Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening.

BACKGROUND: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. Measuring the performance of regulatory systems provides key baseline information to build on regulatory system-strengthening strategies. Therefore, the aim of the study was to evaluate the regulatory performance of the EAC joint scientific assessment of applications approved between 2018 and 2021. METHODS: Utilising a data metrics tool, information was collected reflecting timelines for various milestones including submission to screening, scientific assessment and communication of regional recommendations for biologicals and pharmaceuticals that received a positive regional recommendation for product registration from 2018 to 2021. RESULTS: Several challenges as well as possible solutions were identified, including median overall approval times exceeding the EAC 465-day target and median times to issue marketing authorisation following EAC joint assessment recommendation that far exceeded the 116-day target. Recommendations included establishment of an integrated information management system and automation of the capture of regulatory timelines through the EAC metric tool. CONCLUSIONS: Despite initiative progress, work is required to improve the EAC joint regulatory procedure to achieve regulatory systems-strengthening and ensure patients' timely access to safe, efficacious and quality medicines.

Considering claims against the NHS.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses the NHS Resolution annual report and accounts for 2020/21 and recent advice from the Medical Defence Union.

Malpractice litigation and spinal surgery in the National Health Service: a single tertiary-level centre perspective over 12 years.

INTRODUCTION: Medical malpractice litigation is a major concern for all spine surgeons. Our aim was to evaluate the incidence and burden of successful litigation relating to the management of spinal disorders over 12 years within a UK NHS tertiary-level spinal unit and compare these litigation costs with those of other specialties. METHODS: We obtained all data held by our claims department from its inception in January 2008 to December 2019. We also obtained costs for the total financial burden incurred by our Trust during this period. RESULTS: In total, there were 83 closed claims involving spinal pathologies. Over 80% of these comprised negligent surgery (n = 28, 34%), delay to diagnose/treat (n = 25, 30%) and negligent care (n = 18, 22%). The vast majority of claims were withdrawn without incurring any cost to the hospital (n = 59, 71%) and only 24 (29%) resulted in successful litigation for the claimant. The total cost of damages for these 24 successful claims was just over £8 million, including legal costs of £2.5 million, out of total litigation costs of £381 million over this period. DISCUSSION: Fewer than 30% of initial claims against a tertiary spinal surgical referral unit resulted in a successful financial outcome for the claimant. The total costs incurred were just over £8 million, with one-third apportioned to high legal costs, reflecting the complexity of resolving spinal litigation. Our entire legal expenses accounted for only 2% of the total legal bill paid by our hospital over a 12-year period.

Medical negligence in urology: an untapped database.

INTRODUCTION: The aim of this study was to identify the causes of urological litigation in the NHS and to make recommendations how to reduce the burden of litigation to both injured patients and urologists. METHODS: Under the Freedom of Information Act, the National Health Service Resolution (NHSR) was asked to provide the figures for the number of cases of litigation in urology reported between 2010 and 2020. RESULTS: The number of urological claims more than doubled between 2011 and 2020. Many of the claims that are made result from avoidable errors. CONCLUSION: More education is needed, of both urologists in training and consultant urologists, on the causes of errors that lead to litigation and how many of them can be avoided.

The computer says no: AI, health law, ethics and patient safety.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent reports on artificial intelligence (AI) and machine learning in the context of law, ethics and patient safety.

Correia, Diamond and the Chester Exception: Vindicating Patient Autonomy?

In Chester v Afshar [2004], the House of Lords stated they were departing from the traditional rules of causation in order to vindicate the patient's right of autonomy. Subsequent judgments in the Court of Appeal expressed concerns over the lack of clarity of the legal principles to be derived from that judgment. In Correia v University Hospital of North Staffordshire NHS Trust [2017] and Diamond v Royal Devon and Exeter NHS Foundation Trust [2019], however, the Court of Appeal sought to clarify the scope and limits of Chester. This commentary sets out the scope and limits of Chester in light of those judgments and considers the extent to which they can be said to be vindicating patient autonomy. Drawing upon Coggon's typology of autonomy, it concludes that future judgments should utilise that typology to explicate which understanding of autonomy they are seeking to protect.

Brady v Southend University Hospital NHS Foundation Trust [2020] EWHC 158: 'Pure Diagnosis' Claims and Setting the Professional Standard of Care.

In Brady v Southend University Hospital NHS Trust, the High Court was asked to consider the applicability of Bolam and Bolitho principles in a so-called 'pure diagnosis' claim. The claimant suffered from the long-term effects of an undiagnosed bacterial infection after presenting at the defendant hospital with acute appendicitis. It was argued by claimant's counsel that where the primary allegation of fault concerns diagnosis, no issues of acceptable practice arise and therefore Bolam and Bolitho do not apply. Rejecting this, the High Court confirmed the applicability of Bolam and Bolitho and found that the defendant hospital had not been negligent. Initially, this result may signal a continued deference towards those in the medical profession, however, it is suggested that an alternative reading evidences a case which lays the groundwork for reconsidering the doctor-patient relationship in the context of treatment and diagnosis actions.