Professor Brian MacCraith:

I thank the Deputies and Senators and welcome this opportunity to give my opening statement. It is a little longer than five minutes but not too much longer. I will try to shorten it as much as I can to make it more accessible for the members of the committee.

The Government established the High-Level Task Force on Covid-19 Vaccination on 10 November 2020 to ensure that the right oversight and specialist input is available to support the HSE and the Department of Health in the effective, efficient and agile delivery of the Covid-19 vaccination programme. I was appointed chair of the task force, which has met three times to date. A fourth meeting is scheduled for this afternoon.

The agreed terms of reference are: to support the Department of Health and Health Service Executive to deliver a Covid-19 immunisation programme, that meets best practice and provides good governance, as a critical public health intervention in the prevention and control of Covid-19; working with the Department of Health and the HSE, to develop a national Covid-19 vaccination strategy and implementation plan for the safe, effective and efficient procurement, distribution, delivery and recording of Covid-19 vaccines when approved vaccines are ready to be distributed; to provide a focal point for engagements with sectoral and specialist expertise as may be needed to support the development, implementation and agile iteration of both the strategy and the plan; and to monitor progress and report to Government, as may be required, on the development and implementation of the strategy and plan.

When the task force was established, there was already significant work on a vaccination programme ongoing across both the HSE and the Department of Health, and implementation of the strategy will rely in the normal way on the governance structures and statutory responsibilities of a range of existing bodies. Given the range of responsibilities and actors, and the level of responsiveness that will be required as the programme rolls out, there will be a need to augment and support existing arrangements. It is useful in that context to be clear about the role of the task force in the context of those existing roles and responsibilities.

In respect of immunisation programmes and policies, the role of the Department of Health includes making policy decisions based on advice from the National Immunisation Advisory Committee, NIAC, these are then implemented by the HSE through the National Immunisation Office, NIO. In the context of this vaccination programme, the Department of Health has responsibility for overall public health policy, legislative and regulatory arrangements, and EU co-operation arrangements, and it is also leading on communications for the programme. The HSE has ultimate responsibility for the delivery of the Covid-19 vaccination programme through its NIO, which designs and implements all vaccination programmes in Ireland. The role of the NIO in the vaccination programme includes vaccine procurement and distribution; immunisation training; certain communications to the public; and logistical considerations for vaccine storage, and distribution and return where appropriate. The HSE’s Health Protection Surveillance Centre, HPSC, is responsible for compiling and publishing data in respect of uptake and coverage of Covid-19 vaccines, liaising closely with the European Centre for Disease Control, ECDC.

Where medicines are licensed centrally for all EU member states, as in this case, the Health Products Regulatory Authority, HPRA, works closely with the European Medicines Agency, EMA, including participating in the EMA assessment process and post-marketing benefit-risk monitoring. The HPRA operates the national safety monitoring and risk management system and oversees quality defect reports on vaccines and other medicines. It also licences the facilities that carry out related manufacturing and distribution.

The National Public Health Emergency Team, NPHET oversees and provides national direction, guidance, support and expert advice on the development and implementation of a strategy to contain Covid-19 in Ireland.

It advises the Government on the public health aspects of the cross-Government response to Covid-19, including on the vaccination programme and, in particular, prioritisation in the context of pandemic management.

Both the HPSC and the Department of Health work closely with the European Centre for Disease Control, ECDC, and the Department is represented on the Health Security Committee, HSC, of the European Commission, which co-ordinates the EU response to infectious disease threats. These will continue to provide advice on the vaccination programme and its impact in terms of pandemic management, the sequencing of the roll-out of the vaccine and the response to any emerging issues.

The challenge in devising and implementing a vaccination programme of this scale, complexity and desire for speed is unparalleled here and around the world. Successful roll-out of the vaccination programme is dependent upon careful and precise co-ordination across Government, several State agencies, the HSE and a wide range of advisory, regulatory and delivery partners across the health sector and private sector providers.

The high-level task force I chair is ensuring that all of this ongoing work is co-ordinated within a single integrated work programme and supporting the Department of Health and the HSE to deliver a Covid-19 vaccination programme that meets best practice and good governance and it will play an ongoing role in the oversight and monitoring of programme implementation, harnessing the wide range of high-level expertise and experience of task force members. The task force includes senior representatives from across the Department of Health, the HSE, the Health Products Regulatory Authority, the HPRA, the Office of the Government Chief Information Officer, the Office of Government Procurement, IDA Ireland, the Department of Enterprise, Trade and Employment and the Department of the Taoiseach. It includes expertise in the areas of public health, supply chain logistics, cold chain logistics, and programme management.

A programme office has been established to support the high-level task force in its ongoing oversight and support role. An integrated work programme, comprising seven work streams, has been established by the high-level task force, HLTF, which fully integrates the work that is ongoing across the Department of Health and the HSE. The programme is using a structured programme and project management approach to manage and deliver all the core elements. I will not list all of the work streams but I am happy to talk about them at any stage, as they affect all the core elements of the end-to-end vaccination process.

Each work stream is led by a senior responsible officer, SRO, and is supported by programme and project professionals as well as subject matter experts. The SROs, the programme director and a number of subject matter experts form a programme working group, which has been established to co-ordinate, integrate and to report progress on work.