Forecasting for the coming year always takes place around this time of year. Journalists and other commentators highlight the significant events of the past year and lay out their vision for what may be on the horizon. Those with an interest in NHS patient safety and care quality face a mammoth task ahead doing this given the size and complexity of the NHS.
The year 2024 was a busy one, patient safety wise, with a raft of several important consultations on topics including the Duty of Candour, Never Events, and the NHS Constitution (Department of Health and Social Care (DHSC), 2024a; 2024b; NHS England, 2024a). Consultations have closed in these areas, and we await government responses. We also await the response to the report of the Health and Social Care Committee (2022) NHS Litigation Reform Inquiry. Furthermore, we can add Martha's Rule (NHS England, 2024b) and the Dash Review (DHSC, 2024c) to the list of seminal events. Taken together the NHS patient safety landscape could look very different this time next year.
In this column I will focus on Martha's Rule and NHS clinical negligence reform. There have been some recent timely publications in these areas, which will enrich the debate about these important issues.
Implementation challenges for Martha's Rule
Martha's Rule emerged from the tragic circumstances surrounding the death of 13-year-old Martha Mills from sepsis in 2021. The Coroner concluded that she would not have died had she been moved earlier to intensive care. There were major problems in communication and in addressing her parents' concerns. There will be a phased implementation of the rule in the NHS in England and currently 143 hospital sites are due to test it and roll it out in its first year (NHS England, 2024c).
A key issue for discussion is whether the rule will make any real difference to how patients are treated by and communicated with by health professionals. How effective will it be as an NHS patient safety tool? The rule facilitates the exercise of a patient's right to a second medical opinion where they or their family/carers are concerned about a rapidly deteriorating condition. It will face serious challenges for implementation in the NHS.
The patient safety environment in England always appears to be in a state of flux. What we have at present is not working well and Martha's Rule must be seen within this context. It will have to negotiate serious endemic patient safety problems such as the failure of some NHS to staff to learn the lessons of past adverse healthcare incidents, poor working relationships between some clinical teams and defensive cultures when things go wrong. These and many more problems have been highlighted in investigation reports such as that for East Kent (Kirkup, 2022).
In fact, I would argue that the East Kent investigation report is a useful prism through which to view the operational context that Martha's Rule could face in some parts of the NHS in 2025 and beyond. The report drew out well acute patient safety failure themes such as poor team working, professionalism, empathy, communication, listening and so on. We need to develop a proper patient safety culture to host Martha's Rule. This quote from Kirkup (2022) illustrates the type of hurdle that the initiative could face:
‘We heard many examples of uncompassionate care that shocked us. A woman who asked for additional information on her condition during an antenatal check was dismissively told to look on Google. A mother who was anxious about her baby's clavicle, fractured during a difficult delivery, was told that “collar bones break all the time because they are built to do that to get them out easier”.’
Other perspectives on second opinions
Two recent publications on Martha's Rule will usefully contribute to the debate. In their discussion titled ‘Getting rights right’, Graham et al (2024) have provided an excellent and detailed analysis of Martha's Rule and the challenges it must meet. There is a discussion as to whether Martha's Rule gives a right to obtain a second medical opinion or just a right to request one and what all this means. This is an important distinction, and the situation is not clear, they argued. A rights focus can have problems. There are complex, systemic patient safety cultural issues at stake here, which cannot be addressed just from a rights perspective. An approach with a focus on the obligations of the health system is to be preferred.
The article discusses power dynamics, poor culture, implementation, accessibility, effectiveness, efficiency, and other related issues. A deep dive into key practical, conceptual issues surrounding Martha's Rule is given.
Elsewhere, the people who introduced Ryan's Rule in Queensland Health, Australia discussed how they implemented it and what has happened since in a blog (Gifford and Smith, 2024). Ryan's Rule arose out of the death of Ryan Saunders in 2007; his parents felt that their concerns were not properly addressed. Ryan's Rule has been mentioned in discussions, leading to the implementation of Martha's Rule in England. The journey of implementation and practice of Ryan's Rule is discussed, along with some useful findings that can help the implementers of Martha's Rule in the NHS. The blog states that approximately 60% of calls stem from an issue around communication and further that:
‘In 2023, there were 2,355 Ryan's Rule activations in Queensland Health – an average of nearly seven calls per day…
Clinical negligence litigation reform
In 2025, if not before, the government should at last give a formal response to the NHS Litigation Reform Inquiry chaired by Jeremy Hunt (Health and Social Care Committee, 2022). This long delay in a lack of formal response is concerning as a considerable time has elapsed since the report's first publication. There have been subsequently some parliamentary questions to ministers about clinical negligence reforms and the answers have been that the government is still looking at the matter. A change of government has not derailed this and the intention is still to look into possible reform.
The Journal of Personal Injury Law has recently published a series of articles considering clinical negligence. These provide perspectives on the current debate surrounding clinical negligence reform in the NHS. Matters discussed include high costs, the adversarial, fault-based nature of the compensation system, patient rights, duty of candour, and no-fault compensations. One set of articles was written by an author who represents the Medical Defence Union (MDU) (Devlin, 2024a; 2024b) and another set by an author who represents Action against Medical Accidents (AvMA), the UK charity for patient safety and justice, (O'Dwyer, 2024a; 2024b).
MDU perspectives
Devlin (2024a) stated that the system for compensating patients who have been injured in England is not fit for purpose:
‘It is grossly expensive, adversarial, and promotes individual blame instead of collective learning.’
This, he said, was one of the conclusions reached by the Health and Social Care Committee (2022) and one that echoes the critique made by the MDU in a campaign for change that dates back to the 1990s. There was a deep dive into issues such as the high cost of claims, disproportionate legal costs, and the emotional toll on all parties involved in a claim. Devlin (2024a) also discussed some past case law and judicial precedents that he argued have changed the legal landscape and made the defence of claims more challenging, costly, and unfair. Economic and social factors that have affected the size and number of claims were also discussed. Several of these discussed were also raised in the Inquiry report (Health and Social Care Committee, 2022).
Devlin finished with a call for several reforms, which included tackling disproportionate legal costs, limiting damages for loss of earnings and a focus on better ways to learn from error.
‘This is not about defending vested interests. The clinical negligence system needs to be reformed so it is fair and sustainable for claimants, patients, doctors, taxpayers, and the NHS.’
AvMA perspectives
O'Dwyer (2024a) also noted the current cost of paying out for clinical negligence claims is ‘shockingly high’ and on this, there is little doubt, she said. She explained how claimant and defendant lawyers are paid and the differences. The human cost of claims was also discussed.
‘Time and again, we learn that patients do not want to be involved in litigation but all too often they are driven to it because there is a lack of openness and honest discussion about what went wrong at the outset.’
The statutory duty of candour was discussed, along with the national Getting it Right First Time (GIRFT) programme (https://gettingitrightfirsttime.co.uk). Among other key issues, O'Dwyer (2024a) went into some detail about the idea of a no-fault compensation system and its advantages and disadvantages, concluding that if the UK had a social care system that was analogous to the Swedish model, then it might be a feasible option. Both authors also subsequently gave a response to each other's papers (Devlin, 2024b; O'Dwyer, 2024b).
Conclusion
In terms of patient safety developments, the coming year will be a watershed one. The patient safety landscape in England will most probably look significantly different at the end of 2025 from how it looks now. The many consultations on key aspects of NHS patient safety should be answered in 2025, with government conclusions drawn as to what should happen next. How well Martha's Rule is bedding in the NHS should become clearer. We should also see more from the government on any clinical negligence reforms that it might wish to make.