This Act amends the Human Organs, Tissues and Cell Donation Act, Chapter 558 of the Laws of Malta. It was assented to by the President on 27 March 2026 and passed by the House of Representatives at Sitting No. 450 on 25 March 2026.

The sole substantive change is the substitution of Article 12 of the principal Act with an entirely new article. The previous Article 12 is replaced in full; its prior content is not reproduced in this amending Act and is therefore unclear from text.

The new Article 12, titled 'Donation of human organs, tissues and cells from a cadaver', introduces two key provisions. Article 12(1) establishes that deceased organ, tissue and cell donation shall be considered in persons who are certified dead using neurological or circulatory criteria by a clinician. This formalises a dual-criteria framework for the determination of death in the context of donation. Article 12(2) places an obligation on the Superintendent of Public Health to maintain updated and peer-reviewed guidelines for the diagnosis of death using both neurological and circulatory criteria for the purposes of organ, tissue and cell donation, and requires that these guidelines be published on the Ministry's website, ensuring public accessibility and transparency.

The Act contains no explicit commencement clause specifying a future date or ministerial notice; it is therefore presumed to commence upon publication in the Government Gazette in accordance with general Maltese legislative practice, though this is unclear from text as no commencement article is included.

The practical effect is primarily on clinicians involved in certifying death for donation purposes, on the Superintendent of Public Health who bears a new statutory duty to maintain and publish peer-reviewed guidelines, and on healthcare institutions managing potential donor cases. The general public and prospective donors are also affected insofar as the legal framework for posthumous donation is clarified and the diagnostic standards are made publicly accessible.

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