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 anin cameraoral 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.