Human Tissues Act – review of procedures for consent and transplantation conditions

The Human Tissue Act is legislation relating to the removal, donation and use of organs and tissues and cells from deceased and living persons intended for transplantation. Part 1 and 2 of the legislation were enacted on 17 June 2025.

It sets out key rules for organ and tissue donation including:

• Consent requirements (including deemed consent and appropriate consent)
• Conditions in relation to donation 
• Independent panel
• Relevant organ donation opt-out register
• Compliance under part and consequential amendments to Regulations of 2006 and 2012.

The legislation does not apply to tissues and cells for medically assisted reproduction (MAR) i.e. reproductive cells.

What actions should organisations take?

Authorised tissue establishments and organ donation and transplant centres must review their existing procedures in relation to consent and conditions for transplantation. This is to ensure they meet the requirements of the Act.

This review should be done in conjunction with existing tissues and cells and organs legislation. The relevant legislation is available on our organs legislation page.

What activities will the HPRA monitor? 

We will monitor compliance with Part 2 of the act and how  consent is managed during inspections. 

We will not monitor the opt-out register and independent panel, including their authorisation, establishment, compliance with, or operation or maintenance.

Questions

If you have any questions, please contact compliance@hpra.ie. You can also submit a query using our contact form by selecting ‘blood tissues and organs’ as your category and ‘compliance query’ as your topic.