Patient Safety Commissioner Bill Business And Regulatory Impact Assessment
Title of proposal
Patient Safety Commissioner Bill
Purpose and intended effect
The Cumberlege Review examined how the healthcare system in England responded to reports about harmful side effects of medicines and medical devices, focusing on three specific interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants.
While the review was primarily concerned with England, many Scottish patients provided evidence to it, and its findings highlighted issues that applied to healthcare across the UK.
Following the publication of the review’s report, the Scottish Government stated that it accepted all of Baroness Cumberlege’s recommendations and would implement these where it had the devolved legislative competence to do so. This included the report’s second recommendation, which states:
“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.”
In the report, Baroness Cumberlege recommended that the Commissioner would seek to address several areas for improvement in patient safety, including:
- The need for more widespread and timely recognition by the patient safety system of issues identified by patients and the public;
- The need for the patient safety system to get better at listening to, and acting on, patients’ experiences of avoidable harm; and
- The need to be swifter, and for better co-ordination across and between agencies.
To create a Patient Safety Commissioner for Scotland, independent of government and the NHS, who will:
- promote and improve patient safety by amplifying the patient voice within the patient safety system;
- develop a system-wide view of the health care system in Scotland and use it to identify wider safety issues; and
- promote better coordination across the patient safety landscape in Scotland in responding to concerns about safety issues.
Rationale for government intervention
Various inquiries, together with correspondence and complaints received by NHS Boards and the Scottish Government, have highlighted the stories of patients who raised concerns about the care or treatment provided by the NHS but who felt they were not listened to until it was too late. As a result, some patients have died or suffered severe harm which could have been prevented. In some instances, the fact that patients’ concerns were not listened to has subsequently resulted in other patients receiving the same treatment that continues to lead to harm.
When preventable harm is caused to patients, this also has an economic impact. For example, many of the people who are harmed by their treatment are subsequently unable to work, with the consequence that they require support from the welfare system. Furthermore, people who have suffered preventable harm from NHS treatment are often awarded financial compensation which has to be found from NHS budgets.
The creation of a Patient Safety Commissioner is intended to address these issues by amplifying the views and concerns of patients within the patient safety system in Scotland. This includes healthcare treatment carried out by the NHS, by NHS-contracted services such as pharmacists, dentists and ophthalmologists, and independent or private services. The intended result is that patients’ concerns about potentially harmful treatment and care will be listened to and acted on. In turn it is believed this will reduce the negative social and economic impacts of preventable harm to patients resulting from healthcare treatment.
The following government agencies and departments were consulted during the preparation of this Business and Regulatory Impact Assessment (BRIA):
- A meeting was held on 8 February 2022 with representatives from policy teams working in Pharmacy, HIS-regulated independent healthcare providers, community eyecare, optometry, dentistry, and GP contract; no particular issues or concerns were raised;
- A follow-up meeting with the Chief Dental Officer was held in which CDO helped to clarify the regulatory environment in which dentists operate and how complaints tend to be dealt with; again no specific concerns were raised.
We ran a public consultation on the Patient Safety Commissioner role between 5 March 2021 and 28 May 2021. The consultation was drafted with input from two specialist groups, a Patient Reference Group (PRG) and a Specialist Reference Group (SRG). It sought the views of the public and other interested parties on what a Patient Safety Commissioner should look like; who they should report to; and how the role should function.
We received 96 responses to the consultation, of which 46 were from healthcare and related organisations and patient representative groups, and 50 from members of the public. An analysis of the responses was published in December 2021. Where respondents gave permission for their responses to be made public, we also published these on the Scottish Government website. We have taken full account of the consultation responses in preparing the Bill.
We conducted a landscape mapping exercise in February-March 2022 in which we contacted a number of services and organisations which have a role in healthcare-related complaints and patient safety. Returns were received from the following regulatory bodies: General Medical Council, General Osteopathic Council and General Pharmaceutical Council; no particular concerns were raised.
Rather than return a questionnaire a meeting was held with General Dental Council officials on 21 February. Again no specific concerns were raised. GDC officials mentioned that the GDC general does not have time for horizon-scanning and that therefore the horizon-scanning aspect of the Patient Safety Commissioner’s role will be very helpful in helping to understand risk better.
A representative of regulatory bodies sits on the Bill Advisory Group which has been working with officials on some of the detail of the Bill provisions.
The Bill is not expected to have a significant impact on businesses as its scope is limited to the creation of a Patient Safety Commissioner whose interest will be to make improvements to patient safety, albeit within the independent/private healthcare sector as well as the public sector.
Neither the National Pharmacy Association nor the General Pharmaceutical Council, who responded to the public consultation, identified any concerns relating to costs or burdens on pharmaceutical contractors. No other representative body or individual NHS contractor responded.
No independent or private sector healthcare organisations responded to the public consultation, although a number of professional and regulatory bodies did. The Association of the British Pharmaceutical Industry commented that the Patient Safety Commissioner could have a role in helping to reduce dispensing errors, and is generally supportive of the proposed role and the aim to improve patient representation in the safety landscape. In addition the national Pharmacy Association welcome the proposed role and would support opportunities for community pharmacy involvement in patient safety initiatives.
On 26 April the Scottish Government met with the Independent Healthcare Providers Network (IHPN) to discuss the proposals. Representatives of the following organisations were present:
- Castle Craig Clinic
- Circle Health Group
- The Disabilities Trust
- Nuffield Health
- The Priory Group
- Spire Healthcare
- Shaw Healthcare
- The Edinburgh Clinic
There were no significant issues raised at this meeting; questions focused on details of the proposals including information sharing and working with Healthcare Improvement Scotland (HIS).
A representative of IHPN sits on the Bill Advisory Group which has been working with officials on some of the detail of the Bill provisions.
Any issues raised by the private sector as the Bill progresses through Parliament will be considered.
Option 1 – Legislate to create a Patient Safety Commissioner for Scotland
Legislation would create a Patient Safety Commissioner which is established in law, focusing on:
- promoting and improving patient safety by amplifying the patient voice within the patient safety system;
- developing a system-wide view of the health care system in Scotland and using it to identify wider safety issues; and
- promoting better coordination across the patient safety landscape in Scotland in responding to concerns about safety issues.
Legislation would confer the following powers:
- allow the Patient Safety Commissioner to carry out investigations into patient safety issues across the healthcare sector in Scotland, including NHS organisations, NHS contractors such as general practitioners, pharmacies and dentists, and independent healthcare providers;
- allow the Commissioner to request information from relevant organisations and their staff in pursuance of investigations;
- oblige those requested to provide information within a set timeframe – failure to respond could be referred to the Court of Session which may result in a finding of of contempt of Court ;
- allow the Commissioner to make reports on the outcome of investigation with recommendations; and
- oblige the organisations concerned to respond formally to these recommendations within a set timeframe – failure to comply would be publicised by the Commissioner.
Responses to the public consultation indicated strong support for the Patient Safety Commissioner having a statutory basis in order to give the role the right level of power and effectiveness.
Option 2 – Establish an equivalent patient safety office without legislation
This could be achieved by creating a new post within the Scottish Government or NHS with responsibility for monitoring or reviewing patient safety. However as a non-statutory post this would have limited power to enforce change, and without independence from government or the NHS there may be an issue with gaining the trust of patients and the public as someone who could influence change in the right direction.
Responses to the public consultation strongly supported an independent role with powers backed by legislation.
Option 3 – Do Nothing
We could do nothing and not create a Patient Safety Commissioner at all, simply relying on existing mechanisms for identifying and reporting safety issues. This would ignore Baroness Cumberlege’s recommendation and be unlikely to lead to significant improvements.
Sectors and groups affected
The following sectors and groups are likely to be affected by the creation of a Patient Safety Commissioner:
- patients in Scotland, their families and carers;
- NHS Health Boards and special Health Boards and HIS and NHS National Services Scotland;
- other public bodies with an interest in patient complaints such as the Scottish Public Services Ombudsman (SPSO);
- organisations which provide services to the NHS under contract;
- independent healthcare providers; and
- healthcare professional and regulatory bodies.
Benefits – Option 1
Option 1 will fulfil the Scottish Government’s Programme for Government commitment to bring forward legislation to establish a Patient Safety Commissioner. It will create an independent Parliamentary Commissioner with a statutory powers who will amplify the views and safety of patients and members of the public, as well as reviewing and promoting coordination within the patient safety landscape in Scotland, with the overall aim of making improvements to patient safety and reducing the incidence of preventable harm to patients resulting from NHS care.
Giving the Patient Safety Commissioner a statutory basis reflects the overall preference of responses received as part of the public consultation, which showed strong support for the Commissioner being and independent office established in statute.
Benefits – Option 2
As mentioned above, the Scottish Government has committed to bringing forward legislation to establish a Patient Safety Commissioner, which this option would not do
The costs associated with option 2 would be significantly less than for option 1; however the lack of independence and statutory backing would mean the office would be unlikely to achieve the necessary improvements or secure the trust of patients and members of the public.
Benefits – Option 3
None. Not establishing a Patient Safety Commissioner at all would fail to achieve any of the benefits identified for Option 1.
Establishing the office of the Patient Safety Commissioner, whether in statute as per option 1 or without as per option 2, will result in minimal costs to businesses (which here include NHS contractors and independent healthcare providers). We are not asking businesses to implement anything new as a result of the proposed legislation: the intention is to make improvements to existing processes and practices which have a potential impact on patient safety only where an issue is identified and changes to safeguard patients are deemed necessary.
Where the Patient Safety Commissioner decides that it is necessary to carry out an investigation into a safety concern the relevant businesses are required to respond to a request from the Commissioner for information relating to that concern, and so there will be some work to do to comply with the request. Independent service providers are already under an existing obligation to answer requests for information from HIS. However these costs should be minimal, particularly if the business has robust records management practices in place to allow the information to be located easily.
The Patient Safety Commissioner will publish a report on the investigation with recommendations which the business is required to respond to. Response could include implementation of the recommendation, provision of an action plan to work towards implementation of the recommendation, or an explanation as to why the organisation is not able to implement the recommendation. Again depending on the course of action recommended there may be some costs to businesses, but it is not possible to quantify these without knowing exactly what the issue is and what the recommendation would be.
Option 2, having no statutory backing, may likely result in low levels of engagement with requests for information and for action as a result of recommendations which would very much weaken the Patient Safety Commissioner’s powers.
Option 1 does additionally carry a risk of fine to an organisation which does not respond to a request for information from the Patient Safety Commissioner
Costs – Option 3
Choosing not to establish a Patient Safety Commissioner would mean that the benefits identified in Option 1 would not materialise. This would have the further consequence that the negative social and economic impacts of preventable harm from NHS treatment identified in the ‘Rationale for government intervention’ are not addressed.
Scottish Firms Impact Test
As detailed above in the section on ‘Consultation’ we have discussed the proposals with the Independent Healthcare Providers Network, who did not raise any concerns in relation to the proposals. Only two pharmacy representative organisations responded to the public consultation carried out in 2021 and they did not raise any concerns about costs.
While there may be some minimal costs incurred as a result of investigation by the Patient Safety Commissioner, and the possibility of costs in responding to recommendations made by the Commissioner, the intention of the policy is to make improvements to patient safety where issues are found, with the overall benefit to patients; the increased likelihood of avoidance of potential safety incidents will also uphold the reputation of the businesses concerned.
The reduction of harms to patients and poor medical outcomes would provide broad economic benefits in terms of costs associated with sickness absence.
Any issues raised by the business sector as the Bill progress through Parliament will be considered.
Using the four Competition and Markets Authority competition assessment questions in the associated guidance we have concluded that the provisions in the Bill are not expected to limit the number or range of healthcare providers; or limit the ability or incentives of providers to compete, and would be a minor imposition upon a sector which is already, rightly, heavily regulated. In addition they would expand rather than limit the choices and information available to consumers; as the Commissioner’s recommendations will be optional, different providers are likely to implement them differently, creating differentiation between providers and increasing consumer choice. The Patient Safety Commissioner may however choose to undertake a further assessment at any point where aspects of their work would have unintended consequences for the market which could impact on consumers.
Using the Consumer Assessment questions in the associated guidance we assess that the provisions in the Bill will, indirectly and in the medium to long term, have a net positive impact on the quality of healthcare services that patients receive from NHS, NHS-contracted and independent providers This is because the Patient Safety Commissioner will strive to ensure that the concerns of patients (and their families and carers) about care and treatment are listened to, reducing the incidence of avoidable harm resulting from NHS-provided treatment.
The provisions in the Bill are not expected to significantly affect the availability or price of healthcare services. While the Commissioner’s safety recommendations may have a cost to implement – raising the possibility that independent providers reflect this cost by increasing the prices they charge - as discussed above, we assess these costs are likely to be minimal and not applied by all providers (as the providers are likely to choose to implement the Commissioner’s recommendations in different ways.
Test Run of Impact Forms
The Bill will not introduce any statutory business forms.
Digital Impact Test
The provisions in the Bill are not expected to impact on technology – unless the use of a specific technology is found to be harmful to patients – or become redundant as a result of technological advances.
Legal Aid Impact Test
The Bill creates one new criminal offence of breach of confidentiality of information shared with the Patient Safety Commissioner. This will apply to the Commissioner, their staff (which includes agency and contracted staff and staff working for another organisation in a shared office space) or members of the Commissioner’s advisory group. Due to the small group expected case numbers are likely to be less than 1 per year, and so any draw upon the legal aid fund will be minimal.
Enforcement, Sanctions and Monitoring
The Patient Safety Commissioner will have the power to investigate any concerns identified to or by them relating to patient safety, and to require organisations or their staff to provide them with information relevant to that investigation. Failure to provide information within a given timeframe can be publicised by the Commissioner, for example in their report on the investigation.
The Patient Safety Commissioner must report on the outcome of investigations, and make recommendations within that report. Failure of organisations or individuals to respond to these recommendations within a given timeframe can be publicised by the Commissioner, for example in a further report or letter to Parliament.
The Patient Safety Commissioner will be accountable to Parliament and must submit an annual report of their activities in fulfilling their functions. A strategic plan must be prepared and published, and laid before Parliament every four years.
Costs relating to the provision of information in response to a request by the Patient Safety Commissioner should be minimal, particularly if the business has robust records management practices in place to allow the information to be located easily. Costs associated with responding to recommendations are difficult to quantify without knowing exactly what the issue is and what the recommendation would be.
Implementation and Delivery Plan
Subject to the timetabling of Parliamentary scrutiny of the Bill and successful passage, we expect the Patient Safety Commissioner to be appointed in late 2023 or early 2024, with establishment of their office and appointment of support staff in the months to follow. Recruitment of the Patient Safety Commissioner will be carried out by the Scottish Parliament Corporate Body.
The Patient Safety Commissioner will be responsible for amplifying the patient voice in relation to patient safety, and for promoting patient safety to the public. They will be required to appoint an advisory group, of which 50% of members must be patients or members of the public, to advise them on their work.
Stakeholders who may be affected by the implementation of the legislation, that is NHS bodies, NHS contractors and independent healthcare providers, have been involved in consultation and engagement work during development of the legislative proposals. Subject to successful passage of the Bill a communications plan to raise awareness of the new Patient Safety Commissioner will be developed.
The Scottish Government will review the legislation before the end of the tenure of the first appointee to ensure it is still fit for purpose.
Summary and recommendation
The case for creating a Patient Safety Commissioner for Scotland is well established and supported by a range of stakeholders. The Bill will establish a new Parliamentary Commissioner accountable to the Scottish Parliament, to amplify the views and safety of patients and members of the public, as well as reviewing and promoting patient safety and coordination within the patient safety landscape in Scotland.
The Scottish Government considers that Option 1 (Legislating to create a new Patient Safety Commissioner) best supports the delivery of a number of national outcomes and is consistent with the Scottish Government’s wider priorities for public service reform.
Option 1 offers the most benefit and poses the least risk. The cost to businesses are minimal given the policy intention is to make improvements to existing practices where necessary to ensure that major patient safety incidents do not arise, and the legislation does not introduce any new burdens or processes on businesses.
Declaration and publication
The Cabinet Secretary or Minister responsible for the policy (or the Chief Executive of non-departmental public bodies and other agencies if appropriate) is required to sign off all BRIAs prior to publication.
I have read the Business and Regulatory Impact Assessment and I am satisfied that (a) it represents a fair and reasonable view of the expected costs, benefits and impact of the policy, and (b) that the benefits justify the costs. I am satisfied that business impact has been assessed with the support of businesses in Scotland.
Signed: Maree Todd
Date: 5 September 2022
Minister’s name: Maree Todd MSP
Minister’s title: Minister for Public Health, Women’s Health and Sport
Scottish Government Contact point:
Any queries about this BRIA should be addressed to:
Planning and Quality Division
Directorate for Healthcare Quality and Improvement
The Scottish Government
St Andrew’s House
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