John Crown (Independent)

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", so 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 took place 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.