HTA Business Plan 2026/27
Our Business Plan sets out our priorities for the business year 2026 to 2027.
Foreword
Dr Colin Sullivan, Chief Executive
The Human Tissue Authority (HTA) is working to ensure that human tissue, cells and organs are handled with dignity, used with the proper consent of those involved, and stored safely. That’s what we’ll continue to pursue in an environment of ongoing change and multiple technical advances. We aim to be an excellent, modern and accountable regulator dealing proportionately with the sectors we oversee today, whilst preparing for future regulatory challenges.
In recent years, we modernised our approach to regulation whilst delivering a comprehensive licensing and inspection programme for the establishments we regulate. In 2024/25, we set out our current three-year Strategy, challenging ourselves to regulate the sectors we oversee yet more proportionately by deploying a different selection of regulatory tools and engaging collaboratively with partners and stakeholders to work together for the public good.
We set and oversee the required standards through our regulatory approach and it is the responsibility of licensed establishments to ensure their policies, procedures and practices are compliant. If we find shortfalls in practice, we will be open and transparent in our findings and in the steps we take to maintain the confidence of the public and professionals working in the life sciences and across the broader healthcare system. The complexity of activities particularly in the Research and Human Application sectors means we are not regulating in isolation. Collaborating with other regulators and assessment bodies, we seek to ensure our regulatory framework is proportionate, supports the achievement of set standards and does not hinder or stifle innovation or development.
Our Business Plan for 2026/27 represents year three of our three-year strategy, in which we will deliver on our ambitions to achieve our vision and mission in the most innovative, effective and value for money ways possible. We have built this Business Plan around our four strategic themes; Approach to Regulation, Trust and Confidence, Use of Information and Efficient and Effective, capturing both core operations and change activities.
In the Plan we have included an explicit MoSCoW prioritisation in terms of strategic alignment for the various change activities that we are proposing, so that we are being realistic about which items we are able to commit to, and to enable us to manage the Business Plan in a flexible way across the year:
- Must do – firm commitments for the year, often with an external or essential requirement
- Should do – items that we intend to progress during the year and will focus on
- Could do – items that we hope to be able to progress during the year, if we are able to
- Won’t do – items that we have had to deprioritse (not listed).
We will continue to use active Portfolio Management as the dynamic means through which we deliver, manage and report on our Business Plan, tracking progress through successful completions of change activities and Key Performance Indicators. Our agile Portfolio Management approach aligns with the Government’s Functional Standard for Project Delivery. We are publishing our Key Performance Indicators for 2026/27 in this document to ensure that our performance can be scrutinised.
During the year, we will:
- Maintain flexibility in resource allocation
- Respond quickly to environmental changes
- Adjust the Business Plan throughout the year if appropriate
- Make decisions to start, pause, stop or change work as necessary.
We have set an ambitious agenda and will seek to deliver on it, collaborating with our partners to achieve the best possible outcomes. For 2026/27 we are challenging ourselves to fulfil our role efficiently and effectively in line with our statutory obligations under the Growth Duty. This means considering the impact of our activities on economic growth, aiming for proportionate risk-based regulation and supporting innovation. We also commit to working with Government to contribute to the 10 Year Health Plan, the Life Sciences Sector Plan and other relevant central initiatives.
Executive summary
The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care (DHSC) and established under the Human Tissue Act (2004). Our overall goal is to maintain public confidence in the removal, storage and use of human tissue and organs, and to ensure that these activities are undertaken safely and ethically, and with proper consent. This Business Plan sets out our strategic themes and the work we will do during 2026/27 to deliver them.
Our approach to regulation
In 2026/27, we will look to focus our attention on developing our regulatory practices, achieving the challenging Key Performance Indicators that we have set including a comprehensive programme of compliance assessments. We will also continue our innovation in inspection work to hone and refine our operational regulatory compliance tools and techniques, whilst also strengthening our approvals processes for living organ donations and progressing preparations for changes to legislation around Substances of Human Origin. In addition, we will support the implementation of those recommendations from The Independent Inquiry into the issues raised by the David Fuller case that the Government wishes to progress.
Building public trust and confidence
A key priority for 2026/27 will be to continue to build public trust and confidence in our ability as a regulatory body. To this end we will complete our initial review of our own Codes of Practice to assure ourselves and our stakeholders that they are reflective of best practice, and will continue to progress our multi-year work to deliver an updated suite of these resources. As part of delivering our specific commitments for 20262/7, we will continue to refine our website content and ensure that we are communicating effectively, and will operate in a transparent and helpful way.
The use of data and information
The early part of 2026/27 will be an important time for us from a technology perspective, as we conclude important work to move our Customer Relationship Management System to the cloud, so that we improve our resilience and maintain our operational capabilities. Over coming years we intend to focus keenly on digital innovation, and in 2026/27 we will start developing our thinking around strengthening and wherever possible digitalising and automating our operations, beginning with work on our approach to licensing.
Being an efficient and effective public body
Similarly, ensuring that our supporting functions are high performing and efficient is vital for a small organisation with an important role to fulfil. We commit to achieving corporate value for money and operating as an exemplar of public sector performance. In 2026/27 we intend to complete the upgrade of our finance system and undertake year two of our ambitious People Strategy to ensure that we are supporting our colleagues and enhancing the offer to staff. We recognise the importance of valuing our people, in terms of both staff retention and the recruitment of new colleagues when opportunities arise.
Introduction
Our Vision
The safe and trusted use of human tissue. (We will help achieve this through delivering on our mission.)
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 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
- We work collaboratively with partners across the healthcare system
- We actively engage with our stakeholders
- We are open and transparent in our publications to maintain public confidence
- We are proportionate in our approach to our work.
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 Scotland. We license over 1,000 premises across six 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 legislation
Our role in the Government's Health Mission
We support the Government’s Plan for Change / 10 Year Health Plan and acknowledge the importance of regulation in supporting the healthcare system's preventative ambitions by ensuring that treatments using human tissue are safe and effective from the outset.
As a specialist health regulator, dealing with very specific aspects of the much wider healthcare system, our operations and activities don’t all map directly to the 10 Year Health Plan, but we have set out the links between our intended work for 2026/27 and broad themes within the Health Plan, to highlight our supporting role:
Policy initiatives: Progressing preparations for the implementation of the new Substances of Human Origin Legislation in Northern Ireland and more widely translating legislation and Government policies into operational practice.
Analogue to digital: Migrating our Customer Relationship Management System to the cloud and digitalising our approach to licensing.
Operating models: Working to strengthen living organ donation approvals and fulfilling our licensing, inspection, incident management and approvals functions.
Transparency: Reviewing, consulting upon and updating our Codes of Practice.
Workforce: Implementing our People Strategy.
Transformation: Innovating in our inspection and wider regulatory activities and greater digitalisation of our processes and interactions with the establishments that we regulate.
Financial foundation: Upgrading our Finance System and focusing on value for public money.
Consistent with the 10 Year Health Plan, our interventions seek to ensure that the use of human tissue is safe from the outset.
Our strategic themes also support the Government’s wider priorities, such as the Life Sciences Sector Plan, and the drive to reduce the burden of any unnecessary regulatory activities.
We are focused on maintaining public trust and confidence within the broader context of maintaining effective regulation in our aspects of the healthcare system during a period of significant reform.
We will continue to support the growth agenda / efficiency drive and will undertake our regulatory activities in a proportionate and ‘right touch’ way.
Our values
Collaboration: We work together to achieve a common goal whilst seeking and valuing diverse perspectives. We share ideas and best practices, striving for excellence collectively. Through active listening and teamwork, we promote a culture of teamwork and collaboration.
Openness: We aim to work transparently, with integrity and accountability for our actions and decisions. Embracing change, we take responsibility and remain honest in our interactions, fostering a culture of boldness and candid communication.
Respect: We respect the diversity of people and value their perspectives, professionalism and skills. Fostering trust and promoting autonomy in decision-making. We will challenge unprofessional behaviour while actively listening and being respectful of others' viewpoints.
Excellence: We strive to deliver excellence through expertise, leadership and collaboration. We are committed to personal and professional development, coaching colleagues, and fostering a culture of learning and growth.
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. Our three-year Strategy is focused around the following four strategic themes.
- Approach to regulation
- Trust and confidence
- Use of information
- Efficient and effective
As we embark on the final year of the current three-year Strategy, we will be bold and ambitious as we focus on efficient delivery whilst striving to develop and innovate even further.
Approach to Regulation
Trust and Confidence
Use of Information
Efficient and Effective
Finances and other information
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
- The on-costs of operating our organisation.
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 2026/27 is shown below:
EXPENDITURE | 2025/26 | 2026/27 |
TOTAL STAFF COSTS | 5,034,465 | 5,548,086 |
TOTAL OTHER COSTS | 193,120 | 245,558 |
TOTAL CORPORATE SHARED SERVICE COSTS | 1,205,469 | 1,105,227 |
TOTAL EXPENDITURE | 6,433,054 | 6,898,870 |
INCOME | 2025/26 | 2026/27 |
TOTAL CENTRAL FUNDING | 475,334 | 479,559 |
TOTAL LICENCE FEES | 5,898,098 | 6,363,311 |
TOTAL OTHER INCOME | 59,622 | 56,000 |
TOTAL INCOME | 6,433,054 | 6,898,870 |
Capital
Our capital investment plans for 2026/27 support the implementation of our Digital and Information Technology Strategy. 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 license. Following many years of making efficiencies, we are a very lean organisation. We are committed to delivering our core functions to a high standard, continuing to be efficient and effective in the way we work, and being mindful of the importance of focusing on those outcomes that really matter to the public and professionals.
Shared services
Having moved to office premises in Stratford, we are co-located with four other health regulators and have outsourced our human resources service. We are seeking to explore further potential for sharing services with these bodies to improve organisational and operational resilience.
Monitoring and performance
We operate a comprehensive Portfolio Management approach to business planning and performance management, linked to the best-practice Management of Portfolios syllabus. This allows us to transparently demonstrate our delivery against our 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.
Risk
We manage organisational risk according to His Majesty’s Treasury Orange Book Management of Risk. As part of this, we maintain both a Strategic Risk Register and detailed Operational Risk Registers, and review these monthly. We report our strategic risks quarterly to the Audit and Risk Committee, Board and DHSC.
The areas of strategic risk that we anticipate for 2026/27 are:
- Operational
- Reputational
- Financial
- Strategy
- People
- Security
Workforce
Going into 2026/27, our budgeted workforce complement for the year was set at 64 FTE (full-time equivalent) staff (by carrying unfilled vacancies there were 61 FTE staff on payroll in February 2026), but we recognise the requirement from DHSC (set in April 2026) to limit our on-payroll headcount to 59 FTE by the end of this financial year. We commit to managing our workforce carefully across the course of 2026/27 to ensure that we meet our statutory duties, maintain regulatory effectiveness, and deploy our resources in the most efficient and effective way that we can, whilst working to achieve the headcount reduction target set by the DHSC Permanent Secretary.
