Medical Examiners - statutory reforms

Reforms to the Medical Examiner system within inquest law were given statutory effect on 9 September 2024. The reforms require all deaths in England and Wales to be independently scrutinised, either by a coroner or by a Medical Examiner (“ME”).

Background to the reforms

The Shipman Inquiry, chaired by Dame Janet Smith DBE, was set up in January 2001 following the conviction of Harold Shipman for the murder of 15 of his patients.

The Inquiry was tasked with investigating the extent of Shipman's unlawful activities, enquiring into the activities of the statutory authorities and other organisations involved, and making recommendations on the steps needed to protect patients for the future. The Inquiry published a total of six reports and found major flaws in the processes of death registration, prescription of drugs and monitoring of doctors. The Inquiry also established that he had killed at least 215 of his patients over a period of 24 years, and may have killed as many as 300, although the true number could be even higher.

The third report, dealing with Death Certification and the Investigation of Deaths by Coroners, provides the backdrop to the recent reforms:

“12. Since 1926, the law has required that, before a death can be registered and the body disposed of by burial or cremation, the medical cause of death must be certified by a doctor who has attended the deceased during his/her last illness or by a coroner after autopsy or inquest. The procedure for certifying the medical cause of death has remained virtually unchanged for over 75 years.

The current procedure has three very real advantages; it is speedy, cheap and convenient. However, it has a number of disadvantages. The most serious of these is that it is dependent on the integrity and judgement of a single medical practitioner. That medical practitioner, if s/he has attended the deceased during the last illness, must decide whether s/he should report the death to the coroner or whether s/he can properly issue the medical certificate of cause of death (MCCD).
One of the circumstances in which a death should be reported to the coroner is if the death is sudden and the cause is unknown. Many of Shipman’s patients died suddenly in circumstances in which no honest doctor could have claimed to know the cause of death. Yet Shipman, who had killed them, was able to certify the cause of death, avoid a report to the coroner and thus also avoid any official enquiry into the death.”

The Inquiry identified numerous deficiencies with the system of single certification by a doctor. For instance, a doctor may know that a death was caused or contributed to by the misconduct of a colleague, lack of care or a medical error. In such circumstances, it can be extremely difficult to refuse to certify a death, as the result would be referral to a coroner for investigation. Pressure may also be exerted by the patient’s family, so as to avoid a referral and autopsy or to persuade the doctor to certify a less embarrassing cause of death. There was no oversight of such decision-making:

“19. Once a doctor has certified the cause of death then, provided that s/he has completed the MCCD fully and in appropriate terms, there is no check on the truth or accuracy of what s/he states. There is no system of audit or review of those cases where a doctor certifies the cause of death and does not report the death to the coroner. The relatives of the deceased person will take the MCCD to the register office, the death will be registered and a disposal certificate issued. A burial can then take place without any further check or formality.”

In addition, the Inquiry found that, even absent such pressures, doctors still had difficulties in recognising those deaths that should be reported to the coroner. This task often fell to junior doctors with little training in death certification, with the Inquiry identifying that different ‘local rules’ (see paragraph 5.46) added further complexity.

The process where a body is to be released for cremation was also antiquated. Those rules, dating back to 1903, introduced an additional safeguard whereby a second doctor would consider the MCCD and the somewhat fuller Form B. The second doctor would carry out his/her own enquiry and complete a confirmatory certificate (Form C). A medical referee, on behalf of the crematorium, would examine the forms and satisfy him or herself that the forms were in order, that proper enquiry had been made and that the cause of death had been definitely ascertained. However, the Inquiry discovered that none of that was working properly: the second doctor was often not remotely independent, made few enquiries and the exercise carried out by the medical referee at the crematorium was clerical only. The fees for the three professionals concerned were just under £100 in total.

Dame Janet’s conclusions were followed by several further reports that indicated that the system was ripe for overhaul: see, for instance, the report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, the Report of the Morecambe Bay Investigation and the Government’s response to the report of the Gosport Independent Panel.

The reforms: an overview

The reforms require an independent review to be carried out for all deaths in England and Wales, without exception, to be performed. In the main this independent scrutiny is to be carried out by an ME but, in certain cases, the scrutiny will undertaken by a coroner.

The scrutiny undertaken by MEs will be of the causes of death, which will involve undertaking a proportionate review of medical records and working with doctors to complete the MCCD, so as to ensure its accuracy and highlight any concerns about the care of the deceased person prior to their death.

So who are the MEs? An ME is a senior medical practitioner who is contracted for a number of sessions per week to provide independent scrutiny of causes of death, outside of their usual clinical duties. MEs are required to be trained in the legal and clinical elements of death certification processes and will not have been involved in caring for the patient.

In fact MEs have been carrying out independent scrutiny of causes of death since the launch of various pilot projects, including a trial implementation of the reforms by NHS England and NHS Wales Shared Services Partnership beginning in 2019. However, the reforms are now placed on a statutory footing and underpinned by two key sources of primary legislation.

The Coroners and Justice Act 2009 (“the 2009 Act”), section 21 (commenced in June 2018) allows NHS bodies in England and Wales to appoint medical examiners. The 2009 Act also enables the governments to make regulations in several areas: sections 19-20. Details of how MEs and the reformed death certificate process operate are set out in The Medical Certificate of Cause of Death Regulations 2024, The Medical Examiners (England) Regulations 2024 and The National Medical Examiner (Additional Functions) Regulations 2024.

There are specific regulations for Wales as well in The Medical Examiners (Wales) Regulations 2024.

The Health and Care Act 2022 (“the 2022 Act”), section 169 (commenced in October 2023) furnishes NHS bodies in England and Wales with the power to appoint MEs, and places obligations on the Secretary of State to take steps to ensure that MEs can discharge their functions.

The statutory and regulatory framework is supplemented by detailed guidance. This guidance makes clear what the legal requirements will be in each area, ahead of the publication of more detailed guidance. It should be read together with the regulations to support those involved in the death management system to understand and prepare for the reforms.

The reforms ushers in the following notable changes:

From September 2024, a medical practitioner will be eligible to be an attending practitioner and complete an MCCD if they have attended the deceased in their lifetime. The attending practitioner will propose a cause of death, if they can do so, to the best of their knowledge and belief. This simplifies the current rules which require referral of the case to a coroner for review if the medical practitioner had not attended to the patient within the 28 days prior to their death, or had not seen the patient after their death.
Under the new system, the attending practitioner must share the MCCD with the ME to enable the latter to scrutinise the cause of death proposed by the attending practitioner independently, prior to submission to the registrar. Previously, the MCCD was sent to the registrar by the attending practitioner. The representative of the deceased will be notified at the same time that they can contact the registrar to arrange the registration of the death.
The existence of implantable medical devices must now be recorded on the MCCD by the attending practitioner.

A further significant development is Regulation 8 of the Medical Examiners (England) Regulations 2024. Regulation 8 requires the ME to discuss the cause of death with a person who is qualified to give the information concerning the death under the Births and Deaths Registration Act 1953. Importantly, this includes relatives and any person present at the death, or any occupier or inmate of the house where the person died, who knew of the happening of the death.

Publicly available reports suggest that the ME role is particularly appreciated by family members. For example, one family commented that speaking to someone not involved in care empowered them to say what they really felt. Another family said the ME office kept them informed about an unfamiliar process – which the act of death certification so often is for bereaved people – providing much appreciated support at a difficult time. Another ME office arranged a meeting for the family with the clinical team to address their concerns in greater detail.

Evidence presented to the Royal College of Pathologists – the leading medical royal college for MEs – noted the positive impact of the independent ME in rural areas, where the GP certifies death and members of the family typically all have the same GP. Access to an ME empowered family members to raise their concerns.

The role of the coroner

Under the new framework, deaths will be considered by the coroner where:

The attending practitioner is not able to establish the cause of death (reg 3(1)(b)(ii) of the Medical Certificate of Cause of Death Regulations 2024) or the ME feels unable to confirm the cause of death; or

The duty to notify under The Notification of Deaths Regulations 2019 applies, either in the view of the attending practitioner or in the view of the ME.

The Notification of Deaths Regulations 2019 lay down a duty to notify the coroner of a death in several circumstances, including where there is reasonable cause to suspect that the death was due to poisoning by an otherwise benign substance, exposure to a toxic substance, use of a controlled drug, self-harm or neglect. The coroner must also always be notified when:

The registered medical practitioner suspects that the person’s death was unnatural, but does not fall within any of the above circumstances;
The cause of death is unknown;
The registered medical practitioner suspects that the person died while in custody or otherwise in state detention;
There is no attending practitioner, or an attending practitioner is not available within a reasonable time to sign a MCCD in relation to the deceased person; or
The identity of the deceased person is unknown.

The length of time that has passed since the person died does not impact on the duty to notify a coroner of the death once relevant circumstances come to light.

Overall, the reforms seek to achieve a balance between the objectives of reducing the number of deaths referred to a coroner and improving the safeguards and scrutiny within the death management process. They mark a significant step towards enhancing the independence and reliability of the death certification process.

This blog was written by Samantha Broadfoot KC.