Dáil Éireann debate -
Tuesday, 19 Oct 2004

Vol. 590 No. 4

Adjournment Debate.

Medicinal Products.

Dr. Twomey

I congratulate the Tánaiste on her new position as Minister for Health and Children. She has taken on a very responsible job and I wish her the best in it as the area is a very difficult one. In her role as Minister for Health and Children and in mine as Fine Gael spokesperson on health, patient care is our primary concern.

Ireland has a significant pharmaceutical industry and the issue I now bring up is no reflection on it because most of the businesses involved operate to highly ethical standards. Three weeks ago an anti-arthritic drug was rapidly withdrawn from the market due to the highly adverse side effects picked up in the trials which follow the launch of such drugs. The matter was treated very quickly and professionally, which is how we like to see things done because we all know that adverse reactions can show up at a later date, while not necessarily showing up during extensive clinical trials.

However, allegations made in a recent "Panorama" programme about another drug must be raised in this House because of the serious implications not only for psychiatry but for all medicine and especially the medication and drug industry. I do not know if the Minister is aware of this but if so I would like to know if she has made inquiries about the "Panorama" programme, if she knows what was said on it and if she has had inquiries from Glaxo SmithKline regarding the issues raised.

I am not making specific allegations against the drug company involved. Given that such a wealth of clinical data is made available on every drug, the information can sometimes be overlooked and missed, rather than deliberately being presented in a misleading manner. However, concerns were raised on "Panorama" about some of the data on this anti-depressant drug and since the drug is available in this country and is widely used, we should investigate the matter. I will read some remarks made on the programme by the President of the Royal College of Psychiatrists in the UK:

I personally felt cheated, and heaven only knows what the children, adolescents, their parents and their GPs on the other end of that felt — very much the same. I also felt very confused because I know that there are some of my patients in the past for whom the SSRIs have been important in their recovery as well as all the other things that I might be doing with them, and yet suddenly the balance between risk and benefit was quite clearly tilted in a different way.

He was talking about the clinical trials data which were shown up in the course of the programme, suggesting the company was deliberately misleading the regulatory bodies in the UK as to the effectiveness of the drug. It was stated on the programme that the drug, which would increase the adverse reactions for children, in other words increase the risk of suicide, had no beneficial effects compared to placebos and other treatments for those children. Further clinical trials showed that the drug raised the risk of suicide through all age groups. That may be an effect of all selective serotonin re-uptake inhibitors, SSRIs, but the company involved with this drug seems to have moved to cover up its status. An indication that this was so was given in the following note quoted on the programme:

Confidential — for internal use only, October 1998. It would be commercially unacceptable to include a statement that efficacy has not been demonstrated, as this would undermine the profile of the drug in question.

As legislators and Members of the Oireachtas, we must take seriously such practices that may be occurring with regard to pharmaceutical products, which I am using for my patients and which are being prescribed for other patients in Ireland. Will the Tánaiste inquire into the matter? Many thousands of drugs are prescribed in this country every year and we are lucky to have a very low adverse incidence with mandated drugs. There may be some hype involved regarding the drug in question but the issue is important enough to be dealt with at official level.

Minister of State at the Department of Health and Children (Mr. T. O’Malley)

I thank Deputy Twomey for raising this issue and I welcome the opportunity to reply. I am well aware of this problem, which has been in the public arena since before the screening of the "Panorama" programme. Unfortunately I did not see that programme but I have discussed it with several members of the expert group which I set up about a year ago to examine the mental health area. That group will examine the issue, on which it has very strong views, and will return to me next year.

The Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland. It is responsible for monitoring the safety of all medicinal products licensed for use in Ireland and for evaluating all new scientific data that emerge. In consultation with its European colleagues, the IMB has continuously monitored the safety of the class of medicines known as selective serotonin re-uptake inhibitors since they were first licensed for the Irish market several years ago.

The board has taken regulatory action on these products when deemed necessary. Most recently the board took part in a European-wide review of medicinal products containing paroxetine, one of the group of SSRIs used to treat mild to moderate depression and which includes Seroxat. This review was undertaken on the basis of safety concerns relating to these products. The board actively participated in the review, which involved a complete benefit-risk reassessment. The review concluded that the benefit-risk profile of products containing paroxetine remains positive. A number of recommendations were made for inclusion in the products licence documents, the purpose of which was to harmonise the information on these products throughout member states. This documentation includes special warnings and precautions for use, particularly on the need for close monitoring of patients using medicinal products containing paroxetine.

I am informed that the majority of these recommendations are reflected in the licence documentation currently approved in Ireland. These include a warning to reflect that paroxetine should not be used in children and adolescents. In the EU paroxetine is not authorised for use in this population. Data from clinical trials raised concerns regarding suicidal behaviour and hostility. In addition, data from clinical trials have not adequately demonstrated efficacy in these age groups. Although paroxetine is not authorised for use in children and adolescents, doctors can prescribe this product for an individual patient if they feel it may be of benefit. However, they are advised to exercise caution. Alternative treatments for childhood depression such as cognitive behavioural therapy may be prescribed by child psychiatrists.

Prescribers are warned to recommend close monitoring of patients at high risk of suicidal behaviour. These include patients with a known history of suicidal behaviour or suicidal thoughts prior to starting treatment and possibly young adults. There is also a recommendation that prescribers and patients should be warned regarding the occurrence of withdrawal reactions on stopping treatment. Generally, these are mild to moderate and self-limiting. However, in some patients they may be severe and-or prolonged.

Following a review of the existing data on paroxetine by medical experts from the member states, these recommendations were issued. Ireland — via the IMB and its national experts — participated in this review and I am advised these recommendations are considered appropriate on the basis of the data assessed. The committee for human medicinal products, a scientific committee of the EMEA, will take further action on paroxetine if new data emerge which indicate that this is necessary. This committee is currently considering a review of all the other SSRIs and related anti-depressants and I understand a review of these issues is also ongoing in America.

The Deputy will appreciate that the full safety profile of a medicine only becomes apparent after long-term and widespread use. As regards medicines used in the treatment of psychiatric disorders, it may be particularly difficult to distinguish between the underlying condition and the possible effects of new treatment. These issues are under continuous review by the Irish Medicines Board and its European counterparts. The Deputy may rest assured that my Department, which is continually monitoring the situation, will take any further regulatory action deemed appropriate.

Accident and Emergency Services.

Ms McManus

This is the first time in my recollection that relatives of very sick people lying on trolleys have taken to the streets and have stood outside the gates of Dáil Éireann. They have come from the Mater Hospital, from Tallaght and from James Connolly Memorial Hospital in Blanchardstown. Nurses and nurse managers, who have been driven to these extraordinary lengths, have joined them.

Let us consider the Mater Hospital as just one example, where between 20 and 35 people are stuck on trolleys at any one time. The accident and emergency department is short four nurses and needs more medical staff. There are 60 nurse vacancies in the hospital. More than 70 beds are inappropriately occupied and 100 additional beds are desperately needed. This hospital is in the Taoiseach's constituency. He was even employed there at one point. However, his response in the House earlier reveals an extraordinary disregard for the harsh reality facing patients waiting on trolleys and chairs and unable to obtain the treatment they need.

There are patients who never reach a hospital bed and who spend their entire stay in hospital on a trolley. Lying on a trolley in an accident and emergency department means discomfort, sleeplessness, and total lack of dignity and of privacy. Has the Minister for Health and Children considered the health and safety issues in accident and emergency departments where the pressures are so great that, in some cases, even the toilet facilities are grossly inadequate? The previous Minister for Health and Children failed to address the problem. In fact, it is now worse than ever and we have not yet even faced the onset of winter.

Is the Minister not afraid of the impact a flu epidemic could have on an already pressurised service? In this city there were 164 patients waiting on trolleys in our accident and emergency departments today. However, hospital wards are closed, new facilities remain unopened and more than 300 beds are inappropriately occupied. Countrywide today, there were 222 patients on trolleys in accident and emergency departments. The response of the Taoiseach earlier was bereft of a single solution. Instead he returned to the mantra of investment in the health service that he has depended on since he came to office.

The response, or lack thereof, of the Minister for Health and Children has been even more disconcerting. It seems that she has even refused to do interviews in recent days in respect of the escalating crisis in accident and emergency services and to inform us with regard to how she intends to respond and deal with the situation. I welcome the fact that she is present to reply to this matter.

In July 2002 the then Minister for Health and Children announced 850 community nursing beds to help alleviate the crisis. As of today, not one of these beds has been provided. So much for the much vaunted public private partnership process. It has not worked, nor has it delivered. We need to hear what will be the alternative. According to hospital consultants, there are 3,500 fewer hospital beds than there were in 1990. In my estimation, a pitiful 700 beds have come on stream in recent years. This is nowhere near sufficient to meet demand.

Will the Minister of Health and Children introduce a Supplementary Estimate at this stage and will she take initiatives in the following areas? Will she use spare private nursing home capacity, open up the new facilities immediately, provide a significant number of additional beds, deal with the nursing shortage, particularly in ICU and accident and emergency departments and lift the cap on medical training places for doctors? On a day on which 222 Irish citizens are lying in discomfort and pain on trolleys in hospital corridors, it is not good enough for the Government to run away from this problem any longer.

Tánaiste and Minister for Health and Children (Ms Harney)

Deputy McManus acknowledged that I am present in the Chamber. She might also have been gracious enough to acknowledge that I was here on time. When a Deputy is delayed, it is customary to acknowledge the fact that the relevant Minister was present on time.

The difficulties being experienced in accident and emergency facilities throughout the country are not acceptable to me, to the Government or to the average person who cannot understand how, at a time when we have trebled spending on health care to €10.5 billion, these things can happen. Many patients are experiencing long delays and difficulties, notwithstanding the enormous efforts made by the dedicated and caring staff who look after them.

The problems of the accident and emergency services are not unique to them. They also affect the health service as a whole. When seeking solutions, we must consider those that are sensible, sustainable and which fit into the overall strategy of reform. Everyone in the House acknowledges — as those who have reviewed the health services have already acknowledged — that there are no quick fix solutions or magic wands that can be waved. If it were easy, it would have been done a long time ago.

I intend to bring forward a package of measures to improve the experience of all patients who enter our hospitals via accident and emergency departments. As Members are aware, 78% of patients who enter accident and emergency departments in the six hospitals in the Dublin area do not require to be admitted. The 22% of patients who require admission are experiencing particular difficulties. When I met the chief executive officers of the six Dublin hospitals, I asked them to provide patient data. I received that data this evening from the Mater Hospital. If we are to make sensible decisions, we must do so on the basis of the best possible information. We do not need to know who the individuals are but we need to know their circumstances.

Among the issues we will have to address in the context of the package I will bring forward will be those relating to step-down facilities. As Deputy McManus has acknowledged, some of the patients in our hospitals at present do not require an acute hospital bed, provision of which can cost up to €5,000 per week. Other patients require different medical facilities. In some cases, they may require access to rehabilitation facilities. Cancer patients may require hospice related facilities. I need to have that data if we are to come forward with an appropriate package of measures to address the difficulties being experienced.

I will, however, give this commitment. There will be no grandstanding on my part. I will not build up any false expectations and I will not play politics with seriously ill people. However, I will work as hard as I possibly can with the resources available to me to bring forward radical, sensible and sustainable solutions that will form part of the package not only of the accident and emergency reforms I want to bring forward but the overall reforms I wish to introduce in respect of the health services.

From 1 January, the Health Services Executive will assume operational responsibility for the work currently done by the health boards. I intend to take the legislation through the Oireachtas before Christmas to ensure this becomes a reality. I am delighted to inform the House that the chief executive officer designate of the Health Services Executive has agreed to bring forward the start-up date of his contract from 1 April to the end of January. This will mean he will be in place to ensure that the new systems of administration, accountability and responsibility will work more efficiently and effectively for all patients.

Hospital Services.

Dr. Cowley

Thank you for the opportunity to raise this matter on the Adjournment.

Six Mayo patients requiring dialysis are currently obliged to pass by a state-of-the-art dialysis unit at Mayo General Hospital in Castlebar, County Mayo — the third largest county in Ireland — and travel to a unit a considerable distance away in Galway. This involves a round trip of 1,000 miles per week in some cases for people who are very ill or elderly.

Only 30% of the people in question would be suitable for a renal transplant. One man awaiting dialysis is vomiting day and night from a build-up of urine in his blood because his kidneys no longer function. Despite living in Castlebar where the renal unit is located, he must travel to Galway to receive the treatment he needs. He is not fit to endure the ordeal of making a 330 mile round trip at least once a week. He has suffered a stroke, has double vision and requires an ambulance to transport him to Galway. Although he has a medical card and despite representations made by his family, it is still not certain an ambulance will be guaranteed three times a week. He has no choice other than to travel to Galway because he will die without dialysis. He is nauseous and experiences vomiting and must use the machine in Galway as it will perform the function his kidneys cannot. It is a scandal that this man cannot have this treatment in the unit in Mayo General Hospital in Castlebar which has capacity for 26 patients and is currently treating 28 patients.

Many years ago, I and others campaigned for a renal unit at Mayo General Hospital. My contribution to the campaign was to provide information to the media and supply car stickers with the message "Mayo dialysis unit now". It is a scandal that disabled people and five other individuals, including a man from the fringe of County Mayo, cannot use the unit. Some parts of the county are almost as far from Galway as this House. I ask the Acting Chairman to imagine if he or a relative had to make a round trip to Galway three times per week to spend four hours attached to a machine. This is almost the distance from Galway to the furthest point in County Mayo. One would not expect anybody to make such a journey, yet ill people who should be resting at home are expected to do so. When such a unit is available in one's own town, one should expect to get access to it.

This problem could be solved overnight if the health board were not prohibited from hiring the four staff necessary to provide an extra shift. The renal dialysis unit in Castlebar General Hospital operates two shifts as opposed to the three shifts operated in Galway. A third shift cannot be provided because four nurses are needed and cannot be recruited because of a recruitment embargo. The people affected are going through hell on earth when the problem could be solved overnight with the recruitment of four nurses. If the Tánaiste were to allow them to be recruited, it would be a superb gesture. It would mean a great deal to those concerned and provide encouragement to the consultants, nurses and other staff in the unit.

A sum of €150,000 available for a water treatment unit would increase the capacity of the renal unit. However, because it is needed for capital development, it cannot be used for this purpose. Even if it was possible to use it for the renal unit, it should not be used for this purpose because the development of a water treatment unit is also necessary. Expansion of the renal unit at Mayo General Hospital will be necessary in future. Ideally, nine staff — five nurses and four health care assistants — would be available.

The ratio of people who receive dialysis here is 600 to 800 per 1 million inhabitants. In the United States and Japan the figure is 1,000 per million inhabitants, while in County Mayo 256 persons per million inhabitants receive dialysis. When compared with the United States, Japan and the national figure, County Mayo is suffering badly. I ask the Tánaiste to help us by expanding the service.

We should consider the cost of taxis and ambulances. I am sorry for those working in the ambulance service in County Mayo. How can they supply a proper emergency service when they are expected to provide an ambulance three times per week to transport dialysis patients? Why should they have to provide this service because the local unit has insufficient capacity? It would be easy to provide additional capacity.

I have received also representations on this issue from emigrants who cannot return home because no dialysis service is available. The number of patients in Mayo General Hospital has doubled while the number of staff has remained the same. I ask the Tánaiste to examine the matter.

Ms Harney

I thank the Deputy for raising this issue. Renal services are one of the main priority areas for development. Additional revenue funding of more than €20 million has been provided since 2000 to develop renal services in response to increased demand at national level. This includes an additional €5 million provided in the current year, of which €400,000 was allocated to the Western Health Board. This investment has supported the development of renal services on a regional basis. More patients than ever before are now accessing renal dialysis units.

As regards renal dialysis at Mayo General Hospital, I understand from the Western Health Board that in 1997 the unit was treating 12 patients and is currently treating 26 patients. Staffing levels in the unit have increased and arrangements are being made to increase capacity of the dialysis stations in the unit from nine to 13. Since 2000 in excess of €1.2 million has been provided to the Western Health Board as part of the structured programme of investment in the development of renal services for the region. Two consultant nephrologists currently provide services in the region.

While the hospital has attempted to meet the increasing demand for dialysis and is currently treating 26 patients, a number of patients from County Mayo receive dialysis treatment in Galway. The hospital has informed me that it is exploring all possibilities of meeting the existing demand within current financial and human resources constraints. I assure the Deputy that in my time as Minister for Health and Children I will continue to develop services at hospitals such as Mayo General Hospital.

Dr. Cowley

Why can four nurses not be hired? With the recruitment embargo in place, the hospital can do nothing.

Acting Chairman

There is no provision in Standing Orders for Deputies to respond to a Minister's reply.

Industrial Disputes.

Mr. Cregan

I thank the Ceann Comhairle for affording us the opportunity of raising this issue. I will share time with Deputies Collins and Neville who are equally concerned about this issue. I congratulate the Minister of State at the Department of Agriculture and Food, Deputy Brendan Smith, on his appointment and wish him well during his tenure of office.

I am glad to have an opportunity to raise this issue because I am gravely concerned about the situation in west Limerick where poultry growers are locked in dispute with Castlemahon Foods. I am not asking the Minister of State to take sides but to use every option available to him to intervene and encourage both sides to negotiate. I have never come across a dispute which has not been solved by negotiation and this one is no different.

I am concerned for the growers and their families who are living without an income as we approach Christmas. I am also concerned that if the raw material for processing dries up in the coming weeks, employees of Castlemahon Foods normally involved in processing will also find themselves outside the gate locked in dispute with their employers. I appeal to the Minister of State to endeavour at every opportunity to ensure that meaningful negotiations take place to resolve the dispute at the earliest possible date. While I recognise it involves a private company and do not wish to set a precedent, I ask the Minister of State to make every effort to encourage negotiation.

Mr. Collins

I, too, congratulate the Minister of State on his appointment. A serious problem has arisen as regards poultry growers and processors in Castlemahon, County Limerick. The Department or the Minister personally must intervene because the company in question, Castlemahon Foods, is at a standstill. The growers who supply the company receive 28 cent per bird, whereas growers in other areas receive 38 cent. The growers' business is not viable and they are unable to pay their mortgages, insurance and so forth.

I understand matters were proceeding reasonably well until the growers formed a co-operative as a non-trading company. Since then they have not been able to negotiate because the company, as a private entity, will not agree to do so, which is where the problem lies. However, we only know one side of the story; we do not know the company's side. If something does not happen in the near future, there will be a major problem for the 400 employees at the factory. At present, there are 28 or 29 growers and they have approximately 1 million birds between them. If the other half pull out, there will be a serious problem in the factory.

I urge the Minister to do his best to intervene. Perhaps he could appoint somebody as an acting chairman to bring both sides together. If this escalates, there will be serious consequences.

Mr. Neville

I welcome the opportunity to contribute to this debate with my colleagues. This problem could escalate into a serious situation and I entreat the Minister to involve himself in any way he can. Without telling the Minister what to do, there is a need for intervention at ministerial level to break the logjam.

It is a serious situation for the growers in the area. This was a good farming area but with changes in farming and due to circumstances in the area, farming has deteriorated to an extent. These people depend for their livelihood on the rearing and finishing of chickens. Historically, this has been a good business for farmers in the area. Any hint of it being endangered would have serious consequences for the farmers concerned and for west Limerick.

There are uneconomic margins for growing chickens at present, as my colleagues mentioned. The producers are only getting 30 cent per bird and need 40 cent per bird to make the work viable. They do not have the option of going elsewhere because there is no competition. The growers have jointly invested millions of euro in chicken production facilities in the hinterland of Castlemahon and it has provided a viable living for them. To interfere with or endanger production now would have serious consequences. I entreat the Minister to use his good offices to intervene in the dispute.

Minister of State at the Department of Agriculture and Food (Mr. B. Smith)

I thank the Deputies for their good wishes on my appointment as Minister of State at the Department of Agriculture and Food and I am glad to have the opportunity to respond to this debate. The poultry and egg sector is an extremely important part of the overall agri-food industry. The sector has a farm gate value of €150 million and provides valuable employment throughout the country, supplying quality products to the domestic and export market.

Last year, 66 million chickens and 10 million birds of other species were slaughtered, maintaining a high level continuity of production in the face of increased competition from imported products. Despite increased import penetration, the poultry sector is a net exporter, out performing imports by 22,000 tonnes last year and contributing €244 million to our balance of payments. Increasingly, the industry here, in common with other sectors, must continuously face up to the pressures of severe price competition from lower cost producers from abroad. This is a fact of international trade. Its implications are felt across the chain, where costs of production are constantly scrutinised and kept under control. Part of this is due to higher costs of feed, compliance costs associated with welfare and environmental legislation, inefficiencies at slaughter level and downward pressure from the retail sector.

While the retail sector is dominated by Irish produced poultry, all other aspects of the business at catering and wholesale levels are largely supplied by imported product. There is strong competition across the EU and in third countries at this level of trade and Irish processors have performed extremely well in maintaining their strong share of the domestic retail market while these competitive pressures grow.

I understand that the dispute between Castlemahon Food Products and some of its poultry suppliers concerns the price being paid by the company to the growers of the birds. The practice in the poultry industry is that the processor supplies the day old chicks and feed to the producer and also covers the catching and loading costs. The producer provides the labour and carries such costs as electricity, capital repayments and litter disposal. A price per bird is paid to the producer and this can vary from processor to processor.

In the Castlemahon case the producers involved in the protest are claiming that the price being paid by the company is insufficient to cover their costs and are seeking an increase. A large number of Castlemahon suppliers are not party to the dispute. The protesting producers are refusing to place day old chicks so it will be some weeks yet before the shortfall will be felt at plant level.

Castlemahon is a major poultry processor, employing 300 people. It is vital to the west Limerick economy and, indeed, to the rural economy. While the issues between Castlemahon management and its producers are matters that relate to the commercial operations of the company, it is in the interests of all concerned in the sector to ensure that there is no resultant disruption in the level of poultry supplies in the country. This will simply fall into the hands of importers and risk a more permanent loss of market share.

It is vital to an industry such as this that the integrated nature of the producer-processor relationship is recognised as of fundamental importance to the future success of the industry. In this respect, it is important that margins must be available for all parts of the industry, both at production and processing levels, and that quality of product be encouraged and rewarded. I urge both sides to consider again how they might find a compromise that will continue to bring economic benefits to the poultry chain and in so doing demonstrate the industry's capacity to respond effectively to the wider competitive challenges in the market.

This is a major issue for the people of west Limerick, as is evident from the fact that the three Deputies for the constituency tabled it for debate. I have listened carefully to the points and suggestions they made and, in the morning, I will consult with senior officials in the Department to see if there is any way we can help to facilitate progress in resolving the issue. I accept that it must be resolved at the earliest date.

The Dáil adjourned at 9.10 p.m. until 10.30 a.m. on Wednesday, 20 October 2004.