Patient Reference Group - draft consultation paper: December 2020

Draft consultation on the establishment of a Patient Safety Commissioner role for Scotland 

About the consultation

The Scottish Government's Programme for Government 2020-21 committed the Government to establishing a Patient Safety Commissioner for Scotland. This paper therefore seeks views on what that role should look like; who it should report to; and how it should interact with existing legislation and policies, as well as with the various organisations involved in providing and improving health and care services in Scotland.

The Scottish Government will be carrying out complementary consultation and engagement activities during the consultation period. 

Responding to this consultation

Please respond to this consultation using the online platform 'Citizen Space'. You can save and return to your responses whilst the consultation is still open. 

Please ensure that consultation responses are submitted before the closing date.

If you are unable to respond using 'Citizen Space', please send your views and comments either by email to PSC@gov.scot.

However you respond, please complete the Respondent Information Form (see 'Handling your response' below). Responses should reach us by [insert date] . Earlier responses would be welcome.

Handling your response

If you respond using 'Citizen Space', you will be automatically directed to the Respondent Information Form at the start of the questionnaire. This will let us know how you wish your response to be handled and, in particular, whether you are happy for your response to be made public.

If you are unable to respond via 'Citizen Space', please complete and return the Respondent Information Form attached to the end of this document. This will ensure that we treat your response appropriately.

All respondents need to be aware that the Scottish Government is subject to the provisions of the Freedom of Information (Scotland) Act 2002, and would therefore have to consider any request made to it under the 2002 Act for information relating to responses made to this consultation exercise.

Next steps in the process

Where respondents have given permission for their response to be made public, and after we have checked that they contain no potentially unlawful or offensive material (for example defamatory material), or personal data, responses will be made available to the public. If you use the consultation hub to respond, you will receive a copy of your response via email.

Following the closing date, all responses will be analysed and considered along with any other available evidence to help us. Responses will be published where we have been given permission to do so. An analysis report will also be made available.

Comments and complaints

If you have any comments about how this consultation exercise has been conducted, please send them to the email address above.

Scottish Government consultation process

Consultation is an essential part of the policymaking process. It gives us the opportunity to consider your opinion and expertise on a proposed area of work.

You can find all our consultations online. Each consultation details the issues under consideration, as well as a way for you to give us your views, either online or by email.

Responses will be analysed and used as part of the decision making process, along with a range of other available information and evidence. We will publish a report of this analysis for every consultation. Depending on the nature of the consultation exercise the responses received may:

• indicate the need for policy development or review;
• inform the development of a particular policy;
• help decisions to be made between alternative policy proposals; and/or
• be used to finalise legislation before it is implemented.

Whilst details of particular circumstances described in a response to a consultation exercise may usefully inform the policy process, consultation exercises cannot address individual concerns and comments, which should be directed to the relevant public body.

Ministerial foreword

[To be drafted]

Glossary

• HIS - Healthcare Improvement Scotland
• HPTs - Hormone Pregnancy Tests
• MHRA - Medicines and Healthcare products Regulatory Agency 
• Patient Reference Group - Advises the Scottish Government on the development of proposals for the appointment of a Patient Safety Commissioner for Scotland.
• SPCB - Scottish Parliamentary Corporate Body 
• Specialist Reference Group - Maps out the roles and responsibilities of existing bodies and policies to help determine how the Patient Safety Commissioner will work within present structures in the Scottish context
• SPSO - Scottish Public Services Ombudsman
• SPSP - Scottish Patient Safety Programme

Chapter 1: Introduction

On 8 July 2020 First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review (the Cumberlege Review) was published. The review examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, and made recommendations on how to respond to them more quickly and effectively in the future.  

Although the report was focussed on England, the issues covered within it related to all four of the UK nations, and people from Scotland also gave evidence to the investigation. The Scottish Government, therefore, accepted all of the recommendations within the report, and agreed to implement them, where it is within Scottish Ministers’ powers to do so.

A key recommendation within the report is:

Recommendation 2: The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.

Scottish Ministers committed, in Protecting Scotland, Renewing Scotland: The Government's Programme for Scotland 2020-2021 to establishing the role of a Patient Safety Commissioner. This paper takes forward that commitment, and looks for the public’s views on what that role should look like; who it should report to; and how it should function.

The Scottish Government have established a Patient Reference Group, with the remit of advising on the development of proposals for the appointment of a Patient Safety Commissioner for Scotland, whilst representing, and connecting with, their wider networks. Membership of this group was drawn from the three patient groups covered by Baroness Cumberlege’s review - those who received hormone pregnancy tests (HPTs), such a Primodos, or were prescribed sodium valproate during pregnancy; and those who have had pelvic mesh implants. 

There are already a large number of policies, pieces of legislation, and organisations involved in looking to improve patient safety, and ensure that the patient voice is heard in Scotland. It is key that the Patient Safety Commissioner role adds value for patients in Scotland – rather than replicating what already exists - and, with this in mind, a Specialist Reference Group was also formed. Their remit is to map out the roles and responsibilities of existing bodies, as well as the current policies in Scotland, to help identify where gaps exist.  

The work of both the Patient Reference Group and the Specialist Reference Group continues, and they will have a role in determining next steps once the responses to this consultation have been analysed.

Chapter 2: Scope of the Patient Safety Commissioner role

Baroness Cumberlege was asked to investigate what had happened in respect of two medications and one medical device – HPTs, sodium valproate and pelvic mesh implants. As such, the recommendations within First Do No Harm focus specifically on medicines and medical devices, with recommendation 2 stating that “the Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices”.

In line with this, the commitment for the Scottish context is that the remit of the Patient Safety Commissioner would focus initially on patient safety in these areas, with a view to the role possible expanding to cover other areas in the future.

We note that this limited initial remit may pose challenges in separating safety issues around medicines and medical devices from wider safety issues. We also note that this could cause confusion for patients, who may wish to highlight a safety issue which does not relate to a medicine or medical device.  

That being said, there is also concern that too wide a remit will also be challenging, as the Patient Safety Commissioner will not have the time necessary to build up a good knowledge and understanding of the key issues related to specific topics – something which the Patient Reference Group felt was an important aspect of the role. With this in mind, and given the potential breadth of this role, it is very likely that this would not simply be an individual working alone, but that the Patient Safety Commissioner would have a support team.

Question 1: Do you agree that the focus of the Patient Safety Commissioner role should initially be on medicines and medical devices, as set out in the Cumberlege Review? (Yes/No/Don’t Know)

Question 2: Why do you feel this way?

Question 3: If the role were to expand in the future, do you feel that there are any specific aspects of patient safety that the Patient Safety Commissioner should not be involved in?

Chapter 3: Independence of the Patient Safety Commissioner

Baroness Cumberlege set out, in First Do No Harm - and has reiterated many times - that the Patient Safety Commissioner must be independent. The Patient Reference Group have indicated that they must be independent of both the NHS and the Government. However, it is important that – although they are independent – the Patient Safety Commissioner should be accountable to someone. Having looked to other similar roles in Scotland, there are a number of ways that this can be achieved.

During the Parliamentary debate on 8 September 2020, Alex Neil MSP suggested that the Patient Safety Commissioner should report to the Scottish Parliament, as the Children and Young People’s Commissioner Scotland and the Scottish Information Commissioner does. As such, they would be nominated by the whole Scottish Parliament, and appointed by the Queen. They would be accountable to the Scottish Parliament and the people of Scotland through the Scottish Parliamentary Corporate Body (SPCB), which is formed of MSPs from several political parties. This is the most common route to setting up such a role independently.

Another possible route to ensuring the Patient Safety Commissioner’s independence would be to set them up as either a limited company or a company under a trust deed. However, it is not possible for the Scottish Parliament to impose statutory duties on a company. It would, therefore, be for the Patient Safety Commissioner themselves to determine their functions and priorities, and neither the Scottish Government or Scottish Parliament would have any control over this. Nor would the Scottish Parliament be able to give powers directly to the Patient Safety Commissioner. As such, if statutory duties were required (which is discussed further in chapter 5), these would have to be conferred on Health Boards and other relevant health bodies to require them to comply with the requests of the Patient Safety Commissioner.

It is also possible that the Patient Safety Commissioner role could be modelled on other organisations, such as Victim Support Scotland (VSS), which is a charity, although it is largely funded by the Scottish Government. However, similar to a company, it is not possible to confer powers or duties upon a charity, and so the same issues exist in this respect.

Question 4: Which of the above models would you prefer for the set-up of the Patient Safety Commissioner role? (Reporting to the Scottish Parliament/ Limited company/ Company under trust deed/ Charity/ Don’t Know/other)

Chapter 4: Functions of the Patient Safety Commissioner

What has come across clearly, both from First Do No Harm and from the Patient Reference Group, is that patients need to be treated with dignity and respect; they need to be listened to; and their voice needs to be strengthened so that they can influence changes to the healthcare system. However, what is less clear is how this is to be achieved.  

There are other policies and pieces of legislation – in particular the Patient Rights (Scotland) Act 2011 and the Organisational Duty of Candour Procedure – that have this as an aim. It is, therefore, imperative that the Patient Safety Commissioner role adds value for patients, rather than replicating what already exists. A summary of the existing policies is at Annex A.

Despite existing duties placed upon NHS bodies, through the Patient Rights (Scotland) Act 2011, to encourage patients to give feedback or comments, or raise concerns or complaints on health care, discussions with the Patient Reference Group highlighted that patients have a varying knowledge of the current patient safety landscape, and of the ways that they can currently raise concerns or complaints. Even where patients do know how to do this, they do not always feel that these are handled appropriately, and there is a perception that complaints are often handled by the same people being complained about. Also, patients do not always receive feedback on what – if anything – has been done as a result of them having raised a concern, particularly where this has been done informally.  

It is recognised that the handling of NHS complaints sits within the remit of the SPSO, although the Patient Safety Commissioner may have a role in working with the SPSO, as well as Health Boards, to use data from complaints to identify, and address, themes around patient safety. In particular, there is some suggestion that, rather than being focussed on events which have already taken place, the Patient Safety Commissioner’s role should be focussed on the prevention of future events.  

There has also been discussion, amongst the Patient Reference Group, about the need for improved communication between the various parts of the healthcare system, both in Scotland and more widely across the UK, as well as with other bodies with an interest in the provision of safe healthcare (e.g. charities and the third sector), and it was suggested that the Patient Safety Commissioner may have a role in addressing this.

Further discussions on the role and functions of the Patient Safety Commissioner have focussed on how this is to be carried out. For instance, whether they would deal with patients and members of the public on a case-by-case basis, or focus on systemic issues.

If the focus is to be on addressing systemic issues, then consideration also needs to be given to how the Patient Safety Commissioner role would complement, rather than duplicate, that of organisations like Healthcare Improvement Scotland (HIS), who are responsible for inspecting NHS hospitals to ensure safety and cleanliness, and also to how they would ensure that they are truly representing the views of patients.

There has also been some discussion on the importance of the professional background of the person appointed to the Patient Safety Commissioner role. Some members of the Patient Reference Group indicated that they felt this person should have a legal background; others a clinical background; and some suggested that this should not matter so long as the person had a good knowledge and understanding of the issues they were dealing with, and was approachable and genuinely interested in improving the safety of the health service. What was felt to be key was that the person must have the power to influence real change (which is discussed further in chapter 5).

As noted in chapter 2, it is unlikely that the Patient Safety Commissioner would be a single individual working alone, but they would instead have a support team, which could consist of people from a range of professional backgrounds.

Question 5: What do you think the gaps are in the current system to support the patient voice to be heard on patient safety issues?

Question 6: In your view, what should the key functions of the Patient Safety Commissioner be?

Question 7: What do you think the Patient Safety Commissioner’s professional background should be, and what support do you think they would require?

Chapter 5: Powers of the Patient Safety Commissioner

A key point, raised by both Baroness Cumberlege and the Patient Reference Group, is the need for the Patient Safety Commissioner to have statutory powers. However, it should also be noted that, even if the role is established in legislation, there will be limitations on the powers that can be granted to the Scottish Patient Safety Commissioner. For instance, as the regulation of medicines and medical devices is a reserved issue, the Scottish Parliament is unable to place duties on the Medicines and Healthcare products Regulatory Agency (MHRA) to comply with the recommendations of the Scottish Patient Safety Commissioner. Such a duty would have to be placed on the MHRA by Westminster. That being said, the Scottish Patient Safety Commissioner could be given a function to try to work with regulatory bodies, like the MHRA, to improve patient safety.

Consideration needs to be given to what powers the Patient Safety Commissioner is to be given; over who; and the challenges that such power brings to the role. Much of the discussion amongst the Patient Reference Group focussed on the lack of trust in the NHS and the Government, and on people feeling let down. In particular it was noted that there was a feeling of clinicians ‘banding together’.  

Overcoming these issues will take not only systemic changes, but also changes in long-held cultures and beliefs. These types of changes can be particularly difficult to achieve when it is felt that there is an imbalance of power, as it is often found that the type of ‘banding together’ described by the Patient Reference Group comes as a result of people feeling in some way threatened. A key challenge for the Patient Safety Commissioner will be to create a safe space for those working in the health service to admit faults or mistakes without fearing the likely repercussions, so that they – and others – can learn from these mistakes. Indeed, achieving this culture of openness and learning was one of the key tenets of the Duty of Candour legislation, and continues to be a focus for organisations such as HIS, through programmes of work such as the Improvement Hub (iHub), which incorporates the Scottish Patient Safety Programme (SPSP), and Health Board reporting of adverse events.

Question 8: Do you think that the Patient Safety Commissioner role need to be established in legislation? (Yes/No/Don’t Know)

Question 9: What powers do you think the Patient Safety Commissioner should have, and over who?

Chapter 6: Impact assessments

In developing proposals for the establishment of a Patient Safety Commissioner role for Scotland, the Scottish Government will be carrying out various Impact Assessments, including an Equality Impact Assessment and a Fairer Scotland Assessment.

The Scottish Government intends to identify potential negative impacts, and to consider what might be done to address these.

Question 10: Do you have any views on potential impacts of the establishment of a Patient Safety Commissioner on equalities (the protected characteristics of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, and sexual orientation)?

Question 11: Do you have any views on potential impacts of the establishment of a Patient Safety Commissioner on socio-economic equality (the Fairer Scotland Duty)?

Question 12: Do you have any further comments on the Patient Safety Commissioner, not covered in your responses to the previous questions?