Consultation Report - Consultation on recommendations for no-fault compensation in Scotland for injuries resulting from clinical treatment

6. Scottish Government Response - Action taken or proposed

6.1 This section of the report sets out action already taken or proposed in response to the feedback received. The consultation paper sought views on twelve questions which focused on:

• meaningful apology (Question 1)
• essential and desirable criteria for a compensation scheme (Questions 2 & 3) and its contribution to wider issues (Question 4)
• the Review Group's recommendations for the introduction of a no-fault scheme (Questions 5, 6, 7, 9 &10)
• transitional arrangements if no-fault system introduced (Question 8)
• suggested improvements to the current system (Question 11)
• a suggestion for consideration of a limited no-fault scheme for neurologically impaired infants (Question 12).
• The final section of the consultation also invited general comments.

6.2 Where appropriate the actions and/or the Scottish Government proposals are shown below against the relevant questions.

6.3 Question 1

6.3.1 In response to Question 1 the general view was that the new NHS "Can I Help You?" guidance¹¹ issued in March 2012 (which reflects the requirements of the Patient Rights (Scotland) Act 2011 in relation to the handling and learning from feedback, comments, concerns and complaints) together with the SPSO¹² and GMC¹³ guidance provides sufficient advice for staff to ensure that they understand that when an error has occurred patients should receive a meaningful apology.

6.3.2 Some respondents also suggested that better education and training structures should be in place to support staff. The revised "Can I Help you?" guidance mentioned above acknowledges that training, initially through induction is key to ensuring that staff are empowered to handle feedback, comments, concerns and complaints if the procedures are to work effectively. The guidance also makes it clear that NHS Boards and their health service providers have a responsibility to ensure that their staff are competent and confident, as appropriate to their role, in dealing with feedback, comments, concerns and complaints in a manner that is person-centred and aims to resolve issues as they arise and to get it right first time.

Action 1 - Training and Education programme

6.3.3 The Can I Help You? guidance¹⁴ advised of a two year education programme during (2012/13 and 2013/14) led by NHS Education Scotland (NES), the Scottish Public Services Ombudsman (SPSO) and the Scottish Government Health and Social Care Directorates to provide core education, training and learning materials to help support NHSScotland meet the requirements of the Patient Rights (Scotland) Act 2011¹⁵. Launched on 31 May 2013 the online educational resource developed for NHSScotland staff and their service providers (such as GPs, dentists, pharmacists and optometrists and their staff) provides training on handling and learning from feedback, comments, concerns and complaints. The modules also raise awareness of topics such as the value of apology and of encouraging feedback.

6.3.4 The modules are available for use via the learning management system (LMS), or for those who do not have access to an LMS, via the NES website www.knowledge.scot.nhs.uk/making-a-difference.aspx. A training DVD has also been developed and Master classes were provided for Executive and Non-Executive Board members during 2013-14. Consideration is being given to further training opportunities that will be provided.

6.4 Questions 2 and 3

6.4.1 These questions sought views on the essential and desirable criteria suggested by the Review Group for a compensation scheme, those which were regarded as a priority and of high importance and any additional essential criteria that should be added. You told us that you considered that priority and high importance should be placed on - Ease of use, independence, access to specialist advice, appropriate compensation, affordability and timeliness.

Action 2 - revised essential criteria for a compensation scheme based on responses

6.4.2 The criteria considered essential for a compensation scheme have now been revised to include additional criteria suggested by respondents. The essential criteria revised to take account of views expressed are now as follows:

• The scheme provides an appropriate level of compensation to the patient, their family or carers
• The scheme is compatible with the European Convention on Human Rights
• The scheme is easy to access and use, without unnecessary barriers, for example created by cost or the difficulty of getting advice or support
• People are able to get the relevant specialist advice in using the scheme
• Decisions about compensation are timely
• People who have used the scheme feel that they have been treated equitably
• The scheme is affordable
• The scheme makes proportionate use of time and resources
• The scheme has an appropriate balance between costs of administration (e.g. financial or time) and the level of compensation awarded
• Decisions about compensation are made through a robust and independent process
• The scheme has an independent appeal system
• The scheme treats staff and patients fairly/equitably
• A reasonable time limit is set for compensation claims

Additional essential criteria

• The scheme discourages frivolous or speculative claims
• The scheme encourages responsible behaviour from patients and staff
• The public (and the professions, NHS staff and others) trust the scheme to deliver a fair outcome (moved from desirable)
• The scheme encourages transparency in clinical decision-making (moved from desirable).

Action 3 - revised desirable criteria based on responses to consultation

6.4.3 Respondents considered that two of the desirable criteria considered under Question 3 of the consultation were actually essential and these have been included in the essential criteria as indicated above. This means the desirable criteria are now:

• The scheme does not prevent patients from seeking other forms of non-financial redress, including through the NHS Complaints system
• The scheme contributes to rehabilitation and recovery.

6.4.4 A relative of someone who had died suggested that it would have been beneficial to have had access to specific counselling to help deal with the trauma.

Action 4 - Shaping Bereavement Care

6.4.5 Guidance in the form of a framework for shaping and improving bereavement care services was issued under Chief Executive Letter CEL 9 (2011)¹⁶ in February 2011. The good practice guidance includes advice in relation to support for those who have been bereaved, including bereavement counselling, where this is appropriate for bereaved relatives. The Scottish Health Council¹⁷ was commissioned to review progress and the impact of the framework and the Scottish Grief and Bereavement Hub¹⁸. Following on from this funding has been agreed from 1 July 2014 for a Project Lead within NHS Education Scotland to assume responsibility for promoting and developing Bereavement Care Education in Health and Social Care.

6.5 Question 4

6.5.1 Question 4 sought views or ideas on how a compensation scheme could more effectively contribute to the wider issues namely:

• The scheme contributes to:
  • organisational, local and national learning
  • patient safety
  • quality improvement
• Lessons learned can be used to influence organisational risk management in the future

• The scheme encourages and supports safe disclosure of adverse events
• The scheme does not put barriers in place for referral to regulators of any cases which raise grounds for concern about professional misconduct or fitness to practise.

6.5.2 The general view was that, if introduced, there were benefits to be gained from a scheme designed to contribute to these wider issues in order that lessons are learned and improvements are made.

Action 5 - review of the management of and learning from adverse events

6.5.3 Following the launch of this consultation Healthcare Improvement Scotland (HIS)¹⁹ was asked by the Cabinet Secretary for Health and Wellbeing to review the management of adverse events by the 14 territorial NHS Boards, The State Hospital, NHS 24, Scottish Ambulance Services, National Services Scotland (NSS) and National Waiting Times Board and to develop a national approach to learning from adverse events. The aim is to provide a clear, consistent governance framework for managing adverse events that supports preventative measures and reduces risks of serious harm to people.

6.5.4 A national approach has been developed following consultation and engagement with NHS Boards, clinicians, patients and a number of national groups and organisations. Its development has also been informed by the rolling programme of adverse event reviews across NHS Boards, between November 2012 and April 2014. The national approach provides a framework to support standardised processes of managing adverse events across all care settings within NHSScotland. It is intended for all health professionals and has been designed to produce achievable and measureable changes in Board systems to support learning and improvement after adverse events.

6.5.5 The national approach outlines the actions to be taken when an adverse event occurs and provides consistent definitions and categories of events.

6.5.6 The level of review will largely be determined by the category of the event and whilst the national approach will provide a guide to promote a consistent national response, NHS Boards will be ultimately responsible for determining the action that should be taken and for ensuring that decisions are clearly documented. The framework includes a requirement to ensure that the patient, their family and staff members are involved and kept informed of the progress of the review.

6.5.7 The national approach provides a framework that is applicable to clinical and non-clinical events, across specialties and services, with principles, which support the Healthcare Principles, set out in the Schedule to Patient Rights (Scotland) Act 2011²⁰. These principles are also reflected in the 'Can I help you?' good practice guidance²¹, for handling and learning from feedback, comments, concerns or complaints about NHS health care services, issued in March 2012.

6.5.8 All NHS Boards have been reviewing their policies and processes to reflect the definitions outlined in the national approach. It is proposed that a phased approach will be taken, with initial focus on acute and managed community services. This will be aligned with the health and social care integration agenda.

6.5.9 Healthcare Improvement Scotland will be reviewing and updating the national approach guidance in 2014 following the completion of the programme of adverse event reviews and following initial feedback regarding implementation of the approach.

6.6 Questions 5, 6, 7, 9 and 10 - Review group recommendations 1 to 9

6.6.1 Questions 5, 6, 7, 9 and 10 within the consultation sought views on the No-Fault Compensation Review Group's recommendations (reproduced in Annex A).

6.6.2 We did not attempt to set out or scope within the consultation what such a no-fault scheme might look like as it was considered important first of all to gather wider views from key stakeholders on the Review Group's recommendations and to seek to better understand the practical implications of adopting these recommendations.

6.6.3 The following paragraphs seek to recap on the main points raised in the consultation responses to Questions 5, 6, 7, 9 and 10 with the details of action proposed given at paragraph 6.10.

6.6.4 Recommendation 1 (question 5) suggests the introduction of a system along the lines of that in Sweden. Fewer than 50% of respondents supported this approach with several of the others commenting and raising concerns that the system of social care provision in Scotland was not as well developed as the system in Sweden and they were therefore not convinced that a similar scheme could operate successfully in Scotland. They commented that the payments under the Swedish model were lower than payments in Scotland where the provision of future treatment and care in the independent sector could not be disregarded.

6.6.5 It is worth noting at this point that the calculations/assumptions made by the researchers in calculating the estimated costs assume that if a no-fault scheme was introduced in Scotland the level of payments under this would be similar to those made under the current clinical negligence system in operation in Scotland and not at the level in Sweden.

6.6.6 Respondents raised major concerns in answer to question 6 which sought views on Recommendation 2 that eligibility for compensation should not be based on the 'avoidability' test as used in Sweden, but rather on a clear description of which injuries are not eligible for compensation under the no fault scheme. There were concerns about how this might work in practice given that all procedures carried a risk. It was suggested that the 'avoidability' test should be used and that it would be difficult to identify any other just or workable criteria for eligibility.

6.6.7 Question 7 focused on Recommendations 3 and 4 and the scope and cover of a no-fault scheme. Fewer than 50% of respondents supported the view that if introduced, a no-fault scheme should cover all clinical treatment injuries (e.g. private healthcare and independent contractors) and all registered healthcare professionals and not just those employed by NHSScotland. Others acknowledged that whilst it would be logical to extend such a scheme as widely as possible there were lots of concerns about the complexities and cost of doing so. Some thought that a scheme should cover NHS funded care only and others suggested that it was much more likely to succeed if it was done in stages i.e. introduce for NHS hospital care and only extend to Primary Care providers and the private sector once the scheme had been properly established and funding evidence obtained.

6.6.8 Major concerns were raised about the complexity and potential impact of including independent contractors. There were concerns about how historical liabilities would be managed and funded given that a significant number of GPs in Scotland would have 'occurrence based protection' and given that there were nearly five thousand GPs and three thousand dentists. It was suggested that at present a GP might be sued for negligence once in every 75 years and that under a no-fault system this might result in a claim once in every five years.

6.6.9 Several respondents raised concerns about the cost of indemnity and insurance and whether insurance companies would withdraw their services as a result.

6.6.10 The majority of respondents supported Recommendation 5 (question 9), which suggests compensation should be based on need rather than a tariff system, but concerns were expressed that 'need' was a subjective assessment and that the needs-based element was more contentious and difficult to quantify and agree, and would result in different compensation to different people for the same harm which was inequitable.

6.6.11 Concerns were raised about:

• the potential for tens of thousands of claims if a no-fault system was introduced given the estimated level of adverse incidents and complaints relating to clinical treatment
• the increase in the overall level of payments even if the number remains the same because almost all of the current claims are settled extra-judicially at a discount from their full value
• the robustness of the assumptions and calculations used to provide the lower and upper estimates given in the Manchester University Study²²
• the impact of changes to the Ogden discount rate²³.

6.6.12 We acknowledged in the then Cabinet Secretary's foreword to the consultation that further work was needed to help in our understanding of the volume, level and cost of compensation claims handled by the Medical Defence Unions and private healthcare providers and that we would seek to explore this further with the relevant stakeholders. To allow us to take account of any comments respondents may have had on the assumptions and calculations used in the Manchester University Study²⁴ we waited until the consultation had closed before seeking co-operation from the medical defence organisations.

6.6.13 It is worth reiterating here that the lower and upper estimates produced in the Manchester University Study²⁵ suggested that at the lower end the costs of a no-fault scheme would be similar to the existing scheme, while at the upper end costs in a typical year could increase by one half.

6.6.14 These estimates were calculated based on a range of assumptions about the potential increase in claims; the level of award for the additional successful claims; and the lower cost of processing claims. The estimates used for actual awards settling under the proposed scheme are based on the average awards for settled claims made under the current system and claims handled by the Central Legal Office between the period 2004 and 2009. The report notes that the proportionate increase in public expenditure represented by the upper estimate is considerably lower than that previously estimated for the introduction of a no-fault scheme in England.

6.6.15 We are grateful to the Medical and Dental Defence Union Scotland (MDDUS) for their co-operation and for the work they did to help us calculate total additional costs. We should make it clear at this point, however, that the information provided was based on assumptions we provided and should not be taken to imply in any way that MDDUS accept the validity of the assumptions or of the methodology used. The assumptions provided for use in the calculations were in line with those detailed in the Manchester University Study²⁶.

6.6.16 The estimates provided by the MDDUS suggest a Lower Bound percentage increase of 37% and Upper Bound percentage change of 110% from the actual expenditure had the No Fault Scheme been fully operational during the period 2004-2009 and had it been extended to MDDUS members in Scotland.

6.6.17 MDDUS has stressed that it is important to note that all of these figures are very sensitive to the many assumptions set. They are also sensitive to the years selected and a different set of years would have produced a different set of outcomes.

6.6.18 We also acknowledge and are grateful for the additional work undertaken by the Central Legal Office to help identify the scale of costs associated with expert reports commissioned in relation to the consideration of claims.

6.6.19 Recommendations 6, 7, 8 and 9 (question 10) seek to ensure that the scheme would be fully compatible with the European Convention of Human Rights (ECHR) and provide appropriate appeals mechanisms with an ultimate right to the courts on a point of fact or law.

6.6.20 Just over half of respondents confirmed they supported these recommendations. However, concerns were raised about the rights of the clinician and also the potential for challenge under Article 1 Protocol 1 of the ECHR.

6.6.21 Any legislation required to introduce a no-fault scheme would be drafted appropriately to ensure that it would be fully compatible with the European Convention of Human Rights (ECHR).

6.7 Question 8

6.7.1 This question sought views on what transitional arrangement should be put in place given that, if introduced, the no-fault system would not be retrospective. Very mixed response to this question with some suggesting the scheme should only apply to incidents that occur after its introduction and others suggesting the scheme should be retrospective.

6.7.2 The Medical Protection Society (MPS) raised the point that there were two types of claims and that both would need to be taken into account when determining future provision. The first type is a known claim (an incident has occurred and a claim has been raised) and the other is known as incurred but not reported (IBNR) and is more complex.

6.8 Question 11 - review Group's Recommendation 10 in relation to problems with the existing system

6.8.1 The consultation paper explained that the Review Group's analysis of the problems with the current system would be considered and taken forward by the Scottish Government Justice Directorate as part of their proposed consultation on the Courts Reform Bill. The paper also noted in addition that Sheriff Principal Taylor's Review of Expenses and Funding of Civil Litigation in Scotland²⁷ would also consider a range of issues.

6.8.2 The comments received in response to this question and views expressed on the analysis of the problems with the current system were shared with colleagues in Scottish Government Justice Directorate in order that these could be taken into account in the consideration of the Courts reform Bill. This included a suggestion that if the current system was improved there would be no need to move to a no-fault system.

Action 6 - Consultation on Courts Reform (Scotland) Bill

6.8.3 'Making Justice Work - Courts Reform (Scotland) Bill'²⁸ - A consultation paper published on 27 February 2013 sought views on proposals to restructure the way civil cases and summary criminal cases are dealt with by the courts in Scotland. The proposals provide the legal framework for implementing the majority of recommendations of the Scottish Civil Courts Review, led by Lord Gill the former Lord Justice Clerk and now Lord President of the Court of Session. The proposals discuss a redistribution of business from the Court of Session to the sheriff courts, creating a new lower tier of judiciary in the sheriff court called the summary sheriffs with jurisdiction in certain civil cases and summary criminal cases. Other proposed measures include the creation of a new national sheriff appeal court and a new national specialist personal injury court.

6.8.4 A total of 115 responses were submitted from a variety of different bodies, organisations and interest groups as well as individuals. There were many responses from judiciary and judicial bodies; stables or other groups representing Advocates; arbitration and mediation services; solicitors and groups representing or providing access to solicitors; advocacy groups including consumer bodies; unions; public bodies; local authorities; insurers or insurers groups; business other; and others. The non-confidential responses received have been published at: http://www.scotland.gov.uk/Publications/2013/06/2336.

6.8.5 The analysis of the responses to the consultation²⁹ was published in September 2013. This Scottish Government Courts Reform Bill³⁰ was introduced to the Scottish Parliament, by Kenny MacAskill MSP, on 6 February 2014.

6.9 Question 12 - Review Group's suggestion for scheme specific to neurological impaired infants in the event that it was decided that a general no-fault scheme would not be introduced.

6.9.1 Although the majority of respondents indicated they supported this recommendation there were still concerns about what this would mean in practice and that if introduced it could mean compensating parents for the failure of biological development for different reasons rather than the failings of medical care and that this would be challenging, expensive and perhaps impractical.

Action 7 - Proposed way forward

6.10 We have noted and recorded in this report the significant concerns raised about the introduction of a no-fault compensation scheme and in particular the major concerns raised in relation to costs and the complexities involved if such a scheme was to be introduced and extended to independent contractors and private healthcare providers.

6.10.1 However, we are still committed to ensuring that patients who have been harmed as a result of clinical treatment have access to redress in the form of compensation, where this is appropriate and that they have access to this without the need to go through lengthy court processes. We will continue to work towards developing a fair system and in doing so will aim to ensure that this will not be at the expense of other essential NHS services.

6.10.2 The Manchester University Study - Summary of their research findings³¹ notes that:

'Fault-based schemes focus solely on the need to prove negligence and it has been argued that this does little to improve the quality of care, produces defensive medical practices, discourages error reporting and institutional learning, and blocks transparency. While it has been argued that no-fault schemes may address some of these problems, the primary goal should be to prevent errors from occurring in the first place.'

For scheme providers and their members, costs of claims need to be contained, and while savings can be made by minimising costs associated with litigation, such as excessive legal fees and expert reports, the most significant cost driver is the number and extent of claims."

6.10.3 NHSScotland aims to provide high quality care that is safe, effective and person-centred. The national approach to learning from adverse events explained earlier (paragraph 6.5.3) provides guidance for the whole of NHSScotland on how to develop and implement effective adverse event management systems. Safety is one part of high quality healthcare services and the national approach contributes to delivery of our NHS Quality Strategy (2010)³² and 2020 vision³³. It is proposed that the national approach be reviewed in 2014.

6.10.4 The Scottish Patient Safety Programme³⁴, plays a significant role in delivering the Safe Quality Ambition and aims to reduce adverse surgical incidents and healthcare associated infection, while improving critical care outcomes and organisational and leadership culture on safety.

6.10.5 The Patient Rights (Scotland) Act 2011 and the revision of the 'Can I help you?' guidance also seek to support the development of a culture that actively encourages and welcomes feedback, comments, concerns and complaints in order to learn from people's experiences and make improvements. As part of this process NHS Boards are required to publish anonymous details annually on patient feedback, comments, concerns and complaints which provides evidence that action is or has been taken, where appropriate, to improve services and show where lessons have been learned. The NHS Board reports for the first year have been received and reviewed by the Scottish Health Council³⁵. The Scottish Health Council followed up on the review with a meeting with each NHS Board to discuss the learning from the first year of reporting, to share examples of good practice and to highlight common challenges. The findings from these discussions will be published in the spring of 2014 and considered by the Scottish Government with the aim of ensuring that NHS Boards across Scotland consistently listen to and learn from feedback, comments, concerns and complaints.

6.10.6 The national roll-out of Patient Opinion³⁶ from March 2013, the patient experience surveys³⁷ and the Patient Advice and Support Service³⁸, established in April 2012, also provide routes for patients and their families to provide feedback and comments on their experience in order that the NHS can learn and make improvements.

6.10.7 Improvement work is also being taken forward across NHSScotland, Social Care and the third sector through the Person-centred Health and Care Collaborative launched by Mr Neil, Cabinet Secretary for Health and Wellbeing, in November 2012. The aim is to enable care to be centred on people by December 2015, through improvements in care experience, staff experience and co-production.

6.10.8 We will monitor the progress of the measures which have been put in place to improve the quality and safety of the services provided. In particular we will monitor:

• the implementation and effect of the national approach to learning from adverse incidents
• claims handled by the Central Legal Office
• Improvements and actions taken as a result of feedback, comments, concerns and complaints
• Improvements made through the Scottish Patient Safety Programme and the Person-centred Health and Care Collaborative.

6.10.9 We will also continue to progress and monitor the impact of the work being taken forward in relation to the Courts Reform (Scotland) Bill and how this will improve the existing legal claim system.

6.10.10 Given the complexity of the issues and the potential costs we will proceed with caution to:

• Explore the scope, shape and development of a no-fault compensation in Scotland for injuries resulting from clinical treatment and the subsequent introduction of such a scheme. This will involve further detailed work especially in relation to projected cost and eligibility criteria; and
• consider how the scheme could more effectively contribute to patient safety, learning, improvement and how it links with and supports safe disclosure of adverse events and aligns with the complaints and claims procedure. We will also link this with the HIS review of the national approach to learning from adverse incidents and plans to review clinical governance arrangements in NHS Boards.

6.10.11 We will develop and consult on draft proposals once the work outlined above has been completed.