The hospital groups issue is being discussed today and there are two key elements. I am not an instinctive "save our local hospital" person and I have spoken for many years about the need to reform the Irish health system. The numbers may have changed slightly but as a general rule we had the highest number of hospitals and smallest number of hospital beds of any country in the OECD. That was a few years ago and the position may have changed slightly since. There was a clear and dramatic need for real and fundamental change in the number and configuration of our hospitals, with a particular need to concentrate resources.

We used to have absolute absurdities and even in our capital city, a hospital group had seven small hospitals - all allegedly university hospitals - with cardiology in one, endocrinology in another and some parts of surgery in one hospital and other parts elsewhere. As recently as a few years ago if a person had to have complicated treatment for primary bone cancer, care could be divided among four hospitals, which exemplifies the key need for a rationalisation of resources. I am 100% behind the Minister on the issue.

I am troubled by the bigger administrative picture emerging from this. The model of developing highly-centralised State-owned care in a trust system with a highly-developed cadre of managers is an extraordinarily accurate copy of exactly what happens in the UK National Health Service. The Minister should not take this as an unduly negative criticism but it should be thought through at this early stage of the reform process. It is not the right way to implement the process of money following the patient as money can only follow the patient where the patient goes. If, in a hospital trust system, all choice goes and a patient must go to one hospital, we may as well give the money to the hospital before the patient goes there on the basis of prospective budgeting. The purpose of money following the patient is so the patient can have a negotiable insurance instrument and can go to hospital A or B if he or she does not like the way hospital A is run or that fellow Crown. That is the way the process must be devised.

I am trying not to be pejorative but the copying of the British model to the extent of using the terminology of "trust" is not the way the go. It is easier to do it in places like Dublin where there can be a degree of choice between hospitals but we have seen the ultimate logic of the people being put in charge of this process. We have seen how they have acted in cancer care, and they have tried to take away that choice. Their model would be based on designing the system and deciding how many patients go through it, determining what they see as appropriate standards and auditing to see if those standards are met. Standards can be set high or low, which is the fundamental problem of the health quality movement, as it measures compliance rather than quality.

The Minister is aware that currently in the UK there is a major scandal brewing with regard to the spin-off in the Mid-Staffordshire hospital and health district, where systematic management issues have come to light in one NHS hospital, and as a result the Public Accounts Committee in the UK Parliament has called in the head of the NHS. There have also been calls for his resignation, as well as a focus on the notion of the gagging order culture. If there is a bureaucracy with a manager in charge, with the best will in the world, Acton's law will apply and power will corrupt. If there is no system of competition built in, there will inevitably be an emergence of a system of repression.

I agree with the Minister's comments on the extraordinarily high quality of our nurses and the general very high quality of our doctors. My concurrence with the diagnosis at that stage probably reaches a stone wall as I do not believe the next problem is that we need better managers. We should have the great doctors, nurses, physiotherapists and people who rise through the ranks of a profession put in positions of real leadership instead of being regarded as technicians. Currently, default leadership is provided by highly technically skilled managers who have no capacity for true leadership. We should follow such a model but I fear it will not happen here.

I may have to engage Mr. Bill O'Herlihy to get access to a high-powered ministerial team to make the following point. The Minister will come before the Seanad to deal with the health information Bill, which has within it the seeds of a real problem for clinical research in this country in the centralising, formalising and bureaucratising one of the few elements of the system that works relatively well in the hands of HIQA, the governance of ethical oversight for clinical trials.

I believe in an America where the separation of church and state is absolute; where no Catholic prelate would tell the President - should he be Catholic - how to act and no Protestant minister would tell his parishioners for whom to vote ... I believe in an America that is officially neither Catholic, Protestant nor Jewish; where no public official either requests or accepts instructions on public policy from the Pope, the National Council of Churches or any other ecclesiastical source; where no religious body seeks to impose its will directly or indirectly upon the general populace or the public acts of its officials; and where religious liberty is so indivisible that an act against one church is treated as an act against all.

I believe that two specific actions should be taken. I do not know if there is a formal mechanism through which the Department of Foreign Affairs and Trade or our local consular office in Boston can express the displeasure of the people of this country at the disrespect shown to our democracy by the boycott of the Taoiseach by the Catholic hierarchy of Boston when he gave the commencement address at Boston College. Second, in the spirit of good fellowship in this and the other House, it would be good to agree a policy of 100% voluntary disclosure of all Members of any support, be it financial or otherwise, they have received from any organisations attempting to influence the vote on this critical measure, which could determine the lives of Irish women.

A certain amount of circumstantial evidence would suggest there is a potential interweave between current and former members of Government and of the Minister of State's party with people who have been involved in advocacy and lobbying on behalf of the tobacco industry. Were any of these channels explored in setting up this meeting?

We should have no business meeting representatives of the tobacco industry under any circumstances. There is no agenda item we should ever discuss with these people. The only thing we should tell them is that we intend ending their industry and making it extinct by making it illegal to do commerce in tobacco at some stage in the future. We should advise them to considering divesting, learning new skills, retooling their factories, and telling the farmers to grow something else in a world that is desperately short of food and does not need tobacco. Furthermore, sitting down and doing the arithmetic would show that our State would be richer. If tomorrow morning tobacco disappeared, the Exchequer would be richer and our country would be a richer place.

We need an explanation from the Department of Finance because apparently the primary purpose of the meeting was to discuss smuggling, although it is being reported that it strayed into inappropriate lobbying by the industry against very worthwhile initiatives being taken by the Minister for Health, Deputy Reilly, in another branch of Government to try to row back the access to and sales of tobacco, particularly to younger people, by introducing plain packaging, and banning menthol and roll-your-own tobacco. It has been reported today that there was lobbying against these initiatives and that the meeting strayed far beyond the discussion on smuggling. I am beside myself with rage about this.

As well as that, their close family, their sisters and daughters, have a 50% chance of inheriting the gene which causes breast cancer, if they have the gene. It is important to know this. It is not a tremendously common problem but it is an important one. If it is managed correctly, lives can be saved and the State can be spared costs.

Approximately one in 1,000 people carries the gene and approximately 5% of breast cancers are caused by these genes. The problem is as follows. There is a 12-month waiting list to get a genetic assessment and the only statutory unit in the country that is doing this for public patients is the one situated in Our Lady's Hospital for Sick Children in Crumlin, run by an extremely gifted medical geneticist, Professor Andrew Green. Professor Green, with great vision, set up the service, not with health service money, but with money from research, and from that defaulted into running a clinical service which is, I would say, grotesquely underfunded.

I suspect there is "grotesque underfunding" fatigue when people hear me talk about the health service. Parenthetically, I do not believe it is in general underfunded as I believe it is mal-funded, but this is a case where it is clearly underfunded. However, lest I be seen as somebody else who is whinging and shroud-waving about a deficiency in a health service which is full of deficiencies, in a public service which is underfunded, in a country which is broke, I make the point that this decision is costing money. What happens to the patients while they are on the waiting lists for a year? They are getting multiple expensive MRI scans, gynaecology tests, specialist ultrasounds of their ovaries and extra evaluations, but, not only that, their extended family may also be getting these while they are waiting that one year for the blood test. I have no doubt about this. The blood test has come down substantially in cost and it is now several hundred euro rather than €1,000 to get one test done. Clearly, part of the bottleneck is that the staff in Crumlin do not have national specialist unit funding and this is being absorbed in the general costs of that hospital which, as we know, has had its allocation cut in recent years despite its national status in so many areas.

I can understand how we all have to grit our teeth when we see deficiencies in the health services, but it makes no sense to impose a deficiency which is costing us money. I would ask that this be brought to the Minister's attention. I understand the Taoiseach made reference to genetic testing in the Dáil yesterday. When the decisions are being made, I ask that it be taken into account that there are real cost savings to be made.

I am honoured to make this speech on the one-year anniversary of the death of a good friend and patient of mine, Geoff Prendergast, whose son, Joe Prendergast, at the age of ten and as part of his mourning process for losing his father so sadly, has just published several wonderful children's books. The proceeds from these will be used for cancer research through the CCRT. I would like the record to reflect this brave young boy, Joe Prendergast, and his Dad.

Let us be blunt - my primary motive in advancing my Bill - I am sure the same applies to my colleagues - is not to save the Seanad for its own sake but to reform the Oireachtas. I joined the House comparatively recently as an outsider. It appears, with no disrespect to those who run the country and work extremely hard at public representation, that the two Chambers are dysfunctional and have failed, although they have given us a constitutional democracy in the face of threats from various sources over a long period. On reflection, few countries have enjoyed such a continuous period of parliamentary democracy for as long as ours. The number is relatively few and in Europe there have been very few. In terms of where we are economically in the national crisis, it is plausible to blame it in part on the political structure in place. I have long argued that two forces are represented in the Parliament - parochialism and localism, owing to the way we elect Members to the Dáil, coupled with inexpertise. There was a cadre of professional politicians who did not, in many cases, bring a substantial life skills set to the Houses of Parliament. The original idea was to have a balanced Upper House that would introduce a different skills set. I was going to say it was created by the founding fathers, but I think we all know who the founding father was. Owing to the natural political evolutionary process and the way local councils are elected, the Seanad has become a mirror image of the other House. I am respectful, however, of the opinion advanced that the Seanad is a bulwark of democracy that needs to be defended. However, I am hard-pressed to think of a case, in the past two years, in which I have seen it act as a bulwark and a defender of democracy. As I said, the main reason to reform the Seanad is not that it is doing something so critically important that we need to protect it but that it will show up the other House. If we were to enact reforms, or a synthesised version of them outlined in the two Bills, there would be a Chamber in which the majority of the Members would be elected in national constituencies. That would be hugely important and would remove the element of parochialism, although I do not mean to run down the importance of local politics. The primary political motive of the good people in the other House and many in this House is to work out how to negotiate a local constituency organisation and a local constituency general electorate at the time of the next election.

I have a few technical difficulties with the Bill being discussed. In the event that it reaches Committee Stage - perhaps that is just fantasy - I shall table a number of amendments. I am most troubled by the nominating process for Seanad Éireann and its nominating bodies. The notion behind them is that they act as a filter between the wishes of the people and the those who appear on the ballot paper. In an absolute democracy, which is what I believe in, that filter should end. There is a contradiction between the Bill and the other Bill we will move at the end of the debate. I have been told that we have received the blessing of the Leader and the Government parties to do so, for which I am grateful. We propose that any citizen should be able to run for the Seanad as long as he or she has the signatures of 1,000 of his or her fellow citizens on a nominating paper. I shall not get into comparing and contrasting the two Bills. However, I am troubled by the idea of having nominating bodies, including two lots of people who sell alcohol, written into the framework for deciding who can be nominated. Why not let the tobacco industry also act as a nominating body? What about the muddying of the Medellín or Cali cartel? It makes no sense to me whatsoever that we should allow for this. We also have the banking federation. We have two groups representing advertisers who have done rather well historically from the Oireachtas. We also have the Road Haulage Association which I am sure will have an opinion when we debate legislation to decrease emissions.

I am unambiguously voting for and supporting the Bill and I am delighted that it will be passed. Let me be slightly light-hearted for one moment. I noted the mention of North Korea. I am delighted that, like North Korea, we, in Seanad Éireann, have a dear Leader.

I am delighted that the good offices of the Government parties have been used to foster democracy by allowing these two Bills to get to a nominal next Stage. That will enable us to create a template for a vigorous constitutional debate before the people vote in a referendum in October. That referendum is justified because it is what the Government indicated it would provide for before it ran for office. We need to have that referendum.

I would have let this matter lie because I understand there are various historical sensitivities associated with the issue. More recently, however, it has come to light that there are Members of both Houses who advocate overthrowing our Constitution. There are people who suggest that we should ignore the wishes of the people in solemn constitutional referenda, two of which have given a particular verdict on a particular issue of public policy which will come before us in the near future.

It is one thing for alleged legal and constitutional experts to sit at public hearings here and basically tell parliamentarians to ignore the Supreme Court and referenda and answer instead to a higher authority. In their personal lives, people may believe that they do answer to higher authorities, but when Members attend the Dáil or Seanad to represent those who elected them, there is no higher authority. The highest authority we should recognise is our Constitution.

I believe that over the next couple of months, some people will be advocating a gentle little Irish-style coup. There will not be tanks on Leinster Lawn, but they are people who are basically thumbing their noses at Bunreacht na hÉireann and saying we should ignore it. Therefore, the Leader should ask the Taoiseach and his Cabinet colleagues to consider if it might be wise at some stage to bring ourselves into line with other mature democracies and have a basic oath of loyalty to Bunreacht na hÉireann by those who are elected in accordance with that Constitution to serve and represent the people.

Thankfully it was only a directive, although we did not quite realise at the time. We thought there would be a catastrophe but it turned out we could not ignore it because it was a directive, not a regulation. Now, however, one regulation is coming down the pipeline on clinical trials and another on data protection. Huge collateral damage will result. Two of the biggest advances in cancer therapy in the last few years could not have been achieved under the regime that will apply after the data protection directive is put in place. It will require explicit consent from people, which must be spelt out, for the use of their bodily materials for research purposes when many of these people are already deceased. The research has led to cures for some breast cancers and to huge improvement in treatment for chronic myeloid leukemia. It required looking at specimens from patients who were archived and stored. They were treated with respect and anonymised. I hope the Commissioner will give this her attention as there is a real risk of disaster here.

I would, however, like to say that from a practical and democratic point of view, harmonisation, laudable as it may be in many areas, should not be an end on its own. It should not be an absolute goal we aim for because harmonisation sometimes means winnowing things down to the lowest common denominator rather than striving to the highest plateau, where things are at their best. This has certainly been the case with some aspects of health and research. There have been a few areas in recent years where an attempt to enforce harmonisation has had potentially negative, and in the future could have potentially disastrous, consequences on areas that are very close to my heart, for example, clinical trials.

About seven years ago, Europe introduced the clinical trials directive, which attempted to address the kind of chaos many people who work in bureaucracies do not like when they see dissonant sets of criteria and goals, and different jurisdictions over which they have some kind of loose authority doing the same jobs. It just happened there were very different ways of approving clinical trials in Europe and an attempt was made to harmonise them. As part of the harmonisation process, a number of the measures which were introduced, which I will not bore my colleagues with today, are now generally recognised to have been very negative. However, because this passed the Commission and then passed the Parliament, there was not a mechanism in Europe to roll it back.

At the time that harmonisation was dawning, a few of us started an information campaign to try to get people to wake up to what they had actually signed up to. We were told politely that, because it had passed both entities, it is now written in granite, cannot be changed and we are stuck with it. Luckily, it was a directive and not a regulation, which basically meant we could ignore it, although people did not quite understand it at the time. There should be a big learning curve attached to that.

A regulation is now coming in and I believe it needs real and careful attention. The instinctive, visceral harmonisers, well-intentioned as they may be, as they are not familiar with the realities on the ground of how a lot of research works, may end up taking some of the worst jurisdictions from the point of view of research and enforcing their standards on the rest of us. Without in any sense being disrespectful to our near neighbours, clinical trails in the United Kingdom have been extremely difficult to conduct in recent years. The approvals process has become so long that many British patients, in particular British patients with breast cancer, have been denied early and expeditious access to drugs which could have been very beneficial for them. I greatly fear that, in pursuit of compliance with forthcoming European regulations, the same kind of regressive regime may be imposed here. In the next month or two, I hope we will be looking at this closely in a number of fora in our own jurisdiction, but I would like to mark Ms Childers's card that there are problems with it.

Other collateral damage which arises from good intentions relates to the attempts to bring in data protection legislation. Those who wish to bring in such legislation have their hearts in the right place in that they are trying to protect private and personal data that people may have online and so on. However, they did not think it through to the extent that there is a real risk the kind of cancer and other research which involves collecting specimens in many cases from people who are deceased - this is the kind of research that enabled us to introduce a number of critical drugs like Trastuzumab, otherwise know as Herceptin - could not take place now under the new regime because dead people cannot give consent to have their anonymised materials used for research purposes. Again, not only is the baby going out with the bath water, there is potential for real disaster which needs to be addressed.

On the issue of drug pricing, there is a bigger picture. In Ireland, we have been misinformed about what we need to do. Obviously, we need to move in a large way to the use of generic drugs and the cheapest alternative drugs. As I said, I have voted with my own health on this. I now insist on taking a generic cholesterol lowering drug myself and I believe everybody should insist on getting the cheapest generic drug for whatever conditions they have.

However, there are some things we cannot do in this jurisdiction. I want to draw attention to something that is happening with cancer drugs. For many years, we had no new meaningful cancer drugs because science and technology had not yet caught up with the theoretical science to give us new drugs. There has been a revolution in this regard. In the last decade we have seen several drugs per annum and in the last few years we have seen several drugs per month coming out, with data which looked extremely promising. People have this idea that drugs have been priced by some kind of a mark-up principle on top of the development cost of the drug. That is changing. What is happening now is that highly technically proficient and skilled marketeers, using the principles, theory and practice of marketing, are trying to work out what is the highest price one can charge at which the inflection point for demand occurs - when it becomes elastic and people will basically say we will no longer pay for that drug because it is too expensive. They are pitching for the very highest point on that curve.

Coupled with the kind of emotional blackmail which is built into the availability of new drugs, we have the situation where a drug like Herceptin, with which I was very involved, cost about €30,000 per annum to provide. However, I know the trials that were used to licence Herceptin involved 15,000 patients, so there was an expense involved in developing the drug. There are drugs coming out now that are being priced at between €100,000 and €200,000, and I know in the case of one drug that the licensing trial which led to this drug being licensed involved fewer than 100 patients. There is an absolute, utter and complete mismatch occurring between the development costs of drugs and what companies are going to attempt to charge for them in the future. This is because of market forces. While I am broadly sympathetic to market forces when they are true markets, this is not the case with regard to monopoly markets, which is what drug companies with a new product for an emotionally draining cancer have.

What we need to do collectively in the Western world, including in Europe and with our colleagues in other parts of the Western community of similar democratically and economically constituted countries, is to have a concerted policy which will say to the companies "You make great products and you deserve to make a profit, but this is the limit and we are never paying more than this for any drug you come out with. Learn to live with it, make the drug viable and it can be done." This is something we will be attempting to launch as an information campaign over the next while.

What we need to do collectively in the Western world, including in Europe and with our colleagues in other parts of the Western community of similarly democratically and economically constituted countries, is to have a concerted policy which will say to the companies "You make great products and you deserve to make a profit, but this is the limit and we are never paying more than this for any drug you come out with. Learn to live with it, make the drug viable and it can be done". This is something we will be attempting to launch as an information campaign over the next while.

I heard Ms Childers's comments on second-hand smoke exposure. I am the sponsor, together with Senators van Turnhout and Daly, of the legislation which we hope, perhaps in this session, will result in one of the successors to Ms Childers's late, great father's office signing legislation which will make it illegal to smoke in cars in which there are children. We are trying to go further. What we are trying to do is to create a debate in Europe around the idea that the tobacco trade, which is a part of the drug trade, is not just something we should be regulating and reining in, it is something we should be ending. People may have a right to smoke, and I do not dispute that, but no one has a civil right to addict children to cancer-causing chemicals. It is absurd to think there is a civil liberty to make a profit from selling cancer-causing addictive products whose very commercial continuation depends entirely on recruiting new underage smokers to the ranks of the abusers.

That is why we have started a campaign called SOS 2030, which has a website I hope Ms Childers will sign up to and ask all her European parliamentary colleagues - a minority of whom, I presume, do not smoke - to sign up to. This will commit us to the idea that we will start the wheels rolling so that by the year 2030, after we give the farmers time to grow something else, give the pension funds time to divest and give the factories a chance to re-tool the plants and to make food products rather than tobacco products in an increasingly food deprived and challenged world, it will just not be legal to engage in any commercial transactions with tobacco.

People might argue that this will encourage smuggling and the black market. Yes, it will but if the people in the boardrooms of British American Tobacco, R. J. Reynolds and all these other entities wish to sell tobacco by that date, they will be doing it with the same commercial plan and according to the same business model as the Medellin or Cali cartels or the Taliban in Afghanistan. If they wish to continue doing it, let them do it. It will suck the money out of the PR companies and lobbying agencies which have so polluted public policy in this area. It may sound a bit quixotic but it is something we should aim to do and I believe it is quite practical to get people to sign up and join it now. I thank Ms Childers for the opportunity to meet her again and look forward to working with her on a number of these health-related issues in the future. I apologise as I must leave the Chamber as I have been called to another health-related meeting.

Some will say there are precedents for prohibition having not worked. We are not advocating the prohibition of the practice or the growth of tobacco. What we are advocating is the prohibition of commerce in tobacco. People may have a civil right to smoke or to grow a tobacco plant in their back garden and roll their own cigarettes, but no one has an innate civil right to profit from cancer-causing addictive drugs. When I talk of the tobacco industry, I include everything from the mom and pop shop on the corner in the suburbs of Dublin, Cork or Abbeyfeale to the people in the boardrooms of RJR or British American Tobacco and the people who own the vast plantations in Virginia or Turkey. Let us face it, the business plan of the entire tobacco industry can be summed up in four words: addict children to carcinogens. If they do not do it, the business ceases to exist. If anyone tells me there is any civil, human or legal right to that, they are clearly incorrect. This is why I am delighted to have the Minister as our leader in many of our smoking initiatives. On behalf of Senators Daly and van Turnhout, I am grateful for his confirmed and explicit commitment today to ensuring the passage of our own little practical step along this way by banning smoking in cars with children.

While I can be very supportive of what the Minister is doing, I hear a noise in the Chamber today. It is a grinding noise and I think it is the noise of gritted teeth. I can only presume the Minister is not happy he has been handed the chalice of passing this particular legislation by the European Commission. I am less bound by the conventions of party loyalty and diplomacy than he is, so I will say what I think. This stinks.