Liz McManus (Wicklow, Labour)

The Irish Medicines Board is an important and powerful body within the health service and will increasingly become so as medicines become more available, effective and inevitably more expensive. The issue of patient safety is obviously central to the debate and to any changes we are making in the law.

It is worth noting the level of consumption of medications in Ireland is not inordinately high. Some members of the Joint Committee on Health and Children recently visited France to learn of its health service. It was interesting to see a high consumption of medications there. It is fair to assume this arose from the easy access to specialists. In turn, this leads to shopping around by patients until they find the doctor who will prescribe whatever they want. Two factors control the level of consumption of medications in Ireland. The first is the role of GP as gatekeeper. The second, unfortunately, is due to inequality with people unable to access primary or secondary health care owing to low incomes and the inadequacies of social protection.

The establishment of the Irish Medicines Board was the manifestation of a trend within the health service, accelerated in recent times, where institutions and agencies now operate large chunks of it. The largest organisation is the Health Service Executive which has the overall responsibility of managing the health service. The role of the Department of Health and Children, meanwhile, has been considerably circumscribed over time. This trend raises particular problems with accountability. Across the House, Members are concerned about the lack of accountability in the health service. There will always be an issue with any board operating in the health service that is not directly accountable to the House. The old question of quis custodiet ipsos custodes arises.

This Bill will not ensure there is adequate oversight for a body as powerful as the Irish Medicines Board. I raise this point not to be unfair to anyone but because two years ago a situation arose which to this day remains unanswered. The case relates to an eminent oncologist, Dr. John Crown. No one in the health service can say he is anything but a major specialist in his field, with a high reputation. However, his history with the Irish Medicines Board is most regrettable. I do not believe the questions he legitimately raised were dealt with in a proper or fair fashion.

Some three years ago, cancer patients were denied access to a potentially life-saving breast cancer drug at St. Vincent's Hospital for nine months in 2002 and 2003 as a result of a dispute at the hospital. The controversy first erupted in September 2002 when Dr. John Crown discovered St. Vincent's Private Hospital had erroneously billed private patients and their insurers to the tune of €1 million. Approximately 50 women with breast cancer had been participating in a major international clinical trail, spearheaded in Ireland, using a combination of promising high-powered drugs. As it was a trial, the drugs, Herceptin and Taxoterre, had been provided free of charge by the international pharmaceutical companies that manufactured the medication. This is the standard procedure followed for the use of drugs in clinical trials. St. Vincent's Hospital, however, had billed patients and their insurers for about €1 million.

When Dr. Crown discovered this, he reported it to the Irish Medicines Board. One would expect the matter to be investigated by the board and whoever was responsible would have been held to account, as it was fraudulent practice. Instead, the work of Dr. John Crown was interrupted for almost nine months and clinical trials did not proceed. In the view of Dr. Crown, lives were lost as a consequence, a direct result of decisions made by the Irish Medicines Board which is not accountable to the House.

This is a matter of concern which raises issues for the Government in respect of the need for legislation of protect whistleblowers. It has never been more important to protect whistleblowers in the health service. While I appreciate the legislation to establish the Health Service Executive made certain changes, the record shows that the Irish Medicines Board affair was disgraceful. Fortunately, the relevant clinical trials have been reinstituted but only after the individual concerned experienced considerable stress.

My colleague, Deputy Quinn, tabled a parliamentary question on 21 November 2002 asking the then Minister for Health and Children, Deputy Martin, about this issue. Essentially, the Minister's reply was a hand-washing exercise. Despite being the shareholder of the VHI, he did not consider it his role to intervene, even though the company was an aggrieved party in the sense that it was told to pay out money it did not have to pay. Eventually, the VHI was reimbursed by the hospital but if the hospital had not been found out, the practice would, I presume, have merrily continued until this day. This is a serious matter about which all of us should be concerned.

Deputy Twomey referred to the misuse of prescriptions and we are all probably aware of examples of doctors using their position to illegally prescribe drugs in return for favours. In addition, however, in the area of alternative therapies and complementary medicine there have been a number of grave examples of practitioners taking advantage of patients who are suffering, in some cases from a terminal illness, by taking money from them on completely fraudulent grounds and to the detriment of their health. We do not appear to have any real protection against such persons. While safeguards, in the form of the Medical Council, are in place to protect patients from medical practitioners, they do not apply to alternative practitioners. This is an important issue because interest in this area of health care, if it can be so described, is growing.

It is important to note that both the clinical trials I mentioned affected women. One related to women with breast cancer while the other involved female cancer patients who encountered difficulties accessing clinical trials in the Mater Hospital due to an issue which arose at the hospital's ethics committee, although it is still unclear whether the ethics committee took the decision. The fact that a decision made on ethical grounds — in reality on religious grounds — impacted on a woman's right to have the best possible care is a central issue. While I appreciate that European directives have yet again saved us from ourselves, this does not mean we can abdicate responsibility for ensuring that something which is legal here — contraception in this case — can never be used to prevent a woman accessing health care and the best treatment, whether by way of clinical trial or otherwise, as happened in the case in question, which was, fortunately, resolved.

The Bill covers more than the Irish Medicines Board. I share the justifiable unhappiness expressed in the Seanad by my colleague, Senator Ryan, about the form of the Bill. It is a compendium of this and that brought together under a Title which bears no relation to many of its sections. This approach creates a lack ofclarity. It is difficult for people referring back to consider that meat labelling or ophthalmic entitlements for children in home schooling belong in legislation entitled the Irish Medicines Board (Miscellaneous Provisions) Bill 2005. There is no relationship between these issues and the Title, and I am unhappy that compendium, portmanteau type Bills such as this come before the House from time to time. For the sake of clarity, people would be better served in future if a couple of small Bills were introduced and Deputies would not need to spend an excessive amount of time on them to justify ourselves.

Senator Ryan, who has been around these Houses for some time, described the legislation as "one of the most badly constructed pieces of legislation I have seen in my political career". His point was that as well as being a mix and match of items which needed to be dealt with, the Bill was then subjected to a series of major, complex amendments in the Seanad. This approach to legislation is not helpful in terms of ensuring clarity as the legislation proceeds and people start to get involved in the process. One must be aware that professional bodies are frequently not 100% familiar with the process in which the House engages, which is a little obscure, even to Members at times. Rather than making it difficult to submit amendments, we should try to facilitate those on the outside who try, sometimes helpfully, to make inputs into the work we do. From time to time, proposed amendments received from concerned individuals have arrived too late or have been found to be inappropriate simply because of a lack of information and knowledge. If procedures were clear and accessible, the legislation may have been improved.

Another important change in the Bill which has no connection with the Irish Medicines Board is the extension to nurses of the capacity to prescribe. This measure has been sought by the Irish Medical Organisation for some time and the practice is common in other countries. Although it is a positive step forward, it is not good enough to state that the entire matter will be governed by regulation at some point in the future. We do not know who will prescribe, when they will prescribe or how they will do it. This is shoddy, poor practice, particularly given the significance of the change.

While I hope this change will be for the better, the best safeguard against the system not working in such a difficult area is good preparation and working out beforehand how a change will operate in the complex, high pressure context of the health service. This is a political decision as much as anything else and I am critical of the Minister in this regard. She makes a grand announcement, as she is perfectly entitled to do, but fails to deliver on the actual form of the change, that is, in terms of protocols, liability and all the other issues raised in this debate. Instead, the change will be made by some regulation to be published at some point in the future. People cannot feel secure that best practice will prevail because issues arise in terms of training and the context in which this change is being made. Anybody looking at our hospital service knows just how difficult it is to provide the best kind of care.

Only yesterday, there was a distressing court case concerning Tallaght Hospital. It was a terrible case for the woman involved. As far as one can gather, it would seem a serious mistake was made because the provision did not exist within the hospital, in terms of its physical capacity, to deliver full information for that patient when it was needed. I am not making excuses but obviously somebody is responsible. Doctors and nurses make errors like the rest of us. There is always a danger that we expect doctors never to make mistakes. Having read what was said in the court, however, it seems there were issues about the fact that our health service does not have the capacity to provide for doctors and nurses to work at their very best. We must be conscious of that.

The idea of ensuring that there is a capacity for nurses to prescribe makes sense as regards repeat prescriptions, palliative care and nursing home care. Presumably it also makes sense within the hospital context. It would be helpful, however, if we could tease out what we are talking about in a much more detailed and thoughtful way instead of something simply being presented to us without that kind of reflection.

We have seen criticism in the area of psychiatric care. On a number of occasions the Inspector of Mental Hospitals has made the point in his reviews that there is excessive prescription of medication for psychiatric patients. Such patients are extremely vulnerable, so one can imagine circumstances where the use of drugs is not justified but is being applied. We need to be careful about that because there is a requirement for transparency. There have been many problems concerning mental health legislation and the failure of systems to protect patients. The hard facts exist, however, and we know from the inspector's reports that, time and again, he has complained about the excessive prescription of drugs.

Another issue that I hope comes within the remit of the Irish Medicines Board is that of drug shortages. From time to time, pharmacists and doctors complain that prescribed drugs are not available. A woman came to me who was quite disturbed because she availed of a product called B12 which she needed to have monthly by injection, I think, although I am not a medical person. She received one injection and was told that from then on the product would not available for some time, and when it became available again it would not be on the General Medical Service. I tabled a parliamentary question on the matter but the answer I received was not terribly reassuring. It stated:

The vitamin B12 product concerned was removed from the common list of reimbursable drugs and medicines when the manufacturer advised my Department that due to problems in the manufacturing process, it had become temporarily unavailable both in Ireland and the UK. As soon as the manufacturers inform my Department that the problems have been resolved, the product will be restored to the common list.

That is just one example of what I am talking about. In attempting to discover what is going on with regard to these shortages, the phrase "due to problems in the manufacturing process" tends to crop up. The suspicion is that as companies produce newer drugs which are more expensive, but do exactly the same thing as the older, less expensive drugs, they construct manufacturing problems as an excuse to retrain doctors to prescribe more expensive drugs. This may be happening in the area of contraception, for example, and if that is so, it must be ended. We already have a large drugs bill and, in addition, there are all the arguments about generic drugs and banned drugs. If it is the case that drugs are being taken out of the system to introduce a newer drug which is the same and no better except in making more profits for pharmaceutical companies, that must be addressed. I presume the appropriate body to do that is the Irish Medicines Board.

From time to time, patients visit the pharmacist but cannot obtain what they have been prescribed. I know the Progressive Democrats are the great proponents of the free market, but if we do not have freely available on the market drugs that we need, it is up to the Government to sort that out. We should not be subject to the whims of drug companies that are trying to expand their profits.

I was reading an article in the IPU Review, a journal with which I am sure the Minister of State is familiar. The author of the piece, Mr. Jack Shanahan, referred to the continual shortages of a range of medicines. His particular concern was about palliative care medications, which were not available on the GMS. I hope that issue will be addressed. Mr. Shanahan said he would complain to the chief State pharmacist only that we do not have one anymore. I was not aware of that, so perhaps the Minister of State will respond to that point.

Mr. Shanahan wrote:

Palliative care is one of the great services of modern medicine. It allows a team to facilitate dying with dignity and comfort . . . Bureaucracy is important and allows for the safe provision of drugs. When it starts to impede the delivery of an important service then the rules need to be revisited. Not only would a rule change make a more effective service, it would also be more efficient and less expensive. My suggestions are simple. Drugs used in palliative care should have GMS codes. Drugs used in palliative care should be readily available in all pharmacies in the same way as the bulk of the medicines that we buy.

Until I read that article I was not aware that there was an issue concerning palliative care drugs. Surely we need to deal with this matter. If we cannot look after people dying in a humane manner with the best possible treatment, then there is something amiss in the health service.

I was interested in Deputy Twomey's references to pharmacists. My understanding was that this legislation related to extending the power of nurses to prescribe. Significant changes are already occurring in Britain where, from next spring, qualified nurses and pharmacists will be able to prescribe any licensed medicine for any medical condition with the exception of controlled drugs. Obviously, there is another structure in Britain where general practice operates rather differently than it does here, but it seems to be a major shift. If the Minister has such a proposal in mind, then we need to know about it.

According to Ms Ginette Howell, the head of pharmacy in Britain, this is a major step forward in providing care that is more responsive to the needs of patients and the public. It is ground-breaking for the pharmaceutical profession. As independent prescribers, Ms Howell said pharmacists will fully use their expertise in medicines, in partnership with patients and other members of the health care team. It is a major change in the role of pharmacists and it might be useful to extract the Minister's view.

The Minister made an announcement a few weeks ago regarding nurses prescribing. That was in response to a review of nurses and midwives in the prescribing and administration of medicinal products, which was jointly carried out by An Bord Altranais and the National Council for the Professional Development of Nursing and Midwifery. I support the idea and if nurses are given that extra authority, pharmacists will naturally enough seek a similar dispensation. It is difficult to see how one can leave them out of such changes. I would be very interested to explore the matter further since I am sure that there is a down side to that change of which we need to be conscious, as well as the possibility of an up side.

We cannot underestimate the abuse of prescribing powers. There have been very high profile cases such as that of Dr. Shipman, but also quite regular cases subject to Medical Council investigation whereby doctors have abused their power to prescribe drugs illegally. Even where treatments are perfectly legal, some medications can be extremely potent. I am very much struck by the fact that, in all communities, young men in particular have died because of illegal drug overdoses. I am also conscious of the fact that some have died from methadone. That drug is legal, and yet they are able to secure enough of it, or mix it with illegal substances, that they lose their lives.

I welcome the fact that children in all primary schools will receive entitlements under this Bill. It is extremely welcome, since that anomaly existed for too long.

My last point concerns HIQA, which I understand will have a role in assessing medicines and medical technology. I know that it has been learning from such bodies as the National Institute for Clinical Excellence, NICE, in Britain. However, it would be very useful if we had the HIQA legislation to see where exactly the two roles are defined — that of the IMB and that of HIQA. It was grossly deficient of the Department and the Minister to set up the HSE 12 months ago without establishing the protective counterbalance of HIQA at the same time. That was the concept behind the reforms, but all that we got was the HSE. We still do not have HIQA on a statutory footing and that is a real problem when it comes to ensuring best practice.

See this speech in context