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Chapter 11 of 11 · Ethics, Law & Safeguarding

Four principles, GMP 2024, candour and complaints

The professional standards half of the syllabus: what the GMC expects, what the law compels, and what happens when something goes wrong.

Free — no account neededGMP 2024 · Regulation 20~14 min read

The four principles

Beauchamp and Childress: autonomy, beneficence, non-maleficence, justice. They are prima facie binding — none automatically outranks another, and conflicts are resolved by specification and balancing rather than by a hierarchy.

Know the standard criticisms too, because they are what turns a recital into an answer: principlism gives no decision procedure when principles conflict; it is culturally individualist and under-weights family and community; it neglects virtue and care ethics; and “justice” is left substantively empty.

Consent: Montgomery, Bolam and McCulloch

The law

Montgomery v Lanarkshire Health Board [2015] UKSC 11: you must take reasonable care to ensure the patient is aware of any material risk in the recommended treatment, and of any reasonable alternative or variant treatments.

A risk is material if a reasonable person in the patient’s position would be likely to attach significance to it, or the doctor is or should reasonably be aware that this particular patient would. Two limbs — objective and subjective.

Exam trap

Montgomery did not abolish Bolam. Bolam (as qualified by Bolitho, which requires the responsible body of opinion to be logically defensible) still governs diagnosis and treatment. And since McCulloch v Forth Valley Health Board [2023] UKSC 26, Bolam also decides what counts as a “reasonable alternative treatment” — Montgomery then governs disclosure of the material risks of those alternatives.

Key point

The one-line version: the profession decides what the options are; the patient decides between them.

Good Medical Practice 2024

In effect from 30 January 2024, replacing the 2013 edition. Four domains:

  1. Knowledge, skills and development
  2. Patients, partnership and communication
  3. Colleagues, culture and safety
  4. Trust and professionalism

New in the 2024 edition: explicit duties on tackling bullying, harassment and discrimination; duties for those in leadership and management roles; and clearer provisions on sexual boundaries.

Exam trap

Domain 2 is “Patients, partnership and communication”. Options offering “partnership and care” or “collaboration” are distractors. And note the GMC separately markets six “duties of a doctor” — if the question asks for domains, there are four.

Duty of candour

Two duties, often confused. One is professional and applies to you; the other is statutory and applies to the organisation.

 Professional dutyStatutory duty
SourceGMC/NMC joint guidance Openness and honesty when things go wrongRegulation 20, Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Applies toYou, personally, as a registrantThe provider — the practice, the trust
ThresholdAnything that goes wrong, including near misses (report those internally)A notifiable safety incident
EnforcementFitness to practiseCriminal offence; CQC can prosecute

The GP practice threshold

GP practices are not “health service bodies” for these purposes, so regulation 20(9) applies. A notifiable safety incident is an unintended or unexpected incident that, in the reasonable opinion of a healthcare professional, appears to have resulted in:

  • death directly related to the incident;
  • impairment of sensory, motor or intellectual function lasting or likely to last 28 days or more;
  • changes to the structure of the body;
  • prolonged pain or prolonged psychological harm (28 days or more); or
  • shortened life expectancy;

— or that requires treatment to prevent any of those outcomes.

Exam trap

The trust threshold, regulation 20(8), is lower: “could result in, or appears to have resulted in” death or severe, moderate or prolonged psychological harm. Getting the two the wrong way round is the classic error — “moderate harm” is the trust trigger, not the GP one.

What you must actually do

  1. Tell the patient (or their representative) in person, as soon as reasonably practicable
  2. Apologise
  3. Give a true account of all the facts you know at that point
  4. Explain what further enquiries will be made
  5. Follow up in writing with that account, the apology and the results of enquiries
  6. Keep a secure written record of it all
Key point

Regulation 20 sets no fixed number of days — the test is “as soon as reasonably practicable”. And an apology is not an admission of legal liability: the Compensation Act 2006 s2 says so expressly.

Does candour bite?

A prescribing error at your practice means a patient received the wrong dose of methotrexate for six weeks. She developed mouth ulcers and fatigue, needed a fortnight off work, and has now fully recovered with no lasting effects.

Is this a notifiable safety incident for the practice?

Not automatically

Harm occurred, but the regulation 20(9) threshold is specific: impairment lasting 28 days or more, prolonged pain or psychological harm of 28 days or more, structural change, shortened life expectancy, or death. A fortnight of symptoms with full recovery does not meet it.

But read on — that is not the end of your obligations.

Correct

The statutory threshold is not met on these facts. The professional duty of candour is not threshold-based: you must tell her what happened, apologise, explain the consequences and what you are doing to prevent recurrence.

Also do: a significant event analysis, a check of your practice’s methotrexate monitoring system, an LFPSE report, and inform your medical defence organisation.

Wrong

Falling below the statutory threshold does not switch off the professional duty, the need for a significant event analysis, or the need to fix the system that allowed it.

Badly wrong

Candour is proactive. Waiting to be asked is exactly the behaviour both duties exist to prevent, and is far more likely to end in a complaint or a claim than early honesty.

Pick an option to see the answer.

Complaints in England

  • Two stages: local resolution by the provider or commissioner, then the Parliamentary and Health Service Ombudsman. There is no independent second stage in between — that was abolished in 2009.
  • Time limit: 12 months from the incident, or from when the complainant knew of it, with discretion to extend.
  • Acknowledge within 3 working days.
  • There is no fixed statutory response deadline — respond as soon as reasonably practicable after investigating, and keep the complainant informed if it will take longer than agreed.
  • Anyone affected may complain, or a representative may complain for a child, someone lacking capacity, or someone who has died.
  • Since 1 July 2023, complaints about primary care in England are handled by ICBs, not NHS England.
Exam trap

NHS Resolution has nothing to do with complaints. It handles clinical negligence claims, Practitioner Performance Advice and primary care appeals. And no MP referral is needed to reach the PHSO for a health complaint in England.

Clinical negligence

Four elements: duty of care, breach, causation, damage. Breach is Bolam as qualified by Bolitho. Causation is the “but for” test.

Limitation: 3 years from the cause of action or the later date of knowledge. For children, time runs from their 18th birthday, so a claim can be brought until 21. For people who lack capacity, time does not run at all while incapacity persists. The court has a discretion to disapply the limit.

Key point

CNSGP — the Clinical Negligence Scheme for General Practice — gives state-backed, unlimited indemnity for NHS general practice incidents on or after 1 April 2019. It covers GPs, salaried GPs, locums, nurses, PCN and ARRS staff and trainees. It does not cover private work, Good Samaritan acts, GMC proceedings or criminal matters, and its inquest cover is limited to inquests connected to a claim within the scheme — which is precisely why you still need a medical defence organisation.

Fitness to practise

The threshold is whether there is a current risk to public protection requiring action. Stages: triage → investigation → case examiners (no action, warning, undertakings, or referral to the MPTS) → MPTS hearing.

The standard of proof is the civil standard — the balance of probabilities — and has been since 2008. Interim orders (conditions or suspension for up to 18 months) are not sanctions and are not a finding of impairment; they hold the position while the case is investigated.

MPTS sanctions: no action, undertakings, conditions up to 3 years, suspension up to 12 months, or erasure — with restoration not possible for 5 years. A warning can be issued even where fitness to practise is not impaired.

Changed recently

The GMC has regulated physician associates and anaesthesia associates since 13 December 2024, and the MPTS now hears their cases. The Leng Review (July 2025) renamed the role “physician assistant” and recommended that they should not see undifferentiated patients except in clearly defined cases, with clear team structures led by a senior clinician.

Learning from things that go wrong

  • Significant event analysis remains the core primary care tool and an appraisal expectation.
  • PSIRF replaced the Serious Incident Framework in NHS trusts by autumn 2023. It is not mandatory in general practice, though its concepts are being introduced through the Primary Care Patient Safety Strategy.
  • All practices report incidents to LFPSE, which replaced the NRLS.
  • Reflective notes are not legally privileged. The GMC does not ask for them when investigating a doctor, but a court can compel them. Write reflections about learning, and keep the factual account of events in the record and the SEA.

Death certification since September 2024

In force since 2024

The reformed system has been statutory since 9 September 2024. What changed:

  • The MCCD is completed by an attending practitioner — any doctor who attended the deceased in their lifetime. The old “seen within 28 days” rule is abolished.
  • All non-coronial deaths are independently scrutinised by an NHS medical examiner before registration.
  • Registrars no longer refer to coroners — the attending practitioner or the medical examiner does.
  • Cremation Forms 4 and 5 are abolished, so there is no longer a second confirmatory doctor. The crematorium medical referee role continues — it was not abolished.
  • Coroner referral criteria (Notification of Deaths Regulations 2019) are unchanged: violence, injury, self-harm, neglect, poisoning, industrial disease, custody or state detention, unknown cause, no attending practitioner, or an unidentified body.

Martha’s Rule

Named after Martha Mills, who died of sepsis in 2021 after her family’s concerns about her deterioration were not acted on. Three components: staff can request an urgent second-opinion or critical care review from a different team; patients and families have the same escalation route via an advertised 24/7 number; and there is structured daily enquiry of the patient about their condition.

Rollout: 143 sites from May 2024, with phase 2 extending it across acute trusts from April 2025. NHS England expects implementation across acute inpatient services to be complete during 2026/27, and is currently testing it in a small number of maternity, neonatal, emergency, community and mental health services rather than operating it there routinely.

Key point

Martha’s Rule is an inpatient mechanism — it does not operate in general practice. What travels to primary care is the underlying finding: over 80% of escalation calls in the first sixteen months would not have been triggered by a standard early warning score. Family concern about deterioration is an independent red flag, and safety-netting should say so out loud.

Self-testA patient asks you to apologise in writing for a delayed cancer diagnosis. Your practice manager says not to, in case it is used against you. Who is right?

You are. The Compensation Act 2006 s2 provides that an apology, an offer of treatment or other redress does not of itself amount to an admission of negligence. Both the GMC and NHS Resolution actively encourage early, meaningful apologies — and failure to apologise is one of the most consistent drivers of complaints escalating into claims.

Apologise for what happened and its effect on her. That is different from conceding a legal breach of duty, which is a matter for your defence organisation and the facts.

Self-testWhat is the difference between the professional and the statutory duty of candour in one sentence each?

Professional: a duty on you personally, from the GMC, to be open and honest with a patient whenever something goes wrong — with no harm threshold.

Statutory: a duty on the organisation, under CQC regulation 20, triggered by a notifiable safety incident, with prescribed steps and a written follow-up, breach of which is a criminal offence.

And a point worth keeping straight: there is currently no statutory individual duty of candour on doctors. The Public Office (Accountability) Bill would create a separate duty for public authorities and officials, but it is not yet law.

Written and checked by NHS GPs. Last reviewed 24 August 2026. UK law and guidance change — always follow current local policy and your defence organisation’s advice in a real case.

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