I move: "That the Bill be now read a Second Time."
I am pleased to introduce the CervicalCheck Tribunal Bill 2019 to Dáil Éireann. On behalf of the Minister for Health, I thank Deputies for facilitating the taking of Second Stage at this early date.
The purpose of this important legislation is to establish an independent statutory tribunal to deal with claims arising from the CervicalCheck controversy. The Bill is very much based on the recommendations set out by Mr. Justice Charles Meenan in his 2018 report on an alternative system for dealing with claims arising from CervicalCheck. Following the issues that emerged last year, it is safe to say there is much greater awareness of the limitations of cervical screening and Members will be aware that false negatives do arise. As Mr. Justice Meenan noted in his report, where a woman develops cervical cancer following a false negative, of itself, this is not sufficient to prove negligence. To establish negligence, evidence would have to be given by a suitably qualified expert that the reading of the smear had fallen below the appropriate standard required. Recognising that any alternative system to the court process would need to recognise the issue of liability, Mr. Justice Meenan proposed that a tribunal be established under statute for the purpose of hearing and determining claims arising from CervicalCheck. The Bill does exactly that.
The Bill also provides for restoration of trust meetings. This takes account of what Mr. Justice Meenan said in his report and the view expressed by Dr. Gabriel Scally last year in the final report on the scoping inquiry into the CervicalCheck screening programme. Restoration of trust meetings are not part of the courts process, but the Minister believes it is important to facilitate them through the Bill. The CervicalCheck screening programme has played a vital part in saving lives. It is essential, therefore, that women and their families have confidence in the programme and that women continue to use it.
Before going into the detail of the Bill, I would like to take time to briefly give further context and set out some of the important steps taken so far in dealing with the CervicalCheck issues. They include the reports by Dr. Gabriel Scally, supports for women and their families and changes to the HSE’s open disclosure policy and practice. A further, very significant initiative is the ex gratia scheme for women affected by non-disclosure which just this week has begun to make payments to individuals impacted on by non-disclosure.
We are implementing in full the recommendations made in Dr. Scally’s report and have accepted two further recommendations in his recent supplementary report. They relate to procurement and quality assurance processes. Actions to implement them are being identified and they will then be incorporated in the approved implementation plan for all of the recommendations made in the scoping inquiry and reported on quarterly as part of it. The HSE continues to strengthen governance, quality assurance and management in the CervicalCheck programme and the wider national screening service in line with Dr. Scally’s recommendations.
In terms of supports for women affected, funding has been given to the 221+ CervicalCheck support group to enable advocacy and supports to be made available to these patients. Also, last year the Minister announced the establishment of a primary and social care support package for women and families affected by the CervicalCheck issues. This comprehensive package of supports is for the cohort of 221 plus women for whom the audit carried out by CervicalCheck found discordance with the original reading of their slides. The package will also be provided for any other woman for whom the independent clinical expert review being carried out by the Royal College of Obstetricians and Gynaecologists identifies discordance with her original smear test reading. Deputies will know that the review is ongoing and that its purpose is to provide women with independent clinical assurance on both the quality of the screening programme and the timing of diagnosis and treatment.
The third point I mentioned was open disclosure. This goes to the heart of the matter for many of the women concerned. Deputies will be aware that the HSE recently published a revised interim open disclosure policy. It is in line with recommendation No. 28 in Dr. Scally’s final report on the scoping inquiry into the CervicalCheck screening programme. It emphasised that the open disclosure policy should be revised to reflect the primacy of the right of patients to have full knowledge of their healthcare and, in particular, their right to be informed of failings in that care process however and whenever they arose. The interim policy will be further reviewed when the patient safety Bill is published. That Bill will provide for mandatory open disclosure of patient safety incidents and is at an advanced stage.
Regarding the ex gratia scheme, Deputies will know that earlier this year the Minister received Government approval for the CervicalCheck non-disclosure ex gratia scheme for women affected by the non-disclosure of the CervicalCheck audit. It ensures the women affected can have the impact of non-disclosure addressed without recourse to court through the establishment of a non-statutory scheme to provide ex gratia payments. The scheme is overseen by an independent assessment panel. All of t he women, or their next of kin, in the 221+ group will receive a payment where the panel which is chaired by Mr. Justice Aindrias Ó Caoimh determines that appropriate disclosure did not take place. An initial tranche of payments will issue this week, with further payments to be made as individuals apply and have their applications assessed.
I am aware that there are other issues which are of great interest to Deputies. Regarding the Ruth Morrissey case and the finding made in Mr. Justice Cross’s High Court judgment that the screening programme must have “absolute confidence” before giving a test the all-clear, the State Claims Agency has lodged an appeal in order to obtain clarity on the legal position. However, irrespective of the outcome of the appeal, the Government has given an assurance to Ms Morrissey that the full amount of her award of damages in the High Court will be protected.
In his second report Dr. Scally indicated that a form of no-fault scheme might be appropriate for those individuals impacted on by the CervicalCheck issues. In 2018 the Government established an expert group, chaired by Mr. Justice Charles Meenan, to consider issues associated with medical indemnity claims, including the possible use of no-fault schemes. The Minister looks forward to receiving the report of the group later this year.
Turning to the Bill, I propose to begin by giving a short overview. The tribunal will hear and determine liability in claims in relation to CervicalCheck, subject to the consent of all the parties to the claim, recognising the issue of liability. The Bill sets out who may make a claim and the period within which claims may be made. The Bill enables the tribunal to determine and adopt pre-claim protocols and the chairperson to issue practice directions in relation to the conduct of claims in the interests of hearing and determining claims in a manner which is just and expeditious. The tribunal’s determination of a claim may be appealed to the High Court. Where no appeal is made, the tribunal will apply to the High Court for confirmation of the determination. The tribunal’s hearings will be held otherwise than in public, except where the claimant requests otherwise and the tribunal agrees. This respects the privacy of the women concerned.
As I said, the tribunal will also facilitate restoration of trust meetings. The intention behind a restoration of trust meeting is to document experiences, facilitate discussion and provide information for the woman concerned or her family. In addition to these functions, the tribunal may also provide advice or recommendations for the Minister related to its work.
Moving on to the detailed provisions, the Bill is divided into three Parts. Part 1 is the preliminary and general Part; Part 2 provides for the CervicalCheck tribunal, while Part 3 includes miscellaneous provisions.
Section 1 is a standard section on the Short Title of the Bill and commencement provisions.
Section 2 is the definitions section. A key definition is the definition of “relevant woman” which is central to the scope of the tribunal regarding who may make a claim. They include a woman identified as part of the review of cervical screening as having CervicalCheck cytology review findings that were discordant with those of the original cytology examination, and a woman whose cytology slides were re-examined as part of the retrospective CervicalCheck audit and whose cytology review findings were discordant with those of the original cytology examination.
Section 3 is a standard provision for expenses incurred by the Minister in the administration of the legislation.
Part 2 contains sections 4 to 36, inclusive. Sections 4 to 10, inclusive, deal with establishing the tribunal and its functions. Section 4 provides for the establishment day of the tribunal. The Minister expects to establish the tribunal once the necessary arrangements are in place for it to begin its work.
Section 5 provides for the establishment of the CervicalCheck tribunal. The tribunal may sit in divisions. It will be independent in the performance of its functions and will regulate its own procedures.
Section 6 is the membership section. The tribunal will consist of a chairperson and not less than two ordinary members who will be appointed by the Minister. As announced, the intention is that Ms Justice Mary Irvine will be the chairperson. The Minister may appoint additional persons to the tribunal, if necessary. The chairperson must hold or have held judicial office in the superior courts. Ordinary members must hold or have held judicial office in the superior courts or be a practising barrister or solicitor of not less than ten years' practice.
The tribunal’s functions are outlined in section 7. As I said, the tribunal shall hear and determine claims made to it, facilitate restoration of trust meetings and report on and make recommendations, as it deems appropriate, on any other matter related to its work.
Section 8 deals with staff for the tribunal.
Section 9 enables the tribunal to appoint people with expertise to provide it with advice or assistance. The section also enables the tribunal to conduct or commission research, again subject to the prior approval of the Minister, given with the Minister for Public Expenditure and Reform.
Section 10 allows the tribunal to appoint its own counsel.
Sections 11 to 13, inclusive, are concerned with making claims to the tribunal. They are important sections, on which I will go into some detail. Section 11 provides for claims before the tribunal and who may make a claim. Claims may be made by an appropriate person. In the Bill an appropriate person is defined as a relevant woman, or where the woman is deceased, a dependant of the woman. A claim for compensation may be made seeking damages for negligence, breach of duty, breach of statutory duty or breach of contract arising from any act or omission concerning CervicalCheck. A claim may also be made seeking damages for alleged negligence or breach of duty arising from an alleged failure to inform the relevant woman or her dependant of the results of the retrospective CervicalCheck audit. It is important to state, as a general point, that the legal principles of liability and quantum of damages as applied in the High Court to such cases will apply to claims before the tribunal. A claim may not be made where a person has received an award from any court or settlement in respect of any action arising from any circumstance which could give rise to a claim before the tribunal. The exception is an award under the ex gratia scheme.
Section 12 deals with the reckoning of time for the purposes of the Statute of Limitations, etc. In the case of a woman identified as part of the review of cervical screening, a claim must be made within nine months of establishment day for the tribunal or within six months of being notified of findings of the review of cervical screening, whichever is the later. In the case of other women within the scope of the tribunal, a claim must be made within nine months of establishment day for the tribunal. A person may not make a claim where the person was entitled to institute proceedings in respect of a relevant claim, and the limitation period in respect of instituting those proceedings has expired.
However, the period beginning on the making of a claim and ending on the date on which the tribunal notifies the claimant that one or more of the relevant parties have failed to agree in writing to the claim being determined by the tribunal will be disregarded in reckoning any period for the purpose of limitations period.
Similarly, the period beginning on the making of a claim and ending on the date on which the tribunal notifies the claimant that one or more of the relevant parties have notified the tribunal that they no longer consent to the claim being determined by the tribunal will also be disregarded in reckoning any period of time for the purpose of limitation periods regarding a claim.
Section 13 provides that the tribunal will hear and determine only claims in respect of which there is an agreement in writing from the relevant parties. The relevant parties are the claimant, the HSE and the cytology laboratory services retained by the HSE for CervicalCheck.
Sections 14 to 26, inclusive, provide for claims before the tribunal and procedures. Section 14 provides for the manner of determination of issues. The tribunal will hear and determine claims in the same manner as such matters are determined by the High Court in respect of claims for personal injuries.
Section 15 provides for third party procedures and consent issues. The tribunal may grant an application to join a third party to a claim in the same manner as such applications are determined by the High Court. The claim will proceed before the tribunal only where the third party consents to having all issues arising in the claim determined by the tribunal. Where the third party does not consent to having all issues arising in the claim determined by the tribunal, the tribunal shall not continue to determine and hear the claim.
Section 16 requires the tribunal to take into account any sum paid or payable to a claimant under the CervicalCheck non-disclosure ex gratia scheme when considering whether an award should be made in relation to non-disclosure. Section 17 provides for applicable principles to awards of the tribunal. An award shall be made on the same basis as an award of the High Court. A claimant will have 21 days, or such longer period as the tribunal may determine, from the making of the award to accept or reject the award or to appeal the award. A claimant shall be deemed to have rejected the award where the claimant neither accepts or rejects the award nor appeals the award within the 21 day period or such greater period determined by the tribunal. Where the claimant decides to accept the award, the acceptance must be made in the prescribed form, a “notice of acceptance” and shall be accompanied by a waiver. Rules contained in the Civil Liability Acts 1961 to 2017 shall be applied to the tribunal in the same manner as would be applicable in an assessment of damages were proceedings to be brought to the High Court in relation to the claim.
Section 18 provides that parties appearing before the tribunal shall be entitled to be legally represented. Section 19 provides that the tribunal may award costs in relation to a claim. Under section 20, hearings are generally to be otherwise than in public. However, a hearing or part of a hearing will be conducted in public where a claimant requests and the tribunal agrees that it would be appropriate to do so. Section 21 provides for the form and manner in which evidence may be given. Section 22 provides for powers relating to witnesses and documents. Section 23 provides for privileges and immunities of witnesses. A person who gives evidence to the tribunal or who produces or sends documents to the tribunal as directed by the tribunal has the same immunities and privileges in respect of that evidence or those documents, and is subject to the same liabilities, as a witness in proceedings in the High Court.
Section 24 provides that the tribunal may apply to the High Court for directions relating to the performance of its functions or for the approval of the court of an act proposed to be done by the tribunal for the purposes of performing its functions. The High Court may hear an application otherwise than in public having regard to the subject matter or any other matter relating to the nature of the evidence to be given at the hearing of the application. An important section in the Bill is section 25 which enables the tribunal to determine and adopt pre-claim protocols. These are procedures governing requirements to be complied with before claims are brought. The aim is to promote timely communication between parties, facilitate early identification of the relevant parties, facilitate early identification of the issue in dispute in respect of a possible claim and facilitate the hearing and determination of claims in a manner which is just and expeditious. Section 25 also enables the chairperson to issue directions – practice directions – in relation to the conduct of claims, in the interests of hearing and determining claims in a manner which is just and expeditious. Section 26 provides for the tribunal to make rules to regulate practice and procedure and the conduct of claims.
Section 27 provides for appeals. An appeal may be made to the High Court from a determination of the tribunal not later than 21 days from the date of making the determination, or such longer period as the tribunal may determine. An appeal lies from a decision of the High Court to the Court of Appeal on a point of law only. Appeals must be heard otherwise than in public, except where a claimant requests otherwise and the High Court agrees. When making its determination available to the public the High Court and the Court of Appeal will exclude any information that identifies or that could reasonably lead to the identification of any of the parties.
Section 28 provides for confirmation and publication of the tribunal’s determinations. Where no appeal to the High Court from a determination of the tribunal is made in the allowed period, the tribunal will apply to the High Court for confirmation of the determination. On hearing an application, the High Court shall confirm the determination unless the Court considers that it is not in the interests of justice to do so. Where there are proceedings pending in the High Court in respect of the claim, the High Court shall provide by order for the discontinuance of those proceedings and may make such order as to the costs of those proceedings as it thinks fit. The tribunal shall publish the determination where confirmed by the High Court but will exclude any information that might identify the parties. Section 29 provides for enforcement of awards.
Sections 30 to 33, inclusive, contain the restoration of trust provisions I spoke about earlier and include provision for a facilitator in regard to the meetings. Under section 30, an appropriate person - that is, a relevant woman or her dependant - may make a request to the facilitator irrespective of whether the appropriate person has made, or intends to make, a claim. Section 31 provides for the Minister to appoint a facilitator to carry on and control generally the administration and business of restoration of trust meetings. Importantly, the facilitator is independent in the performance of his or her functions. Section 32 sets out the detail in regard to restoration of trust meetings. As I said at the beginning, these meetings are for the purposes of documenting experiences, facilitating discussion and providing information to the appropriate person in respect of that person’s experience in relation to CervicalCheck. The sequence is that an appropriate person may request the facilitator to convene a restoration of trust meeting. The request must specify the persons to participate in the meeting. The meeting may proceed with those persons who have consented to participate. This is subject to the consent of the appropriate person. An appropriate person may be accompanied by a person or persons of his or her choice when attending a restoration of trust meeting.
The facilitator will establish and maintain a panel of suitable persons to be moderators who will convene a restoration of trust meeting and act as chairperson. A restoration of trust meeting may, with the unanimous agreement of those participating in the meeting, make recommendations to the Minister. Records of the meetings are otherwise confidential. It would be important that real discussion takes place and section 33 therefore provides appropriate protections for participants. Evidence is not admissible in any court or the tribunal of any information, statement or admission disclosed or made in the course of a restoration of trust meeting.
Information provided by a participant at a restoration of trust meeting will not invalidate professional indemnity insurance policies or contracts of insurance, etc., nor will information provided at the meeting constitute an admission of fault, etc., or be admissible as evidence of fault, etc., in determining complaints or fitness to practice matters.
Sections 34 and 35 deal with tribunal recommendations and the tribunal’s annual reports. Under section 34, the tribunal may make recommendations to the Minister and the Minister will publish any recommendations made by the tribunal. Section 35 requires the tribunal to prepare and submit these to the Minister. These will be published by the Minister.
Section 36 provides for the dissolution of the tribunal and that the Minister may by order dissolve the tribunal. This would be done following consultation with the tribunal.
Part 3 provides for miscellaneous matters and has sections 37 to 40. Section 37 provides that where an appeal from a determination of the tribunal is made to the High Court, rules of court may make provision for the hearing and determination of those appeals in a timely and efficient manner. Section 38 provides for offences and penalties for offences. Section 39 provides for restriction of the data protection regulation to enable the tribunal, the facilitator and moderators to perform their functions. Section 40 amends the Freedom of Information Act 2014 to provide that the 2014 Act does not apply to certain records relating to the tribunal.
Before I conclude, I want to inform the House about two amendments that the Minister for Health, Deputy Harris, will propose on Committee Stage. The establishment of the tribunal is in response to the CervicalCheck controversy, and our objective is to have it available to both those individuals in the 221 cohort and also those women who consented to participate in the current review of cervical screening, RCOG review, and where the outcome of the review in their case indicates a discordance with the original cytology examination. However, in recent weeks, it came to light that, for a small number of women, one or more slides cannot be located, and therefore, through no fault of their own, they will not be able to participate in the RCOG process. The purpose of the first proposed amendment will be to open the tribunal to these women.
A second amendment of a technical nature will be introduced providing that the tribunal will establish and publish procedures for the restriction of the data protection regulation to the extent necessary to carry out its functions. Such restrictions are necessary to ensure that claims can be heard and determined with appropriate confidentiality and publishing these procedures will provide clarity to all parties regarding what is involved.
This Bill faithfully implements the Meenan report in respect of hearing and determining claims arising from CervicalCheck outside the court process. The Bill will help to build and restore trust and confidence in the cervical screening programme, a programme that is a crucial part of our health services. I look forward to hearing the views on Deputies on the Bill and I commend this Bill to the House.