David Cullinane (Waterford, Sinn Fein)
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159. To ask the Minister for Health the reason that he sought Government approval to delegate product liability claims in relation to mesh implants to the State Claims Agency; the effect this will have on ongoing litigation; and if he will make a statement on the matter. [3706/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Firstly I want to acknowledge the pain and suffering of people impacted by mesh complications. Given that there are legal proceedings ongoing I do not wish to comment unduly on these cases.

The delegation of mesh claims to the State Claims Agency (SCA) is a technical matter that will not impact on how these claims are handled. The SCA has a statutory remit to manage personal injury claims on behalf of Delegated State Authorities including the Health Service Executive. The Clinical Indemnity Scheme (CIS) indemnifies hospitals (HSE and Voluntaries) in respect of clinical negligence actions against those hospitals by persons alleging personal injuries resulting from such negligence. CIS cover is confined to clinical acts and/or omissions and does not cover product liability exposures, i.e., where the personal injury is alleged to have occurred as a result of a product not being fit for purpose etc.

The Transvaginal Mesh litigation, currently being handled by the Agency, involves allegations in relation to the product itself (the mesh, tape etc.) and allegations of clinical negligence i.e., practitioner error/faulty surgical technique. The CIS indemnifies the hospital in respect of alleged practitioner error, but it does not indemnify the hospital in respect of any product liability exposure that the hospital might have i.e., allegations that the product failed or was not fit for purpose.

The State Claims Agency manages general indemnity claims, in named State authorities, as provided for in Delegation Orders under the National Treasury Management Act, under a Scheme known as the General Indemnity Scheme (GIS). Delegating the management of claims to the SCA ensures the efficient and effective management of claims and removes duplication of effort and legal costs where multiple State Authorities are defending a claim. Such claims relate to personal injuries, including bullying and harassment and third-party property damage claims, and their associated risks, against State authorities. Mass action claims and claims relating to product liability, where the latter have been specifically delegated to the SCA, are also dealt with under the GIS.

An indemnity issue has arisen in some hospitals and in a minority of ‘Mesh’ claims where the product manufacturer cannot be identified due to the relevant hospital charts not containing device/product labels. The Liability for Defective Products Act, 1991 states that where the manufacturer/producer of the product cannot be identified by taking reasonable steps, the supplier of the product (in this case, the hospital) is at risk of being found to be the producer of the product. Put simply, this means that the hospital could potentially be responsible for the product liability aspect of the “mesh” claim. As hospitals do not carry product liability cover, these hospitals could have an uninsured/un-indemnified liability exposure in the circumstances described above. Such a situation would benefit neither the hospital nor the claimant, and so I have acted to ensure that it does not arise.

In order to ensure that hospitals are not exposed to an uninsured liability and the financial exposure consequent upon that, Government agreed to the provision of general indemnity cover for the product liability elements of claims and the delegation of their management to the SCA, in a minority of cases where the manufacturer cannot be identified. This decision does not change the practical position with regard to the HSE - the SCA have been managing these claims to date, on behalf of the HSE on an administrative basis.

David Cullinane (Waterford, Sinn Fein)
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160. To ask the Minister for Health the additional actions he plans to take to provide redress for mesh-injured persons; and if he will make a statement on the matter. [3707/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I understand that complications from a mesh implant can be very distressing and painful for the women experiencing them. Since concerns about mesh complications came to the attention of the Department in late 2017, the ongoing priority focus for both the Department and the HSE has been to meet the care needs of women experiencing mesh complications.

Considerable work has been done and continues to progress in Ireland in relation to the safe use of mesh implants and ensuring that all women who develop mesh-related complications receive high quality, multi-disciplinary and patient-centred care is a priority for the Minister and the Department.

Regarding steps taken to improve services in Ireland, multidisciplinary specialist services, including trans-labial scanning facilities, are now available for women suffering from mesh complications through a national multidisciplinary mesh specialist service which was established in 2020 across two centres, Cork University Maternity Hospital and the National Maternity Hospital, Dublin. These centres also have two National Mesh administrators, based in each centre, available to assist patients with their appointments and navigate the service.

Women's health is a Government priority, as outlined in the Programme for Government. Budget 2022 and the HSE National Service Plan 2022 provide significant investment in services that are important to women, including gynaecology services. A Women’s Health Fund is also provided for, which will support proposals arising from the work of the Women’s Health Taskforce to improve women’s health outcomes and experiences of healthcare.