This guide is maintained as a current resource for August 2026 and covers only the laws of England and Wales. Information is for general guidance, not legal advice. Consult a qualified solicitor for advice specific to your situation.
Learn how the Pre‑Action Protocol works in clinical negligence cases in England and Wales. This comprehensive guide explains key stages including obtaining records, Letters of Claim and Response, timelines, expert evidence, alternative dispute resolution options and how the Protocol supports early resolution before litigation.
Before most clinical negligence claims in England and Wales can be issued in court, parties must follow a structured process known as the Pre‑Action Protocol for the Resolution of Clinical Disputes. This protocol, part of the Civil Procedure Rules, exists to ensure both sides exchange key information early, investigate issues thoroughly, and attempt resolution without unnecessary litigation. It helps to reduce delays, limit legal costs, and clarify disputed facts before formal proceedings begin. This article explains how the Pre‑Action Protocol works, its key stages, time limits, practical considerations, and its role in clinical negligence claims involving hospitals, general practitioners (GPs), dentists and other healthcare providers.
What Is the Pre‑Action Protocol?
A Pre‑Action Protocol is a formal set of procedural steps that claimants and defendants are expected to follow before court proceedings are started. The Pre‑Action Protocol for clinical disputes applies to almost all claims alleging harm from clinical negligence - whether in the NHS or private healthcare - and sets out a standard of reasonable pre‑action conduct. Courts treat compliance with the Protocol as the baseline for sensible pre‑action behaviour. If parties depart from it without good reason, courts may impose costs sanctions or other penalties.
The protocol does not replace statutory limitation periods for starting a claim. If proceedings are issued outside the applicable limitation period, the defendant can raise this as a defence, even if the protocol was followed.
Aims of the Protocol
The Pre‑Action Protocol has several core objectives:
- Encourage early, transparent exchange of information so both parties understand the issues in dispute.
- Promote investigation and expert analysis before litigation.
- Facilitate early resolution or narrowing of issues without court proceedings.
- Encourage alternative dispute resolution (ADR) such as mediation where appropriate.
- Avoid unnecessary delays and disproportionate costs in progressing claims.
- Support effective case management if proceedings become necessary.
The protocol thus aims to benefit both claimants and defendants by providing clarity early in the dispute and reducing the need for costly litigation.
Key Stages of the Pre‑Action Protocol
1. Obtaining Medical Records
Before framing a detailed claim, the claimant or their solicitor must obtain relevant healthcare records. The protocol expects requests to be clear about which records are needed and why. Defendants must provide copies within 40 calendar days at a cost no greater than permitted under health‑records legislation. If records are not provided or delayed unreasonably, the claimant can apply to the court for a pre‑action disclosure order under the Civil Procedure Rules (CPR).
Claimants should also organise records into an indexed and paginated bundle for ease of review and future use.
2. Letter of Notification
After initial investigation - including reviewing records and obtaining any provisional expert input - a claimant may send a Letter of Notification to the defendant. This letter:
- Alerts the defendant that a clinical negligence claim is likely.
- Summarises the adverse outcome and potential breach issues.
- Invites the defendant to start their own investigation.
On receipt, the defendant should acknowledge the letter within 14 days, identify whom the claimant should send the formal Letter of Claim to, and consider early investigation or information sharing.
3. Letter of Claim
Once the claimant's solicitor is satisfied there are grounds for a claim, they must send a Letter of Claim. This is the key step in the protocol and must include:
- A clear summary of the facts and events giving rise to the claim.
- Allegations of breach of duty and causation.
- A description of the claimant's injuries, prognosis and financial losses.
- Details of funding arrangements and any expert evidence already obtained.
- Reference to records provided or requested.
The Protocol sets a guideline that proceedings should not be issued until at least four months after the Letter of Claim has been served, allowing the defendant time to investigate and respond. If it is not practical to wait (for example, because a limitation period is imminent), the claimant can notify the defendant accordingly and may seek a stay of proceedings while compliance is completed.
4. Letter of Response
After receiving the Letter of Claim, the defendant must:
- Acknowledge receipt within 14 days.
- Within four months provide a Letter of Response setting out whether the claim, or part of it, is admitted or denied.
The Letter of Response should address each allegation, explain any denial of breach or causation, attach relevant documents such as internal policies, and confirm details of indemnity insurers if applicable. If the defendant needs more time, an extension request should be made before the four‑month deadline with reasons for the delay.
5. Experts and Evidence
Claims often require expert evidence to assess breach of duty, causation and prognosis. The protocol allows flexibility in how and when experts are instructed and encourages co‑operation between parties on suitable specialisms. Medical expert reports obtained at the pre‑action stage can only be used in court with the court's permission.
6. Alternative Dispute Resolution (ADR)
The protocol encourages parties to consider ADR before litigation. Options include mediation, arbitration, early neutral evaluation or negotiated settlement. While a party cannot be compelled to mediate, failure to engage with reasonable ADR proposals may influence costs orders if a subsequent claim goes to court.
7. Stocktake and Preparation for Litigation
If the dispute is not resolved following these steps, the parties should conduct a stocktake to review agreed and disputed facts, and prepare for potential court proceedings. This includes drafting chronologies, narrowing issues and agreeing procedural directions to streamline future case management.
Time Limits and Sanctions
The Protocol does not change statutory limitation periods under the Limitation Act 1980 (typically three years from the date of injury or date of knowledge), and claimants must manage these alongside Protocol compliance.
Failure to follow the Protocol can lead courts to impose sanctions, such as adverse costs orders or a reduced costs award for the defaulting party. Courts generally consider whether a party complied “in substance” with the Protocol's aims when deciding sanctions.
Practical Considerations
Cooperation and Transparency
The Protocol promotes an open and cooperative approach. Early disclosure, clear chronology of events and engagement with expert evidence can assist both parties in understanding the merits of a claim and facilitate early resolution, avoiding the expense of court proceedings.
Early Offers and Negotiation
Claimants may make Part 36 offers (formal settlement offers) with their Letter of Claim, supported by medical evidence and schedules of loss. Defendants can respond, and both sides should provide sufficient information to allow informed consideration of settlement.
Limitation Awareness
Solicitors must be aware of limitation periods while progressing pre‑action steps. If a limitation deadline approaches before full Protocol compliance, claimants may issue proceedings early and apply for a stay to complete Protocol requirements.
Common Questions
Does the Protocol apply to all clinical negligence claims?
Yes. The Pre‑Action Protocol for clinical disputes applies to negligence claims against hospitals, GPs, dentists and other healthcare providers in both public and private settings, with few narrow exceptions.
What happens if the defendant admits liability early?
Early admission of liability, either upon review of records or in the Letter of Response, can lead to settlement without formal court proceedings. Parties may then negotiate compensation or use ADR to resolve outstanding issues.
Can a litigant in person follow the Protocol?
Yes. Even without a solicitor, a claimant should comply as far as reasonably possible with the Protocol's requirements, and defendants should provide the protocol to litigants in person when aware of their status.
Final Thoughts
The Pre‑Action Protocol for the Resolution of Clinical Disputes is a structured, detailed framework designed to ensure that clinical negligence claims in England and Wales are investigated and managed transparently and efficiently before litigation. By requiring early disclosure of medical records, clear communication through Letters of Notification, Claim and Response, consideration of expert evidence, and exploration of alternative dispute resolution, the Protocol promotes early resolution and cost‑effective case management. Understanding its stages, time limits and practical implications helps claimants and defendants engage effectively, preserve legal rights, and avoid unnecessary court proceedings.
