Business plan 2023 to 2024
Our Business Plan sets out our priorities for the business year 2023 to 2024.
Foreword by Dr Colin Sullivan, Chief Executive
Ensuring human tissue and organs are handled with dignity, used with the proper consent of those involved, and stored safely, is at the heart of what we do at the Human Tissue Authority. We seek to be an excellent, modern, accountable and agile health regulator dealing proportionately with the different sectors we oversee today, whilst also preparing to meet the regulatory challenges of tomorrow. In 2022 to 2023, the HTA sought to modernise our approach to regulation whilst delivering a comprehensive licensing and inspection programme for the establishments we regulate.
In 2023 to 2024, we are aiming to build on those foundations, being bolder and continuing to challenge ourselves to regulate the sectors we oversee yet more proportionately by deploying a different selection of regulatory tools and engaging with partners and stakeholders to work effectively together for the public good.
Our Business Plan for 2023 to 2024 represents a step change in our approach with a collective will from colleagues to deliver on our Vision and Mission in the most innovative, effective and value for money ways possible. We have set an ambitious agenda and seek to deliver on it.
Executive Summary
The Human Tissue Authority (HTA) is an executive Non-Departmental Public Body sponsored by the Department of Health & Social Care (DHSC). Our overall goal is to maintain public confidence in the removal, storage and use of human tissue and organs and ensure that these activities are undertaken safely and ethically, and with proper consent. This plan sets out our strategic aims and the work we will do during 2023 to 2024 to deliver them.
Strategic direction
2023 to 2024 represents an important year for the HTA, strategically, as we conclude our current three-year strategy. In parallel, we will look to the future by developing the next strategy for how we will regulate the sectors for which we have statutory responsibility. As an organisation we are looking to be ambitious and challenge ourselves to achieve greater efficiency and effectiveness. To this end, we will be undertaking an objective assessment of our impact and looking to garner more advice from experts in the fields we regulate, and around innovation in life sciences in particular, to assist us in fulfilling our Vision and Mission, and how best to deliver the functions entrusted to us.
During the year, we look forward to engaging with the Government’s Public Bodies review programme and working collaboratively across the sector with partners and stakeholders to deliver public protection and confidence in the use of human tissue.
Operational delivery
During 2023 to2024, we will look to continue the important work started in 2022 to 2023 to change and develop our regulatory practices. Building on the work progressed in 2022 to 2023, we will continue the development of a new target operating model for delivering regulation for each of the sectors we cover. We will seek to be creative and innovative in developing our operations, looking to future opportunities and new ways of providing services.
In 2023/24 we will focus more intently on technology and the use of data to improve our risk assessment and operational delivery, digitising wherever possible.
People and capability
In 2023 to 2024, we will aim to further develop our team building and team effectiveness work, seeking to ensure we have a workforce that is confident and capable in the full range of necessary competencies. We will start developing a People Strategy to set the direction for further organisational development improvements, supporting our staff to achieve their potential and delivering the best possible outcomes for the public.
The financial landscape anticipated for 2023 to 2024 is one where it is expected that parts of the public sector will be required to provide enhanced efficiency. We anticipate tighter controls and scrutiny on public spending. As an organisation we are committed to supporting this drive and fulfilling our functions in the most effective ways that we can.
Moving forward
A key focus for 2023 to 2024 will be to progress those enabling workstreams that are essential if we are to develop over coming years. We will focus on developing our regulatory insight to make better use of available data to improve our operational practices and decisions. As part of this, we will seek to provide certain datasets on an open-source basis to drive compliance and public protection through transparency.
During 2023 to 2024, we will also look to achieve a shared services model for Information Technology and Human Resources, which we know are essential to ensure that we have the resilience and resource necessary to innovate in the medium term.
Introduction
Our vision
The safe and trusted use of human tissue.
Our mission
To be an excellent regulator for the use of human tissue with consent and safety, sustaining public and professional confidence, today and in the future.
How we work
- We license organisations that remove, store and use human tissue for certain activities under the Human Tissue Act (2004).
- We license organisations that carry out a range of activities associated with the use of human tissues and cells for patient treatment, as required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
- We license organisations undertaking organ transplants as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended).
- We monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our Codes of Practice.
- We use our powers to take regulatory action where we identify non-compliance.
- We assess living organ donations to ensure donors are protected from duress or coercion, and that no reward is offered or given.
- We provide information, advice and guidance to the public and professionals about the nature and purpose of activities within our remit.
- We monitor developments relating to activities within our remit and advise Government on related issues.
In addition to our statutory role, we are increasingly called upon to provide advice on areas related to, but not specified in, legislation. This is especially important in areas of emerging technology and research not originally envisaged when the Human Tissue Act was enacted.
Our remit under the Human Tissue Act (2004) covers England, Wales and Northern Ireland and under other human tissue legislation includes England, Wales, Northern Ireland and Scotland1. We license over 800 premises across 6 sectors and publish standards and requirements that those working within these regulated fields must meet.
Whilst the HTA has a statutory duty to superintend compliance and an influential role in promoting good practice, public confidence in the use of human tissue cannot be safeguarded by the HTA alone. Public confidence is also dependent on the individuals and organisations that undertake activities within the HTA’s remit acting within the standards and requirements of the legislation.
Our values
Following the setting of our revised Vision and Mission, we are well advanced in the process of refreshing our values for the important and ambitious role that we play as we seek to be more inclusive and further improve performance. The values that we are currently developing are; Collaboration, Openness, Respect and Excellence.
Our Strategic Approach
Our strategic approach is based on being clear about the risks we are regulating, and then being proportionate and targeted in response. In 2022 to 2023 we developed the initial themes from our three-year Strategy – delivery, development and deployment – into four strategic objectives, so as to take a more ambitious stance. We intend to continue in this vein in 2023 to 2024 as we conclude this strategic plan. We will be bold and ambitious as we focus on efficient delivery whilst striving to develop and innovate even further.
Strategic Direction
Confirm the direction for the HTA as a sector leader and highly regarded regulator.
- Senior Management Team – strategic direction and leadership of operational delivery across the organisation (including risk management)
- Portfolio Management – producing the business plans and supporting and monitoring delivery against them through the Portfolio approach
- Create a new strategy for the HTA to position the organisation to achieve our Vision and Mission
- Engage with Government’s Public Bodies review programme, demonstrating our value, impact and the provision of positive outcomes for the public
- Undertake a comprehensive and objective assessment of our impact to understand both our effect on the regulated sectors and how we can deliver increased positive outcomes in the future
- Establish an expert advisory group to contribute to our horizon scanning on emerging developments and innovation in the use of tissues and cells and to inform the direction of travel in the regulation of human tissue now and in the future
Operational Delivery
Be an excellent, modern accountable regulator - efficient and effective, performing and communicating well.
Regulation – fulfilling our licensing, inspection, incident management and approvals functions, and providing technical advice and guidance across the sector:
- Ambitious programme of inspection and other regulatory assessments across our regulated sectors
- Undertaking assessments of new licence applications
- Providing accurate and fit-for-purpose technical advice and guidance to a wide range of stakeholders, including the public
- Structured regulatory responses to reported incidents
- Fulfilling all statutory obligations relating to Living Organ and Bone Marrow donation
- Decision-making and action for identified shortfalls and reported incidents
Undertaking a proactive and responsive cycle of work seeking to facilitate flows of critical information and engagement across stakeholders in accordance with our published Communications and Stakeholder Engagement strategy, including sector-based forums and roundtable events, to strengthen our expert voice as a thought leader, and as a partner in the wider health system
Supporting Department of Health & Social Care, Devolved Administrations and wider government departments with advice and guidance on legislative matters within our remit and related to human tissue and the sectors currently and potentially within future scope of human tissue regulation
Stable technology operations (moving to a shared service model to achieve greater resilience) with appropriate tools and support
Facilitating Board, Committee, and Senior Management functions, providing good governance support and compliance with Government requirements
Administration of corporate compliance operations including governance quality management, Freedom of Information Act requests, critical incident response planning, health and safety, government standards for operations and enquiries
- Undertaking comprehensive data collection exercise(s) from our licensed establishments to inform our understanding of compliance risk and provide an additional source of up-to-date data for our proposed risk tool, RIMI (Regulatory Insight Model and Index)
- Building on 22/23’s ambitious increase in inspection numbers, we will fundamentally reassess how we fulfil our inspection role to be as effective as possible (considering the depth, breadth and format of assessments)
- Continue to support Sir Jonathan Michael’s Independent Inquiry2 with the provision of information and evidence, as required, ensuring that we are suitably prepared to respond to the findings and our own reviews of related issues, including relevant operational and policy work and participating in the wider sector response
- Support and contribute technical advice, as necessary, to the required legislative work and its application to HTA activities to conclude the Retained EU Law Bill
- Support and contribute technical advice, as necessary, to the required legislative work and its application to HTA activities in line with the Windsor Framework
- Gather requirements for an IT strategy that sets the direction for future innovations across all our work
- Review our records management arrangements to maximise our effectiveness
People and capability
Ensure that we have the right people and financial resources to enable us to deliver our organisational goals.
Stable financial operations (where applicable through shared services to achieve value for money) with balanced budgets and unqualified accounts
Coordination of appropriate organisation controls to facilitate scrutiny and oversight by stakeholders
Stable people operations (moving to a shared service model to achieve greater resilience) with support and guidance for colleagues
- Review our Finance system with an intention for an updated solution that includes ‘procure to pay’ and expenses functionality
- Start developing a People strategy that sets the direction for our organisational development and builds on the values and behaviours work from 22/23
- Review our performance management processes to ensure they are fit for purpose and drive us to be efficient and effective
Moving forward
Modernise how we regulate with better use of data and analytics, more risk-based prioritisation and joint endeavours.
- Comply with the Government’s Data & Security Protection Toolkit, ensuring our effectiveness in information security and providing assurance internally / externally
- Develop our Regulatory Insight Model and Index (RIMI) such that data becomes a driver for our regulatory practices and decisions
- Start the outsource of Information Technology on a shared services model, such that we are better able to innovate
- Outsource Human Resources on a shared services model, such that we are better able to innovate
Finances
The HTA receives funding from two main sources. The majority (over 80%) comes from licence fees, with the remainder provided as grant-in-aid from our sponsor, DHSC. We also receive a small amount of income for undertaking activities on behalf of the Devolved Administrations.
The licence fee income pays for a range of activities associated with our licensed establishments:
- evaluating licence applications
- making licensing decisions and issuing licences
- processing variations to licences
- conducting site visits and following-up shortfalls
- taking regulatory action
- providing advice and guidance to licensed establishments.
Grant-in-aid funds our role in assessing living organ donations and bone marrow / peripheral blood stem cell donation cases and a proportion of our overheads that are not directly associated with our work with licensed establishments.
We place great importance on ensuring that our finances are managed efficiently, effectively and in a way that minimises risk.
As an arm’s length body, we continue to monitor developments in the wider public sector financial environment and are committed to implementing best practice. We have robust financial procedures and policies in place and strict controls in relation to authorisation of expenditure.
The high-level budget for 2023/24 is shown below:
| 2022/23 | 2023/24 | |
|---|---|---|
| EXPENDITURE | ||
| TOTAL STAFF COSTS | 4,207,576 | 4,255,675 |
| TOTAL OTHER COSTS | 131,000 | 170,500 |
|
TOTAL CORPORATE SHARED SERVICE COSTS |
1,042,521 |
1,109,806 |
| TOTAL EXPENDITURE | 5,381,097 | 5,535,981 |
| INCOME | ||
| TOTAL CENTRAL FUNDING | 1,177,694 | 1,003,243 |
| TOTAL LICENCE FEES | 4,145,979 | 4,481,231 |
| TOTAL OTHER INCOME | 57,424 | 51,507 |
| TOTAL INCOME | 5,381,097 | 5,535,981 |
Capital
Our capital investment plans for 2023/24 are based on our cyclical refresh of equipment. As a result, we will limit our expenditure to our normal delegation of Capital Funds from DHSC once confirmed.
Efficiency and productivity
We remain committed to seeking benefits from continuous improvement initiatives and delivering value for money for both the public and the establishments we licence. Following many years of making efficiencies, we are a very lean organisation. We remain committed to delivering our core functions to a high standard, finding further efficiencies in the way we work, where possible, and to the importance of focusing on outcomes that really matter to the public and professionals.
Shared services
We continue to operate our financial resources function as part of a shared service. Having moved to office premises in Stratford, we are now co-located with 4 other Health Sector regulators. We are seeking to explore further potential for sharing services with these bodies to improve organisational and operational resilience.
Monitoring and measuring performance
We operate a Portfolio Management approach to business planning and performance management. This has allowed us to re-evaluate our performance measures to ensure that we can transparently demonstrate our delivery against stated objectives and plans. We account for our performance on a quarterly basis to the Board and to DHSC. The information we use to demonstrate our performance can be found in the “Authority Meetings” section of our website.
- When we refer to human tissue legislation, we mean human tissue legislation that is within the HTA’s remit. This currently includes (but may not be limited to in the future):
- The Human Tissue Act 2004 (“the Act”)
- The Human Transplantation (Wales) Act 2013
- The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (“the 2007 Regulations”)
- The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended) (“the 2012 Regulations”)
- Additionally, the Scottish Government has delegated certain functions to the HTA under The Human Tissue (Scotland) Act 2006.