COMMITTEE OF PUBLIC ACCOUNTS díospóireacht -
Thursday, 22 Nov 2018

Management of Medical Negligence

Mr. Jim Breslin (Secretary General, Department of Health) and Mr. John Conaghan (Director General, Health Service Executive) called and examined.

Chairman

We are dealing with chapter 15 of the 2017 annual report of the Comptroller and Auditor General on hepatitis C treatment in Ireland, on which we will have a discussion with representatives from the Department of Health and the HSE. We will also be looking at the HSE's efforts to prevent medical negligence cases. We had a meeting with the State Claims Agency on the management of medical negligence costs and open disclosure. We have teased out many of the associated issues, to which we should not return today. This meeting is important as it gives us an opportunity to review hepatitis C treatment, its implications and whether lessons have been learned. What, if anything, has been learned by the HSE from hepatitis C cases? The State Claims Agency has told us that there is an estimated liability of €2.4 billion arising from active clinical claims and this figure is growing each year. We have discussed with the agency how the figure could be reduced through open disclosure and mediation. However, to quote the old saying, prevention is better than cure. If costs are to be meaningfully reduced, it will only be done by ensuring there is a reduction in the number of serious medical incidents in the first place. We need to focus on what institutional learning has taken place in the HSE and understand the changes that have been implemented as a result of cases such as those involving hepatitis C and CervicalCheck. We need to hear what the HSE has been doing in general to reduce the risk of cases of medical negligence.

I hope what I have said serves to frame the discussion in order that we will not move beyond that issue today with the Department of Health and the HSE. We can come back to other broader HSE-related issues on another day. We are here to discuss hepatitis C treatment, in particular. We are joined by Mr. John Connaghan, director general of the HSE, who is accompanied by Dr. Colm Henry, Ms Michele Tait, Professor Aiden McCormack and Mr. Ray Mitchell. The Department of Health is represented by the Secretary General, Mr. Jim Breslin, and his colleagues, Mr. Michael Conroy, Mr. Finian Judge and Ms Pamela Carter.

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to so do, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable.

Members are reminded of the provisions of Standing Order 186 to the effect that the committee should refrain from inquiring into the merits of a policy or policies of the Government or a Minister of the Government or the merits of the objectives of such policies. While we expect witnesses to answer questions put by the committee clearly and with candour, witnesses can and should expect to be treated fairly and with respect at all times in accordance with the witness protocol.

We will take the Comptroller and Auditor General's opening statement and then we will have statements from Mr. Breslin and Mr. Connaghan. I understand that Mr. Breslin cannot attend the committee meeting this afternoon.

Mr. Jim Breslin

I understood the committee has scheduled business for the afternoon.

Chairman

Yes.

Mr. Jim Breslin

I must attend a Cabinet committee on health in the afternoon, but I will stay here as long as the committee needs me.

Chairman

That is fine. Mr. Breslin is free to attend that meeting. In the event that we do not finish before the vote, there might be a brief period when we require his presence in the afternoon after the voting schedule, but we do not know that yet. If we keep the meeting to the precise topic at hand today, we will try to complete it before the vote in order that we can do our private business in the afternoon.

I call Mr. McCarthy to make his opening statement.

Mr. Seamus McCarthy

As members will know, hepatitis C is a disease caused by a virus that infects the liver. The Health Service Executive estimates that between 20,000 and 30,000 people in Ireland may have the hepatitis C virus, many of whom may go on to have significant medical needs if they are not successfully treated. Recent advances in the drugs used to treat hepatitis C have resulted in significantly improved treatment outcomes and the Health Service Executive has set a target to make hepatitis C a rare disease in Ireland by 2026. Each course of treatment is expensive, however, and varies between €23,000 and €92,000 per patient, depending on the strain of the disease.

Approximately 1,700 people, most of whom were women, were infected with the hepatitis C virus through the administration of contaminated blood and blood products during periods in the late 1970s and again in the early 1990s. A number of schemes put in place to compensate and support those affected were subsequently extended to include persons similarly infected with HIV. Expenditure on these schemes is accounted for in a variety of ways. In undertaking this review, I wanted to compile an overview of the expenditure already incurred as a result of the contamination. I also wanted to assess the progress being made by the HSE on its current strategies and plans for treatment of hepatitis C.

The expenditure in 2017 under the schemes to compensate or assist those who contracted diseases due to contaminated blood or blood products totalled €36.4 million. Between 1996 and 2017, a total of just over €1.5 billion was spent. Compensation schemes, including insurance subsidy payments, accounted for €1.18 billion of that total. Almost €300 million has been spent on the provision of hospital and primary care services for those affected.

The HSE published a comprehensive national strategy for dealing with hepatitis C in 2012. It included 36 recommendations covering the areas of surveillance and data collection; education, prevention and communications; screening and testing; and treatment. The implementation of the recommendations has been mixed, with just ten considered to have been fully implemented and most partly implemented. The national strategy noted that a comprehensive programme had been put in place for patients who had acquired hepatitis C through contaminated blood products, but recognised that the needs of those who had acquired the disease through other means had not yet been adequately addressed. The Department of Health published a plan in 2014 for the establishment of a multi-year national hepatitis C treatment programme, which commenced in 2015. It aims to prioritise treatment for those at greatest clinical risk.

Since 2015, the Department has allocated €30 million a year to fund delivery of the treatment programme. In the period 2015 to 2017, more than 2,100 patients completed treatment. As my report was being compiled, information about treatment outcomes was available for 90% of those treated in those years. This indicated that the treatment was successful in clearing the hepatitis C virus in approximately 94% of cases. The majority of the annual budget allocation is used to purchase treatment drugs. Under the terms negotiated with the drug suppliers, a percentage of the purchase price for a course of treatment is subsequently refunded in the form of a rebate. The average cost of treatment, net of the rebate, was just under €28,000 per patient in 2017.

It is a complex challenge to ensure treatment delivery to the maximum number of highest-priority patients in eight main treatment centres, with varying drug costs per virus strain, within a set budget, and this is further complicated by the price rebate arrangement. In 2017, the HSE envisaged the smooth utilisation over the year of the available budget of €30 million. Payments for treatment accelerated ahead of planned levels in the second quarter, however, resulting in the majority of the available budget having been spent by the end of July. This led to the suspension of the programme in the middle of the year and uncertainty about what would happen thereafter. As indicated in figure 15.7 in the report, significant rebate receipts in the third quarter brought the net spending level back into line. Figure 15.8 indicates the impact this had on treatment delivery, with significant front-loading in the first half of the year and a stop-start pattern in the second half.

The chapter makes a number of recommendations for management of the treatment programme. The HSE indicated it accepted all the recommendations and I am sure the director general will be able to update the committee in this regard.

Chairman

I thank Mr. McCarthy. I invite Mr. Breslin to make his opening statement.

Mr. Jim Breslin

I thank the committee for the opportunity to meet this morning. I am joined by my colleagues, Mr. Michael Conroy of the Department’s blood policy unit and Mr. Finian Judge of the community pharmacy policy unit, as well as the HSE director general, Mr. John Connaghan, and colleagues.

The Comptroller and Auditor General’s review of hepatitis C treatment in Ireland, set out in chapter 15 of the report, provides a comprehensive overview of this issue. I do not propose to go over that ground in detail, but I will speak to some of the issues examined in it and in particular, the compensation tribunal established for people infected by blood and blood products and the national programme for treatment of people with the hepatitis C virus.

Infection of people through the blood supply was a tragedy of immense proportions, causing great pain and suffering to many people. Approximately 1,700 people in Ireland became infected with hepatitis C or HIV through infected blood products over the period up to 1994. These included women who received anti-D immunoglobulin, people with haemophilia, people who received blood transfusions and people being treated for renal disease. The hepatitis C and HIV compensation tribunal was set up to compensate these individuals. It was established on a non-statutory basis in December 1995 and on a statutory basis in 1997. In 2002, the Hepatitis C Compensation Tribunal Act was amended to extend the tribunal’s remit to include HIV and allow for claims by dependants of people who had been infected.

The tribunal is made up of six ordinary members, all of whom are barristers and solicitors, and is chaired by Ms Karen O’Driscoll, who is a senior counsel specialising in medical law and employment law. The compensation tribunal is independent of both the Minister and the Department of Health. It considers cases and makes awards in line with the legislation. Claims are dealt with by an in camera oral hearing before at least two members of the tribunal or by an offer of settlement. Claimants are entitled to be legally represented at the hearings. The Department’s role is to make payments in line with awards made by the tribunal. The tribunal has heard claims continually since 1996, and it made 3,569 awards up to the end of 2017. Expenditure is approximately €25 million per year and, to the end of 2017, the tribunal had cost a total of €1.18 billion, covering awards, legal fees and administrative costs.

In the years since these infections were discovered, a wide range of actions were taken, based on the recommendations of the Finlay and Lindsay tribunals, to ensure the safety of the blood supply. The Consultative Council on Hepatitis C was established in 1996, while the National Haemophilia Council was established in 2004. Both bodies ensure those most concerned have a say in matters involving hepatitis C and the care of patients with haemophilia and other bleeding disorders. The Irish Blood Transfusion Service, IBTS, documented a range of policies and procedures covering all aspects of blood transfusion screening and the implementation of these is reviewed by the Health Products Regulatory Authority, HPRA.

Ireland has a sophisticated testing regime for screening blood donations, which is kept under continuing review as science and technology develops. The annual HPRA, inspection of the IBTS, a key recommendation of the Finlay tribunal, addresses compliance of its blood-related operations with relevant EU and national legislation. The latest report, from 2017, found that the IBTS was in compliance with legislation. No critical deficiencies which represent a risk to patients and the safety of the blood supply were identified.

On the national hepatitis C treatment programme, hepatitis C is a very serious disease. The public health risk involved is much wider than that pertaining to those who were infected through the blood supply. It is estimated, in line with international data, that more than 30,000 people in Ireland are infected with the hepatitis C virus, with over half of those cases undiagnosed. It is also estimated that over 70% of people with hepatitis C are or were intravenous drug users. In line with the recommendations of a Department of Health advisory group established by the chief medical officer, in 2015 the HSE established a national treatment programme for people with hepatitis C. Although treatment was in place for patients before 2015, it tended to be local and without consistency of approach and outcome measurement was fragmented. The national hepatitis C treatment programme is a multi-annual public health plan to treat all people with hepatitis C in Ireland, irrespective of the source of infection. It is delivered in a range of healthcare settings with a view to making hepatitis C a rare disease in Ireland by 2026 and eventually eliminating it.

The programme has received €30 million in annual funding since 2015. This structured, programmatic clinical approach allowed for the early and timely introduction of very expensive but cost-effective direct-acting anti-viral treatments for very seriously ill citizens, which were new treatments at that time. The treatments are capable of effecting a cure in over 90% of cases. The programme has a programme manager and a clinical lead who are supported by a clinical advisory group and an overall advisory committee. As well as access to anti-viral treatment, it provides a national register to measure treatment plan outcomes; access to treatment based upon agreed clinical prioritisation in line with international criteria; a clear decision pathway for treatment access, involving patient prioritisation, registration and reimbursement approval; treatment for both State-infected and other patients; and that all State-infected patients, clinically prioritised or not, were to be offered treatment by the end of 2017 in conjunction with clinically prioritised patients being treated. I am pleased to state that the latter goal has been met. All State-infected patients identified as suitable for treatment have commenced or been offered treatment. The HSE has advised a 98% success rate in this group of patients.

The HSE has consistently driven down the net cost of treatment per patient and as a result it expects to treat four times as many patients in 2018 within the existing annual budget as it did in 2015. Among the programme's achievements are that nearly 3,000 people have been successfully provided with treatment for hepatitis C since 2015 and hepatitis C was eradicated in the Irish haemophilia population by the end of 2016. Treatment commenced in paediatric patients in 2017. More patients are being treated each year, up from 350 in 2015 to an expected 1,800 in 2018, as the programme achieves better value in drug procurement. Treatment is available to all patients who are clinically prioritised, with no restrictions on availability other than treatment capacity. Treatment is provided outside the hospital setting through HSE addiction treatment centres. This began on a pilot basis in 2017, with plans for additional sites, including prison and homeless services. A treatment registry has been established with the National Centre for Pharmacoeconomics. The current virus clearance rate at 12 weeks after treatment is over 95%.

The Irish health service is a vast undertaking delivered by people for people. The Department recognises the overriding importance of patient safety and quality in the delivery of health services. By any measure, the planned and programmatic treatment of hepatitis C has been very successful. However, it is time to move to a new phase of identifying and treating at-risk individuals and populations. The Department has received a proposal from the HSE to use some of the savings in the annual €30 million budget to develop treatment capacity, which would enable more people to access services. The Minister has given his agreement in principle to the proposed broadening of the model of care into community-based programmes, subject to details on the deployment of resources being worked out with the HSE. This should lead to an even more comprehensive programme which will include all elements of care including screening, testing and treatment. It will be a significant step forward in realising Irish, European and World Health Organization goals of making hepatitis C a rare disease and eventually eliminating it. When I was before this committee in October 2015, I noted that €30 million had been made available by Government to roll out the hepatitis C treatment programme and that, although we could not undo the damage of the past, it was expected that this would represent a very good use of the State’s resources. I am glad that the results have confirmed this to be so and that by any measure the programme has been very successful.

Mr. John Connaghan

I thank the Chairman and members for the invitation to attend the committee meeting today. I am joined today by my colleagues Dr. Colm Henry, chief clinical officer, Ms Michele Tait, programme manager of the hepatitis C programme, and Professor Aiden McCormick, clinical lead to the national hepatitis C treatment programme.

With the permission of the Chair, I will begin part of the way through the provided opening statement in order to avoid repetition. The national hepatitis C treatment programme is led by a clinical lead and a full-time programme manager. It is supported by a programme advisory group which provides oversight and strategic advice. The group is representative of key internal and external stakeholders including researchers, public health specialists, clinicians, pharmacists and service planners and aims to ensure successful implementation of the multi-annual public health plan for the treatment of hepatitis C in Ireland over the coming years.

Since 2015, the national hepatitis C treatment programme has provided treatment to some 3,600 patients, beginning with those most in critical need. The programme has commenced the extension of hepatitis C treatment away from the traditional hospital-based model where appropriate and integrating it into community-based healthcare within a number of HSE addiction treatment centres. The initial outcomes from these programmes are extremely positive, with each patient engaging fully with his or her treatment. Those who have completed their treatment have each received a sustained virological response, that is, a cure. The programme is planning a further extension of treatment availability within the community setting outside of these clinics.

The programme has established a treatment registry, which records anonymised data relating to patients provided with treatment. The registry monitors treatment uptake, activity, prescribing trends and patient outcomes. It provides a platform for clinicians to register patients they intend commencing on treatment. The Comptroller and Auditor General examination of the treatment of hepatitis C in Ireland recommended the linking of data collected through the notifications of hepatitis C under infectious diseases regulations to the national hepatitis C treatment registry. The HSE agrees that linking these data is beneficial in planning treatment. However, it presents a range of difficulties in terms of patient consent, data privacy and feasibility. Our division of public health is examining the barriers that need to be overcome in relation to linkage. The HSE is continuing to develop its existing treatment registry to ensure any patients diagnosed with hepatitis C are registered with the national treatment registry. The Comptroller and Auditor General report also makes recommendations regarding the continued planning of treatment and monitoring uptake to ensure patients continue to be identified for treatment and linked to care in order to make hepatitis C a rare disease in Ireland by 2026.

On the management of and learning from serious incidents, it is the policy of the Health Service Executive that all incidents are identified, reported and reviewed in order that learning from events can be shared. In support of this policy and based on us learning from incidents across the health service, in 2018 the HSE published its incident management framework. It sets out elements of the systems required for a responsive and proportionate approach to the prevention of incidents and the management of and learning from incidents which have occurred. It places considerable emphasis on the importance of learning and the sharing of this learning at all levels in the organisation, including nationally and at hospital and community levels. When an incident occurs, services are required to carry out a rapid risk assessment and take any immediate actions required to ensure that no other person is harmed. Following a formal review, the findings and the recommendations must then form the basis of the development of an action plan with a focus on the improvements required to reduce the risk of recurrence. The framework stresses the importance of sharing the outcome and findings of the review with other services. Cognisant of the criticism that some incidents recur, step 1 of the incident management process focuses on incident prevention. There are six steps in total in the framework.

We know that there is a strong link between the need to proactively manage risks and the occurrence of incidents. An example would be where a service puts in place a fall prevention strategy and monitors the occurrence of preventable falls against it.

The HSE recently established a project team to develop a mechanism in order that the learning from local reviews could be considered alongside information from a number of other sources, for example, closed claims and complaints related to the provision of clinical care. Since 2013, the HSE has undertaken an annual review of completed incident reports. The analysis focuses on both the quality of reports and the analysis of findings. The findings are themed to identify key areas of weakness.

The national incident management system, NIMS, hosted by the State Claims Agency enables services across the HSE and relevant funded agencies to report and manage all safety incidents. As an end to end risk management system, it facilitates the management of a safety incident though its life cycle, from initial reporting through the review process to the tracking of implementation of recommendations, while also fulfilling the legal requirement to report incidents to the State Claims Agency. A range of reports are produced by the NIMS at each level of the organisation. They allow services to monitor trends in levels of reporting, the timeliness of reporting, the severity of incidents reported, active claims and outstanding liabilities. The reports are used as part of the performance management processes and in conjunction with other measures at local patient safety and quality forums to disseminate information and set out objectives for improvement.

Chairman

I thank Mr. Connaghan. The speakers have indicated in the following sequence: Deputy Kate O'Connell who will have 20 minutes; Deputy David Cullinane who will have 15 minutes; Deputy Catherine Murphy who will have ten minutes; Deputy Jonathan O'Brien who will have ten minutes; Deputy Catherine Connolly who will have ten minutes and Deputy Marc MacSharry who will have ten minutes. I ask everyone to stick strictly to the allocated time limits in order that we can complete this section of the meeting before the vote that is due to take place at 1 p.m. We do not want to come back in the afternoon. I may cut members short after ten minutes, but perhaps one or two might get a second chance to comment.

Deputy Kate O'Connell

I thank all of the witnesses for coming. I will focus on where we are as opposed to the tragedy of people being infected with blood products.

The United Nations has a target to eliminate hepatitis C by 2030. Our aim is do so by 2026. I am concerned that the low hanging fruit have been targeted in the initial phases, by which I mean people who are more likely to adhere to a medical regime or are easier to reach. Let us estimate that the number of patients is 30,000 and we say we will deal with 18,000 a year. The HSE will not achieve its target of eliminating the disease by 2026 unless we double resources or the HSE doubles its efforts to eliminate it. Hepatitis C is a communicable disease. The medical treatment emerged in 2014 and was licensed for use in Ireland in 2015. There has been a significant price reduction. I compliment the people who negotiated the price reduction. However, I would not give them too much credit as most countries negotiated a significant price reduction.

Do the witnesses know whether tests on students have been conducted or whether the disease burden or load has been eliminated for 3,000 people? Do they have data to show how many more have been infected, either through intravenous drug use or the exchange of bodily fluids or whatever else?

I assume that the lead agency is in charge of reaching targets, but I did not see an annual target included in any of the reports. Therefore, it looks as if the can has been kicked down the road to 2026. The view seems to be that everything will be fixed by then, but I am concerned that no annual targets have been set.

Intravenous drug users are the cohort of patients who are the hardest to reach and make up probably half of the estimated number of patients. They tend to be hard to engage with because they have chaotic lifestyles. In my experience, as a community pharmacist who worked in a methadone service ten years ago, usually one finds when one engages with people such as these - I do not mean to paint everybody with the same brush - that they tend to adhere to regimes and turn up at their community pharmacy. The relationship tends to be strongest between a community pharmacist and the person receiving the methadone treatment. I very much welcome the suggestion treatment be moved to a community setting because I do not see how else we can target that portion of the population. Obviously, the service will involve prescribing doctors. I am sure pharmacists will be anxious to negotiate a very good price for the provision of such treatment.

It was stated each course of treatment cost between €23,000 and €92,000 per patient. I understand the negotiated drug cost is around €10,000 per patient. Can whoever knows the answer explain the difference between the figures of €23,000 and €92,000? Is it the price of administration or doctors' fees? Have I missed something?

I have seen evidence from other countries that there have been deals done with the drug companies whereby €100 million, for example, would be given to treat whatever number of patients, but if we find another 2,000, they must be treated. Have the witnesses come up with innovative actions to get the best value from the drug companies when it comes to dealing with this issue?

I am concerned about the database and confidentiality issues. It seems completely unacceptable that one does not know how many people have hepatitis C, who they are or where they are. As hepatitis C is a communicable disease, it is very important to know the dataset and who has the disease. The approach seems to be ad hoc. To tackle an infectious disease one must go at it and include every strain. It looks like the easiest people have been dealt with and that the hardest ones to reach have been left until the end. I find that concerning and do not think we will reach our target.

With reference to intravenous drug users, apparently one out of every three homeless people is hepatitis C positive. That is a big concern if people are living in communal hubs or hostels because I imagine the risk of transmission is extremely high. Do the witnesses have any idea of how many have been reinfected?

Mr. John Connaghan

Most of the questions are probably for the HSE. Perhaps we might start with the first question which will be answered by Professor Aiden McCormick in terms of the forecasted numbers. Ms Tait can then answer the rest of the questions.

Professor Aiden McCormick

In terms of the forecasted numbers, we have actually engaged in a modelling exercise and think the figure is actually closer to 20,000 than 30,000. This finding is very consistent with the findings of the most recent study published by the Health Protection Surveillance Centre, HPSC, which also calculated a figure of about 20,000. Part of the confusion is caused by the notified results. Up until 2012 people who were antibody positive were notified. They included those who had the virus and had cleared it. That gives a figure of 15,000 which includes about 4,000 who have cleared the virus.

I agree entirely with Deputy O'Connell that we have targeted the low hanging fruit, the people who will come to clinics. We have to target people who are in the community and that is exactly what we are doing. We now have four treatment programmes linked with methadone. I share the Deputy's observation that the patients who are on a methadone treatment programme are extremely good and compliant. As the one thing they know about is drugs, they know when to take them and we have had a very positive uptake.

We are expanding out to the community and we hope to expand it to level 1 and level 2 GPs and to community pharmacies so the process is ongoing. I do not know if I have answered all the questions.

Mr. John Connaghan

Professor McCormick might want to say something about the target and the position forecast up to 2026.

Professor Aiden McCormick

We have thought about this. We can forecast numbers but we want to find as many people as possible and treat them as quickly as possible. We are telling centres that they do not have a number they have to treat - they should treat as many as they can. If they run into a roadblock, we will give them more resources to treat them. Spending a lot of time on detailed plans is not the right thing to do. These patients are difficult to find and we do not know the exact numbers.

A study was done recently by the Safetynet group into 700 people who were homeless or in hostels. They agreed to be tested for hepatitis C and only 2% tested positive. There is a suggestion that one third of homeless people are positive but it is not fully based on fact. There are a lot but not as many as that.

Deputy Kate O'Connell

It is not ideal having a population carrying hepatitis C in an enclosed communal setting and not knowing about it.

Professor Aiden McCormick

Absolutely. We are in a procurement process to get mobile fibre scans to tell people about their disease. We have tried these in drug treatment centres and when we tell patients that we have a machine that will look at their liver and can tell them how much damage has been done to it, they queue up to be tested. Our plan is to go into hostels and drug treatment centres and test the people there.

Mr. John Connaghan

There was a question about drug costs.

Deputy Kate O'Connell

There are discrepancies in price.

Ms Michele Tait

The published price in the report is the cost price. It is the list price of the medications we use to treat patients and is the price before we apply any rebate we receive from the drug companies. We procure drugs with a public tender, of which there have been two so far. The figure is the cost to the hospital providing the treatment but the HSE has rebate arrangements which we negotiate with the pharmaceutical companies as part of the procurement process.

Deputy Kate O'Connell

When the rebate comes back, where does it go? Does it go into the general hospital budget or back to this particular basket of €30 million?

Ms Michele Tait

It goes into the basket. The primary care reimbursement service, PCRS, is responsible for reimbursing the cost of the drug the hospital purchases to treat the patient and for negotiating the collection of rebates from each of the suppliers based on the commercial terms we that have been agreed. The commercial terms with each supplier are in confidence but we expect the average cost of treatment in 2018 to be below €15,000 per patient.

Deputy Kate O'Connell

Does this include the hospital money or is that simply the cost for the drugs?

Ms Michele Tait

The €15,000 is for the drugs. The hospital will always pay the full list price of the drug directly to the supplier but will have the full cost reimbursed by the PCRS, which will negotiate a rebate from the supplier to get the saving. The €30 million in the PCRS pot is expenditure out of the figure arranged with the suppliers.

Deputy Kate O'Connell

Getting the drug to treat hepatitis was a phenomenal achievement but I compare it with cervical cancer. Australia is heading towards eradicating cervical cancer within ten years. This started in 2004 and we are now in 2018. While the HSE has made good steps, it has been with the low-hanging fruit and good advances in drug treatment. I do not see the same people being successful in eradicating cervical cancer with this approach. If we only deal with the low-hanging fruit and take the easiest options it will not work. If we do not actually know how many people have it or where they are located, it is as if we are making it up as we go along rather than a serious attempt to eliminate the disease.

Ms Michele Tait

The Deputy mentioned the period between 2004 and 2018 but the big advances in treatment have only happened in the last three years, in Ireland and internationally. The programme was established on the basis that we would begin with the patients who were most sick and in most critical need, as well as those infected through State-contaminated products. I cannot comment on the trajectory as regards cervical treatment but the cost of the hepatitis drugs in the first three years was phenomenal and no rebate arrangements were in place. The programme has now reduced the costs, as other countries have done.

It is difficult to capture the number of patients who have hepatitis C and where they are in the system, but our data are getting much better and there are far more opportunities for people who are infected to be tested and treated. We will have another ten years of treating patients before we get to the eradication of the disease in the Irish setting but we have done what we have set out to do so far. I agree that eradication will not come about if we just set a target for the number of patients to treat every year.

I am pleased that we are moving into settings other than the hospital setting and we will improve screening, which will give us the opportunity to diagnose more of our population. We will also be able to know who they are so that we can link them to care.

Deputy Kate O'Connell

Why have only ten of the 36 recommendations been taken on board when the drug has been on the market for three years now? The recommendations are not overly complicated and do not ask for too much. Why is there inertia in this area?

Ms Michele Tait

The hepatitis strategy was written some time before the national hepatitis C treatment programme was established and in a period when the availability of, and access to, treatment was poor in Ireland. The development of medications to treat hepatitis C has only happened in the past few years. We did not have access to these treatments at the time the strategy was written. The recommendations, which are in the process of being implemented, are in areas across the entire addiction services, such as in education and prevention, and they have to be implemented in tandem with providing the treatment. The work is ongoing and the full implementation of all the recommendations is a work in progress.

Deputy Kate O'Connell

I understand that and the reason for the issue when the report came out before the drug was licensed, but all the same principles of education and prevention still exist. I do not buy the idea that the report is out-of-date, in the sense that it was published before the drug was available, because one could have layered the treatment on top of the existing content and added it as another page. It seems strange that for something that is costing so much money - I do not know the cost of a hospital admission for somebody who is not treated, but I imagine it is significant - not to treat an individual who will end up in an acute hospital with cirrhosis, liver cancer or whatever complications one might have from untreated hepatitis. It seems great value for money, even if it costs between €15,000 to €20,000 per patient because of the impact of treatment on the patient versus hospitalisation.

Chairman

Mr. Breslin had indicated.

Mr. Jim Breslin

It would be useful for me to clarify the mandate that the people were working to because they have done the work against the mandate. When the €30 million was made available the mandate was to do State infected clients. We have done all that and have achieved a 98% success rate. There was a particular rationale for that decision because these people were infected by the negligence of the State and the State owed an extra responsibility to them to get this new drug to them in the first instance. That was the decision at the time.

The second element was based on clinical prioritisation to move beyond that group into the general population, so the priority was to give the drug to those who were sickest first. This was at a time when the drug was at its most expensive level. In fairness people have done that but they have also come back to say that with the drop in the price of the drug they could expand the programme and bring it to the community and mobilise the community to get more and more people involved, which is exactly what Deputy O'Connell is arguing for and where we are now and where we need to be to get to 2026.

Deputy Kate O'Connell

Do we need an updated strategy? Do we get rid of the current strategy?

Mr. Jim Breslin

It is a very different situation now as one is going to an individual and telling him or her that we have an effective treatment that he or she will be able to get through the treatment in a time limited period-----

Deputy Kate O'Connell

Three months.

Mr. Jim Breslin

-----without major side effects. In terms of the people Professor McCormick referenced, the strategy is now completely different from where we were before. That will be part of the programme's roll-out and we will be trying to do that in a way that will get people to mobilise and come on board with the treatment. The indicators from the pilot schemes that have been done in the community setting show this is really successful.

Chairman

Deputy Cullinane has 15 minutes.

Deputy David Cullinane

Go raibh maith agat a Chathaorligh. May I start by stating that the Committee of Public Accounts is not a court, there are no kangaroos here so Mr. Breslin and Mr. Connaghan can rest easy?

How many cases are outstanding to be heard by the Hepatitis C Compensation Tribunal?

Mr. Jim Breslin

I do not have the figures in front of me, but I believe it is of the order of 456. There may be additional cases. For example, if a person dies, the dependant can enter a claim at that stage. It is a moving position but as of today, it is 455.

Deputy David Cullinane

Would it be fair to say that in most of the remaining cases, the adults would have been infected when they were children? Of the profile of the 455 individuals, would it be fair to say that most of these adults were infected when they were children?

Mr. Jim Breslin

It is a combination. Now most of the claims are from the dependants of an individual who was infected. The next category are people who have lost their carer or a consort as a result of their death. Of that figure of 455 individuals there are only 75 primary claimants remaining. The Deputy's question is then whether the majority of these 75 individuals are mostly younger people.

Deputy David Cullinane

Would they be mostly young men?

Mr. Jim Breslin

I do not know.

Deputy David Cullinane

Would Ms Tait know?

Ms Michele Tait

Part of the response to the State infecting patients was to establish a database of State infected patients. The individuals had to consent to their clinical data being used in a research-type database. The data is anonymised and it tracks the disease progression. We capture data such as age, gender and other conditions that they live with as well. I think somewhere between 75% to 78% of patients have consented to their data going into the database. The average age of patients who have consented to the database is 68 years of age and predominately there are more females than males because of the anti-D administration. We publish reports and we have a report that we will publish before the end of this year that details the clinical position of those patients. There are also demographics relating to age and the route of infection would be part of the data we collect.

Deputy David Cullinane

At this point, may I commend Dr. Brian O'Mahony, the chief executive of the Irish Haemophilia Society? I know he has worked with Mr. Breslin and the HSE. The Irish Haemophilia Society has done major work for the people who suffered as a consequence of this medical negligence scandal. I spoke to a number of people who have been through the process and have been compensated, which is the reason I am concerned about those who are still going through the process. It can be complex and difficult to determine a liability because one has to determine loss of earnings, whether there was a loss in terms of a career path. Is that still an issue and part of the complexities of arriving at a settlement for an individual?

Mr. Jim Breslin

Yes, but that is very much done by the tribunal based on individual circumstances. I know I am taking up the Deputy's time, but may I agree with his comments on Dr. Brian O'Mahony and the Irish Haemophilia Society and the hepatitis C communities. A key learning from this case come from an absolutely horrendous place for the country and for the groups affected. We have managed to work with them on the redesign of services, with patients at the heart of them. I refer to the National Haemophilia Council. I first worked with Dr. Brian O'Mahony on the product selection group, where the haemophilia community discusses the procurement process to procure the blood products that are used in Ireland and mostly used by the haemophilia community. That tells the committee members the ownership that they have of this issue. There is a learning for us in all of what we have been through over recent months as to how we involve patients in the work of the health service as a core partner in its service delivery and not after the fact, when things go wrong. We have to do that too, obviously.

Deputy David Cullinane

I thank Mr. Breslin. His response is appreciated.

I will now deal with the report of the Comptroller and Auditor General, which is primarily why we are here. The insurance scheme is referenced in page 165 and the report notes that the HSE does not have a current estimate of future expenditure to be incurred on the scheme. Why is there no estimate?

Ms Michele Tait

Originally, when the hepatitis C insurance scheme was established, the expected cost was in the region of €90 million. That figure of €90 million was based on an evaluation that was done at that time by the then Department of Health and Children. The expenditure on the insurance scheme to date has been around €9 million in the ten or 12 years since it has been established. We do not expect that the costs will be €90 million over the duration of the scheme. We do not have a current estimate of what we think it might be, but we do not believe it will be €90 million.

Deputy David Cullinane

May I interrupt Ms Tait? The Comptroller and Auditor General referred to this in his report. Is he simply noting that there is no current estimate of the cost or is he saying that is a difficulty?

Mr. Seamus McCarthy

The point was made that the figure may not be as high as €90 million but that no figure was expressed.

Deputy David Cullinane

There was no learning from the figure being unavailable. Was Mr. McCarthy noting that there was no estimated cost?

Mr. Seamus McCarthy

Exactly.

Deputy David Cullinane

The report of the Comptroller and Auditor General states that in 2012 the HSE estimates that between 20,000 and 30,000 people were infected by hepatitis C with around 10,000 individuals living with chronic infection at the end of 2009. Those figures were from nine years ago. Does the HSE have up-to-date figures? Are the figures much the same or have they changed?

Professor Aiden McCormick

The graph at figure 15.3 shows that 1,234 cases were reported in 2011 and that 874 were reported in 2012. That is when it changed from antibody and PCR positive patients to just PCR positive patients. We have made estimate in respect of the positive viraemic patients on the basis of data from the drug treatment centres and the hospitals. We think the figure is 20,000. However, the trouble is that there are unknowns involved and one will not know what is the exact figure until one gets to the end. As stated, we estimate that it is 20,000.

Deputy David Cullinane

Professor McCormick mentioned the modelling study. Was that Europe-wide?

Professor Aiden McCormick

No. This modelling study is us. It is just on the basis of our data.

Deputy David Cullinane

It estimated that 29,500 people were affected.

Professor Aiden McCormick

No, 20,000.

Deputy David Cullinane

No. I am referring to the modelling study. I am looking on page 167 of the-----

Professor Aiden McCormick

That is an international study. Our study, based on our data, shows the number to be 20,000.

Deputy David Cullinane

Therefore, there were two modelling studies.

Professor Aiden McCormick

There was no other modelling study based on our data. There are assumptions - the assumption based on some UK data is that 50% of the people are undiagnosed. They just take the figure of 15,000 reported to the HPSC and double it. We do not believe that figure of 50%. The figure of 14,000 is incorrect because-----

Deputy David Cullinane

Professor McCormick might be able to help me with this. Paragraph 15.26 on page 167 of the Comptroller and Auditor General's report states, "A modelling study in hepatitis C prevalence in 2015 carried out for 28 EU countries estimated the number infected with the hepatitis C virus in Ireland at 29,500."

Professor Aiden McCormick

However, that is not a modelling study using individual data. That is just taking published material from across the European Union and saying, "This is what it is in this country and that is what it is in that country." It is not using our individual data. The study that is published is the one on European epidemiology produced by Dr. Garvey from the HPSC in 2017. That is the most up-to-date one on the basis of virus reference laboratory data. That gives almost exactly the same figure we have come up with. I think it was 20,200 or something.

Deputy David Cullinane

How did the modelling study work? Is that an estimate?

Professor Aiden McCormick

The modelling study in the virus reference laboratory was done on the basis that they took blood samples which had been sent for various studies, but not for hepatitis C, and then tested them on an anonymised basis. So they had thousands of samples to try and figure out who were the undiagnosed proportion in the country, and using that with the people who have actually been reported giving an estimate in a country. Their figure was 20,000. Our internal figure is 20,000. We think 30,000 is an overestimate.

Deputy David Cullinane

Reference to under-diagnosis and the national screening guideline for hepatitis C is made on page 168 of the Comptroller and Auditor General report. It stated that no national guidance for healthcare providers was developed. Is that still the case?

Ms Michele Tait

No, I do not believe it is. The national screening guideline that the HSE published in 2017 sets out a process whereby anybody who works in any part of the health service and beyond - within the prison service, for example - works to a set of guidelines under which patients are identified on a risk basis and are tested for hepatitis C based on risk. The screening guideline sets out the criteria where patients who may be at risk or who may be identified as having previously been at risk are recommended to be tested for hepatitis C. So there is a national guidance in the form of our national screening guideline that we have produced and published since 2017.

Deputy David Cullinane

The Comptroller and Auditor General might be able to help me with what is meant. Paragraph 15.29 states:

With regard to reducing under-diagnosis, the HSE in collaboration with the Department of Health published the National Screening Guideline for Hepatitis C in 2017. The guidelines acknowledged that while screening for hepatitis C had been ongoing in many settings, national guidance for healthcare providers had not been developed.

I am trying to understand what that means.

Mr. Seamus McCarthy

I would need to go back to source in respect of that. I think this has been in the report. We would have looked for confirmation from the HSE that that was correct.

Deputy David Cullinane

There is a contradiction here between the response Ms Tait has given and what the Comptroller and Auditor General has reported. Either national guidelines were in place for healthcare providers or they were not. It is either a factual observation by the Comptroller and Auditor General or it is wrong.

Ms Michele Tait

It was an observation at the time. The audit was conducted over the period to the end of 2017. At that stage and for quite a significant amount of time prior to us publishing a national screening guideline on hepatitis C, while we had a lot of hepatitis C screening taking place, we did not have a national guideline. The point that is being made in the chapter is that we did not have a national approach to screening, though screening was taking place. Now we do have a national guideline for screening in the form of a screening guideline that was published in 2017.

Deputy David Cullinane

I ask Ms Tait to supply a note on that. The Comptroller and Auditor General may be able to follow up on it and if he is satisfied that is the case, then there is a match. I do not see a match. If there is one, that is fine.

Ms Michele Tait

I think the point was that we did not have a screening guideline and now we do.

Mr. Seamus McCarthy

It went on to recommend the putting in place of that.

Deputy David Cullinane

Therefore, it has been put in place.

Ms Michele Tait

The screening guidelines have been published and are in place.

Deputy David Cullinane

Paragraph 15.31 of the Comptroller and Auditor General's report states:

A strategy document produced by the then Eastern Regional Health Authority in 2004 set out recommendations to enhance prevention, treatment and surveillance of hepatitis C among infected people in the eastern region. The report was never published and an implementation plan was not developed.

Why was it not published?

Ms Michele Tait

I do not know why it was not published, but I know it was used-----

Deputy David Cullinane

Ms Tait does not know why.

Ms Michele Tait

I do not know why it was not published.

Deputy David Cullinane

Does Mr. Connaghan know?

Mr. John Connaghan

No, I do not know for certain.

Ms Michele Tait

What I would say is that it actually formed the basis for the development of a national hepatitis C strategy. The strategy that is referred to is a strategy that was written for the Eastern Regional Health Authority area; so it was confined to that region. I suppose with the move in 2004 for quite a lot of our services moving on to a national basis, that strategy was then developed into a national strategy.

Deputy David Cullinane

I understand that. It was for one region of the country. However, it was a report that was done. The Comptroller and Auditor General has compiled a special report and he notes and observes a number of issues, one of which is that this report was compiled in 2004 but was never published and no implementation followed. It is an obvious question that was going to be asked. We are following through on his observations. Why was it not published? If Ms Tait cannot answer, surely somebody else, perhaps Mr. Breslin, can do so.

Mr. Jim Breslin

I think Ms Tait's answer is probably the best there is. That organisation was wound up and became part of the HSE. People's responsibilities then moved into national responsibilities. Rather than implementing something in one region, which should be implemented nationally, it then formed the basis of a national approach and a national strategy.

Deputy David Cullinane

That helps us as members of the committee and is a reasonable response. Why is that not in this report? When the Comptroller and Auditor General completes his report, does it go to the HSE for comment?

Mr. Seamus McCarthy

It does, yes.

Deputy David Cullinane

I do not see that response in this.

Mr. Jim Breslin

I think the footnote is indicative of what was happening organisationally at the time.

Deputy David Cullinane

However, the footnote does not explain it. It just states that the Eastern Regional Health Authority was subsumed. There is a clear observation that a report was done but never published and there was no implementation plan. There were going to be obvious questions as to why it was not done.

Mr. Jim Breslin

Both things are correct. I am not taking issue with the Comptroller and Auditor General's right. A piece of work was done; it was not published and an implementation plan was not drawn up. If people had stayed in place within that organisation I am sure they would have, but when they took on roles in the new national body-----

Deputy David Cullinane

My quarrel is not with Mr. Breslin or even with the Comptroller and Auditor General. I am just saying it would have been more helpful if that had been incorporated into the report. We would have been in a better position to understand that.

Mr. Seamus McCarthy

I produced the report so I need to address that. I think what we were trying to do in this part of the report was to give an overview of how the service had developed and that to a certain extent there was stopping and starting for whatever reason. If one looks at the diagram, there was the Eastern Regional Health Authority report in 2004. The next significant development in terms of a strategy was in 2012. Obviously, there were many reasons that there might have been delays including structural reasons. Probably that is not the only one. I would imagine that other priorities, perhaps, got in the way as the HSE was developing national strategies across many fronts.

Deputy David Cullinane

I have another question. I am nearly finished. The Comptroller and Auditor General makes a number of observations on the national hepatitis C strategy from 2011 to 2014. The first is that there were 34-----

Mr. Seamus McCarthy

It was 36.

Deputy David Cullinane

There were 36 recommendations and some of them have not been implemented. Mr. McCarthy says that the strategy did not set target outputs in terms of overall treatment numbers. I always look to targets being set to ensure we have a sense of what the output will be and we can measure progress. Is that his observation?

Mr. Seamus McCarthy

Yes, that was my concern there.

Deputy David Cullinane

Was that considered then?

Mr. Seamus McCarthy

We would be looking for quantifiable things whereby one could determine the extent to which progress had been made in implementation.

Deputy David Cullinane

Did Mr. McCarthy see that as a weakness in the strategy?

Mr. Seamus McCarthy

Yes. Where it is possible to set a meaningful quantifiable target it should be done.

Deputy David Cullinane

Could that be addressed? First, why was that quantifiable target not made? Second, how many of the 36 recommendations have been implemented? Did Mr. McCarthy deal with that? How many were not implemented?

Mr. Seamus McCarthy

Yes. In the diagram on the screen one can see that one was not implemented at all and then there was partial implementation of the others.

Deputy David Cullinane

Okay.

Chairman

The Deputy will have a second opportunity. Deputy Catherine Murphy is next.

Deputy David Cullinane

The questions were not answered. One was about why there were no targets and the second was about why the recommendations have not been fully implemented.

Deputy Kate O'Connell

I asked that question too and it was not answered.

Mr. John Connaghan

Okay, we can deal with the one that has not been implemented and then have a comment on how far along we are on the amber category, which is partially implemented. Can Professor McCormick deal with the one that is-----

Deputy David Cullinane

Can the witness deal with the absence of setting target outputs as well?

Mr. John Connaghan

We will deal with both. The Deputy might want to relate the answer to that question to where we are with the current model which gives us a better platform to consider the future demand.

Professor Aiden McCormick

There is a difference between an accountant's approach to this and a clinician's approach. Our approach is to treat everybody we can who is in the clinic. That is what we told the institutions. By the end of this year, 1,700 will have been treated. Hopefully it will be more but it will probably be 1,700. There are approximately 1,000 on the books in the hospital. We are probably going to treat 1,800 to 2,500 next year. If they are not around we have to go out and find them. There is no point in us setting a target of 300 for Beaumont Hospital when it only has 200 patients. Our approach has been to treat as many as we can as quickly as we can and to get to the end. Certainly, we can put targets there, but they will be wrong. Is that a useful thing to do? Clinicians just want to eradicate this as quickly as we can. With a bit of luck, the tools the Department has given us and the fact that we are now implementing Sláintecare where we are moving treatment out of the hospitals into the community I believe we will eradicate this before 2026.

Deputy David Cullinane

I will hold Professor McCormick there because this is important in terms of the work Mr. McCarthy does for us. That appears to be a reasonable response. I assume it was communicated to the Comptroller and Auditor General but it is still stated in the report that there was a weakness. Was it not accepted?

Mr. Seamus McCarthy

I do not think it was put in exactly those terms. For me, it is important that targets are set in strategies and plans, particularly where budgets are involved, so one can establish whether one is hitting them. I accept that there has been better performance. If they had set targets they would probably have set them lower. With regard to the delivery of the programme in 2017, my understanding was that the treatment target was 1,600 but that was not achieved in 2017. Everything has changed. The drug type has changed and the cost has dropped so it is time to reset the target. We do not need to have a disagreement about what is important for clinicians as opposed to for accountants. Both perspectives are valuable.

Chairman

Is this a demand-led scheme?

Mr. Jim Breslin

It is at this stage.

Chairman

I understand both points but it is probably difficult to set a target. It is like setting a target for the number of illness benefit claims that will arise next year.

Mr. Jim Breslin

It is probably even a step further from a demand led scheme. One has to create the demand, whereas in many schemes people will apply. The issue here is that we must get out in the community, tell people about it and create awareness that we have a treatment. In doing that we will get more people into the programme. I believe it is possible to construct a middle ground between the two perspectives. The thing is to continually review the targets. This is changing so much so quickly we could set a target that turned out to be under-ambitious and then only meet that target.

Mr. Seamus McCarthy

I do not agree that it is a demand-led service at present. It is budget controlled.

Chairman

One could say capacity and resources.

Mr. Seamus McCarthy

Figure 15.8 shows what happened in 2017. Effectively, the clinicians would appear to have been responding to demand at the beginning of the year but they had to stop in the middle of the year because the budget ran out. There is obviously demand but the critical matter in terms of the control was the budget in 2017.

Deputy David Cullinane

The point is that it is creating demand.

Mr. Jim Breslin

The need is out there and we have to get the people who have a need but do not know it into the scheme. As already stated, we are moving to a stage where we do not have enough people. We have to find them. When I talked about the prioritisation, we had too many people and not enough money. Now we are moving into a new-----

Chairman

Is there enough money to deal with all of the people who have been identified in 2018? I am presuming you are working on the Estimate for next year and that next year will be the same. It will not be like what happened in 2017 when there was a big demand and then a drop.

Mr. Jim Breslin

As Professor McCormick explained, the job next year will be to find more people. If we are successful we might find many more people. The challenge is that we have a list of people and there is capacity to treat more than is on that list. We must find more people to treat.

Chairman

What is the budget for next year?

Mr. Jim Breslin

It is €30 million.

Chairman

What is it for this year?

Mr. Jim Breslin

Also €30 million.

Chairman

What was it for last year?

Mr. Jim Breslin

It was a straight €30 million from the start.

Chairman

Mr. Breslin is stating that the programme is over the hump in terms of numbers. The €30 million was not enough for last year based on the Comptroller and Auditor General's chart but Mr. Breslin is stating that it is enough for this year and next year.

Mr. Jim Breslin

Yes. Two things have happened - the price has come down and we are getting through the backlog of people we already know about.

Chairman

More people can be treated because of the reduced price. We are getting there. That was a useful exchange. Deputy Catherine Murphy can proceed.

Deputy Catherine Murphy

I remember this well because I was one of the people who got the anti-D and was screened in the 1990s. It was a similar crisis to the one we have had with CervicalCheck. People were very scared. I was one of the lucky ones who got a negative result but some of my contemporaries got positive results and the prognosis was awful at the time. There was worry about contamination. Some people were infected in the late 1970s and would have subsequently had more children. They were worried about the children being infected, as well as partners and husbands. It was a crisis at the time. I remember it well because when something affects one personally one does not forget it. When one looked at others who were not as lucky and got a positive result to the test one could see the challenges they faced with fatigue and so forth. The changes as a result of the drug advances are incredibly important from that point of view because it is an awful infection if one does not have the ability to manage it. We have the drug and there are people in that position. Deputy O'Connell made the point that a person will have to be managed in a hospital if the infection is not managed. There is a quantum in that regard if permanent damage is done so one must consider it in terms of how efficient it is to manage this by way of not trying to row back on damage that is already done.

A few things jumped out from the opening statement by Mr. Breslin regarding the people who were infected through the infected blood in the 1970s and 1990s.

Obviously, the crisis resulted from infected anti-D serum being administered in transfusions. Haemophiliacs were a particularly badly affected group. The statement notes that some 1,700 people in Ireland were infected, but further on it states that the tribunal had been hearing claims continually since 1996 and made 3,569 awards. What is the reason for the different figures?

Mr. Jim Breslin

A person can be the subject of more than one claim. He or she could have an individual claim which is paid on a provisional basis and subsequently re-enter a claim. The person's dependants could also enter a claim.

Deputy Catherine Murphy

Is a profile available in that regard detailing the rate of infection, family members and so on?

Mr. Jim Breslin

We have a profile distinguishing between primary claimants and others which we can provide that to the committee.

Deputy Catherine Murphy

It would be useful.

Mr. Jim Breslin

In the light of what the Deputy stated and what she went through, it might be of interest to her to know that 16,200 women were given anti-D. Those women were tested and it was found that 1,000 of them had hepatitis C. That was the scale of the issue.

Chairman

I ask Mr. Breslin to go through that again for the non-medics present.

Mr. Jim Breslin

Some 16,200 women were given anti-D over the periods where the issue of contamination arose. Those women were screened for hepatitis C and 1,000 of them were found to have hepatitis C.

Deputy Catherine Murphy

On the drugs that are available, is there any difference in their cost here compared to in other European countries?

Ms Michele Tait

The cost varies. Each of the drug companies negotiates different terms in different countries. We do not have detailed intelligence on that but we have some limited information. Every country, including Ireland, negotiates a commercial and confidence agreement with a percentage rebate based on sales. Every country negotiates a different agreement. The terms we have reached with the commercial companies operating throughout the EU are quite favourable. In contradistinction to where we were a few years ago, we are getting very good value on drugs for hepatitis C. We may be getting the best value for them, or among the best.

Deputy Catherine Murphy

Although a small number of people were infected, even relative to our small population, do we have a higher rate of hepatitis C infection than other countries because of the contamination or did such events also happen elsewhere?

Ms Michele Tait

Contaminated products were used in certain other countries around the world. Ireland is considered to have a low prevalence of hepatitis C. Including the 1,700 people infected through State products, the rate is in line with that in other countries.

Deputy Catherine Murphy

Some €1.18 billion went to awards and legal fees. There must have been some learning from the scandal. Was a post-mortem conducted to identify what was handled well and what was not? We have a habit of creating problems or crises in the healthcare system and elsewhere and then resolving them. It is something of a national pastime. We do not always learn from the experiences of the past. Was a review conducted to consider what would be done differently if such a problem emerged now and what could have been done to avoid the problem?

Mr. Jim Breslin

Absolutely. Two tribunals separate to the compensation tribunal tried to identify the learning from this case and that has informed subsequent approaches. One learning identified is that while the issue is being considered in terms of how it happened and so on, people will have been affected and need supports. Generally in such situations the first response is to tackle the problem from a patient safety perspective. That did not happen in this case. There was contaminated blood in the blood supply and that continued after the service gained knowledge of it. There is an absolute understanding across the health service of the need for immediate intervention to prevent further harm resulting from a patient safety issue which has an ongoing implication. Another learning is that one must look back to see who was potentially affected by the issue. Another is that while legal processes and other things take their course, those affected will require supports and one should work proactively to put such supports in place. We have recently tried to work with and support affected people on an individual basis. That has been done in various circumstances, including in dealing with women who underwent symphisiotomies in Our Lady of Lourdes Hospital, Drogheda, and those affected by CervicalCheck.

Deputy Catherine Murphy

The management of medical negligence is part of this discussion. It is very welcome that learnings have been identified. There would be something wrong if they had not. As I stated at the committee last week and on a couple of occasions in the Dáil, some things have not been learned. That women are still seeking copies of their CervicalCheck slides indicates that the system is still very legalistic and that the affected person seems secondary, at least in regard to getting medical information.

There was a recent article in The Sunday Times on genetic testing in Crumlin hospital. The Minister for Health or his Department has initiated a review of 335 positive BRCA genetic tests. Some 3,500 negative tests remain to be reviewed. This goes back to the issue of problems being foreseen or earlier identified. The 2014 Donnai and Newman report initiated by the HSE showed serious dysfunctionality in this area. However, a review is now being initiated based on claims published in a Sunday newspaper. This appears to be a very serious issue which may be on a par with Cervical Check and the blood contamination scandal. It strikes me that the early identification of issues, as referenced by Mr. Breslin, is not happening. If serious dysfunctionality was identified in 2014, but now in 2018 no root and branch review on how to deal with that has been carried out, a lot remains to be learned. Some recommendations of the report were never implemented, for example. It falls into the same category as many major issues.

Chairman

I ask the Deputy to conclude as we are under time pressure.

Mr. Jim Breslin

The HSE can comment on the report and the recommendations. I know work is under way on that and on international involvement in that service to bring about improvement. On the specific question about the BRCA test, that was identified as a transcription error and the 300 or so positive tests are being worked through, and that will be completed. As of today, no further errors have been identified. That fits with the principle whereby, as I said, if a single issue is identified, we look to find other cases that might be relevant to that and we do a look-back process through those. It is in line with good practice. There is a serious incident team managing this in Crumlin through the children's hospital. Again, even in a situation where something like this has happened and, again, it is truly wrong and tragic in the individual circumstances, the incident management approach is to look beyond the individual circumstances into any wider risk there might be and to do a look-back through that. That is exactly what is being done in this situation. The findings to date are that it is an isolated error.

Deputy Catherine Murphy

Mr. Breslin is saying - absolutely, categorically - that this is a transcription error.

Mr. Jim Breslin

That is what the findings to date are, namely, in this one case it is a transcription error, and so far no other errors have been found in the positive tests that have been reviewed.

Deputy Catherine Murphy

I have a doubt about that and I have a reason to have a doubt about it. In regard to CervicalCheck, what was the learning from the blood contamination issue in regard to CervicalCheck and working with the person who has been the subject of the problem? Why are we still waiting for these women to get their slides?

Mr. John Connaghan

I will start and Dr. Henry may also come in. We have been requested to provide, on a slide-by-slide basis, the history of when that slide was requested, where it was dispatched to and what the turnaround time was. At a previous evidence session, Mr. McCallion intimated that the average turnaround time was 22 days and the maximum was something of the order of 70-plus days. We are in the process of drawing that together and the committee will get that very shortly. It will show the exact timetable requested. However, perhaps the most recent issue at hand is the one about the observance of a protocol that we have. It is a very simple protocol, which simply asks what is the transport method, where is it going and who is going to be responsible for receipt of those slides. Most requesters of the slides through legal representatives have observed that and are happy to do so. We have had an issue with perhaps one or two latterly, and we are seeking to overcome these issues. However, the committee will very shortly get a full report on the timetable associated with this.

Chairman

I will come back to Deputy Catherine Murphy. Time is tight but we will try to squeeze everyone in.

Deputy Jonathan O'Brien

What is the waiting time between the assessment and the beginning of treatment?

Professor Aiden McCormick

For hepatitis C treatment, it depends on the unit but it is very short. We now have the capacity to treat people and we have taken away barriers, so we do not biopsy people any more and we do not have barriers in terms of alcohol use or drug use. Basically, when someone comes into hospital, it is about the ability to turn up for the appointments. If people turn up for two appointments, they can be treated. For most people who come into the system now, treatment starts within two months.

Deputy Jonathan O'Brien

Would that be longer for people outside a hospital setting, for instance, within the prison service?

Professor Aiden McCormick

We are currently trying to expand services within the Prison Service. The difficulty in the Prison Service is blood testing. The prison nurses are not trained in phlebotomy and, for the hepatitis C nurses who go into the Prison Service, it can be very difficult to get access to the patients because the place can be in lockdown or there are no prison officers to bring them up. We have a major difficulty in that regard. There is now up to a six-week delay in some prisons to get a blood test for hepatitis C. We are working to overcome that and we will have a meeting about it with the Irish Prison Service in two weeks' time. Fifty patients have been initiated into treatment for hepatitis C within the prisons so far this year.

Deputy Jonathan O'Brien

When we identify risk groups and, obviously, intravenous drug users are a high-risk group, how are we targeting those individuals? I presume it is through drug addiction centres but very few intravenous drug users will get to the stage where they are in addiction centres, and some will end up in prison. Therefore, there is a cohort of people who may not engage with services. Are we actively trying to target that group and, if so, how are we doing it and what methods are we using?

Professor Aiden McCormick

The Deputy is right. Ireland is pretty good in terms of opiate substitution therapy, OST, and recent data from across Europe suggest that some 54% of people with active opiate use in Ireland are undergoing OST, which is higher than in most European countries. However, it is very difficult to target the people who are not in opiate substitution, not in hostels and not in prison, and we are trying to target those three areas. Outside of those areas it is very difficult. One could go on the soup run with the Simon Community as a possibility but it is difficult if people are not somehow linked in with therapy. The advantage of opiate substitution is that people will come for their methadone but, if they are chaotic and will not do that, how are we going to treat them with antiviral therapy for eight weeks or 12 weeks? It is very expensive medication and if they take it for a few days and then stop it for a week, there will be resistance and we will not be able to treat them subsequently. The Deputy is right. It is very difficult to see how we are going to get to this very hard-to-reach community when we do not have a good idea of it.

Deputy Jonathan O'Brien

I want to stay on this area. If an intravenous drug user is diagnosed with hepatitis C, and Professor McCormick said we are waiting about two months to begin treatment-----

Professor Aiden McCormick

In the hospital setting.

Deputy Jonathan O'Brien

Yes. What is the issue? I know, not from personal experience but from family experience, that those individuals share needles. How prevalent is that and how are we trying to address the issue? We have the needle exchange programme running in 120 or 130 pharmacies throughout the State. Although Professor McCormick cannot comment on policy, one of the policy areas that could really bring benefit in this area is in regard to safe injecting centres, which are being proposed for Dublin as a pilot project. While I will not ask him to comment on the policy, I would ask him to share his experience of the international experience of how safe injecting centres can form part of the overall health policy on preventing hepatitis C, particularly for intravenous drug users who are sharing needles.

Professor Aiden McCormick

I think it is fantastic and is the way to go. It is safer for the drug users and safer for the community, certainly if people are using clean needles. I would go further and say that one should give these people the opiates rather than having them buy them on the streets and giving the money to criminals, but that is a different area. If they are in the injecting centres, we have access to them and can go and talk to them and treat them.

Deputy Jonathan O'Brien

Screen them.

Professor Aiden McCormick

Screen them and treat them. These people are the ones who are maintaining the epidemic. We want to get to the people who are chaotic and sharing needles, and treat them to prevent further infections. I think it is an excellent idea.

Chairman

Professor McCormick is speaking personally.

Professor Aiden McCormick

Yes, personally.

Chairman

I do not want to stray into the area of policy. It is a valid point but it is a personal opinion.

Mr. Jim Breslin

I will make a point on the policy position, although I will not go into the issue of the dispensing of the drug.

The supervising injecting rooms are policy and the pilot is well advanced. There are 90 drug consumption rooms operating around the world. We have looked at them. Undoubtedly, there is a reduction in blood-borne transmission of diseases in them. It also presents an opportunity to get a public health message across to people, including those who have hepatitis C, about how they could deal with it. It is one of the core rationales for using supervised injection facilities.

Deputy Jonathan O'Brien

I want to highlight it because when we talk about safe injecting centres, which I fully support and would like to see rolled out beyond Dublin, we talk about fatalities and how, internationally, there has never been a fatality in a safe injecting centre. There are other health benefits such as preventing hepatitis C from spreading. I want to put that on the record.

My understanding is there is almost a screening process within the Prison Service when it comes to hepatitis C. Although it is not a statutory screening process, it is as good as one. Is it based on voluntary buy-in by prisoners? Is it, in effect, a screening process within the prison service?

Professor Aiden McCormick

I have not worked in the screening service. What I am told by the nurses who work there and by the Irish Prison Service is that prisoners are offered the option for testing but they have to accept it. It is a civil liberties issue. Getting the blood sample is the problem with that. There have been studies done using saliva or blood spot but getting a blood sample is the way to go.

Deputy Jonathan O'Brien

I have two more brief questions. In cases where a diagnosis has been made, do we have figures for how many people contracted hepatitis C outside the State? I am talking about the immigrant population who may be seeking asylum here or in direct provision who we know have hepatitis C. Do we look at that to try to identify potential risk groups?

Professor Aiden McCormick

We have done estimates using the census figures and international figures in drug prevalence in the various countries the immigrant population comes from. The net figure I came up with was 392 migrants with hepatitis C viremia per year because a lot of migrants come and go. We estimate the net figure is probably about 400 a year.

Deputy Jonathan O'Brien

Do we treat-----

Professor Aiden McCormick

The thing is, when we are talking about migrants, we are talking about people coming from Poland and Romania, for example. They are not known to the health service. They come here and work. If we are talking about migrants who go to the migrant reception centres-----

Deputy Jonathan O'Brien

Direct provision centres.

Professor Aiden McCormick

-----they are offered checking.

Ms Michele Tait

There is a report that has recently been published. We can send it to the committee. The Health Protection Surveillance Centre, HPSC, has just produced it. It looks at the diagnosis of hepatitis C in 2017 in Ireland and gives a breakdown that includes the country of birth because that is recorded for anybody who has a positive diagnosis. We can send a copy of it to the committee. It was published in the last week or so.

Deputy Jonathan O'Brien

If I can-----

Chairman

We have a copy in our briefing notes.

Deputy Jonathan O'Brien

Okay. I obviously did not do my homework.

I will turn to the Comptroller and Auditor General's report. I am not being critical in any way. I am being genuine because I have an interest in the area. In terms of the amber recommendations - there is only one red one, which is positive - which are only partially implemented, most are in the education area. Many concern the provision of resources for addiction centres and residential beds. If we look at the past number of years, we have been through a really tough time economically and have not seen a significant increase in the number of treatment centres. We have seen a bit of an increase in terms of residential beds mainly from the private sector. One issue I keep raising is the adolescent scene; we only have four residential beds for adolescents in the State. Could Mr. Breslin give us a brief comment on where we are in terms of the education recommendations? Are we confident that any of the amber recommendations will turn to green in the next 12, 24 or 36 months? What partnership is there with the HSE on treatment and addiction centres?

Mr. Jim Breslin

I will not talk about all the hepatitis C ones. Some of them are specific to hepatitis C. With regard to the drugs and addiction service and the role it has to play, we have produced the new national drugs strategy, Reducing Harm, Supporting Recovery. We have refreshed the governance and interdepartmental involvement in it. All of the relevant Departments and agencies meet. It is chaired by the Minister of State. Much inter-agency work is under way. The allocation of resources has started in line with that strategy. I am not here to make a case that we have completed it. We have started it. In 2018, €9 million was made available for a range of initiatives including the supervised injecting room and for addiction services for under 18s. The Deputy spoke about treatment places and beds but it also is about getting people into communities to work on a multidisciplinary basis with children who have addiction and putting in place young people's counsellors, clinical nurse specialists and so on. We have a range of initiatives under way. We could supply details to the committee. They play into making services more accessible but also into prevention and harm reduction. Much of what we are talking about here is harm reduction in order that people who are engaged in a harmful activity understand the implications. We work with them to try to limit it and to try to get them away from behaviour that is harmful to them. That is the core of the national drugs strategy.

Deputy Jonathan O'Brien

I have 30 seconds so I will finish on this. The community provision of services, particularly post release from prison where somebody may have gone through an addiction programme, or from an addiction centre is on a voluntary basis. We give people information on where and how to engage with community-based services. Do we have a register of, or statistics on, the people who engage with those services? Do we have statistics on the people who disengage from the services following an addiction programme? Do we have statistics on how many people relapse in both settings? What is the relapse rate for people who disengage from the service and for people who engage with the service? That kind of information is good information for drug users in particular. When people come out of addiction, those who disengage from the services are far more likely to relapse than those who do not. That is a message we need to be pushing out to that particular community.

Mr. Jim Breslin

It is not an easy area in which to establish reliable information. The Health Research Board, which conduct a drug prevalence study, goes to great lengths because we are trying to establish rates of illicit use. If we just ask people in a shopping centre, they are not going to tell us the answer. A lot of methodology was put behind that in the prevalence study. I do not have them to hand but we can supply them to the Deputy. The biggest drugs that come through that study do not involve the use of needles; they are cannabis, cocaine and so on. We can try to extract out of that relevant information the Deputy might be interested in and supply it to him.

Deputy Jonathan O'Brien

Or we could just legalise it.

Mr. Jim Breslin

There are people making points here, which, as Secretary General of the Department of Health, I am not endorsing in any way.

Deputy Jonathan O'Brien

That was a personal comment. I did not make it on behalf of the Committee of Public Accounts.

Chairman

We are getting interesting personal comments from witnesses and members today.

Deputy Catherine Connolly

Gabhaim buíochas leis na haíonna. Bhí sibh thar a bheith ionraic agus díreach agus thug sibh freagraí.

It is refreshing to have such comprehensive information provided in an open manner. I thank the witnesses for that. Mr. Breslin's comment that the people affected by the State in particular are coming from a horrendous place. That must be borne in mind. The image of the McCole family and a certain Minister at that time will stay in my mind forever.

I welcome Professor McCormick's opening contribution. He said he expects we will meet our target well before 2026. On what is this expectation based?

Professor Aiden McCormick

I hope that we will meet our target before then as we are ramping up. The community treatment programmes that we have established have overperformed rather than underperformed. It is one area of the health service where everyone is trying to help. People are queuing up asking us for access to treatment. We have GPs in Galway, Limerick, Waterford and Cork-----

Deputy Catherine Connolly

That is reassuring but I am looking at a strategy that was set a long time ago. The period of the strategy has passed and the recommendations have not been complied with. At that time, it was recognised that people's lives were chaotic, although I do not like the use of that word. They suffered very chaotic experiences that led them into that. The importance of community was recognised at the start of that strategy. What specific progress has been made in respect of community outreach, given that this was identified back in 2012? There was a pilot project in 2017. Where are we with this? Has it been completed? Have we learned from it? What will we roll out next year?

Professor Aiden McCormick

We have four pilot programmes in the opiate substitution therapy clinics, with one in Dún Laoghaire, one in Castle Street, one in the drug treatment centre and another one that has just started in north Dublin. The therapies are being prescribed and dispensed in the drug treatment centres. They are our community projects. There is also a project in the Mater Hospital where they link with Safetynet. A patient comes to the hospital once and it is then dispensed in the community. There are five community-based projects and one in the Prison Service - in Mountjoy, Wheatfield and another prison. We are trying to ramp up all of these and we are also trying to establish a service in Limerick. We have difficulties in engaging with University Hospital Limerick because it has many challenges, but we are trying to establish a treatment programme in the drug treatment service directly in Limerick and, if necessary, to send a hepatologist down once weekly to see these patients. We are getting mobile fibre scans which will allow us to go out in the community.

Deputy Catherine Connolly

Has the programme analysed communities across Ireland to determine which ones are priorities. Professor McCormick mentioned Dublin.

Professor Aiden McCormick

I mentioned Dublin, Limerick and Galway. However, there is a hole in the midlands and another in the south east and we are trying to fill those.

Deputy Catherine Connolly

From what data or research is the project working? What will be rolled out?

Ms Michele Tait

When the pilot sites were set up it was the first time we had brought hepatitis C treatment outside of hospitals.

Deputy Catherine Connolly

When was that?

Ms Michele Tait

That was in 2017.

Deputy Catherine Connolly

It took some time from the date the strategy was published to roll out a community programme.

Ms Michele Tait

There were patients getting the older treatments. The treatment programme has been using the new directly acting antivirals, with the new curative treatment that has been up and running since 2015. Prior to that, an older treatment was available mostly through the hospital setting. Very few patients went on that treatment but some did get that treatment in drug treatment centres. One or two programmes were running but they had very small numbers of patients and the outcomes for those patients were not great. It was not a good course of treatment. The pilots for the new, recent curative treatments for hepatitis C were set up to look at the feasibility, accessibility, sustainability and safety of using those treatments in that setting. In the first 15 or 16 months of those pilot programmes, where we have commenced approximately 150 patients, we have learned that it is safe, feasible and acceptable to the people who work in those clinics and their patients and also that the outcomes are the same if not better than for patients in a hospital setting.

Deputy Catherine Connolly

I accept that. This has been going from 2017 and the policy was obviously to treat the sickest people first. However, that did not happen because, as has been pointed out, the budget ran out and, from what I am reading, it was suddenly suspended.

Professor Aiden McCormick

No, the sickest patients were treated first but many other patients were also treated.

Deputy Catherine Connolly

I understood that when the budget ran out the programme was suspended.

Professor Aiden McCormick

It was paused for new patients for about six or eight weeks. Patients who were on treatment continued on treatment.

Deputy Catherine Connolly

Therefore, new patients who may have been chronically ill were not getting treatment during the period the programme was suspended.

Professor Aiden McCormick

Exactly. We did an exercise at that stage to look-----

Deputy Catherine Connolly

No, that happened and that is acknowledged. For a crucial period, people who were very ill, new patients, were not getting treatment because of the budget problems. We now have a new problem now. Professor McCormick is saying that we have plenty of money, which is good, and that he hopes the programme will reach its target well before 2026, which is excellent. However, I am not hearing the evidence for this. Perhaps he will come back to the committee and explain what is being rolled out. The news is very welcome but on what is it based?

Professor Aiden McCormick

We are basing it on the opiate substitution therapy figures for where the people who are on methadone are. We reckon that is where the patients who have hepatitis C are distributed around the country. We have reasonably good data on that. We will roll that out through the big opiate substitution therapy clinics that have a pharmacy on site and then secondarily into the community pharmacies. That is how we are basing our figures for how to spread it out.

Deputy Catherine Connolly

The witnesses' openness is very welcome. If such openness had been shown years ago, we would not be in the position where €54 million and rising has been spent on the area. I do not want to exaggerate the cost of the Finlay and Lindsay tribunals but the figure was high enough. The tribunals cost €47 million and there is also the cost of the compensation for all the heartbreak and the terrible implications of what happened. It amounted to €1.5 billion. According to the document provided, everyone who was infected as a consequence of the State's responsibility was to receive care by 2017. Why was that year chosen?

Mr. Jim Breslin

Initially, the programme was set up in 2015. There had to be a set-up of the programme with a call of people into the programme. People had to come into the programme and take the treatment.

Deputy Catherine Connolly

These were the 1,700 people who were identified as having been infected through State action.

Mr. Jim Breslin

Yes, but that would have involved engagement with their consultants, talking to them about the programme and bringing them on board. It was never envisaged that this could happen over weeks, but would take-----

Deputy Catherine Connolly

This goes back to the 1990s. I am sorry, I am mixed up.

Mr. Jim Breslin

The drug that we are talking about is 2015 and it is a game changer.

Deputy Catherine Connolly

It is a specific drug. They had been under treatment prior to that.

Mr. Jim Breslin

Other drugs before that did not have the same outcomes and they had many more side effects.

Deputy Catherine Connolly

I understand. Hepatitis C has been a notifiable disease since 2004. Two things happened that year. A register was established of those infected as a result of the State and a separate register was established in relation to notifiable diseases. Have these two registers been merged?

Ms Michele Tait

No. The 2004 legislation requires all diagnoses of hepatitis C to be notified, that is, any diagnosis that takes place. On the database to which I referred earlier, which related to State-infected patients, it was recommended that a clinical database to measure their progression through their disease would be established. This is based on the patient's consent.

Deputy Catherine Connolly

I saw that, and there is an uptake of around 80%.

Ms Michele Tait

Yes. There may be patients who are part of that group of State-infected patients who have also been notified to the infectious diseases register, but they are not linked. Incidentally, that register is managed by the Health Protection Surveillance Centre, which collates the notifications from departments of public health. It also manages the database of State-infected patients and produces reports.

Deputy Catherine Connolly

The Comptroller and Auditor General made three recommendations. The HSE accepted them save for one relating to the setting up of a national register, citing data protection issues. Where is the HSE on that recommendation and its related actions?

Ms Michele Tait

The recommendation was on linking the notifiable disease notifications of hepatitis C to the treatment registry, which is a separate entity of the HSE's that tracks any patient who has been prescribed the new drugs. This would link the notification of a patient's diagnosis to the patient's treatment. Those data are not linked currently, but we are considering how such linkages may be developed.

Deputy Catherine Connolly

Was the recommendation in the Comptroller and Auditor General's report reasonable or unreasonable? Is it doable and, if so, when will it-----

Ms Michele Tait

An information interface that brought people from the point of diagnosis and linked them with treatment would greatly assist us. It is part of the bigger picture. There are other considerations to do with surveillance, screening and testing.

Deputy Catherine Connolly

I have read that and I understand those considerations, but when does the HSE see itself overcoming them and what steps is it taking? Is there a process in place to achieve it?

Ms Michele Tait

We have had that recommendation for a couple of months. We are examining it with our colleagues in the department of public health.

Deputy Catherine Connolly

I have one last question.

Mr. John Connaghan

May I say something? I spoke to our head of public health on this recommendation fairly recently. I have asked him to examine it with a reasonable degree of urgency. I expect a report in the early part of 2019 on how we can implement this and what the barriers are. When I say "the early part of 2019", I mean within the first quarter of the year.

Deputy Catherine Connolly

My final question has two completely different parts. One will be for Mr. Connaghan. According to the Comptroller and Auditor General's report, there will be an updated report by the end of the year, as the last update in the database only took us to 2013. Is that on time?

Ms Michele Tait

It is. We will have that before the end of this year.

Deputy Catherine Connolly

That will be published before the end of the year.

Ms Michele Tait

Yes.

Deputy Catherine Connolly

I have a general question on learning. We have gone to great effort and people's lives have been affected. Generally, we sit here every week and try to prevent events from happening and to get our heads around liability. Everyone has a right to go to court, but various incidents lead up to such situations. Coincidentally, we were to discuss and learn from the report on Portiuncula Hospital, Ballinasloe, that was published this year, but I understand that it has been adjourned to another day. What jumped out were the failures to learn and the opportunities to learn that were repeatedly missed. The lack of staff also put them under tremendous pressure.

Is tuberculosis a notifiable disease?

Ms Michele Tait

Yes.

Deputy Catherine Connolly

I am being specific and parochial, but this has major implications for learning. If there is a notifiable disease in Galway, as I have been informed, and staff contract it, and if I then ask a question about it, I will be told that a review will be carried out in the future. I have read the opening statements from Mr. Connaghan and the Department. When an event happens, it should be a case of stopping immediately, protecting people, learning from it and carrying out a review. However, the answer to me is that a review will be carried out. We are now in November, but the event in question happened months ago.

I asked what reviews generally have been carried out in Galway. I made the question simple by only referring to external reviews. What was the cost of those reviews and who carried them out over the past ten years? Extraordinarily, I was told that the HSE did not have that information. Following a search for the information I had requested, I was told that the HSE did not have a system to record the number and cost of all external reviews or investigations of patient care at University Hospital Galway. I do not expect Mr. Connaghan to have an answer for me now. I am just drawing his attention to this. There is no database of reviews or their cost even though the matters in question lead to litigation. Regarding my question on a notifiable disease, here we are about to have another review. If Mr. Connaghan could comment, I would appreciate it. If he does not have the details, that is fine.

Mr. John Connaghan

I will make a general comment and follow it up with something more specific. The Deputy's points about prevention rather than cure are enormously important. I started my working career in a quality control department at a point in time when the fashion was to inspect the product as it came off the end of the line and, if found to be defective or the like, reject it.

Deputy Catherine Connolly

We know that. We have sat here every single week. Please, address my specific questions.

Mr. John Connaghan

Prevention must be at the top of our agenda. I need to send the committee something on what we have introduced in 2018 as regards our incident management framework. Claims and safety issues arise through the incidents that occur. The questions were on whether we were capturing these and learning from them and what examples we could provide.

Deputy Catherine Connolly

No, I do not want any more documents. I have read so many documents with my colleagues, I cannot go on half the time. I want to know about implementation. I have cited two specific examples where there are large gaps. We are learning retrospectively after a significant cost, including €54 million for two tribunals not to mention all the others. We do not seem to be learning, which is a point that my colleague made.

Mr. John Connaghan

I will give a specific example of where learning has occurred and what the outcome is.

Deputy Catherine Connolly

I would love it if Mr. Connaghan reverted to me about the two examples I raised.

Mr. John Connaghan

I will indeed.

Deputy Catherine Connolly

I have taken all of my time.

Chairman

We are tight for time, as the Dáil's votes will be starting. Did Deputy MacSharry indicate?

Deputy Marc MacSharry

Yes.

Chairman

Deputy O'Connell also wishes a moment.

Deputy Marc MacSharry

I will be as quick as I can. What is the €25 million per year for?

Professor Aiden McCormick

It is €30 million.

Deputy Marc MacSharry

Sorry. Was there not some-----

Mr. Jim Breslin

There are figures of €25 million and €30 million. The €25 million figure relates to compensation tribunal awards.

Deputy Marc MacSharry

It costs €30 million to run the show.

Mr. Jim Breslin

The budget for drug therapy to remove infection is €30 million per year. People who have been infected with hepatitis C and HIV from the blood supply go to the compensation tribunal. On average, the awards amount to just below €25 million per annum.

Deputy Marc MacSharry

What is the cost of the tribunal itself?

Mr. Jim Breslin

It is €1.18 billion.

Deputy Marc MacSharry

That is the total cost, but I am asking about the annual cost. Obviously, there are legal and administration people in place.

Mr. Jim Breslin

Yes. I can give a breakdown of the costs in terms of compensation, legal fees and administrative costs. We have that. This is the report-----

Deputy Marc MacSharry

Over the 20 years, have we streamlined the process? Have we been able to reduce administrative or legal costs or has it been a one-way trajectory upwards?

Mr. Jim Breslin

Both of those are the case. The tribunal operates independently of the Department, so I do not engage with it on trying to reduce its administrative costs, for example.

Deputy Marc MacSharry

Does anyone?

Mr. Jim Breslin

A chair of the tribunal is in place and manages an effective and efficient operation.

Deputy Marc MacSharry

Does anyone have a role in overseeing that and ensuring that everything is-----

Mr. Jim Breslin

We make the payments. I am not trying to avoid the fact that-----

Deputy Marc MacSharry

I understand that, and I get that Mr. Breslin is not responsible.

Mr. Jim Breslin

The tribunal is audited through the-----

Deputy Marc MacSharry

Does the Comptroller and Auditor General have any role in this?

Mr. Seamus McCarthy

I have some. There is a breakdown of the cumulative spend in the accounts of the tribunal.

Deputy Marc MacSharry

I read those, so I will not hold up the meeting by asking the Comptroller and Auditor General to go through them. I am interested in knowing whether the Comptroller and Auditor General audits the tribunal.

Mr. Seamus McCarthy

Yes, and the audit is submitted to the Oireachtas.

Deputy Marc MacSharry

Have the costs increased?

Mr. Seamus McCarthy

No. In the schedule we have given, the costs have decreased.

Deputy Marc MacSharry

They are pretty static. Have they decreased through efficiencies or a diminishing number of claimants?

Mr. Seamus McCarthy

A diminishing scale, I would imagine.

Deputy Marc MacSharry

Have the legal and administrative costs increased or remained static?

Mr. Seamus McCarthy

I do not have that level of detail here.

Mr. Jim Breslin

During the crash, there was a process to try to moderate legal costs. In line with other bodies, the tribunal moved to-----

Deputy Marc MacSharry

Other tribunals' costs decreased a bit, but then certain heads of tribunals asked that they be increased again. Was this tribunal one of those?

Mr. Jim Breslin

I do not believe so.

Deputy Marc MacSharry

Its costs decreased.

Mr. Jim Breslin

Yes.

Deputy Marc MacSharry

There was an agreement that we would cut them all.

Individual tribunals were saying that we needed more money and that was acceded to in some instances. Was this an example?

Mr. Jim Breslin

We would have to look at it.

Deputy Marc MacSharry

It would be good practice when something has been going on for so long and will continue. Where are we with the legal spending?

Mr. Jim Breslin

I can give a breakdown of the overall spending in 2017.

Deputy Marc MacSharry

That would be good.

Mr. Jim Breslin

There was €21.8 million in total. Of that, the tribunal awards are €14.6 million but one has to add €3 million for reparation payments since every award gets a 20% top-up as a reparation.

Deputy Marc MacSharry

That means €17 million or €18 million.

Mr. Jim Breslin

There was €3.7 million in legal costs for claimants, with some €242,000 for the fees of the tribunal chair and members with administrative costs of €207,000.

Deputy Marc MacSharry

That does not sound prohibitive, which is fine. I know we were to focus on the HPV vaccine today but while Mr. Connaghan is here, I have a related question. I asked him a few times previously about claims that are settled without admission of liability. We established that there is not a mandatory monitoring or retraining period for the health professionals involved. I asked the SCA officials as well. They seemed to be agnostic about it. We toed and froed a little bit but the bottom line was that there is no process and we depend on the regulatory bodies. The bottom line is that there is nothing. Have any moves been made in that direction?

Mr. John Connaghan

We have given some thought to that. That exchange was four months ago or so. I ask Dr. Henry to address it. Some decisions were made on that recently.

Dr. Colm Henry

Deputy MacSharry is correct that we do not have a dedicated service and the NHS does. It is called the National Clinical Assessment Service, NCAS, and was established in recognition of the fact that the approach to regulation is binary. One is referred and either found guilty or not and fit to practise or not. The focus of the NCAS is on remediation and approaches that can be made short of censuring a doctor. That approach in the UK has been successful in re-educating or retraining doctors on whatever deficits are identified and returning them to the delivery system, bearing in mind our significant recruitment difficulties. We have a recent arrangement with the NCAS to use its services regularly for a small number of cases. We are now going to enter a more substantive agreement with the service to allow for a dedicated Irish phone line assessment service and remediation where appropriate in recognition of the fact that the UK service has been up and running for many years and has developed skills and expertise.

Deputy Marc MacSharry

Will that be optional or mandatory?

Dr. Colm Henry

Unsurprisingly, most will consider it mandatory because the alternative is a regulatory hearing at a Medical Council level.

Deputy Marc MacSharry

Even where it is a case that we have settled without admission of liability? Dr. Henry will be aware the point I am making.

Dr. Colm Henry

I am. The discussion depends on each case and would take place at a hospital level between the clinical director and the clinician concerned. That level is where it should happen and the referral would be from the hospital or a community healthcare organisation to this service which in my view, and that of many people, would be much more fruitful and productive than a more stark direct referral to the Medical Council which will make a judgment based on fitness to practise.

Deputy Marc MacSharry

Will Dr. Henry send us a note on that?

Dr. Colm Henry

Yes.

Deputy Marc MacSharry

It would be good practice to have some kind of mandatory follow-up even if there is no liability on an individual or group of individuals. When there is a settlement in the tribunal, are confidentiality agreements signed by the claimants?

Mr. Jim Breslin

Everything is confidential in the tribunal. Nobody knows the name.

Deputy Marc MacSharry

I am not interested in knowing the names of the people. If I am a claimant, go through the tribunal and get my award and reparation, do I have to sign a confidentiality agreement about that outcome?

Mr. Jim Breslin

I am not aware of that.

Deputy Marc MacSharry

I am interested in getting the answer if possible. If the answer is "Yes"-----

Mr. Jim Breslin

If a person wanted to say he or she had an award of a certain amount, I do not think there is an issue. The tribunal will never say that it has certain people in before it.

Deputy Marc MacSharry

I am not interested in the tribunal but in individuals. Are individuals forced in any way? We have come across this before in other areas.

Mr. Jim Breslin

No. Do not forget that one does not have to go before it to prove negligence. Once a person has received a product and has the disease, then that person is entitled to the compensation, so that does not apply.

Deputy Marc MacSharry

In his opening statement, Mr. Connaghan talked about rapid risk assessment. It sounds great. In practical terms, what does that mean? How does the HSE manage on 6 January when there are 600 trolleys with sick people?

Mr. John Connaghan

The root of this is in our incident management framework launched in 2018. When we say "rapid," we mean "immediate". It is not optional but a requirement in the framework. We made that quite clear. Certain things need to happen within the first 24 hours and within the first week. The first 24 hours include a rapid assessment. There is guidance in the incident management framework, which is available. A number of people have been trained in this now. More than 1,200 staff have been trained.

Deputy Marc MacSharry

Are there a number in each acute hospital?

Mr. John Connaghan

There are a number in each acute hospital and in each ancillary service, including CHOs.

Deputy Marc MacSharry

With regard to hepatitis C, is there an individual programme manager in each acute hospital?

Dr. Colm Henry

This framework applies to all care delivery organisations and forms part of their performance management. The Royal College of Surgeons in Ireland, RCSI, hospitals, for example, examines all incidents reported and it feeds into their own quality performance. It does not just publish the incidence of complaints, since most pertained at a lower level to falls, though I am not taking away from the seriousness of it, right up to more serious incidents, but hospital groups and CHOs deal with these by recording them through the national incident management system, NIMS, hosted by the SCA. The reports go through to hospital boards and group executives.

Mr. John Connaghan

The Deputy asked if the framework is looking to be effective and if we can see some changes in this. We can look at serious reportable events under this framework, of which the top two are pressure ulcers and falls and trips. Taking pressure ulcers as an example, a lesson from that in the South/South West hospital group shows that we have a 67.5% reduction in the most serious type of pressure ulcers. That is exceptionally good news from this.

Deputy Marc MacSharry

I will give the remainder of my time to Deputy O'Connell.

Chairman

Before people leave, we will be back at 2.30 p.m. to discuss the periodic report in private session.

Deputy Marc MacSharry

I sent my apologies.

Chairman

That is fine. I received them.

Deputy Kate O'Connell

In light of all that has been discussed, I want to make sure that I have not got this wrong. We do not know how many people have hepatitis or how many more new cases there are, so we do not know if we are running at a standstill. There is no database but there are data-sharing issues which the witnesses hope to have dealt with by the first quarter of 2019. As one of my colleagues said, this has been going on since 2004. It appears as if nothing happened until 2017. I refer to the Eastern Health Board report that was never published. I understand that it fed into the national strategy. I found a graph somewhere last night which I cannot find now. The highest number of cases was in the eastern region under the old health board. Those data would still be useful.

The strategy from 2011 to 2014 is out of date because it is from before the drug came into use. I do not see why it cannot be updated. There are no annual targets. A comment was made about accountancy and clinicians but it all comes down to money at the end of the day and when the money runs out. A clinical decision was made in the frame of accountancy when everything stopped in mid-2017. The two go hand-in-hand. I welcome the move to community care. It is in line with Sláintecare but there is not much connection there apart from it being a good idea.

No guidelines were published until 2017, when the pilots started. There was another issue in the report, and I am not sure if someone brought it up when I was outside, which is the treatment centres did not notify the national treatment registry in 2017. What was that breakdown in communication? The drugs cost so much. If the doctors prescribing them are, for whatever reason, whether it is paperwork or because they do not have to, not notifying that they have started person X on it, it does not seem possible to audit outcomes if the centres were not telling us how many people started on the drugs. I am concerned at this entire process. While I concede that moves have been made in the past year - and we have hopes for early 2019 - I would be concerned if this sort of approach was taken to CervicalCheck in the future.

Chairman

I know the Deputy might have to leave in a moment or two, so we will ask Mr Connaghan.

Deputy Kate O'Connell

I have to leave.

Chairman

The Deputy will get the answer in the transcript. We will get the answer when she has left the room.

Deputy Kate O'Connell

I am sorry I have to go.

Chairman

We will be back here at 2.30 p.m. I will finish off in the next few minutes.

Deputy Catherine Connolly

If there is no confidentiality clause, it is amazing because, for the redress board and all the applicants who went forward, it is an offence for their legal team or themselves to disclose what they got. I never accepted that. That is interesting. It is an offence to disclose.

Mr. Jim Breslin

Let me confirm-----

Chairman

I need the Department to clarify-----

Deputy Catherine Connolly

I hope Mr. Breslin is correct.

Mr. Jim Breslin

I will check that.

Deputy Catherine Connolly

I hope he is correct and I hope it what was done to those who went forward under the redress board has not been repeated.

Deputy Catherine Murphy

----

Chairman

-----

Deputy Catherine Murphy

Is it an ongoing treatment, a cure, or is it a range?

Professor Aiden McCormick

It is a cure.

Ms Michele Tait

Eight to 12 weeks.

Deputy Catherine Murphy

So it is an investment then.

Chairman

Three months.

Professor Aiden McCormick

Three months, and then they have their blood tests done three months later and, if it is clear at that stage, it is gone. They can be reinfected but it is gone.

Chairman

The committee asks the witnesses to put the answers on the record. Even if the members are gone, the answers will be on the record.

Mr. John Connaghan

We note what the Deputy said. She may have a good point about the 2011-14 strategy. We are heading into 2019 and perhaps we need to think again about where we now go because the comments about what we want do to, and how we get there for 2026, are well made.

Chairman

We will see the Deputies later.

I have one or two straightforward questions. How many people have died from the State-infected blood products? I do not know; I am asking an open question.

Ms Michele Tait

The HSE has estimates, which are collated through the database that we set up in 2004. The latest publication will come by the end of this year. There are in the region of 400 patients who have died from the original number. There are currently around about 1,380 people because they also get a Health (Amendment) Act card so they have special access to services, so we have about 1,380 people living at the moment and accessing services.

Chairman

In connection with the compensation or the tribunal, were their cases heard? Was there compensation to the family?

Mr. Jim Breslin

Where there is a death-----

Ms Michele Tait

Yes, if someone is deceased.

Mr. Jim Breslin

-----if one is a dependant, one can enter a claim.

Chairman

Were most of those people next-of-kin?

Mr. Jim Breslin

Yes. It is as-----

Chairman

Would that have been a large portion of the cost of the tribunal? What were the terms of reference in respect of the compensation?

Mr. Jim Breslin

It is a significant, and increasing, portion. Primary claimants will reduce. We are going to have a hepatitis C tribunal for many years yet because when the last person who got hepatitis C or HIV through the blood supply dies, their next-of-kin will enter claims.

Chairman

Why do they not enter a claim for compensation in the meantime?

Mr. Jim Breslin

The primary claimant would be able to say they are not able to work as a result of this and that the family's income is affected, and that would be dealt with in the first claim. The loss of the person when they pass away is also an event that-----

Chairman

It is a secondary-----

Mr. Jim Breslin

Yes.

Chairman

They are probably smaller in terms of money.

Mr. Jim Breslin

They are smaller in terms of the amounts, but the volume will be bigger. The payouts, when this closes, which is a long time away yet, will be for secondary claimants. They will be the final people to be paid and, increasingly, as we go on, most of the payouts on claims will be for that category of person.

Chairman

Are all the primary claims in by now?

Mr. Jim Breslin

There are still some primary claims before the tribunal.

Chairman

But are they all with the tribunal?

Mr. Jim Breslin

Yes.

Chairman

Are there no claims?

Mr. Jim Breslin

One would not think so.

Chairman

How many cases are still with the tribunal?

Mr. Jim Breslin

I had the figures there.

Chairman

How many primary claims?

Mr. Jim Breslin

450. Just to note-----

Chairman

How many of those are primary versus-----

Mr. Jim Breslin

At the moment, it is 75 primary claimants out of 455.

Chairman

Are the remainder next-of-kin?

Mr. Jim Breslin

Yes. Just to note on that figure of 75, if one got a provisional award, one could subsequently come back, so that is not a static number.

Chairman

Can Mr. Breslin send the committee information on the breakdown of the 75 primary claimants?

Mr. Jim Breslin

Yes. We had agreed-----

Chairman

Will Mr. Breslin how many are first claims and how many are subsequent claims?

Mr. Jim Breslin

We had agreed-----

Chairman

There must be a template.

Mr. Jim Breslin

Sorry, 47 of the 75 are an initial claim and 25 are for further compensation.

Chairman

When was the final initial claim lodged?

Mr. Jim Breslin

The very first claim?

Chairman

No, when was the last of the initial claims lodged?

Ms Michele Tait

It depends. Some people are still-----

Chairman

No, there is a date, a year.

Ms Michele Tait

I do not know, but I know that people are coming to us for services who have been newly diagnosed and the connection between their diagnosis and receipt of a blood transfusion may have only been confirmed-----

Chairman

Even this year?

Ms Michele Tait

Absolutely. There are still some new patients being identified.

Chairman

So there could still be some new first claimants.

Ms Michele Tait

Yes. Very small numbers, but there are still-----

Chairman

The numbers are small at this stage.

Mr. Jim Breslin

The ability to come back if there is a provisional award is available. If the trajectory of the illness was not known at the time, a provisional award would have been made, and the person would have come back if they developed cirrhosis of the liver or further damage.

Chairman

The cost of the tribunal is €25 million. How much of that relates to compensation?

Mr. Jim Breslin

I gave that just a moment ago.

Chairman

Sorry, I missed it.

Mr. Jim Breslin

I was using rough figures but-----

Chairman

Per annum.

Mr. Jim Breslin

-----in 2017, the total was €21.8 million, which comprised €14.6 million for the main awards and €3 million for reparation fund payments. They are a 20% increase on the award.

Chairman

What is the total of the payouts then?

Mr. Jim Breslin

The total is €17.6 million out of €21.8 million.

Chairman

So 15% is for the process and handling the tribunal.

Mr. Jim Breslin

The next biggest is the legal costs of the awards. That is €3.7 million.

Chairman

Mr. Breslin might pass that on to us. Are claimants' costs are included?

Mr. Jim Breslin

Exactly. The €3.7 million are the legal costs attaching to the claimants.

Chairman

Mr. Breslin can send us a briefing note with the information he has.

Somebody mentioned the HSE has some new machine for liver tests. Could Professor McCormick explain that?

Professor Aiden McCormick

That is the fibre scan. We used to do biopsies for either fibrosis or cirrhosis, but this is basically an ultrasound scan. It is put on its side and it basically gives a little knock on the side and the speed of transmission of that wave through the liver is directly related to how stiff the liver is and how much fibrosis there is. It can tell you definitely if a liver is normal, or cirrhotic, or if there is some degree of fibrosis. It gives a number-----

Chairman

In how many locations is that machine?

Professor Aiden McCormick

It is in all the treatment locations and there are two-----

Chairman

In the hospitals and the community?

Professor Aiden McCormick

No, all the hospitals have them. There are two mobile scans and we are in a procurement process at the moment for two more mobile scans and, now that the Department is behind the HSE, we need about six or eight throughout country.

Chairman

Is that just for hepatitis C?

Professor Aiden McCormick

Yes, to treat patients.

Chairman

Could the machines be used for other liver tests?

Professor Aiden McCormick

They can be used for hepatitis B, alcoholic liver disease and fatty liver disease. They are versatile machines, but in proof of principle, they are used for hepatitis C and specifically to decide on treatment, depending on how much scarring there is on the liver.

Chairman

That is fine. I noted on the charts supplied that the numbers of males presenting is now much higher than females.

How is that ratio working out?

Ms Michele Tait

We will send the committee the epidemiology report recently published by the health protection surveillance centre, HPSC.

Chairman

I am looking at it now. Perhaps Ms Tait could state the figures for the record. The ratio seems to be nearly 3:1.

Ms Michele Tait

Yes. For 2017, of 620 notifications of hepatitis C, approximately three quarters, that is, 448, were male while 171 were female.

Chairman

I am looking at a chart but perhaps Ms Tait could send the figures to us in numerical form. It also looks as if the number of females presenting is declining, while the number of males has been reasonably static over the past five years.

Ms Michele Tait

We will send the figures in numerical form.

Chairman

On page six of the report there is some information on the different groups that presented. It states that other reported risk factors include tattooing or body piercing and there were nine people who contracted hepatitis C in that way.

Professor Aiden McCormick

These were cases where the risk factor was identified but we cannot say these people got the disease from those sources. Intravenous drug use and blood transfusion are other risk factors.

Ms Michele Tait

There is a risk assessment of each individual patient.

Chairman

It appears that nine people got it through tattooing or body piercing.

Ms Michele Tait

They may have got it from those things.

Chairman

There was a debate in the Oireachtas on this recently. In his opening statement, Mr. Breslin said that in the years since these infections were discovered, a wide range of actions were taken, based on the recommendations of the Finlay and Lindsay tribunals, to ensure the safety of the blood supply. That encapsulates the problem. A problem arises and it is examined to make sure it does not reoccur but I would have liked wider lessons to have been learned from what happened with the blood supply. This is the undercurrent of today's meeting. The issue is dealt with but in a way that is totally divorced from everything else. I do not get the connection in this regard.

At a meeting with the HSE on 5 July this year, we asked a series of questions and we got a reply back dated 16 August 2018, which we read into the record today. The State Claims Agency was before us recently and we asked if it was possible that there were clinicians who were involved in multiple cases. The agency said that if a clinician was listed in legal proceedings, the agency wrote back to say the name of the clinician did not need to be given, on account of the fact that it was the enterprise which was defending the case. It seems the system is geared not to identify cases where learning is needed. The letter we received said the HSE asked for a note on the introduction of a mandatory system of retraining and supervision following legal settlements without admission of liability. It said there was no mandatory retraining and supervision following legal settlements without admission of liability, although retraining and supervision takes place. The letter stated that the HSE talks to the State Claims Agency and looks at the trends the agency has identified but it seems to me that this is not just acting after the horse has bolted - it is acting after the horse is dead and buried. The identification of these issues should be the role of the HSE, not the insurance company which is writing the cheque, which may be years after the event. The last line in the reply states that the office of Dr. Colm Henry, the interim chief clinical officer in the HSE, will have the ultimate responsibility for implementing any necessary retraining and supervision of medical practitioners. We are told that the State Claims Agency sends a report back to each of the institutions but these are landing all over the place. Whose job is it to identify these needs? The State Claims Agency is not picking up on them. The report states that cases can be brought to the medical council but that is not what we are talking about. That is for cases when somebody is judged not fit to be a doctor but that does not solve the problems where a practice is not up to scratch in some way.

This is why we are here. The medical negligence bill is increasing every year. The taxpayers have to pay it and that means less money for everything else. The figure has gone up every year for the past ten years and before that, but we did not get any indication that anyone was really worried about it. There is a demarcation between the HSE and the State Claims Agency. Once a case goes into the latter, the HSE is out of the picture. All it wants to know is what it owes at the end of the quarter. This demarcation does not help the learning process. The HSE should not have to learn anything from the State Claims Agency as the problems happened in the HSE to start with.

In his opening statement, Mr. Connaghan said the HSE had recently established a project team to develop a mechanism so that the learning from local reviews could be considered. He might give us details of that and send them on to us. He went on to say that, since 2013, the HSE had undertaken an annual review of completed incident reports. Are they published? Who is tasked with reducing medical negligence in the organisation when they come into work on a Monday morning? Without this being addressed, it will mean less for patients and lower budgets for the HSE as a whole.

Mr. Jim Breslin

Dr. Henry, in response to Deputy MacSharry's points, talked about some of the specifics of the points the Chairman has just made. The first question was about what we learned from things going wrong in the blood service. The Finlay and Lindsay tribunals identified a range of specific quality control issues within the blood service. It was vitally important that we re-established confidence in the Irish blood service and a programme of work has been put in place to bring the service to a quality level that compares with international standards.

What the Chairman says, however, is correct. The consequences of what happened in the blood service were defining moments for the Irish health service. Internationally, all health services are dealing with the importance of prevention in achieving patient safety as the complexity of services has increased over the years. At both policy level and operationally within the HSE, we have tried to move that agenda forward. There is nobody saying our work is over and all of us are strong advocates for patient safety because we know the importance of it.

The actions that have been taken since then include the establishment of HIQA and the Mental Health Commission to put people who are not in the operating line or the hierarchical structure in to examine services and see how they are operating.

Chairman

How many reports has HIQA done? The Minister has commissioned a report into a hospital. HIQA does not inspect hospitals on a daily basis.

Mr. Jim Breslin

It does.

Chairman

If it did, it would probably close them all.

Mr. Jim Breslin

It has the ability to do that. It can go in and inspect. It has set a standard that has been approved by the Minister. I refer to the national standards for safer and better healthcare. HIQA can go into a hospital and say it wants to examine it under this standard. It can examine things like infection control. It can do targeted inspections.

Chairman

It can inspect on a thematic basis.

Mr. Jim Breslin

That is an important aspect of it. We have put in place the National Patient Safety Office. We have a surveillance programme and a legislative programme. The committee will be aware from our previous engagements of the legislation that is under way in this area. The HSE has put in place a quality and patient safety directorate. There is very much a focus on this at the provider level. Mr. Connaghan has spoken about the serious incident management protocol, which started with maternity hospitals publishing monthly patient safety statements that set out the levels of safety within our hospitals and explain how the risks that exist are managed. All hospitals are now doing that. There is lots of learning.

I would like to mention another learning from the blood service. There is a need for patient involvement and patient advocacy. I have spoken about how the haemophilia and hepatitis C community has come into the design of the service. That is a critical aspect of how we need to operate as a health service in general. In the coming weeks, we will award a national patient advocacy service. When something goes wrong, people lose trust in the health service and need someone to work with them to find answers to their questions. We are going to put in a national patient advocacy service involving skilled people who understand the health service, but are not employees of it, to work with people in such circumstances. I am not telling the committee that we have cracked patient safety in Ireland. It has not been cracked in any healthcare system. We have to work each day to try to improve this. We also have to improve our processes for mediation and engaging with people when things go wrong. I was in Northern Ireland three or four weeks ago for a conference with colleagues there. They spent €117 million on medical negligence and they have every single issue we have here. We are going to work together on those issues. Dr. Henry has spoken about the work that has been done in England, particularly with regard to mediation. We can learn from others. We have done a lot in this space.

Dr. Colm Henry

At the committee's hearing with the SCA weeks ago, we learned that the number of claims is steady but the amounts are going up. We heard that this is just one element of quality, whether it is of doctors or of services themselves. Some services, such as obstetrics, are more complex and more prone to claims than others. Approximately half of all claims pertain to catastrophic birth injuries, the consequences of which sometimes do not become apparent for many years. I assure the Deputy that there is a great deal of learning going on. The national women and infants health programme is examining the introduction of proxies for catastrophic birth injury. That would involve doing immediate incident reports in cases of neonatal cooling, which happens when there is hypoxia, and also in cases of perinatal events. It is absolutely the case that we want to learn. We do not want to wait for claims to come through four years down the line when cerebral palsy becomes evident. We want to learn from the at-risk cases as they happen. We want to apply that learning to all 19 maternity units in their safety statements and the measurements we provide to them through the Irish maternity indicator system, which is a quality report we give to all 19 units. It is absolutely the case that there is learning.

Chairman

Okay. We will conclude shortly. Mr. Breslin gets the point I am making. I am not just talking about things that have happened while I have been Chairman of this committee. I was a member of the committee in the previous Dáil as well. The feeling I got from the HSE at that time was that when these matters go to the SCA, they are dealt with by the agency. The demarcation line is a bit too strong. There needs to be more collaboration and earlier learning. I know about the costs. We know about mediation. We know all that. I am just saying we are back to prevention and learning. That is the best way of reducing anything.

Mr. Jim Breslin

That is where-----

Chairman

We do not have a sense of that yet at this committee. That is all I am saying.

Mr. Jim Breslin

No. In fairness to the State Claims Agency, it could have taken a very narrow view of its role, which involves the legal management of claims. It introduced the national incident management system to ensure it is upstream when something goes wrong in order to learn from it immediately rather than having to wait for the claim to be lodged. The HSE has a lot of work to do on risk management and patient safety. The claims that are lodged are one element of that. They are a bigger piece of the jigsaw that needs to be done. I would like to mention a statistic that will probably cause the Chairman to take an intake of breath. According to the OECD, 15% of hospital expenditure internationally goes on correcting preventable errors or infections people catch in hospitals.

Chairman

I read that the figure is 25% in parts of the United States. I would like to make a final comment. Mr. Breslin will understand why I am saying this. As Deputy Connolly said, even though this is substantially an historic matter, one of the specific reasons we are here today is the case of the late Brigid McCole. It was just a few weeks ago that we spoke about the case of Emma Mhic Mhathúna in the context of the cervical cancer issue. The public sees a connection when these cases of medical negligence arise. The State had a responsibility 15 years ago and following a tribunal, €1.5 billion in compensation was rightly due to those affected. Fifteen years later, it looks as if we are starting down the exact same road again. All of our successors who are here in 15 years' will talk about the cost of that. I am worried that some other case will come up at that stage and the wheel will start turning again. That is where broader learning is needed. Every time there is a problem, we try to solve it. We cannot foresee everything that might happen. People have a sense of "Here we go again". I ask Mr. Breslin to make an observation on that. He can understand people feeling that they are not totally disconnected from these issues, even though medically they are. I am sure Mr. Breslin understands the point I am making.

Mr. Jim Breslin

Yes. There are substantial differences between what has happened in this instance and the infection of people through the blood supply at a time it was known that an issue was live and present. The overall challenge and comment is exactly correct. Patients have to be at the centre of the patient safety culture within healthcare. There are many other things we need to do, but that must be the primary focus of all health service practitioners. We need to build systems that support people to make safe decisions as they go about their duties and we need intelligence that spots things before they become a problem. I will give some examples of the scale of this. Every year, we have 3.3 million outpatient attendances, 1.3 million emergency department attendances, 1.6 million admissions to hospital and 20 million GP attendances. It is not enough to get 99% of those right. If we get 1% of them wrong, that has significant implications. That is the culture we need. A great deal of work will be needed in the health service. We will have to bring the community with us as we to try to break down the old-fashioned "doctor knows best" approach and replace it with a partnership with patients.

Chairman

I thank the witnesses from the Department of Health and the HSE for all the materials they have provided. We look forward to receiving the documentation to which we referred during the meeting. I thank the staff of the Office of the Comptroller and Auditor General. The next public meeting of the committee will take place on Thursday, 29 November, when we will meet officials from the Department of Employment Affairs and Social Protection to consider Vote 37, Chapters 11, 12, 13, 14 and 20 and the 2017 Social Insurance Fund. I am now suspending the meeting until 2.30 p.m., when members will meet in private session.

The witnesses withdrew.

Sitting suspended at 1.40 p.m. and resumed in private session at 2.30 p.m.

The committee adjourned at 4.20 p.m until 9 a.m. on Thursday, 29 November 2018.