Act VIII of 2026 amends the Human Tissue and Organ Donation Act (Chapter 558) to introduce an opt-out (presumed consent) system for deceased organ and tissue donation in Malta. Under the new regime, all persons who are habitually resident in Malta and aged 18 or over are presumed to consent to donation upon death unless they have registered an objection during their lifetime on a newly created National Opt-Out Register. The amendment preserves the right of families to raise objections within a short consultation window, but clinicians are given clear statutory authority to proceed where no objection is recorded and the family cannot be contacted in time.

The Act also introduces new requirements for hospital organ-donation coordinators, mandating their appointment in every public hospital, and places a duty on the Commissioner of Police to assist in verifying a deceased person's registration status. Specific new provisions deal with tissue banking, living donor protections (strengthened informed-consent rules and a mandatory independent assessment for non-directed living donors), and cross-border exchange of organs with EU member states under the EU Organ Directive framework.

Penalties for trafficking in human organs are increased, and a new criminal offence of obtaining an organ by coercion or deception carries a maximum sentence of 10 years imprisonment. The amendments entered into force on a date appointed by the Minister by notice in the Gazette, with the opt-out register to be operational within 12 months of commencement.

Human Tissue and Organ Donation (Amendment) Act (Act VIII of 2026)