Clare Daly (Dublin North, United Left)
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473. To ask the Minister for Health further to Parliamentary Question No. 174 of 5 November 2015, why he has not introduced a statutory duty of candour rather than a purely voluntary open disclosure, as has been done in the United Kingdom. [42963/15]

Clare Daly (Dublin North, United Left)
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474. To ask the Minister for Health further to Parliamentary Question No. 174 of 5 November 2015 why he has not incorporated a statutory duty of candour into the contracts of medical staff that participate in reviews and investigations. [42964/15]

Clare Daly (Dublin North, United Left)
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475. To ask the Minister for Health further to Parliamentary Question No. 174 of 5 November 2015 and given the almost weekly medical negligence cases and the huge amount of money being spent on legal fees, if the failure to disclose should now be a criminal issue as well as an issue of professional misconduct. [42965/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 473, 474 and 475 together.

The safety of service users is of paramount importance and steps need to be taken to anticipate and avoid things going wrong and to reduce the impact if they do. All employees including medical staff are required to disclose and report incidents in line with the HSE's Safety Incident Management Policy. Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making systems safer. Open Disclosure is defined as 'an open consistent approach to communicating with patients and their families when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event'.

I recently announced that the Government has given its approval to the drafting of provisions to support open disclosure of patient safety incidents. This will be included in the Department of Justice and Equality’s draft Bill on Periodic Payment Orders which is well advanced. The legislation is part of a broader package of reforms aimed at improving the experience of those who are affected by adverse events.

This legislation builds on the joint development by the HSE and State Claims Agency of the National Policy on Open Disclosure (2013). The HSE is progressing the implementation of the Policy across all health and social care services. We all know that when error or harm is experienced by a patient, the trust and confidence of that patient and their family are compromised. That is why honest, open disclosure and communication, which demonstrate empathy and sensitivity, are so essential. The intent of this legislation is to provide certain legal protections for healthcare staff for open disclosure, which is undertaken in good faith and in compliance with national standards. This will give further support to those staff in their communications with patients and family members if an adverse event occurs. The Ethical Code of Practice set out by the Medical Council also makes clear the responsibilities of doctors in relation to open disclosure.

Open disclosure is now HSE policy and therefore any unjustified breach of the policy (as with any HSE policy) will be managed in line with the HSE disciplinary procedures. Where potential deviations have been identified the Healthcare records must be reviewed to ascertain any documentation in relation to communication with the patient about the adverse event and to establish if any rationale for non-disclosure has been documented. Where there is no evidence that open disclosure has occurred the incident must be reviewed with the staff involved in the event. The patient must be informed of the event and the impact of the event explained and acknowledged. The patient should also be informed of the initial failure to disclose and an appropriate acknowledgement, explanation and apology provided.

From a patient safety perspective the key focus of open disclosure is on learning so that systems and processes can be improved in order to reduce potential future harms to patients. If a person is not satisfied that a health professional or administrator has fulfilled their obligations regarding open disclosure then that person has recourse to the HSE's complaints procedures. It is also open to a person to raise a complaint with the appropriate professional regulatory body or with the Ombudsman.