Human Tissue Authority Business Plan 2021-22

The Human Tissue Authority (HTA) is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care, established by the Human Tissue Act 2004.

Our overall goal is to maintain public confidence by ensuring that the removal, storage and use of human tissue and organs are 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).

We also have a role in maintaining professional confidence; by assuring that human material being used by professionals has been obtained with the proper consent and is managed with appropriate care.

Our role

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, our legislation. This is particularly important in

areas of emerging technology and cutting-edge research not originally envisaged when the Human Tissue Act was enacted.

Our remit

• Removal, storage and use of human tissue and organs for a number of activities and scheduled purposes as set out in the Human Tissue Act 2004, such as post-mortem examination, anatomical examination, research, transplantation and public display.

Guiding principles

• Procurement, testing, preservation, processing, storage, distribution, import and export of tissues and cells for use in patient treatment (human application).
• Donation, testing, characterisation, procurement, preservation, transport, transplantation and disposal of organs for transplantation.

Our remit under the Human Tissue Act 2004 extends to England, Wales and Northern Ireland; however, we also carry out some activities in relation to the approval of living organ donations on behalf of the Scottish Government. Our remit as the Competent Authority for the quality and safety of tissues, cells and organs used in transplantation extends to the whole of the UK.

We license over 800 premises across the six sectors that we regulate 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

Our values as an organisation in carrying out our role, expressed in all interactions are:

• 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.

Key activities

We group our key activities into three themes:

• Delivery - how we achieve our strategic objectives today.
• Development  how we will improve in the future.
• Deployment - how we effectively use our people and resources.

Through these themes, our strategy sets out the ways in which we will strive to be a more resilient, sustainable and agile organisation in order to meet the challenges ahead.

 

In reviewing the strategy for the coming three-year period (2021 to 2024), the Board and the Executive recognised that there is further to go in the strategic ambitions we first set out in 2018. As a result, the core underpinnings of our strategy remain unchanged.

Due to the pandemic and the additional pressures this imposed, we took the active decision to take a more incremental approach to our development ambitions than had been envisaged at the start of the three-year strategic period ending in March 2021. We will continue with this incremental approach over the coming year; with every stage of each project building new capabilities, and with active decisions at every step both about making further investment, and about the relative priorities for resource allocation across the whole of the HTA. We refer to this as the Portfolio Management approach and plan to fully embed this way of working by the autumn of 2021.

The HTA, like many organisations, is looking to the future in a world altered fundamentally by the COVID19 pandemic. Over the last three years, our vision has centred on achieving greater sustainability, agility, and resilience across our activities. This will continue to be a focus for the HTA in the coming year.

Sustainability

By sustainable, we mean taking a new approach to recruiting, developing and retaining high-quality staff and working in new ways to reduce the growing pressures on the staff we have.

Resilience

By resilience, we mean adapting our operating model to retain staff for longer and developing strategic alliances with other organisations to put us in a better position to manage unexpected demands.

Agility

By agility, we mean providing a highly responsive regulatory framework that supports innovative uses of organs, tissues and cells, burnishes our reputation as an expert regulator and actively supports innovation in life sciences.

Success will mean retaining alignment with core principles and values, whilst developing our staff in a flexible manner to lead and adapt to innovations in our area of regulation.

In order to meet the challenges ahead we require continued focus on our:

• People - recognising our staff as our key asset, widening the pool of candidates for recruitment and investing in training and development.
• Business Technology - ensuring our systems are not reliant on location and making strategic choices about key business systems.
• Information and data - using information and data as a key strategic resource and meeting our obligations relating to data security.
• Finance - being clear about managing our fee levels based on workload and regulatory effort, including longer term planning to ensure continued financial viability.

This business plan sets out our ambitions for 2021/22. The HTA operates a continuous business planning process - we maintain a pipeline of proposed business activities over a three-year period, which allows us to adapt and plan in response to changes in our operating environment. 

Our overarching aim remains to protect public and professional confidence in the safe and ethical use of human tissue, as set out in our governing legislation. We do this by utilising a combination of regulatory tools, which we deploy according to risk across each of the sectors we regulate.  Our core delivery activities are centred on licensing, inspection (including the use of recently introduced Virtual Regulatory Assessment), incident reporting, assessment of living organ donation, providing advice and guidance, and communicating and engaging with stakeholders. 

We have a long-established culture of working with establishments to ensure that they meet our standards, targeting our resources at the areas of greatest risk to patient safety and public confidence.  We encourage improvement through the provision of high-quality advice and guidance and sharing best practice, publishing our inspection reports so we are transparent about our findings, and so that others can learn.  When things go wrong, we ensure that establishments take appropriate action, including measures to prevent future incidents from happening. 

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 network of Designated Individuals and Persons Designate are vital partners in our regulatory framework, and we continue to engage and work with those in key roles across the sectors we regulate. 

Areas of particular focus for 2021/22 include: 

Core regulation 

We anticipate that site visit inspections will be re-introduced over the course of the year, focussing on areas where regulatory risk are considered the greatest, and where we have a legal obligation to undertake site visits. We will continue to embed Virtual Regulatory Assessments (VRAs) as a regulatory tool to be used in place of, or to complement site visits.  

Development Programme 

We will continue with our incremental approach to achieving our development goals, making progress to define both the “as is” and “to be” of our operating model, and building on the proof of concept work for the Regulatory Insight Model and Index. We will also build on our core business systems paving the way for use of an Electronic Content Management System. 

Optimising the use of our new offices 

We have now taken up residence in new purpose built offices in Stratford. Although many staff are no longer on office-based contracts, we will be looking at ways of using the space to come together for collaborative work and to strengthen the culture of the HTA. We will also be looking to use the opportunity of co-location with other Health Sector regulators to build partnerships and collaborations which benefit patients, the public and those we regulate. 

Supporting innovation in the life sciences 

We will be taking an active role in the various system-wide initiatives which support the Government’s priority for making the UK a world-class environment for innovation in the life sciences. We will also run a series of our own round-table events focusing on barriers to innovation in our current legislation, and which look at legislative and non-legislative options for overcoming them. 

Advising on proposals for new legislation 

The Organ and Tissue Donation (Deemed Consent) Bill was introduced to the Northern Ireland Assembly in 2021 with the expectation that the Bill would be passed into law in Spring 2022 subject to Assembly approval. The HTA will produce a Code of Practice which provides advice for practitioners operating under the new law. 

We will also provide briefing to support the parliamentary stages of the Organ Tourism and Cadavers on Display Bill.  

The HTA’s high-level aims, objectives and high-level milestones and deliverables for 2021/22 are set out in this section.  

Delivery 

To deliver the right mix of activity to maintain public and professional confidence in the safe and proper use of human tissue 

Our Delivery objectives for 2021/22 are to: 

1. Deliver a risk-based, data-driven and proportionate programme of licensing, inspection and incident reporting, targeting our resources where there is most risk to public confidence and patient safety.  
2. Deliver effective regulation of living donation.  
3. Provide high-quality advice and guidance in a timely way to support professionals, Government and the public in matters within our remit.  
4. Be consistent and transparent in our decision making and regulatory action, supporting those licence holders who are committed to achieving high quality and dealing firmly and fairly with those who do not comply with our standards.  
5. Inform and involve people with a professional or personal interest in the areas we regulate in matters that are important to them and influence them in matters that are important to us.  
6. Maintain our strategic relationships with other regulators operating in the health sector. 

During 2021/22, we will: 

1. Undertake a risk-based programme of assessments, both on site and remotely, which provide assurance that standards are being maintained; 
2. Continue to use our knowledge of risk in each sector to inform the delivery of the right mix of regulatory tools to support and superintend compliance; 
3. Take a proportionate and risk-based approach to non-compliance, and ensure where there are shortfalls against standards, these are rectified within agreed timescales; 
4. Ensure that decisions on living organ donation cases meet agreed service standards in a way that provides the necessary protections; 
5. Produce a revised Communications and Stakeholder Engagement Strategy which will set out how we will better engage with, and involve, public, Government and professional stakeholders in our work using a wide variety of channels; 
6. Provide high quality and timely responses to enquiries from professionals, the public and the media; 
7. Provide policy interpretation of HT legislation and give advice to support the passage of new legislation as required by Government and the Devolved Administrations. 

Development 

Make the right investment to continuously improve delivery and deployment 

Our development objectives for 2021/22 are to: 

1. Develop and begin to implement our future operating model, which builds our agility, resilience and sustainability as an organisation.  
2. Make continuous improvements to systems and processes to minimise waste or duplicated effort, or address areas of risk.  
3. Increasingly use data and intelligence to provide real time analysis, giving us a more responsive, sharper focus for our regulatory work and allowing us to target resources effectively.  
4. Provide an agile response to innovation and change in the sectors we regulate, making it clear how to comply with new and existing regulatory requirements.  
5. Play a greater system-wide role in supporting innovation in the life sciences.  

During 2021/22, we will: 

1. Further plan, develop, and implement a set of prioritised projects within the HTA Development Programme. 
2. Define both the “as is” and “to be” of our operating model and begin to implement the new model in a phased way. 
3. Build on the proof of concept work for the Regulatory Insight Model and Index.  
4. Embed business technology changes already made to support continued high-quality delivery of our functions. 
5. Complete the Website Development Project ensuring an improvement in accessibility standards. 
6. Take an active role in system-wide initiatives which support the Government’s priority for making the UK a world-class environment for innovation in the life sciences.  
7. Run a series of round-table events focusing on barriers to innovation in our current legislation, and identify options for overcoming them. 

Deployment 

Make the most effective use of people and resources in pursuit of our goals 

Our deployment objectives for 2021/22 are to: 

1. Manage and develop our people in line with the HTA’s People Strategy  
2. Ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money  
3. Provide a suitable working environment and effective business technology, with due regard for data protection and information security  
4. Plan and prioritise our resources to carefully balance activity across the organisation  

In 2021/22, we will: 

1. Embed a new Portfolio Management approach for planning, allocating resources and monitoring organisational performance. 
2. Continue to prioritise staff health and wellbeing in response to extended remote working and the impact of the pandemic. 
3. Take a planned approach to using the new office space, and use this as an opportunity to strengthen the working culture at the HTA with a particular focus on further embedding the HTA Values. 
4. Continue to build on the HTA’s practices to ensure Equality, Diversity and Inclusion in the workplace. 
5. Review our current fees to ensure the costs to regulated establishments are fair and proportionate. 
6. Further embed information governance and cyber security good practice within the organisation. 
7. Retender the support contract for our business technology. 
8. Identify opportunities for further sharing of service that stem from collocation with other Health Sector Bodies. 

Our people 

	Q1	Q2	Q3	Q4
Starting count – payroll	45	44	48	49
Starting count – non-payroll	1	1	3	4
Expected transfers in – payroll	2	5	1	4
Expected transfers out – payroll	4	1	3	3
Changes in non-payroll staff	1	3	1	0
TOTAL at end quarter	43	48	49	51

As a small, expert regulator, the HTA has long recognised a strategic risk related to staff recruitment and retention – in particular, our vulnerability to the loss of experienced staff undertaking our frontline regulatory work. In response to this risk, we implemented our People Strategy, which has made good progress in mitigating our human resource risk through initiatives such as flexible working and a career development scheme. However, the ability to recruit high-quality candidates, and retain and develop staff expertise, remain significant areas we need to address to improve our resilience and sustainability.  

In 2021/22 we will continue to strengthen our framework to support remote working and will focus on ensuring that the well-being of our staff is maintained. We will also use the opportunity provided by taking up new office premises to build new ways of working and to strengthen our organisational culture. 

During 2021/22, it is expected that: 

• the HTA will have 3.5 Full-Time Equivalents (FTEs) who are classified as executive senior managers, within the total of 51 FTEs;
• there will be 2 FTE Human Resources members of staff within the full complement of 51 FTEs;
• the training budget will equate to around 1.5 per cent of the pay bill. 

Any non-payroll staff will be subject to defining programme requirements for the Development Programme and will likely be limited in their duration of engagement. 

Finances 

The HTA receives funding from two main sources. The majority (80 per cent) comes from licence fees, with the remainder provided as grant-in-aid from our sponsor, the Department of Health and Social Care. 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 2021/22 is shown below: 

Total Staff costs	3,513
Estates costs	221
Other costs	1,178
Non-cash costs	78
Total Costs	4,990
Total Income	4,990

Efficiency and productivity

As an organisation, we remain committed to seeking benefits from continuous improvement initiatives and delivering value for money for both the public and the establishments who we licence. We also recognise that 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 the importance of focusing on outcomes that really matter to the public and professionals. Our recent relocation has enabled the organisation to reduce its operating costs by over 5% in the 2021/22 financial year. 

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 collocated with a number of other Health Sector regulators. We will be using this as an opportunity to explore further potential for sharing services with these bodies with the goal of improving organisational resilience. 

Capital 

Our capital investment plans for 2021/22 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 the Department of £100k (which has not yet been confirmed at the time of publication). 

Monitoring and measuring performance 

During 2020/21, the pandemic made our usual methods of tracking performance less effective and KPIs less relevant. We have this as an opportunity to review our approach to planning and allocating resources and to monitoring performance. During 2021/22 we plan to introduce a new Portfolio Management approach which will include proposal for a new suite of management information and new KPIs to provide assurance to external stakeholders.  

We account for our performance quarterly 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.