467. Deputy John Paul Phelan asked the Minister for Health if he will provide a breakdown of the membership of the multi-stakeholder departmental group on the management of ongoing or anticipated high-impact medicine shortages; the frequency with which it meets; the work that it is currently conducting; and if he will make a statement on the matter. [28159/24]

The Medicines Criticality Assessment Group (MCAG) is convened by the Department of Health and chaired by the Health Service Executive (HSE) to facilitate rapid assembly of relevant government and agency bodies to assess, address and resolve emerging medicinal product supply issues.

MCAG was established in 2018 by the Department of Health as part of a whole of government response to Brexit. The group has since evolved to its current form.

The Department of Health convened a standing iteration of the Medicines Criticality Assessment Group (MCAG) during the Winter of 2023/4 to pre-empt any possible shortages over the winter period. It currently meets on an ad hoc basis when a serious shortage is notified.

The Medicines Criticality Assessment Group role is to:

• Discuss the impact of any identified or expected supply chain issues on medicines availability, including but not limited to, increased demand brought about by public health threats, manufacturing issues, geopolitical factors.

• Assess implications of current medicinal product shortages on the healthcare system and patients and escalate any key concerns to Ministerial level.

• Identify any further actions required and assign responsibility for their completion.

• Liaise with Office of Chief Clinical Officer, where appropriate, to develop clinical guidance for mitigation of impact of medicinal product supply issues.

• Prepare coordinated communication(s) to relevant health system stakeholders and patients/patient groups, as required.

• Disseminate communication(s) via agreed mechanisms as decided by a meeting of the MCAG.

The Medicines Criticality Assessment Group comprises of relevant ‘Standing Members’ from:

• The Department of Health (DoH),

• Health Products Regulatory Authority (HPRA),

• Pharmaceutical Society of Ireland (PSI), and

• Health Service Executive (HSE)

Depending upon the matter at issue, attendees may also include any relevant clinical team and/programme of the HSE, and additional stakeholders invited to meetings of the MCAG, on a case-by-case basis.

Consequent to its deliberations and where the MCAG deems it necessary, the MCAG membership shall issue communication(s), to healthcare professionals and patients, via any, some, or all of the following, dependent upon necessity:

- Health Products Regulatory Authority (HPRA) website: The Health Products Regulatory Authority (hpra.ie),

- Health Service Executive (HSE) website: HSE website - Health Service Executive - HSE.ie,

- Pharmaceutical Society of Ireland (PSI) email list of registrants,

- Medical Council (MCIRL) email list of registrants.

By nature of the manner in which MCAG meets on an ad-hoc basis currently, the Group are not engaged in work around shortages at this time.