skip to main content
ukmla 2026

Organ and Tissue Donation

Legal and ethical framework for organ retrieval from deceased and living donors — England moved to an opt-out (deemed consent) system in 2020 under Max and Keira's Law

Ethics, Law & Patient Safetyless-commonacute
On this page
Condition details
Ethics, Law & Patient Safety
less-common
4 min read
reviewed 2026-04-05
practice ukmla questions →

About This Page

This is a clinician-written, evidence-based summary aligned to the 2026 MLA Content Map. It is intended for medical students and junior doctors preparing for the UKMLA. Always cross-reference with NICE guidance, local protocols, and clinical judgement.

Key points

  • England moved to OPT-OUT (deemed consent) in May 2020 — Max and Keira's Law (Organ Donation (Deemed Consent) Act 2019)
  • All adults are deemed to have consented UNLESS: they opted out on the NHS Organ Donor Register, are in an excluded group, or family provides evidence of known wishes against donation
  • Excluded groups: under 18, people who lived in England <12 months, people who lack capacity to understand deemed consent
  • Two types of deceased donation: DBD (donation after brainstem death) and DCD (donation after circulatory death)
  • Brainstem death testing: performed by 2 doctors (one must be a consultant), at least 6 hours after the onset of coma. Tests: absent cranial nerve reflexes + no respiratory drive on apnoea testing
  • Living donation: kidney and partial liver most common. Requires independent assessment by HTA-approved assessor. Must be voluntary and informed

Overview

Organ and tissue donation is regulated by the Human Tissue Act 2004, overseen by the Human Tissue Authority (HTA). In May 2020, England moved from an opt-in to an opt-out (deemed consent) system. This means that unless a person has registered a decision not to donate, or is in an excluded group, consent for organ donation after death is deemed to exist. This was enacted through Max and Keira's Law. Despite this, the family is still consulted and their input is considered — the specialist nurse in organ donation (SNOD) facilitates this sensitive process. Brainstem death testing follows the Academy of Medical Royal Colleges Code of Practice (2008) and is the prerequisite for donation after brainstem death (DBD).

Epidemiology

Approximately 6,500 people in the UK are on the organ transplant waiting list at any time. In 2023-24, approximately 4,800 organ transplants were performed. Despite the opt-out system, the demand still far exceeds supply. Approximately 400 people per year die waiting for a transplant in the UK. The opt-out register has not yet produced the dramatic increase in donation rates that was hoped — family consent rates remain the key bottleneck, currently around 65–70%.

Key Concepts

Symptoms
Deemed consent: applies to all adults who have been resident in England for ≥12 months and have not opted out
Excluded from deemed consent: under 18, resident <12 months, lacks capacity to understand deemed consent, actively opted out
DBD (Donation after Brainstem Death): patient is confirmed brainstem dead while on ventilatory support. Organs maintained with perfusion. Higher quality organs
DCD (Donation after Circulatory Death): death confirmed after cessation of circulation (5-minute observation period). Increasing proportion of all donations
Living donation: most commonly kidney (single kidney) or partial liver. Must be voluntary, informed, and independently assessed
Signs
Brainstem death criteria: (1) known cause of irreversible brain damage, (2) exclusions ruled out (hypothermia <34°C, drugs/toxins, metabolic derangement), (3) absent brainstem reflexes, (4) absent respiratory effort on apnoea testing (PaCO₂ >6.65 kPa with no respiratory response)
Brainstem death tests: fixed dilated pupils, absent corneal reflexes, absent vestibulo-ocular reflexes (cold caloric), absent gag/cough reflex, absent motor response to central pain in cranial nerve distribution, apnoea test

Assessment

First-line
Brainstem death testingTwo sets of tests by 2 doctors (one must be a consultant, both >5 years qualified, one not involved in transplant team). Tests separated by adequate interval. Time of death = time of completion of first set of tests
PreconditionsKnown cause of irreversible structural brain damage. Exclude: hypothermia, drug intoxication, severe metabolic derangement (Na⁺, glucose), neuromuscular blocking agents
Second-line
NHS Organ Donor Register checkCheck whether the patient registered a decision to donate or opted out
HTA-approved assessor (living donors)Independent assessment: voluntary consent, understanding of risks, no coercion, no financial incentive
Specialist
SNOD (Specialist Nurse in Organ Donation)Facilitates discussion with family, coordinates donation logistics, provides emotional support
Transplant coordinatorManages organ allocation, recipient matching, surgical logistics
1
Identifying potential donors
  • Consider organ donation for all patients at end of life — it is a routine part of end-of-life care
  • Refer all potential donors to the SNOD — early referral improves donation rates
  • Do NOT let personal views about donation influence clinical decisions about treatment withdrawal
2
Deemed consent process
  • Check the NHS Organ Donor Register for opt-in or opt-out decision
  • If no registered decision and not in excluded group → deemed consent applies
  • Family is ALWAYS approached — SNOD discusses with family, explores known wishes, and supports the process
  • If family provides evidence the person would not have wanted to donate → donation should not proceed (soft opt-out)
3
Brainstem death and donation
  • Complete brainstem death testing as per AoMRC Code of Practice
  • Legal time of death = time of completion of first set of brainstem death tests
  • Maintain ventilation and organ perfusion pending donation (this is treatment of the organs, not of the patient — the patient is dead)

Complications

  • Family refusal: Remains the most significant barrier to donation — approximately 30-35% of families decline
  • Delayed referral: Late SNOD referral reduces the window for successful donation
  • Organ trafficking: Selling or buying organs is a criminal offence in the UK (Human Tissue Act 2004)
  • Ethical controversy: Opt-out systems raise concerns about autonomy and state presumption of consent
UKMLA Exam Tips
  • 1England = opt-out (deemed consent) since 2020. Excluded: under 18, lived in England <12 months, lacked capacity to understand deemed consent
  • 2Brainstem death: 2 doctors, one consultant, both >5 years qualified. Tests include pupillary, corneal, vestibulo-ocular, gag/cough, motor response, and apnoea test
  • 3Time of death = completion of FIRST set of brainstem death tests (even though two sets are performed)
  • 4Preconditions before testing: exclude hypothermia, drug effects, and metabolic derangement
  • 5DCD = death after circulation stops. DBD = death after brainstem testing. Both are legal forms of death
  • 6Selling organs is illegal in the UK. Living donors must be independently assessed by an HTA-approved assessor
  • 7A patient's wish to donate cannot be vetoed by the family — but in practice, donation rarely proceeds against strong family objection (soft opt-out)

Put your reading into practice

Topic-specific question practice is not linked for this article yet.

Choose UKMLA questions from the existing bank. General exam practice covers your selected topics; it is not filtered to this article. Your usual question-bank access applies.

Choose UKMLA practice

After your session, return to this section to revisit the reading and choose your next review.

Verified Sources & References

Human Tissue Act 2004
Organ Donation (Deemed Consent) Act 2019
AoMRC — A Code of Practice for the Diagnosis and Confirmation of Death (2008)
Your learning path

Save your place and choose what comes next

Ethics, Law & Patient Safety · Article 9 of 15