Dr. Tom Ryan:

I thank the Chairman and committee members for giving me the opportunity to address them on this important issue. The Irish Hospital Consultants Association, IHCA, has over 2,500 members and represents 85% of hospital consultants in Ireland. The association and its members support the adoption of a national policy on and standards for open disclosure. In fact, the association has been engaging constructively since May 2013 with the HSE’s national advocacy unit and the State Claims Agency in this regard. It is to be welcomed that the policy and standards will soon be placed on a statutory footing.

As doctors, patient safety is at the heart of everything we do. It must be recognised that the provision of health care is complex and becoming more complex with the passage of time. In the provision of complex care adverse outcomes will always occur for a proportion of patients. In some cases, the adverse outcome arises as part of the normal risk of complications associated with therapy, surgery and other procedures. In a more limited number of cases mistakes and errors may occur. Naturally, the risk of mistakes and errors is exacerbated where care is being provided in a health system that is under-resourced and overstretched. When things do go wrong, it is important that we communicate with patients and their families in an open, honest and transparent manner. However, we must also recognise and cater for the needs of the far greater number of patients and their relatives who encounter a recognised complication of therapy not related to deficient care but which is nonetheless disabling and distressing for those involved.

In so far as the draft heads of the Bill are concerned, we note that much of the detail of open disclosure will be contained in standards to be set out by HIQA and the Mental Health Commission following enactment of the legislation. We note, however, that the heads of the Bill include a definition of "patient safety incident" which, as drafted, extends to events where no actual injury or harm has occurred. This is a more expansive definition in the light of the current national guidelines which define an "an adverse event" as an incident which results in actualharm. In this context, the association urges the committee to consider applying the standards as detailed in the current national guidelines.

We consider this to be important because otherwise we would end up with open disclosures for many incidents such as patients spending a night on a trolley which could be regarded as a patient safety incident without causing harm; surgery being cancelled because there are not enough theatre nurses available, or a patient waiting six months to be seen in the outpatients department. It is important that there be some harm in dealing with the patient safety issue. Contemporary medical care has to take account of individual variation in the response to patients and allow doctors to administer patient specific therapy. Variations in care, the way it is provided and its outcome are well recognised as an acceptable part of practice. They are to be encouraged and should not be regarded as a safety incident. We are concerned that variations in care that did not result in patient harm might end up being regarded as a safety incident and subject to open disclosure. This flexible approach to patient care should be adopted to take account of the normal processes of patient care which might be inhibited by an excessively expansive definition of patient safety incident.

The association welcomes the inclusion of provisions that an apology made in connection with an allegation of clinical negligence will not constitute express or an implied admission of fault or liability and that evidence of an apology will not be admissible in associated court proceedings. Nonetheless, while the association supports open disclosure, there remains a concern that it could potentially have a negative impact in increasing the number of clinical negligence claims in the courts. The association understands from the national advocacy unit that there is no evidence in other countries to indicate that litigation increases following open disclosure. We are conscious that this experience may not be extrapolated directly from other jurisdictions which have a fundamentally different legislative framework and claims culture. Overall, Ireland experiences a significant number of legal claims alleging clinical negligence. This, of course, gives rise to serious implications for the State in terms of compensation and legal costs. It also impacts on the affordability of clinical indemnity cover for doctors. The cost of clinical indemnity cover in Ireland has doubled in recent years. The net effect of the escalating costs is that some consultants have ceased practice, retired early, limited the scope of their practice or emigrated. Our understanding is the State Claims Agency has also experienced a significant rise in the level and cost of claims in recent years. These are all risks linked with open disclosure. Accordingly, while welcoming the introduction of the legislation on open disclosure, the association would also welcome the introduction of more extensive legislation to address the concerns in this area. In particular, it considers that the open disclosure legislation would be enhanced if it also provided for a mediation service. Such a service would ideally help to remove the concerns of patients and their families without recourse to an adversarial legal process and would benefit patients, doctors and everybody involved in the health care system.

When litigation does occur, it is preferable for it to be conducted speedily. The last Government introduced legislation on pre-action protocols to speed up the exchange of information between parties in clinical indemnity cases, but this legislation has not yet taken effect. We understand it is awaiting an order from the Minister for Justice and Equality.

The association would also welcome the committee's support for the reform of the law of tort applying to clinical indemnity cases. Other jurisdictions reformed the law in this regard several decades ago. The Medical Protection Society, the indemnifier for Ireland, has proposed that a Bill also be introduced to define the tort of clinical negligence such that a wrong that unfairly causes someone else to suffer loss or harm would only be established where both a breach of duty and direct causation of injury was proved. It is very important that the breach of duty or practice be shown to have directly caused the injury. We understand the Department of Health is concluding an assessment of the potential benefits of reducing the caps and extending the provisions of the State Claims Agency's clinical indemnity scheme.

Many of the association's members have supported and continue to support the implementation of the current open disclosure policy and guidelines. The association wishes to reaffirm its support for open disclosure and will continue to engage constructively with all relevant stakeholders having particular regard to the draft legislation and the subsequent formulation of standards by the relevant authorities. The association and its doctor members welcome the work of the committee in this important area. We continue to be available to engage with it.