Centred around three core areas – working together to integrate care, reducing bureaucracy, and improving accountability and enhancing public confidence – a number of key measures are proposed. These include proposals to:
- Establish multiple statutory integrated care systems in England, defined by geographical location, to bring together local NHS bodies, local government authorities, and social care and community health partners;
- Reduce bureaucracy by allowing NHS foundation trusts to restructure without the involvement of the Competition and Markets Authority, and the establishment of a new NHS provider selection regime, which is currently being consulted upon until 7 April 2021; and
- Merge NHS England and NHS Improvement into a single and unified legal organisation, with the Secretary of State for Health and Social Care having greater national oversight and accountability of the NHS, and additional intervention powers to reconfigure services, and align strategy with the government’s wider priorities in respect of health and social care.
In addition to this core package of measures, the White Paper makes several additional legislative proposals in relation to social care, public health, and safety and quality. In this blog, we focus on the last of these proposals, relating to patient safety and proposed changes to the regulatory landscape for healthcare professionals.
The White Paper proposes to bring the provisions of the draft Health Service Safety Investigations (HSSI) Bill 2019 into the new Health and Care Bill, and reintroduce before Parliament the long-standing proposals to establish an independent Health Services Safety Investigations Body (HSSIB) to investigate major patient safety incidents. This proposal is therefore not entirely new, and this is reflected in the White Paper, which explains the HSSIB will continue the work of the Healthcare Safety Investigations Branch which became operational in April 2017. The Health and Care Bill seeks not only to legally formalise the body’s status as an independent investigations body, but also extend its remit to cover healthcare provided in or by the independent sector.
As a proposed Executive Non-Departmental Public Body, the HSSIB will have powers to investigate serious patient safety risks, deliver investigation reports and recommendations, and require organisations to respond within prescribed timescales. In addition, it will be responsible for providing organisations with advice, guidance, and training to promote better standards and improve learning, service quality and effectiveness.
Under the proposals, the HSSIB will not be required to disclose any information relating to its investigatory function in order to ensure that information is provided to the HSSIB openly and in confidence. Certain exceptions to this will be set out in the new Health and Care Bill, which will also give the Secretary of State for Health and Social Care a regulation-making power to introduce additional circumstances where the exception to disclosure will apply.
The proposal further includes a new power to enable the Secretary of State for Health and Social Care to require the HSSIB to carry out thematic investigations concerning “particular qualifying incidents or groups of qualifying incidents”.
Complementing the proposals on patient safety, are a number of measures designed to reform the regulatory landscape of healthcare professionals. The White Paper notes the current “UK model of professional regulation for healthcare professionals has become increasingly rigid, complex and needs to change to better protect patients, support the provision of health services, and help the workforce better meet current and future challenges.”
So what does it have in mind?
Core to the proposals is the expansion of scope of section 60 of the Health Act 1999, particularly the powers by which the government can change the professional regulatory landscape through secondary legislation. The new Health and Care Bill seeks to add to these powers, enabling the Secretary of State for Health and Social Care to ask Parliament to approve much broader decisions.
The proposed additional powers include:
- The power to remove a profession from regulation – The White Paper is clear at the outset that the proposals are not about deregulation, reaffirming the government’s view that “vast majority of professionals such as doctors, nurses, dentists and paramedics will always be subject to statutory regulation”. However, it follows this statement with the view that over time, and with the increasing technological advances in society, the risk profile of certain healthcare professionals may change, such that while their regulation might be appropriate now, this may not be the case in the future, or at least to the same degree.
- The power to abolish an individual health and care professional regulator entirely – this proposal follows the government’s intention to review the number of healthcare regulators which dates back to its 2019 response to the Promoting professionalism, reforming regulation consultation. The White Paper reiterates its view of the “inevitable duplication in having nine regulatory bodies (10 including Social Work England) performing similar functions in relation to different professions”. While section 60 of the Health Act 1999 currently affords the government the power to create new regulators using secondary legislation, the new Health and Care Bill will extend this power to enable Parliament to close a regulator where its functions are duplicated by another body or where the profession it regulates is removed from regulation.
- The power to allow regulators to delegate some of their core functions to another body – Currently, regulators are restricted from doing this. Functions which the White Paper suggest should be capable of being delegated include: “the keeping of a register of persons permitted to practise; determining standards of education and training for admission to practise; giving advice about standards of conduct and performance; and administering procedures relating to misconduct and unfitness to practise.” This extension of power would mean that a single regulator could take on the role of any one of these functions across some of all of the current regulatory bodies.
- The inclusion of NHS managers and leaders within the professional regulatory framework – Finally, the White Paper suggests a clarification is needed to section 60 of the Health and Care Bill as to the definition of healthcare professionals, and sets out an extension of the regulatory framework to cover professionals working within healthcare senior management teams. This proposal follows the recommendations set out in the 2019 Kark Review, which suggested the applicability of a fit and proper persons test to senior leaders and managers, but did not go so far as to suggesting this should be a statutory requirement. While the White Paper is clear that the Secretary of State for Health and Social Care has no immediate plans to statutorily regulate such individuals, it does request the power to do this in the future.
Additional Safety and Quality Proposals
Alongside proposals for increased patient safety and regulatory reform, the White Paper sets out two additional measures to bolster safety and quality. The first is the establishment of a new statutory medical examiner system within the NHS, which will be responsible for investigating all deaths that do not involve a coroner. An amendment to the Coroners and Justice Act 2009 is thus proposed to allow NHS organisations to appoint medical examiners directly, without the involvement of the local authority.
The White Paper further makes proposals for a new national medicines registry system which will be developed and maintained by the Medicines and Healthcare products Regulatory Agency (MHRA), and will include data captured from private providers. Currently, the MHRA can request private medical companies to capture data regarding medicines, such as their use and safety; however, the White Paper suggests this data is not always delivered within the timescale requested. The new registries system will give the MHRA greater control over the routine collection and maintenance of data, and will enable early identification of any issues over the safety or effectiveness of medicines, as well as ensuring regulatory investigation is taken in instances of potential non-compliance.
The White Paper, and the planned new Health and Care Bill which underpins it, present some significant legislative proposals in a number of areas across health and social care in England and, in some cases, affecting the devolved administrations of Scotland, Wales, and Northern Ireland. The government’s intentions to reform the professional regulatory framework for healthcare professionals are not new, and in some ways have been expected since 2019. What is new is the level of detail concerning what these reforms could potentially involve, which we now have, set out in the White Paper.
A central theme to the paper is the greater power bestowed on the Secretary of State for Health and Social Care to change the regulatory landscape, should the proposals be approved. Critically, however, the proposed creation of new powers for the removal of professions from regulation and abolishment of individual regulators may or may not be exercised. The White Paper does not lay out any specific plans to exercise these powers any time soon, and in any event, they will be subject to the passing of secondary legislation, which Parliament will need to approve. While the reform programme is still in its early stages, and will require continued engagement with the devolved administrations and wider consultation with relevant stakeholders, the White Paper does not set out a date or timescale for this consultation process.
If you have any questions or concerns about the content covered in this blog, please contact Shannett Thompson or a member of the Regulatory team.
About the authors
Shannett is a Partner in the Regulatory Team having trained in the NHS and commenced her career exclusively defending doctors. She provides regulatory advice predominantly in the health and social care and education sectors. Shannett has vast experience advising regulated individuals, businesses such as clinics and care homes and students in respect of disciplinary investigations. She is a member of the private prosecutions team providing advice to individuals, business and charities in respect of prosecutions were traditional agencies are unwilling or unable to act. In addition Shannett has built up a significant niche in advising investors and businesses in the cannabis sector.
Lucinda is a professional support lawyer in the Regulatory team, and is responsible for knowledge management and practice development. Her work focuses on leveraging the team’s collective knowledge and expertise, ensuring that know-how and current and emerging regulatory developments are identified, evaluated, synthesised, and shared. She is particularly experienced in the adoption of technology to aid the delivery of these outcomes.