Pre-Action Protocol for Clinical Negligence: Letter of Claim Walkthrough

What the Protocol is for

The Pre-Action Protocol for the Resolution of Clinical Disputes (commonly called the "Clinical Negligence Protocol") is the framework for what the parties must do before clinical-negligence proceedings can be issued. It sits within the Civil Procedure Rules and is the gateway every claim has to go through.

The aim is straightforward: get the parties exchanging proper information early, narrow the issues, and resolve cases without going to court where possible. NHS Resolution reports that 84% of the clinical negligence claims it handled in 2025/26 were resolved without formal legal proceedings (England). The Protocol is the scaffolding for that.

The Protocol applies to:

• NHS Resolution claims (against NHS trusts and English GPs). In Wales, NHS claims are handled differently; ask the health board or trust.
• Independent-sector claims (private hospitals, private consultants)
• Direct-claim defendants (community pharmacists, dental practices, paramedics in some scenarios)

It does not apply to claims covered by the Pre-Action Protocol for Disease and Illness Claims, the Pre-Action Protocol for Personal Injury Claims, the two low-value personal injury protocols, or mesothelioma claims under Practice Direction 3D (para 1.1).

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Before the Letter of Claim — what comes first

Before the Letter of Claim is sent, the Protocol expects you to have gathered the basics.

1. Letter of Notification (optional but recommended)

You can send a Letter of Notification to the defendant after you have analysed the records and, if appropriate, obtained an initial supportive expert opinion (para 3.11.1). The defendant should acknowledge within 14 days (para 3.12.1). It is short — half a page — and tells the defendant a claim is coming so they can preserve records and reserve.

2. Medical records request

Under UK GDPR Article 12(3) and the Data Protection Act 2018, the controller must respond to a Subject Access Request without undue delay and within one month of receipt — extendable by a further two months where the request is complex, with notification to the data subject within the first month. Records are free of charge unless the request is "manifestly unfounded or excessive". For a clinical negligence claim, use the Protocol's Annex B request form; the Protocol expects records within 40 days (paras 3.3–3.4.1).

You will usually want:

• Full GP records (paper and electronic)
• Hospital records — including imaging, reports, charts, drug charts, theatre notes, anaesthetic charts
• Out-of-hours service records if relevant
• Any other treating clinician's records (community nursing, mental health team)

Ask for everything in date order, with imaging on a separate USB or DVD.

3. Independent expert evidence

You should have a letter or short report from a suitably qualified independent expert before the Letter of Claim, confirming that:

• There is an arguable case on breach of duty
• There is an arguable case on causation

The Protocol does not require you to disclose the expert's report at this stage. The Protocol contemplates the Letter of Claim being sent after the records and any necessary expert advice have been obtained (para 3.14).

4. Witness statements

Get the claimant's account in writing as a draft witness statement. It does not need to be in final form for the Letter of Claim, but the facts should be clear: who, what, when, where.

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Anatomy of a Letter of Claim

The Protocol prescribes the contents at paragraph 3.16: a clear summary of the facts and the main allegations of negligence; the injuries, present condition and prognosis; an outline of financial loss; the method of funding and whether any funding arrangement was entered into before or after April 2013; and the discipline of any expert already consulted. Headings B to E and G cover items (a) to (c); heading J covers items (d) and (e). Headings A, F, H and I are good practice rather than Protocol requirements:

A. The claimant's identity

Full name, date of birth, address, NHS number where relevant. If there is a litigation friend, identify them and the basis on which they act (parent of a child, deputy under the Mental Capacity Act, etc.).

B. A clear summary of the facts

A chronological narrative of what happened. It does not need to be a witness statement; keep it concise. Include:

• The treatment relationship (GP appointment dates, hospital admission dates)
• The specific treatment events alleged to be negligent
• The clinicians involved (named where known)
• The injury suffered and when it became apparent

C. The main allegations of negligence

The "Bolam-Bolitho" case for breach of duty. State each alleged failure as a numbered allegation. Be specific.

A weak allegation reads: "The defendant failed to provide proper care."

A strong allegation reads: "On 12 March 2024 at 14:20, when the claimant attended the Emergency Department with chest pain radiating to the left arm and a heart rate of 130 bpm, the defendant failed to perform an electrocardiogram promptly, contrary to [the specific guideline, edition and paragraph your expert identifies]."

The latter ties the breach to a recognised standard. The former is too vague to investigate.

D. The alleged injury

What injury did the claimant suffer? Set out the diagnosis, the prognosis, the impact on day-to-day life, the impact on work, the financial losses incurred and projected.

E. Causation

The link between the alleged breach and the alleged injury. Causation is often the hardest element in clinical negligence. State the case on causation clearly:

• "But for" causation: the injury would not have happened but for the breach
• Material contribution: where multiple causes operated, the breach made a material contribution
• Loss of chance: rarely available in clinical negligence (Gregg v Scott [2005] UKHL 2), but sometimes argued

F. Documents you have considered

Listing the medical records, expert opinion summary (without disclosing the report itself), witness accounts, and any other evidence considered.

G. The remedy sought

Damages. Quantum is not usually pleaded in detail at this stage, but a "broad band" indication is helpful. The Protocol asks for an outline of the financial loss, with the heads of damage and the scale of the loss unless impracticable (para 3.16(c)); the defendant needs it to put an initial valuation on the claim (para 3.18).

H. A request for a Letter of Response within four months

Refer to paragraph 3.24 of the Protocol. Confirm the date by which the response is expected.

I. Identity of the proposed defendant

For NHS hospital cases, this is usually the NHS trust. For GPs, it is the GP partner(s) or the practice if a limited company. For private consultants, it is the consultant personally and any private hospital that is jointly responsible.

Send the Letter of Claim to the NHS trust responsible for your care (NHS Resolution's advice for claimants) and send a copy to NHS Resolution, the operating name of the NHS Litigation Authority (Protocol para 3.14); NHS Resolution will usually handle the claim for the trust. Send any Letter of Notification to the trust with a copy to NHS Resolution (para 3.11.2).

J. Funding and experts consulted

State the method of funding and whether any funding arrangement was entered into before or after April 2013 (para 3.16(d)), and the discipline of any expert from whom evidence has already been obtained (para 3.16(e)).

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Common Letter-of-Claim mistakes

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What the defendant does in the four months

The Protocol gives the defendant four months to investigate and respond. In that time NHS Resolution or the private-sector defendant will:

1. Acknowledge the Letter of Claim within 14 days
2. Pull the medical records
3. Take internal accounts from the clinicians involved
4. Instruct breach-of-duty and causation experts
5. Draft a Letter of Response

The response will either:

• Admit liability
• Admit some allegations and deny others
• Deny liability in full
• Make a Part 36 offer or other ADR proposal alongside

A denial does not end the matter. Many cases continue through Particulars of Claim, Defence, and exchange of expert evidence before settlement.

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What if the defendant does not respond?

If four months pass with no Letter of Response, you can issue proceedings without further delay. The Protocol's failure point is reached. You may issue; the defendant's failure to respond will be relevant to costs (CPR 44.2(5)(a)).

You can also issue earlier than four months if:

• A Limitation Act 1980 deadline is approaching (issue protective proceedings; serve later)
• A child claimant is approaching their 21st birthday (the claim must be issued before the 21st birthday — see Clinical Negligence Time Limits)

If you must issue early, the parties should seek to agree a stay while they comply with the Protocol (para 3.20).

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ADR within the Protocol

The Protocol expects parties to consider ADR throughout. Common ADR routes in clinical negligence:

• Round-table meetings — often booked for after exchange of expert evidence
• Mediation — increasingly common; CEDR and Trust Mediation are established providers
• Joint settlement meetings — variation on round-table
• NHS Resolution mediation scheme — the centralised scheme for NHS cases

Refusing ADR without good reason can attract costs sanctions. Halsey v Milton Keynes General NHS Trust [2004] EWCA Civ 576 set the original framework on cost consequences of unreasonable refusal. The Court of Appeal in Churchill v Merthyr Tydfil County Borough Council [2023] EWCA Civ 1416 went further: the court can now lawfully order or stay proceedings to compel ADR, provided Article 6 rights are respected. From 1 October 2024 the overriding objective includes "promoting or using alternative dispute resolution" (CPR 1.1(2)(f)) and the court may order parties to engage in ADR (CPR 3.1(2)(o)). Refusing reasonable ADR proposals is increasingly costly.

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How BundleCreator helps

Trial bundles in clinical negligence are voluminous: medical records, witness statements and exhibits, expert reports on breach of duty, causation, condition and prognosis, care and accommodation, the schedule of loss and counter-schedule, and the joint statements.

The trial bundle is filed by the claimant 3 to 7 days before trial (CPR 39.5) and must be paginated continuously and indexed (PD 32 para 27.8), following any court guide and directions. BundleCreator's Medical Negligence trial template structures the bundle into these sections:

• Pleadings
• Case Management
• Expert Evidence
• Medical Records
• Quantum
• Witness Evidence
• Legal Submissions

Pagination, hyperlinked index, OCR, and bookmarks are produced automatically.

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Frequently asked questions

Can I send a Letter of Claim while the defendant is still investigating my complaint?

Yes. Complaints to the trust, the Parliamentary and Health Service Ombudsman, or the GMC are separate from Protocol litigation. Many claimants run both in parallel. The Letter of Claim formalises the legal route.

What if the records reveal a different defendant?

You may discover during records review that another clinician or organisation is the proper defendant. Send the Letter of Claim to the correct defendant once you know. Limitation keeps running against the correct defendant while you do so.

Do I need a solicitor?

No. The Protocol applies whether or not you have a solicitor. But clinical negligence is technically demanding, expert evidence is expensive, and quantum is hard to assess. Many claimants instruct a specialist clinical-negligence solicitor on a Conditional Fee Agreement (no win, no fee).

What if the defendant offers settlement during the four months?

Consider it. A defendant making an early offer is signalling concern about the merits or quantum. Compare against your expert's view of value, take advice if you have it, and respond. Negotiation can be informal at this stage; a Part 36 offer can be made at any time, including before proceedings are issued (CPR 36.7(1)).

What does "Bolam-Bolitho" mean?

The two-stage test for breach of duty. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582: a doctor is not negligent if they acted in accordance with a practice accepted as proper by a responsible body of medical opinion. Bolitho v City and Hackney Health Authority [1998] AC 232: the body of medical opinion relied on must itself be capable of withstanding logical analysis. The two together set the modern test.

How much does a Letter of Claim cost to prepare?

Under a CFA, a success fee is not recoverable from the defendant; in personal injury claims it is capped at 25% of general damages and past losses, net of recoverable benefits (Conditional Fee Agreements Order 2013 art 5). A litigant in person bears expert fees and their own time.

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Further reading

• Pre-Action Protocol for the Resolution of Clinical Disputes — Official Protocol text
• Civil Procedure Rules Part 3 — Court's case management powers
• NHS Resolution — Handles clinical negligence claims against NHS bodies in England
• Clinical Negligence Time Limits: The 3-Year Rule and the Date of Knowledge
• Clinical Negligence Expert Evidence: Breach of Duty vs Causation Reports