — still does not have the type of cancer services infrastructure that is needed. The previous Government committed to the delivery of a fully dedicated and integrated oncology unit, with the three modalities of cancer care to be provided on-site at the public hospital in Waterford. That commitment was not met. We have a fantastic oncology team in Waterford but we do not have the types of facilities that are needed. It is the only region in the country, for example, without a hospice unit. There is an urgent need for capital investment in the south east, as I am sure is also the case for other parts of the country. The previous Administration produced a very good national cancer care strategy. Unfortunately, because of the economic situation in which we find ourselves, the capital investment required to deliver the strategy has not been forthcoming. An effective cancer care service requires not just access to medicines but also the provision of the world-class infrastructure necessary to provide the cancer treatment citizens require.

I join colleagues in commending Senators John Crown and Marc MacSharry for bringing forward this Bill. We all recognise that their intentions in doing so are absolutely honourable and that they have patients' interests at heart. There has been some criticism of the script delivered by the Minister of State, Deputy Kathleen Lynch. While other Senators want to know who wrote it, I want to know who typed it. I cannot read it because the print is so small. It was proofed by Dr. Susan O'Reilly, director of the national cancer control programme——

On a point of information, has it been confirmed, officially and on the record, that Dr. O'Reilly was responsible for the script?


Senator Moloney to continue, without interruption.

It is a cause for grave concern. If Dr. O'Reilly really believes that the European Medicines Agency approved drugs without due concern for health and safety, there is something very wrong with our democracy.

I ask the Senator to resume his seat.

I will withdraw what I just said because I am not absolutely sure it is correct.

I have asked Senators to refrain from referring to named individuals.

It was proofed by, not written by, Dr. O'Reilly.

People who are not here to defend themselves should not be named in the House.

I will withdraw what I said because I am not entirely sure it is the case. It is just what I have been told.

As a person with no medical background, I find it somewhat difficult to follow somebody like Senator Crown who has such an immense knowledge of oncology. It is his field of expertise. However, what chiefly struck me in reading through the Bill was my concern that the provisions in section 3, if enacted, would leave the State open to legal action by a cancer patient or his or her family.

They certainly would.

Notwithstanding the veto afforded to the Minister under section 5, the section 3 provisions leave open the possibility that any patient could go to court on the basis that he or she has an entitlement to a particular drug regardless of the price. That is my major concern.

Senator Crown spoke about a drug which, because it cost €100,000, he could not justify prescribing in order to prolong a patient's life. I do not envy him the task of telling a person that he or she cannot receive a particular drug because it is too expensive. I was contacted some time ago by a person who had been refused treatment with a drug called Zytiga, produced by Johnson and Johnson. Even though it was approved for use in the United States last year and has also been approved for use in Europe, including Ireland, the Health Service Executive has refused to reimburse it. In other words, cancer patients can access it only if they pay out of their own pockets. The cost is so prohibitively high, however, that oncologists in this country are not even offering it to patients. This is particularly disturbing given that trials in the United States showed that it significantly slowed down the progression of bone metastasis and offered significant pain relief to thousands of patients. This is a drug that could potentially significantly extend the life expectancy of a category of cancer patients.

While focusing on access to cancer treatment, the Bill seems to ignore the issue of access to cancer services. I have called repeatedly in this House for the universal provision of medical cards for cancer patients. I spoke recently to a constituent who was refused a card despite being in active treatment. That is absolutely unacceptable. The Government has given a commitment to provide medical cards to all persons with long-term illnesses. The reality, however, is that some people in that cohort are quite wealthy and can well afford to access medical assistance. Our priority at this time should be to ensure that anybody undergoing cancer treatment is eligible for a medical card.

I would have liked to see an emphasis in the Bill on cancer services as well as treatment. We all realise that certain drugs are so costly that their provision under the public health system at this time is simply not possible. My main concern, however, is that the Bill contains provisions which might leave the State vulnerable to legal action.

I propose to share time with Senator Mark Daly.

That is agreed.

I am quite flabbergasted by the attitude adopted by certain Government Senators in regard to this legislation. I commend Senators Marc MacSharry and John Crown — the latter of whom is a professional in this field — for the work they have put into drafting the Bill and presenting it to the House. I would have hoped that in the case of a proposal that affects almost every family in the country, the Government might approach the debate in a proactive and rational manner. Instead it has merely adhered to a rejectionist position. Indeed, the first line in the speech by the Minister of State, Deputy Kathleen Lynch, indicated the intention to reject the Bill. That is dreadful.

If the Government is serious about drafting alternative legislation in this area, why will it not allow this Bill to proceed on Second Stage and introduce amendments thereafter, either in this House or in the Dáil? That would be a constructive approach which brings the expertise, professionally and otherwise, of Senator Crown and others into consideration. To reject it outright does no service to current and future cancer patients. It does no service to this House. When it comes to an issue like this, we should be above playing politics.

The evidence internationally, as outlined by previous speakers, shows that where medicines are available to the greatest extent possible, the lives of cancer patients can be extended and the quality improved. If the relevant drugs are approved by the European drug approval authority, we should accept their considered, professional opinion and not question it. It appears to me that by rejecting this Bill, we are insinuating that we are rejecting the European approvals that are being provided.

The Bill gives total scope to the Minister of the day.

It gives the Minister total scope. Section 5 of the legislation allows that, following consultation, if the Minister believes a drug should not be used, he or she may issue a decision to that effect. It gives scope to the Minister and I cannot understand where the difficulty lies. The Bill is very simple and I cannot see why it cannot be accepted.

Cancer patients are being attacked from every angle. I have a letter from the HSE concerning cancer services in my constituency, which I received earlier today. The bus operator who provides a transport service from Donegal to Dublin for cancer and other patients was informed at 12.15 p.m. today that the service was being discontinued because it costs €100,000. At the moment, cancer patients cannot even get carer's allowance. I know of three or four cancer patients in St. Luke's who cannot go home because they have no-one to look after them because their carer's allowance applications have been refused. We must examine the wider issues surrounding cancer care.

The drugs issue is primary to extending life. It is not about playing politics. I was listening to the debate in my office earlier and was absolutely shocked at the direction in which this debate was heading, from a Government point of view. It is very regrettable.

We were shocked too.

Yes, and so you should be. There are Senators in this House who put forward legislation on a non-partisan basis.

They were well meaning.

It is being rejected outright, without any constructive engagement whatsoever. That leaves a lot to be desired.

In 2008, over 1,200 people were diagnosed with melanomas in Ireland. Senator Crown presented evidence on drugs such as ipilimumab, which can improve the life expectancy of such patients. A new drug that has been developed for the treatment of prostate cancer was rejected outright on the grounds of cost-effectiveness by the National Centre for Pharmoeconomics. Who are these people? Can they answer to the families of patients who have been refused very important drugs? These people are not responsible to the public which is why I believe that passing the onus of responsibility to a Government Minister would be much more prudent.

It is regrettable that this Bill is not being accepted in a constructive, bipartisan manner, in order to pave the way for amendments to be tabled, if desired, in this or the other House on Committee Stage.

I welcome the Minister to the House. I commend Senators MacSharry and Crown for introducing this Bill. Senator MacSharry is well aware of the importance of cancer, having fought the fight in his own family in Sligo for many years. Many families have been affected by cancer and we all know someone who has suffered with the disease. The Bill is given added weight by the inclusion of Senator Crown's name on it because there is no one in this building who is more qualified to discuss cancer treatment than him.

The response we have received today from the officials in the Department is disgraceful. I draw particular attention to the following:

Many factors shape decisions around access to therapeutic interventions. These include benefit to patients, quality of evidence, existence of alternatives, treatment duration, potential to save or prolong lives, total population of patients affected and cost to the system. These factors are not part of the EMA evaluation.

As far as I am concerned, that is not correct.

This Bill is timely in that it proposes to place access to cancer treatment drugs on a statutory footing. Senators will be aware of the instance where, through the intervention of Senator Crown and others, a cancer drug was made available to a patient, but only because the case was highlighted in the media, on "Liveline" and elsewhere. If that is the way the health service is run then it is very easy to see why it is not working properly. Cancer treatment drugs should not be made available just because a Senator and media personalities highlight certain cases and the Government running its cancer services on such a basis is not acceptable. This Bill attempts to make the provision of cancer drugs more efficient and to set it within parameters than anyone can follow. The guidelines laid down would mean that patients who need a particular treatment would get it. To see a patient who badly needs a drug getting it only because of the intervention of a Senator who, in a personal capacity, contacted the media rather than on the basis of legislation such as the Bill before us is appalling. The fact that a media campaign resulted in a patient receiving the treatment required is an illustration of crisis management at its worst. This Bill is an attempt to regularise the system and make sure that people who need it get the treatment required.

I have read some of the contributions to this debate but I am no expert in this area. However, when someone of the ability of Senator Crown puts his weight behind the Bill and the Government dismisses it with contempt, it is hard to understand. The response to the Bill was written by people who would not be as qualified as Senator Crown.

I was a member of the last Seanad, when Senator MacSharry argued the case for retaining cancer treatment services in Sligo. He went against his own party time and again on the issue and spoke out on it, to his own detriment at times. He had the courage of his convictions. Access to cancer treatment is something he believes in strongly. For people to come into this House and read, verbatim, the reply approved by Dr. Susan O'Reilly, which gives a long and sometimes inaccurate rejection of the Bill——

On a point of order, is the Senator qualified, technically, to criticise Dr. O'Reilly?

That is not a point of order.

It is a point that needs to be made.

I was pulled up for mentioning names.

Senator Daly has one minute remaining. Dr. Reilly is a Minister.

Senator Daly is not talking about Dr. Reilly. He is talking about the person who approved this script and is questioning her credentials.

She is not as qualified——

We have pointed out on several occasions that Members should refrain from naming people who are not present in the House to defend themselves.

I am surprised at my colleagues opposite for intervening when I mentioned Dr. Susan O'Reilly's name, given that they have already put it on the record themselves.

I have asked the Senator to refrain from naming people in the House when they are not here to defend themselves.

I am merely pointing out that the name has been mentioned by others. If someone can mention it in a positive way, it can also be mentioned in a negative way.

If qualified to do so.

I have stated the most qualified person in the Chamber has his name on the Bill which Government Senators are about to reject.

I thank the Cathaoirleach for his indulgence. I support the Bill, as there is no one more qualified than Senator John Crown, while no one has a better track record on the issue of cancer treatment than Senator Mark MacSharry.

I thank Members for participating in this debate. I am shocked, however, having listened to the Minister of State. I will not cast aspersions on any individual, but her script was a disgrace. As I did not interrupt anyone during the entire debate, I expect to have the full four minutes available to me to respond.

If the director of the national cancer control programme, whose name I will not use, despite the fact that others have used it, approved the script, I am calling for her resignation because, frankly, she is incapable. I have not used anyone's name, but she is incapable of carrying out the duties the head of that organisation must be able to carry out if she is happy to stand over the script. In delivering it the Minister of State delivered an answer to a question she was not asked.

May I raise a point of order?

A Minister cannot raise a point in the House.

As the Minister of State cannot raise a point of order, perhaps I might be allowed to continue. Nowhere in the Bill is it stated we should make all drugs available to everyone, whatever the cost. Far from it, it would provide for a process where the patient comes first, not last.

On a point of order, in the context of the Senator's remarks, speeches are drafted by civil servants and checked by relevant experts. Others, as well as the director of the national cancer control programme, approved the speech.

That is not a point of order.

It is a very important point.

This is the first time in ten years that an official has beenallowed to prepare a note to be given in reply to a Member of the House. I object to this; it is wrong.

Senator Mark Daly mentioned that the director of the national cancer control programme had allegedly proof-read the script. This was mentioned by the other side of the House. It was also said the EMA did not consider and evaluate the issues of safety and efficacy. It does. The Minister of State has said the objectives of the Bill run contrary to the mission of the Department. Senator John Crown and I reject this. It is alleged in the script that what we propose would lead to unsafe procedures. We propose drugs be made available as approved and licensed on the say so of the Minister.

Any section of a Bill can be judged to be unconstitutional in its own right and the entire Bill falls as a result. When a Bill is being considered, all sections are relevant. The Government talks about section 3, but sections 4 and 5 are also relevant. Section 5 is explicit in pointing out the Minister of the day would have to affirm. If a drug is approved, the Minister of the day would still have to affirm its provision.

Every speaker, including me, probably has health insurance. The Bill would provide for those who do not have it, who do not have the benefit of VHI. The cost of membership this year for my family is €2,500. I can afford to pay it — lucky me.

It was said it was an abdication of the responsibility of the State to allow the EMA to provide drugs. What clown wrote this script? That is what I think of it — I will rip it up. It is an insult in the extreme.

I ask the Senator to withdraw the word "clown".

To withdraw what.

The word "clown".

For what reason?

A person has been identified.

I withdraw the word "clown" and restate my remarks. The person who wrote this script would be better at juggling in a circus ring than writing scripts for Ministers.

On a point of order, I really think ripping up a script is offensive.

I am sorry if Members find it offensive.

It is very disrespectful of civil servants.

I regret that it is disrespectful because the content of the script shows an inability to read legislation and, as someone said, complete contempt for what we are attempting to do — introduce a non-adversarial Bill. It is non-political in nature and puts the patient first. What we have seen is an exercise in making sure the patient will not come first. This is a sad day for patient advocacy groups. This is simple legislation which was not just drawn up by me; it is co-sponsored by the foremost expert in this field and what has the Government side done? It has rained all over it. Shame on the Government.

I do not take back a single thing I said, including on the issue of clarification which I hope will be provided regarding the involvement of the director of the national cancer controlprogramme in the script which is nothing short of a disgrace and a urination on the rights of patients.

Question put.
The Seanad divided: Tá, 17; Níl, 28.

  • Barrett, Sean D.
  • Byrne, Thomas.
  • Crown, John.
  • Cullinane, David.
  • Daly, Mark.
  • Leyden, Terry.
  • MacSharry, Marc.
  • Mooney, Paschal.
  • Ó Clochartaigh, Trevor.
  • Ó Domhnaill, Brian.
  • O’Brien, Darragh.
  • O’Donovan, Denis.
  • O’Sullivan, Ned.
  • Power, Averil.
  • van Turnhout, Jillian.
  • Walsh, Jim.
  • White, Mary M.


  • Bacik, Ivana.
  • Brennan, Terry.
  • Burke, Colm.
  • Clune, Deirdre.
  • Coghlan, Eamonn.
  • Coghlan, Paul.
  • Comiskey, Michael.
  • Conway, Martin.
  • Cummins, Maurice.
  • D’Arcy, Jim.
  • D’Arcy, Michael.
  • Gilroy, John.
  • Harte, Jimmy.
  • Hayden, Aideen.
  • Heffernan, James.
  • Henry, Imelda.
  • Higgins, Lorraine.
  • Keane, Cáit.
  • Kelly, John.
  • Landy, Denis.
  • Moloney, Marie.
  • Moran, Mary.
  • Mulcahy, Tony.
  • Mullins, Michael.
  • Noone, Catherine.
  • O’Neill, Pat.
  • Sheahan, Tom.
  • Whelan, John.
Tellers: Tá, Senators John Crown and Marc MacSharry; Níl, Senators Ivana Bacik and Paul Coghlan.
Question declared lost.

When is it proposed to sit again?

At 10.30 a.m. tomorrow.