Business plan 2022-23

Ensuring human tissue and organs are handled, used and stored safely and ethically, with proper consent, is at the core of what the Human Tissue Authority does. In delivering a regulatory framework to that goal 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.

I joined the HTA in January 2022 and have been impressed with the work of the organisation and the positive light in which our stakeholders view us. This is important to maintain public confidence in the sector through effective regulation.

The HTA, like the sectors it regulates, has needed to respond to the challenges posed by the pandemic, adopting different approaches. As we hopefully move to a new period of living and working with Covid, we are considering how we combine our old and new regulatory approaches and, during 2022/23, we will be seeking to develop a revised approach that provides improved oversight across the sectors we oversee.

2022/23 also represents the second year of the HTA 2021-2024 Strategy and, as such, we continue with the main thrust of previously published priorities. However, with fresh eyes I have taken the opportunity to refine our delivery themes, adding an additional theme to capture the activity we are proposing to move forward and develop the organisation. Throughout this business year ,we will undertake further work to refresh our mission and vision, as well as revisit the values and behaviours that underpin the approach by which we operate. It is our ambition to continue to progress, with renewed pace, within the resource envelope available to improve our technology, systems and engagement. I look forward to working with my new HTA colleagues, our Board, the Department and our wider stakeholders and partners, as we seek to support the further development of the Health and Life Sciences sectors.

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 2022/23 to deliver them.

Strategic direction

Over the coming year we will progress activities that support the following:

• Operational business delivery of regulatory service for the sectors we cover.
• Strategic planning for future regulatory requirements including any changes to legislation.
• Accountability to our sponsor Department and support for wider Government objectives relating to life sciences.

This will include taking account of DHSC priorities, with the HTA contributing to the successful delivery of these priorities in the following areas:

• We will help support the UK’s ambition to increase research and development in Life Sciences by providing robust regulatory oversight that provides international assurance that research utilising human tissue is ethical and safe.
• The levelling-up agenda and places for growth strategy –the HTA will support these priorities through its approach to recruiting its workforce across the UK and ensuring that its employees can work in locations outside of London and the South-east.
• We will work with other regulators and the wider health and research communities to share our data to support innovation and collaboration, so that regulatory burdens are minimised through the sharing of assurance data whilst recognising the importance of appropriate and informed consent.
• Consistent with the DHSC Secretary of State’s recent speech entitled the “Road to Recovery” we will re-emphasise performance with the creation of new KPIs (Key Performance Indicators) and new aspects of how we undertake performance management.

Operational delivery

Regulatory oversight

We will undertake a risk based, data-driven, and proportionate programme of regulatory activity. We are planning to increase the number of establishments we inspect this year by using a greater variety of risk-based regulatory and data driven interventions. During 22/23, we will collect data from all establishments we regulate, to inform our risk assessment and risk profiling. We will respond to both reported incidents as well as maintaining active management of all shortfalls we identify from our regulatory reviews.

Governance and finance

We have implemented new and revised approaches to risk management, our business planning and portfolio management process and have developed revised Key Performance Indicators. Over the coming business year, we will be using these tools to refresh our overall approach to Executive and Board reporting, to ensure focussed oversight on the activities outlined in this plan and monitor the performance of the organisation. We will be reshaping the governance function within the HTA, increasing administrative support and appointing to a new Deputy Director role to further develop this function, whilst remaining lean. Our future finances will be a key enabler of our future delivery. We will be looking to further strengthen our in-year reporting to minimise underspends and undertaking a review of budgets and fees for future years with changing activity levels across the different sectors.

Communications and engagement

We will continue to develop and then implement the HTA’s communication and engagement strategy, designed to promote the recognition of HTA as a thought-leader in life sciences regulation and an authoritative voice respected by stakeholders and the public.

Information technology and services

To support our workforce, and to respond to the increasing importance of technology and information systems in our work, we will enhance our existing provision of digital tools and ensure our staff can access services essential for effective operational delivery. We are conscious of the increased cyber risk that all organisations face and will be vigilant and act to keep the data we hold secure and protected from threats.

People and capability

Under the people and capability theme, we will promote a culture of wellbeing so that colleagues can develop and enjoy a healthy balance to their working lives. We will continue to support our staff in their development, welcoming feedback from our colleagues on their working environment and how we can further promote a high performing culture. We will continue to further embed Equality, Diversity and Inclusion in the HTA, across our workforce and our Board.

We have ambitious plans to develop the HTA

The HTA is an organisation that performs well today but we face challenges as the sectors we regulate evolve. We will look to leverage our resources to continue with a sound regulatory regime whilst progressing with our change and improvement agenda. We plan to make significant strides this business year in reviewing the mix between on-site and remote assessments. We will also review the balance between the breadth and depth of our inspections as we seek to be more risk-based and proportionate. This will also require us to enhance our technology and data tools, as well as consider whether our fees model accurately recovers the cost of regulation from those areas that drive our expenditure.

With these ambitions guiding our approach to our core regulatory activity and change programmes, the HTA seeks to continue to maintain public confidence across our regulated sectors.

Our goal is to maintain public and professional confidence by ensuring that the removal, storage and use of human tissue and organs is undertaken safely and ethically, and with proper consent, in accordance with the provisions of the Human Tissue Act 2004, Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended).

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 involved in preparing tissues and cells for use in patient treatment as required by the Human Tissue(Quality and Safety for Human Application) Regulations 2007.
• We license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
• 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 2004covers England, Wales and Northern Ireland and under other human tissue regulation includes England, Wales, Northern Ireland and Scotland.

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):

1. The Human Tissue Act 2004 (“the Act”)
2. The Human Transplantation (Wales) Act 2013
3. The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (“the 2007 Regulations”)
4. The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended) (“the 2012 Regulations”)
5. Additionally, the Scottish Government has delegated certain functions to the HTA under The Human Tissue (Scotland) Act 2006.

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

As we revisit our vision and mission, we will also refresh our values for the role we play as we seek to be more inclusive and further improve performance. Meanwhile, we seek to work within our values:

• Professionalism -the high standards we apply in the conduct of our individual and collective responsibilities.
• Respect proper regards for the abilities and perspectives of others.
• Expertise -the skills, knowledge and experience we apply for the benefit of our stakeholders and each other.
• Agility -rapid and positive response to changes in the internal and external environment without losing momentum.

Our strategic approach is based on being clear about the risks we are regulating, and then being proportionate and targeted in response. We have previously grouped our key activities into three themes-Delivery, Development and Deployment. Whilst we feel these remain broadly correct, we have taken the opportunity to reframe them and add a fourth.

Key Themes

Delivery - How we achieve our strategic objectives today. This will become operational delivery, which will maintain a similar focus on the core regulatory and assurance functions of the HTA. We seek to be an excellent, modern accountable health regulator, efficient and effective, performing well and willingly open to scrutiny by colleagues, stakeholders and the wider population, and hence enjoying high levels of public trust.

Development - How we will improve for the future. This will become Strategic Direction, with a narrower focus on our overarching strategic approach to the HTA’s remit and methodology and how we are more active as a sector leader.

Deployment - How we effectively use our people and resources. This will now become people and capability, with a renewed focus on recruiting, retaining and developing our people and how we might re-imagine our organisational structure to increase agility and responsiveness to emerging activities. This will include ensuring our culture matches what is needed for us to excel. It is also focussed on supporting colleagues to be proactive, agile, high-performing and engaged; able to see the bigger picture and understand how best they can contribute to our organisational goals.

Moving Forward -  How we modernise to regulate with better use of data and analytics, more risk-based prioritisation and joint endeavours with other regulators and other relevant parties.

This refreshed approach does not look to change the strategic objectives we agreed with the Board and DHSC for 2021 /24. We will continue with our strong focus on developing our regulatory model and tools, and on innovation, to better use our data and share it more widely with trusted partners. We will continue to use our position within the system to be a key voice in the life sciences landscape, developing better strategic relationships with other regulators and with partner bodies. We will continue to support the Government’s ambition of making the UK a world-class environment for innovation in the life sciences.

The HTA will co-operate fully with Sir Jonathan Michael’s independent inquiry into the offences committed at the Maidstone and Tunbridge Wells NHS Foundation Trust. In our initial response to the DHSC Secretary of State, we committed to review our current regulatory frame work in the Post Mortem sector and consider revisions to regulatory tools or standards. We will continue to provide information in support of the Fuller independent inquiry.

The Organ and Tissue Donation (Deemed Consent) Bill has completed its passage through the Northern Ireland Assembly in 2021.The HTA will continue to work with the NI Assembly to bring forward the implementation of this legislation during the 22/23business year.

Strategic direction

Over the coming year, we will progress the following strategic priorities:

• Finalise a revised Framework Agreement with our sponsor Department by the end of June 2022
• Develop HTA's role and participation in Life Sciences and other cross regulatory work including identifying the top 10 policy issues facing the HTA, informed through our improved Horizon Scanning capability throughout the year.
• Develop further our legislative review register to include a robust set of proposals for legislative change based on technological change and cutting-edge research and ensure interim management of the operational and strategic risks we identify throughout the year.
• Develop our business plan, to be produced annually with Board sign off in advance of the new Business year by the end of March 2023.

Moving forward 

In addition, we will be undertaking a series of activities in support of our change and improvement agenda. 

• Develop and publish a Vision and a Mission Statement for the HTA that clearly articulates our role and ambition by the end of June 2022.
• Revisit our organisational Values & Behaviours to align them to our Vision and build on existing organisational strengths by the end of December 2022.
• Work to refresh of our corporate strategy for the next 3 years, aligning this with our new vision and mission by the end of December 2022.

Operational Delivery

Regulatory oversight.

• Implement a revised, forward-planned programme of inspection / Virtual Regulatory Assessments across our regulated sectors throughout the year.
• Adopt a consistent, structured and effective regulatory responses to reported incidents throughout the year.
• Fulfil all statutory regulatory obligations relating to Living Organ and Bone Marrow donation within agreed timescales throughout the year.
• Ensure consistent and transparent decision-making and regulatory action for identified shortfalls and reported incidents throughout the year. 
• Respond to and support the Fuller Independent Inquiry into offences committed at the Maidstone & Tunbridge Wells NHS Foundation Trust throughout the year. 
• Undertake compliance data collection across all our licensed establishments by the end of December 2022.

Governance and finance

• Provide support to, and further develop, reporting and governance processes aimed at ensuring Board oversight of HTA activity throughout the year.
• Deliver a balanced income and expenditure position for 2022/23 whilst fully supporting our strategic and operational activities by the end of March 2023.
• Meet all statutory reporting and quality requirements in line with governance standards for arms-length bodies throughout the year. 

Communications and engagement

• Finalise and publish our revised Communications & Stakeholder Engagement strategy and programme of activity by the end of June 2022.
• Establish a stakeholder engagement framework and schedule of activity to include roundtables, stakeholder groups and an annual conference throughout the year.
• Generate and publish content to maintain and promote patient safety and public confidence in the use of tissues, cells and organs throughout the year.

Information technology and services

• Review our digital, data and technology strategy, creating a new strategy for development and delivery of required technology and systems to support priorities and objectives by the end of July 2022. 
• Ensure operational maintenance of IT systems including the provision of first line support, the management and replacement of IT equipment and exploring the replacement of core systems throughout the year
• Develop further our cyber security and assurance approach and reporting – to include day-to-day monitoring and detection, providing assurance to our Board, Audit Committee and external bodies throughout the year. 

Moving forward

• Undertake a review of our regulatory inspection model, to consider the scope of our assessment process and consider the balance we should strike between on-site and virtual assessments by the end of November 2022.
• Develop and implement a programme of reviews and updates to our Codes of Practice by the end of July 2022, then throughout the year.
• Implement our Communication & Stakeholder Engagement strategy between September 2022 and March 2023.
• Strengthen the use of data, providing insight to areas of risk, improvement, and operational effectiveness through the continued development of the Regulatory Insight Model & Index (RIMI) by the end of November 2022.
• Review the HTA’s funding model in line with proposed changes to regulatory focus and organisational structure, including assessment of the organisation’s future resource requirements by the end of December 2022.

People and capability

• Deliver a clear and robust People Strategy to support staff through their career and that enables the delivery of the HTA objectives by the end of September 2022.
• Provide a new toolkit to support line managers and employees in the performance management process, including the rollout of 360 feedback tools to the wider organisation March 2023. 
• Continue with the work set out in the HTA people plan, providing support and training opportunities to staff, including ways of working, personal and professional skills, and partnership working throughout the year.

Moving forward

To maintain capacity and capability to deliver our strategy and our core statutory duties we will begin the delivery of our people strategy to further improve our offer to current and future staff. We will invest further work to enable us to understand the current skills of our workforce and identify our future skills needs to ensure we can adapt to future changes in our approach to regulatory delivery. 

• Commence delivery of our People Strategy by the end of January 2023.
• Complete a workforce skills audit of current staff, roles and organisational structure, identifying future skills required and options for delivery based on a gap analysis assessment against future needs By the end of March 2023.

The HTA receives funding from two main sources. The majority (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. 

Capital  

Our capital investment plans for 2022/23 are based on our cyclical refresh of Information Technology equipment.  As a result, we will limit our expenditure to our normal delegation of Capital Funds from DHSC of £80k. 

Efficiency and productivity 

We remain committed to seeking benefits from continuous improvement initiatives and delivering VFM 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 resources function as part of a shared directorate with the HFEA. Having recently taken up new office premises in Stratford, we are now co-located with 4 other Health Sector regulators. We will be seeking to explore further potential for sharing services with these bodies to improve organisational resilience.  

Monitoring and measuring performance  

We have introduced a new 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. 

Expenditure

Income