Combining regulators into one entity

The time is right in Ireland for a combined healthcare regulator

Ireland needs a regulatory system capable of seeing the whole picture: The healthcare professional, the team, the organisation, and the management decisions that shape care.

In my own area of practice, when a deteriorating patient on the ward is not escalated to intensive care in a timely manner, any of the clinical staff involved in the patient’s care may face regulatory action.

Depending on the focus and conclusions of an internal serious incident investigation, a complaint may go to the Nursing and Midwifery Board of Ireland, the Medical Council, or HIQA. In fact, all three regulators may receive complaints arising from the same adverse event. Combining regulators to ensure that the patient doesn’t fall through the gaps between their individual legal remits would increase accountability for patient safety.

Complex episodes of care like those found in emergency departments, operating rooms, mental health services, and intensive care units, cross the jurisdictions of multiple regulators, because care is delivered by a team of professionals from different disciplines. Involvement of multiple regulators results in costly duplication of some processes. But more importantly, multiple regulators acting under different pieces of legislation introduced at different times may result in gaps in regulation.

Our healthcare system has published numerous reports, including the recent Clarke report into the tragic death of Aoife Johnston, which highlight the current fragmented professional regulatory system. Reading that report, it is not possible to establish who has responsibility for ensuring that a known patient-safety risk is recognised, escalated, investigated, and acted upon across all the relevant levels of the health sector.

There are three key findings in Judge Clarke’s report. They related to protocols that existed, but were not implemented consistently; communication failures between management and frontline staff; and capacity and organisational pressures due to hospital reconfiguration. These led to intolerable pressure on emergency services. A single regulator would not have prevented the tragedy; however, it would have provided broad oversight to every decision contributing to the failure in care, rather than focusing on individual clinicians who were rostered that day.

Similarly, the 2006 Harding Clark report into care in Our Lady of Lourdes Hospital, Drogheda, examined clinical practice and the wider organisational environment. It criticised management deficits, lack of audit, lack of agreed protocols, staffing, and resources, and a lack of transparency as to how resourcing decisions were made. Many of the concerns raised remain relevant in our healthcare system and fall outside the legislative powers of individual regulators.

Much has changed in healthcare since Judge Harding Clark’s report. It is reasonable to ask whether structures for patient-safety oversight have evolved sufficiently alongside a health sector that is now considerably larger than it was 20 years ago. There is an increased dependency on the multidisciplinary team structure to deliver care. Also, there are new roles and expanded scopes of practice emerging in healthcare which fall outside current regulation, such as physician associates. These changes mean that patient safety is no longer uniformly upheld by regulation.

Seamless oversight of organisational safety and accountability, rather than separate standards and fitness to practise proceedings emanating from single regulators, would be more effective in managing risk and harm to patients within a healthcare system, which now encompasses traditional and non-traditional practitioners.

These challenges have been addressed in other jurisdictions. Australia amalgamated healthcare regulators almost a decade ago. All providers of healthcare services are now regulated by their combined regulator, the Australian Health Practitioner Regulation Agency (AHPRA), from Chinese medicine to robotic surgery. The rationale for bringing Australia’s individual health regulators into a unified national system was better public protection, aimed at overcoming fragmentation, risks, and administrative burden. A shared regulatory body allowed for common investigative frameworks, which have helped advance public protection.

Amalgamation under a single operational backbone allowed the AHPRA to pool resources, streamline corporate governance, standardise data handling, and implement shared learnings across different professions.

The time is right in Ireland for a combined regulator. The governing legislation for doctors, dentists, pharmacists, and nurses is out of date, drafted and implemented in a healthcare environment, which is very different from how care is delivered now.

The Harding Clark and Clarke reports were published decades apart. Along with a multitude of other reports, they both revealed weaknesses that a more integrated regulatory system might have been better placed to identify and address.

A merger of regulators is not a cure for failures that are fundamentally caused by inadequate staffing, insufficient capacity, or lack of management action. If there are insufficient ICU beds for the population, a super-regulator cannot create capacity. Its value would lie in having the authority, information, and independence to identify risks, demand action, and hold the appropriate people and organisations accountable.

That would be a win for public protection.