Consultation outcome

Consultation on the appointment and operation of the Patient Safety Commissioner

Updated 6 January 2022

Applies to England

Executive summary

This consultation seeks views and any comments from those who may be affected or have a particular interest in the set up and functions of the new Patient Safety Commissioner. This consultation specifically seeks views on the proposed legislative details on the appointment and operation of the Commissioner. This consultation is not seeking to revisit policy decisions on the scope or core duties of the Commissioner, which are now enshrined in statute.

The policy objective is to ensure that the appointment and operation of the Patient Safety Commissioner is as efficient and effective as possible, so that the Commissioner will be able to work for, with and in the best interests of patients.

The proposals on the appointment and operation of the Patient Safety Commissioner cover a range of topics, including the terms of office for the role, remuneration and funding and the establishment of an advisory panel to support the Commissioner.

Background

Patient safety remains a top priority for the government. Enormous emphasis has been placed on patient safety and good progress has been made. For example, through the NHS Patient Safety Strategy, which at its core, seeks to improve the way in which the NHS learns, treats staff, and involves patients, as well as through initiatives such as Freedom to Speak Up Guardians, helping to protect and encourage staff to speak up when things go wrong.

The Patient Safety Commissioner will add to and enhance this existing work to improve patient safety by acting as a champion for patients and helping us to learn more about what we can do to put patients first. It is integral that patients are listened to in our healthcare system and the Commissioner will help to make sure patient voices are heard. The core role of the Commissioner will be to promote the safety of patients in the context of the use of medicines and medical devices and to promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.

The Patient Safety Commissioner will complement the work of the many existing regulatory bodies already operating in our health service. The Commissioner will have the power to request and share information with relevant persons in the NHS or independent sector in carrying out their core duties.

The introduction of a Patient Safety Commissioner also acts on the second recommendation of the Independent Medicines and Medical Devices Safety Review, First do no harm, published in July 2020 by Baroness Cumberlege, which examines the consequences of the use of Primodos, sodium valproate and pelvic mesh and its effects on patient safety. The establishment of a Patient Safety Commissioner will work to help bridge the gaps identified in the review regarding strengthening patient voice and influence.

Legislative background and basis

The Medicines and Medical Devices Act 2021 (‘the Act’) received Royal Assent on 11 February 2021. Part 1 is about the Patient Safety Commissioner, and section 1 establishes the Commissioner position and sets out its “core duties”.

Under the Act (paragraph 6 of Schedule 1) the Secretary of State is able to make legislative provisions about the appointment and operation of the Commissioner, for example the terms of office, finances and other support for the Commissioner. This detail on the appointment and operation of the Commissioner is what this consultation is seeking views on and is included in the proposal section of this document.

It is important that the Commissioner is able to work effectively for patients. This consultation will help to ensure that the legislative underpinning about the appointment and operation of the Commissioner are appropriately considered.

This is not the only time that interested parties will be able to comment on matters relating to the Commissioner. As detailed in Schedule 1 of the Act, when they are appointed, the Commissioner must prepare and publish a set of principles to govern the way in which they will carry out their core duties. In preparing or revising these principles the Commissioner must carry out public consultation. The Act ensures that the Commissioner must continue to take reasonable steps to engage patients.

This consultation is conducted in line with the consultation requirement in section 45(1) of the Act.

The proposals

The following section describes the proposed arrangements for the appointment and operation of the Commissioner which will eventually be set out in secondary legislation.

Terms of office

The terms of office are that the Patient Safety Commissioner will serve for a term of 3 years and that a person will be eligible for one reappointment after having held office once.

The legislation also makes provision to provide for the Commissioner to be able to resign from office at any time by notice in writing to the Secretary of State and that the Secretary of State may also remove the Commissioner from office if the individual has become unfit or unable to properly discharge their functions or if they have behaved in a way that is not compatible with them continuing in office.

Question

We propose that the Patient Safety Commissioner shall serve for a term of 3 years.

What do you think of this length of service?

• Too long
• Just right
• Too short
• Don’t know

Please explain your answer.

Question

We propose that the Patient Safety Commissioner will be eligible for one reappointment after having held office and that they may resign and be removed by the Secretary of State, if appropriate.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Remuneration

Question

We propose that the Patient Safety Commissioner will receive remuneration.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Funding

The Secretary of State is to fund the operation of the Patient Safety Commissioner, including in regards to staff and facilities.

Question

We propose that the Secretary of State will fund the operation of the Patient Safety Commissioner.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Business plan

The Patient Safety Commissioner is to prepare a business plan which will set out, in relation to the discharge of the Commissioner’s functions, what the Commissioner’s proposed main activities for the period (12 months) covered by the plan will be, including any areas or matters the Commissioner intends to consider, and what the Commissioner’s proposed strategic priorities for that period will be.

In order to ensure continuous and relevant direction, a new business plan is to be published before the end of the period covered by the preceding business plan. The Commissioner is to take reasonable steps to consult before publishing a business plan.

Question

We propose that the Patient Safety Commissioner produces an annual business plan setting out their strategic priorities for that year, and that they will have to take reasonable steps to consult before publishing each plan.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Accounting

The Patient Safety Commissioner is to keep proper accounting records and prepare a statement of accounts for each financial year. A copy of this statement is to be provided to the Secretary of State.

Question

We propose that the Patient Safety Commissioner is to keep proper accounts, including a statement of accounts each financial year, a copy of which is to be provided to the Secretary of State.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Annual report

The Patient Safety Commissioner is to be required to publish an annual report as soon as possible after the end of each financial year. This report should detail the way in which the Commissioner has discharged their functions and what they have found in the course of exercising these functions during the year.

This may also include more specifically:

• a summary of the Commissioner’s activities and an analysis of the effectiveness of those activities in relation to the Commissioner’s core duties
• an account of the steps taken by the Commissioner to consult patients or otherwise involve them in the discharge of his or her functions
• a summary of how the Commissioner has taken into account the results of any such consultation and anything else resulting from involving patients in the discharge of his or her functions

A copy of the annual report to be sent to the Secretary of State and be laid before each House of Parliament.

Question

We propose that the Patient Safety Commissioner must publish an annual report to explain the activities they have undertaken during the year in relation to the Commissioner’s core duties.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Advisory panel

The Patient Safety Commissioner may appoint an advisory panel who will provide the Commissioner with advice and assistance relating to the discharge of his or her functions and encourage good practice in involvement with patients. We will want to ensure the panel will consist of persons who represent a broad range of interests which are relevant to the Commissioner’s functions.

For example, members with experience and/or knowledge of the health system or sector and types of patient experiences. The Commissioner may invite additional members to join the panel if a requirement for expertise in a particular area is identified.

Question

We propose that the Patient Safety Commissioner may appoint an advisory panel, whose members will have a broad range of relevant interests, such as experience and/or knowledge of the health system, sectors and types of patient experiences.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Conferring of functions on others

We are looking to ensure that any staff of the Patient Safety Commissioner, so far as authorised by the Commissioner, may exercise any of the Commissioner’s functions. Such flexibility will be helpful if, for example, the Commissioner is temporarily incapacitated or otherwise unavailable or to support with the volume of work the Commissioner may receive.

Question

We propose that any staff of the Patient Safety Commissioner, so far as authorised by the Commissioner, may exercise any of the Commissioner’s functions.

Do you agree or disagree with this proposal?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Question

Do you have any additional thoughts on the operation and appointment of the Patient Safety Commissioner?

Next steps

The consultation will close at 11:45pm on 5 August 2021. Responses received before this time will be carefully considered and reviewed and will feed into the drafting of the secondary legislation for the Patient Safety Commissioner.

A summary of responses, including the next steps, will be published after the consultation has closed.

Further information

The independence of the Patient Safety Commissioner

The government agrees wholeheartedly that the Commissioner must have the freedom to act independently if they are to be effective.

It is common practice for Commissioners to be sponsored by the government departments with relevant policy responsibility while maintaining their independence and performing their duties to a high standard.

We would also expect the Secretary of State to work with the Commissioner to agree how the Commissioner’s independence will be safeguarded.

Independence will necessarily be exercised in the carrying out of the Commissioner’s functions. For example, the Commissioner will have the power to make recommendations to the Secretary of State, who will then be under a duty to respond, ensuring that the department is kept accountable.

Working with other organisations

It is integral that the work of the Commissioner is complementary to and enhances the work of the many existing regulatory bodies already operating in our health service.

The Commissioner will have the power to request and share information with relevant persons in the NHS or independent sector in carrying out their core duties, which will facilitate joined up working.

Shared accountability to the Secretary of State for many of these public bodies and the Commissioner will also help collaboration and cooperation across organisations with a responsibility to improve patient safety.

Working with independent providers

The Patient Safety Commissioner will be ‘provider neutral’. They will be able to exercise their powers in both the NHS and independent sector.

The Commissioner would have the power to react to non-compliance from private providers through their core functions although, they could not issue fines for example, as this is not in their statutory powers. If private providers fail to respond to requests for information and reports or recommendations, the Commissioner could, for example, share information or make a report to the CQC as the regulator of such bodies.

Investigating individual cases

The Commissioner will not be responsible for, or have the power to investigate, individual cases. This function is already the responsibility of a number of existing regulatory bodies. For the Commissioner to be successful, it must not duplicate what is already in place.

The inability to investigate individual cases, is common among existing commissioners. For example, neither the Children’s Commissioner, nor the Victims Commissioner have the power to conduct individual investigations.

How patients can contact the Commissioner

The finer details on the everyday workings of the Commissioner are still to be finalised and it will be up to the Commissioner to determine how best to involve patients in the conduct of the Commissioner’s duties.

How to respond

The consultation period began on and will run until 5 August 2021. Please ensure that your response reaches us before the closing date.

Responding online

You can respond to this consultation online.

Due to the number of staff working from home, it will unfortunately not be possible to receive responses via post.