Mandatory open disclosure in healthcare: To be or not to be?

In the wake of the Vicky Phelan case and the cervical screening issues that are emerging, a mandatory legal requirement for doctors to be open following an adverse healthcare event is now being proposed and the Minister for Health Simon Harris has indicated his intention to bring proposals to Government.

At the current time, the Civil Liability (Amendment) Act 2017, which has not yet been commenced, introduces a voluntary requirement for health service providers to be open with patients who are involved in an adverse incident. One of the aims of this legislation is to help foster an environment of trust where health service providers feel able to be open with patients about adverse incidents. For instance, an apology, if made in the correct form, cannot be used as evidence of an admission of liability in any subsequent civil or professional proceedings.

The rationale of this legislation is that it should normalise ‘saying sorry’ when things go wrong and allow the doctor-patient relationship to flourish by way of open communication, improving the patient experience, promoting a culture of reporting and learning from adverse incidents and potentially reducing litigation. The idea is to create a cultural shift which focuses more on open communication and less on blame.

The concept of open disclosure is not new and has been a feature of the Medical Council ethical guidelines since 2009. The 2016 edition of the guidelines states that patients and their families are entitled to honest, open and prompt communication about adverse incidents that may have caused them harm and that doctors “should” acknowledge the event, explain how it happened, apologise if appropriate, and assure the patient and family that the cause will be investigated. The guidelines do not utilise the word ‘must’, meaning that open disclosure is not an absolute professional duty and doctors can exercise their judgment in relation to communication about adverse events. The HSE also introduced guidelines on open disclosure in 2013, as part of a national policy.

The Act defines an apology as an “expression of sympathy or regret”. Only apologies in a prescribed form will be considered as inadmissible in any proceedings. However, the ‘form’ of the apology is not set out in the legislation. How the courts will interpret this rather nuanced language remains to be seen. Will doctors, therefore, feel confident of the legal status of their apology or will apologies simply be avoided altogether or fall into the ‘I am sorry you feel that way’ category of non-apologies? This remains to be seen. It is well observed that an apology in form only or a botched apology can have serious consequences for the doctor-patient relationship.

Repeated studies have shown that when an adverse incident occurs, patients predominantly want a clear explanation about what happened, an apology and an assurance that efforts will be made to ensure that the same harm will not befall another patient. The Act goes some way to addressing these concerns. However, the absence of a mandatory requirement for open disclosure and a mandatory requirement to offer an apology may potentially make the open disclosure provisions in the Act less effective if it introduces ambiguity for doctors, as opposed to a clear process. This may in turn undermine the efforts being made on the ground to encourage a culture of open disclosure.

A mandatory requirement for open disclosure with a mandatory requirement to offer an apology, in whatever form, would arguably provide more clarity to health service providers. As the current legislation only renders ‘expressions of sympathy and regret’ inadmissible in proceedings, clinicians may find themselves in even more of a quandary about whether and how to apologise to a patient and apologies may become prescriptive at best, and avoided at worst.

The UK statutory Duty of Candour makes the disclosure of a patient safety incident and the requirement to offer an apology a mandatory legal obligation and a failure to comply is a criminal offence, punishable by a fine of £2,500, per breach, for the relevant organisation.

If Ireland introduces a mandatory duty of candour, as is now the intention by the Department of Health, would this in fact better assist in ensuring openness in the healthcare system? Is the threat of sanction really what it will take to engender a cultural change, or is what is required an even greater level of education, training and focused support for doctors and nurses, the overwhelming majority of whom are dedicated and committed but under-resourced to manage a highly technical and overloaded healthcare system?

Do we as a society, therefore, further support or further sanction our doctors and nurses? Patients, families and healthcare providers deserve legislative measures which best provide them with both clarity and protection. It should be possible to achieve a mechanism whereby both the best interests of patients are served and where healthcare professionals are supported; any legislation must provide clarity of process for mandatory disclosure. This must elucidate what is required by practitioners and organisations, and how it is required.

In addition, however, there must also exist an underlying willingness at a political and organisational level to ensure that any process of disclosure is not treated as a tick-box formula to simply meet the legislative requirements. This can only be accomplished if the relevant support is provided for medical practitioners through continued education and training on open disclosure. Creating a supportive and open environment at ground-level will hopefully allow for open disclosure to be truly embraced as a positive development for patients, but also health professionals.

Ms Joanne O’Sullivan is Healthcare Partner at Kennedy’s Law, Dublin, specialising in healthcare defence litigation and medical law.

Mr Asim Sheikh is a practising Barrister specialising in clinical negligence and medical law.