Last updated on 26 Oct 2022
HTA Strategy 2021-2024
Three years ago, the HTA embarked on a strategy to achieve greater agility, sustainability and resilience in its operations.
The last eighteen months have, without a doubt, been one of the most challenging periods in the HTA’s history and have proved to be a significant test of whether this strategy and the associated delivery plans are proving successful.
The impact of COVID 19 on our stakeholders and staff, and the limitations on undertaking site visit inspections - one of our central regulatory tools - have provided the opportunity to adopt new ways of working and new regulatory tools at pace.
That we have been able to respond to our stakeholders and adopt new ways of working is a testament to the effectiveness of our business continuity and critical incident response plans and to our agility as an organisation.
Most significantly our success over this period is due to the willingness of our staff to do whatever was required to ensure the HTA continued to operate in a way that supported the sectors we regulate.
Strategic review - what we have achieved in the last year
2020/21 was the third year of our three-year strategy cycle and our plans were necessarily adapted to enable us to respond to the changed environment. In adapting our business-as-usual activities the HTA was able to:
- Build on progress already made on more flexible working and improved digital tools to move immediately to a remote working approach. All staff were able to work from home with full functionality of HTA systems available. Governance meetings proceeded as planned through virtual means.
- Respond immediately to changing needs in the regulation of the Post Mortem sector, which has been under particular stress during this period. We introduced a revised emergency licensing process and responded to a significant increase in enquiries and requests for advice relating to mortuary capacity.
- Introduce alternatives means of achieving regulatory assurance in the absence of site visit inspections. We introduced self-assessment questionnaires to provide assurance during the first lockdown which led to the development of a Virtual Regulatory Assessment process that now allows us to undertake a thorough assessment of compliance within establishments. The HTA retained the option to undertake site visits where it was felt there was substantial risk to public confidence or patient safety.
- Work more flexibly across sectors and priorities to allocate resource to where it was most needed.
Whilst rethinking our core business activities over this period, the HTA also achieved a number of strategic development objectives and implemented wider changes in response to the UK’s departure from the European Union and the associated transition. In particular, the HTA successfully delivered:
- Sector readiness of all HTA stakeholders for changes resulting from the UK’s transition from the European Union.
- The full migration of HTA physical servers to cloud based servers, providing more resilience and flexibility.
- The implementation of an upgraded Electronic Document and Records Management System.
- The successful relocation of our physical office from Central London to the new DHSC hub in Stratford, East London.
- New HTA Intranet and Internet sites which meet improved accessibility standards.
Strategy for 2021 to 2024
In reviewing the strategy for the coming three-year period, the Board and the Executive recognised that there is still further to go in the ambitions we first set out in 2018.
Due to the pandemic and the additional pressures this imposed, we took the decision to take a more incremental approach to our development ambitions than had been envisaged at the start of the strategic period. We will continue with this approach over the coming year: every project stage will build new capabilities, and at every stage of every project we will make decisions about further investment, and the relative resource allocation across the whole of the HTA. We plan to fully embed this way of working in the autumn of 2021.
The HTA, like many organisations, is looking to the future in a world altered fundamentally by the COVID-19 pandemic. Over the last couple of 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.
As a result, the core underpinnings of our strategy will remain unchanged although our strategy for the coming period will see a shift in emphasis. In particular, this will be evident in the ambition outlined below for even greater collaboration with our partners and through our desire to play a more influential role in the future of regulation in the Health and Care sector.
As we emerge from lockdown, there will be a stronger focus on two areas:
- Further developing our regulatory model and tools to improve outcomes for patients and the public. In particular: The introduction of new regulatory tools and approaches. A number of our licensed establishments will have already experienced some changes such as to licensing and the roll out of Virtual Regulatory Assessments. These will continue alongside our more traditional site visit inspections as these are gradually reintroduced.
- Internal innovation to target regulatory interventions better. Greater exploitation of advances in data analytics and technology and the pursuit of data sharing between trusted partners to enhance risk insight and to reduce data collection burdens.
Contributing to a life sciences system-wide approach that will promote the UK as a world leading regulatory environment for innovation in the life sciences. We have an opportunity to use our position within the system and our expertise to become a leading voice in the life sciences landscape. In particular:
- Collaboration with other regulators. With the move to our new office premises in Stratford, we will be co-locating with a number of partner organisations. This close proximity will allow us to foster even closer strategic relationships with those regulators working across the health and care sector and we are already playing a leading role in the regulators round table, advising Ministers on future regulation.
- Collaboration with other partner bodies. We plan to improve how we communicate and work with stakeholders so that regulatory considerations are hard-wired into innovation and do not become a barrier or an afterthought. We will also act as a convener amongst system partners to deal with specific challenges of which regulatory issues may form a part.
We will over the coming year be saying farewell to a number of well-established Board Members and welcoming a number of new appointees. We will use this as an opportunity to strengthen our governance arrangements and to improve our focus on our equality, diversity and inclusion.
This will no doubt continue to be a challenging period for us all, but we look forward to working collaboratively with you to protect and improve public confidence and patient safety.
Lynne Berry CBE - Chair to the Human Tissue Authority
Allan Marriott-Smith - Chief Executive of the Human Tissue Authority
About the HTA
The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care, established under 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 both public and professional confidence, by assuring that human material being used by professionals has been obtained with the proper consent and is managed with appropriate care.
- We license organisations that remove, store and use human tissue for activities set out within 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 both within our remit, and in areas related to (but not covered by) our current legislation and advise Ministers on these. This is particularly important in areas of emerging technology and cutting-edge research not originally envisaged when the Human Tissue Act was enacted.
Areas which we regulate
- 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: post-mortem examination, anatomical examination, research, transplantation, public health monitoring, and public display.
- 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 regulator 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 regulatory remit acting within the standards and requirements of the legislation.
Four guiding principles continue to drive our work and underpin our regulatory framework. They should be followed in dealing with human bodies, tissue and organs:
- Consent - and the wishes of the donor (or in some cases, their nominated representatives or relatives) are the primary consideration when removing, storing and using human tissue.
- Dignity - is paramount in the treatment of human bodies and tissue.
- Quality - must underpin the management of human bodies and tissue.
- Honesty and openness - are the foundation of communications in matters pertaining to the use of human tissue and bodies.
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 regard 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.
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 lead and manage our people and how we use our other strategic resources: finances, data and technology
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.
By sustainability, 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.
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.
By agility, we mean providing a highly responsive regulatory framework that supports innovative uses of organs, tissues and cells, strengthens our reputation as an expert regulator, and actively promotes and supports innovation in the life sciences. We also mean working flexibly to dedicate expert resource to where it is most needed.
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 by remote working and investing in training and development
- Business Technology - making long-term decisions about investment in strategic business systems
- Information and data - meeting our obligations relating to data security and using information and data as a key strategic resource
- Finance - being clear about managing our fee levels based on workload and regulatory effort, including longer term planning to ensure continued financial viability
Our strategic approach
Our strategic approach is based on being clear about the risks we are regulating, while being proportionate and targeted in regulating those risks. To achieve this, we take into account the role of professional bodies and other regulators and use the minimum necessary direct intervention to achieve compliance and improvement.
Effective communication is also integral to our strategic approach to ensure that professionals can access advice and guidance from us, and that the public is clear on what they should expect from us and the areas we regulate. How we do this in our daily operation is described in the Delivery section of this strategy.
The HTA has never been an organisation to stand still, and is continually striving to enhance public confidence, better target our regulation, and adapt as an organisation. The Development section of the strategy describes the renewed focus for our development goals during this strategic period to ensure sustainability, resilience, and agility in addition to continuing our programme of continuous improvement.
Neither Delivery nor Development is possible without resources. The Deployment section of the strategy describes how we lead, manage and develop the HTA’s people. It also outlines how we raise and use our finances as well as our plans for accommodation and other key assets.
Our objectives are therefore grouped into three themes. All these aspects will require a careful balance to make the most of our limited resources and ensure success in delivering our overall aim.
- Delivery - to deliver the right mix of operational activity to maintain public and professional confidence.
- Development - to make the right investment to continuously improve delivery and deployment.
- Deployment - to make the most effective use of people and resources in pursuit of our goals.
Our regulatory approach aims to be in line with the principles of better regulation and the Regulators’ Code. This means that we primarily focus our regulation and resources on areas that involve an inherently greater risk to patient safety and public confidence if standards are not maintained.
We employ a range of regulatory tools in order to ensure compliance with the legislative requirements, including licensing, inspection (including remotely), reporting requirements, and the provision of advice and guidance.
The legislation prescribes certain activities that can only be undertaken by a licensed establishment.
We license establishments across six sectors:
- Post Mortem, Public Display, Research, and Anatomy (under the Human Tissue Act 2004)
- Human Application – tissues and cells used in patient treatment (under the Human Tissue (Quality and Safety for Human Application) Regulations 2007)
- Organ Donation and Transplantation (ODT) (under the Quality and Safety of Organs Intended for Transplantation Regulations 2012)
The establishments we license must adhere to our standards, which align to our core principles. We welcome the significant degree of trust that the vast majority of our licensed establishments have in us, as demonstrated by their openness and willingness to improve. As a result, we only use significant regulatory action when it is appropriate and in the public interest.
Inspections and audits
In normal operating conditions we conduct site visits of licensed establishments to assess whether our standards are being maintained. We schedule inspections or audits (in the case of the ODT sector) based on a number of factors, including the legislative requirements, and according to the risk of the activities being carried out.
Since the COVID-19 pandemic we have introduced remote inspections which we refer to as Virtual Regulatory Assessments. These will become a standard part of our regulatory toolkit used either in conjunction with site visits or as a stand-alone activity.
We also undertake non-routine inspections, both announced and unannounced, when we have information which indicates that an inspection may be necessary due to the risks presented.
We require incidents and events which pose the highest risk to public confidence and patient safety to be reported to us by licensed establishments. This reporting, along with issues and complaints about licensed establishments that are raised with us by third parties, allows us to act if required.
Living donation assessment
The HTA maintains a system to ensure that donations of organs or tissue for transplantation from living people are given without duress, coercion, or reward. The system relies on donor and recipient interviews, undertaken by a group of independent and accredited assessors. They are predominantly volunteers whom we train, accredit and support in order to fulfil our statutory functions. Complex cases are reviewed by panels, made up of HTA Board Members.
Advice and guidance
We provide advice and guidance to both the public and professionals, and recognise the value in supporting establishments to comply, rather than dealing solely with non-compliance. We publish Codes of Practice and sector specific advice and guidance, as well as answering individual enquiries from establishments and members of the public.
Communication and engagement
We recognise communication as a key component of effective regulatory delivery. We utilise a range of channels to communicate with professionals, the public, and key stakeholders to ensure that there is confidence in HTA regulation and in the services being regulated. We share learning gained through our newsletters and publications and aim to use our regulatory insight to provide guidance that promotes compliance and provides clarity for our stakeholders on how to meet our regulatory expectations. We engage through stakeholder groups to ensure we make decisions that take into account, as far as possible, the operational realities faced by professionals and the concerns of the public. We also engage virtually via our public panel.
During this strategic period, we will undertake a fundamental review of our Communications and Stakeholder Engagement Strategy to ensure that we have the right engagement with our stakeholders in pursuit of our own objectives and shared goals, using the most effective channels.
Working with other organisations
Many of the establishments within our remit are also regulated or accredited by other bodies. We continue to see collaboration that produces joined-up results, reduces costs, and lessens regulatory factors as a key tool for achieving benefits for professionals and the public. . The HTA has bilateral agreements with organisations across the areas we regulate. We will look to build on these through opportunities to strengthen both formal and informal working arrangements.
- 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.
- Deliver effective regulation of living donation.
- Provide high quality advice and guidance in a timely way to support professionals, Government and the public in matters within our remit.
- 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.
- Inform and involve professionals and the public in matters that are important to them and influence them in matters that are important to us.
- Maintain and further develop our strategic relationships with other regulators operating in the health sector.
In the period covered by this strategy, we will:
- Ensure that new applications meet appropriate standards before issuing a licence.
- Further utilise our knowledge of risk in each sector to apply the right mix of regulatory tools to support compliance.
- Undertake a risk-based programme of inspections which provide assurance that standards are being maintained, returning to site visit inspections when conditions allow and are deemed necessary, and embedding and refining virtual regulatory assessments.
- Publish exception-based reports of inspections in the interests of transparency and to share learning.
- Take a proportionate and risk-based approach to non-compliance, and ensure that where there are shortfalls against standards, these are rectified within agreed timescales or escalated appropriately.
- Ensure decisions on living organ donation cases meet agreed service standards in a way that provides the necessary protections.
- Engage with, and involve, public and professional stakeholders in our work using a wide variety of channels.
- Use the results of our public evaluation to create awareness of what drives public confidence, what the public are most interested in, and why.
- Seek out opportunities to build new collaborations for the benefit of stakeholders.
To ensure that the HTA’s regulatory approach remains relevant, we actively prepare for the future. We do this through our development activities. Our development goals will continue to focus on building resilience, agility, and overall sustainability through a programme of targeted projects, alongside a plan of continuous improvement.
We see innovation across all the sectors we regulate and actively horizon scan to keep abreast of developments to inform our work, often in collaboration with other organisations. The pace of change requires a highly responsive regulatory framework that supports innovative uses of organs, tissues, and cells while ensuring patient safety and maintaining public confidence.
Where emerging issues can be accommodated within the current regulatory framework, we will work to achieve this with agility, proportionality, and appropriate assessment of risk. Where they cannot, we will advise relevant government, professional, and public stakeholders, and actively consider the use of alternative approaches where this is appropriate to risk.
In the Human Application sector, we will continue to work closely with the Medicines and Healthcare products Regulatory Agency and other regulatory bodies on the Regulatory Advice Service for Regenerative Medicine (RASRM), which we see as a key foundation for the future regulation of novel tissue and cell therapy-based products. As well as helping the sector to navigate the regulatory landscape, this joint working is essential to our ability to remain agile and to regulate effectively in a changing environment.
The Organ and Tissue Donation (Deemed Consent) Bill was introduced to the Northern Ireland Assembly in July 2021 and it is anticipated that the Bill will be passed into law in Spring 2022. The HTA will support clinicians to interpret the new law by producing a Code of Practice.
The Organ Tourism and Cadavers on Display Bill seeks to introduce penalties for UK citizens and residents travelling abroad for organ transplants when it is not clear that donors have given appropriate consent. It would also impose the same consent requirements for imported cadavers used in exhibitions as exist for cadavers sourced from England, Wales and Northern Ireland. The HTA will provide expert advice during the progress of this Bill.
Although in general we see a high level of compliance in licensed establishments, we are continuing to see shortfalls against standards on inspection in some sectors and have identified areas where we could strengthen our oversight. We will use the data and insight that we hold, and close links with key stakeholders, to implement a targeted approach aimed at addressing these issues.
Better use of data and information
We already use data and information to inform our risk-based approach to regulation and have implemented measures to more routinely review and utilise core data. We recognise that we can further improve the quality of our data gathering and analysis. By making better use of automation and technology to manage the data and information we hold, we can identify trends and prioritise and target resources effectively across the organisation and share insight with those we licence to improve compliance.
In addition to seeking continuous improvements to processes, this strategic period will see us continue to invest significant resources in developing our people, data capabilities and technology. Balancing how we use our resources between strategic development, continuous improvement, and core delivery activities will mean a greater emphasis on clarifying priorities, and promoting cohesive, organisation-wide approaches to addressing key business concerns.
Further details on how we will shape our future approach are described in the deployment section of this strategy.
Collaboration and influence
We will reflect our experience of regulating across diverse sectors in submissions and dialogue on the future of regulation. In particular, we will play an active role to support Ministerial priorities around providing a regulatory environment that promotes and supports innovation in the life sciences, whilst also protecting public confidence and patient safety.
We will be available to offer advice and guidance to colleagues across government and those we regulate as and when it is needed and will work in partnership with innovators to advise, guide and shape best practices to drive consistent implementation.
Our development objectives are:
- Use data and information to provide real-time analysis, giving us a more responsive, sharper focus for our regulatory work and allowing us to target resources effectively.
- Make continuous improvements to systems and processes to minimise waste or duplicated effort as well as address areas of risk.
- 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.
- Implement and embed a future operating model, which builds our agility, resilience, and sustainability as an organisation.
In the period covered by this strategy, we will:
- Further plan, develop, and implement a set of prioritised projects within the HTA Development Programme
- Develop and implement our new operating model
- Implement and refine a Regulatory Insight Model and Index
- Embed business technology changes already made to support continued high-quality delivery of our functions
- Complete the Website Development Project, ensuring an improvement in accessibility standards
- Take an active role in system-wide initiatives that support the Government’s priority for making the UK a world-class environment for innovation in the life sciences
- Continue to use our unique position to advise the Government in matters relating to our remit
Our staff are our key asset and are fundamental to successful delivery of our objectives. Our staff surveys continue to give us assurance that the HTA is a good place to work, but also offers insight into areas we can improve. Over the last three years we have made great progress on updating our people strategy, in order to achieve our vision of a more resilient and sustainable organisation.
As we begin to benefit from recruiting staff from a wider geographic pool, we will continue to build on the work we have done to remodel induction and training. This will allow staff to become competent more quickly and means that we will be less dependent on the location of our staff.
As a small, expert regulator, it is imperative that we retain the specialist skills of staff for longer, and that we improve the resilience of standalone roles. We will continue to promote work/life balance and flexible working, with a renewed focus on effective line management, training, and development to make the best use of expert resources.
Our People Strategy, as outlined above largely drives our approach to estates. As an organisation that now works remotely by design, we will continue to focus our efforts on ensuring that our culture and connectivity are maintained.
Our business technology has never been more crucial to the success of the organisation and underpins much of what we set out to achieve. We will support our staff with the technology they need to work effectively and efficiently, in the office and remotely. We also recognise the opportunities for technology, digital, and data to improve the services we offer, reduce burden, and target our resources most effectively.
We take our commitment to information and cyber security very seriously and will strive to meet our obligations under data protection legislation, the National Data Guardian’s data security standards, and relevant UK Government cyber security frameworks.
The HTA is funded through licence fees and Grant-in-Aid from the Department of Health and Social Care. For a number of years, we have worked hard to keep costs down by finding efficiencies, sharing office space, and splitting Director and Head posts with the Human Fertilisation and Embryology Authority (HFEA). Our recent review of the arrangements with HFEA highlighted further opportunities to boost the resilience of both organisations by developing a stronger strategic alliance.
We are aware of the budget constraints faced by many of our licensed establishments and remain committed to living within our means. As part of our sustainability programme, we aim to signal our budget intentions over the next three years, with a view to providing certainty on fee levels for establishments. In this strategic period, we will ensure that our regulatory model ensures that our fee level is kept in line with our regulatory approach. Robust oversight and governance of our organisational change programme will ensure that we use our funds prudently to achieve tangible benefits for our stakeholders.
Our Deployment objectives are to:
- Manage and develop our people in line with the HTA’s People Strategy
- Ensure the continued financial viability of the HTA while charging fair and transparent licence fees and providing value for money
- Provide a suitable working environment and effective business technology, with due regard for data protection and information security
- Plan and prioritise our resources to carefully balance activity across the organisation
In the period covered by this strategy, we will:
- Embed a Portfolio Management approach to running the HTA to ensure clear oversight of allocation of people and financial resources to all parts of our business
- Act on the feedback provided by our staff to address key issues of concern
- Strengthen the management of capabilities we will need to achieve success over this strategic period
- Build on our experience of home working during the pandemic and develop a clear model for how working practices and use of office space are best used to support an effective organisational culture as we emerge from pandemic restrictions
- Strengthen the HTA’s practices to ensure Equality, Diversity, and Inclusion in the workplace
- Continue to refine our information and risk management arrangements
- Assess options for sharing services with co-located bodies to improve resilience across the system
The HTA’s Board is made up of a Chair and nine Members:
- Seven are appointed by the Secretary of State for Health and Social Care;
- One is appointed by the Welsh Cabinet Secretary for Health and Social Services; and
- One is appointed by the Minister of Health in Northern Ireland.
The Board is made up of both lay and professional Members. The professional Members of our board come from medical and scientific backgrounds linked to our work, and the lay Members bring a wide range of business, commercial, academic, and public sector experience.
The Board’s primary role is to ensure that the HTA’s statutory responsibilities are met and discharged effectively. It achieves this by setting the HTA’s strategic direction and providing both support and challenge to an Executive, which is responsible for the delivery of these responsibilities on a day-to-day basis.
While the Executive implements this strategy by way of business plans, there are mechanisms in place by which the Board steers, scrutinises, and reviews performance.
The HTA holds four Board meetings per year, one of which is in public, and an annual strategy away day. These meetings provide the opportunity to assess a range of management information and more detailed reports on progress against elements of the strategy. They also allow the Board to hold the Executive to account for the HTA’s performance.
The Board meetings also provide the main means by which Board Members set the direction on issues of strategic importance that emerge over the course of the year.
The HTA’s Board is supported in its work by two standing committees:
- Audit and Risk Assurance Committee
- Remuneration Committee.
The Executive also holds quarterly meetings with the Department of Health and Social Care to review progress and ensure the effective management of strategic risks.