HTA Strategy 2019-22

The 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 (as amended).
• We license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended).
• We monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our Codes of Practice.
• We use our powers to take regulatory action where we identify non-compliance.
• We assess living organ donations to ensure donors are protected from duress or coercion, and that no reward is offered or given.
• We provide information, advice and guidance to the public and professionals about the nature and purpose of activities within our remit.
• We monitor developments relating to activities within our remit and advise Government on related issues.

In addition to our statutory role we are increasingly called upon to provide advice on areas related to, but not specified in, 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.
• 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 approximately 855 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.

Guiding principles

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

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

• Expertise - being responsive, providing specialist knowledge
• Excellence - focus on achieving exceptional results and inspiring others to do the same
• Integrity - be trustworthy, honest, fair, and consistent
• Respect - have empathy and be impartial; value others’ expertise and experience
• Transparency - be open and collaborative, and involve and communicate effectively

Key activities

In our previous strategy, we described our key activities as grouped within 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

This strategy continues to build on these themes, with a renewed focus on striving to be a more resilient, sustainable and agile organisation in order to meet the challenges ahead. More detail can be found in the Strategic Approach section of this document.

In 2017 the HTA undertook a fundamental evaluation of the extent to which our strategic approach protects public and professional confidence in the proper use, and quality and safety of, human tissues, cells and organs. We based this evaluation on evidence and analysis from a variety of sources, including the views of those working in establishments we regulate, a new evaluation of public opinion, analysis of the data we hold, and the views and opinions of HTA staff and Authority Members.

As a statutory body, our aim remains unchanged. As such, our review focused on evaluating our future operating environment and whether our resources are optimally aligned to where the risks are greatest.

An assessment of the evidence provided us with great reassurance that both the public and professionals think we are on the right track with our regulatory approach. However, the review identified a number of opportunities and challenges relating to our operating environment that will require us to adapt as an organisation.

The pace of innovation in cell, tissue and organ based therapies, in life sciences research, and the use of imaging and artificial intelligence in pathology, all have the potential to impact hugely on the way the sectors we regulate work. Many of these developments were unforeseen when the legislation was framed, and we need to be realistic about the limited opportunity for legislative change.

As one of the regulators operating in the field of life sciences, we are clear that effective, right-touch regulation can make a positive contribution to patient outcomes and economic growth. We are determined to play our role in the ambitious plans set out by the Government through the Industrial Strategy. In this last year we have also contributed to the development of the proposed legislative changes to consent provisions for organ donation in England, and have been fully engaged in preparations for the UK’s exit from the European Union.

We recognise that our staff are our key asset – their skill and dedication lie at the heart of our organisation - and therefore staff recruitment and retention contribute significantly to our strategic risk. As the regulator of six increasingly complex and diverse sectors, and with continued pressure to control our resources, we are acutely aware of the demands this can place on our staff.

Our strategy therefore continues to focus on the steps we need to take over the next three years in order to operate in a more sustainable way by 2021, building in greater resilience and agility in the face of increasing complexity and uncertainty in our external environment. To achieve this we have further refined and shaped our plans for how we need to adapt as an organisation:

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 the Industrial Strategy for 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.

When we launched our new strategy last year we acknowledged that 2018/19 was a transition between the previous 3 year strategy and the new priorities. During the last year we have laid the foundations for changing the way we work. In 2019/20 our business plan will focus on the initial phase of our organisational change programme, and delivering this alongside our core regulatory activity.

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 beyond the South East 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 - 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 work load and regulatory effort, including longer term planning to ensure continued financial viability

Our strategic approach is based on right-touch regulation. This means being clear on the risks we are regulating, being proportionate and targeted in regulating those risks, taking into account the role of professional bodies and other regulators, and using the minimum necessary direct intervention to achieve compliance and improvement.

Effective communication is also critical 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, how we raise and use our finances and our plans for accommodation and other key assets.

Our objectives are therefore grouped into three themes. All of 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 right-touch and 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, reporting requirements and the provision of advice and guidance.

Licensing

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, as amended)
• Organ Donation and Transplantation (under the Quality and Safety of Organs Intended for Transplantation Regulations 2012, as amended)

The establishments we license must adhere to our standards, which align to our core principles.

Inspections or audits

We conduct site visits of licensed establishments in order to assess whether our standards are being maintained. We schedule inspections based on a number of factors, including the legislative requirements, and according to the risk of the activities being carried out. 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, which we believe is a key factor in the high level of compliance we see. As a result we only use significant regulatory action when it is appropriate and in the public interest.

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.

Reporting requirements

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 take action if required. 

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 a range of Codes of Practice and sector specific advice and guidance, as well as answering individual enquiries from establishments and members of the public. We share learning gained from inspections, incident reports and compliance updates through our newsletters and publications.

Living donation assessment

The HTA maintains a system to ensure that donations of organs or tissue for transplantation from living people are given without 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 Authority Members.

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 involve these 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. Our formal groups, which report to the Authority include:

• Stakeholder and Fees Group
• Histopathology Working Group
• Transplantation Advisory Group

We also engage virtually via our public panel and licensed establishment engagement programme, which provide fora for wider participation and further opportunities for those interested or affected by our work to be involved in, and inform, it.

Working with other organisations

Many of the establishments within our remit are also regulated or accredited by other bodies. We continue to see collaboration as a key tool for achieving benefits for professionals and the public that produces joined up results, reduces our costs or reduces regulatory burdens. The HTA has bilateral agreements with the following:

• The Care Quality Commission;
• The Health Research Authority;
• The Human Fertilisation and Embryology Authority;
• The Medicines and Healthcare products Regulatory Agency; and 
• The United Kingdom Accreditation Service.

Delivery objectives

• Deliver a right touch 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 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.
• Maintain 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 site visits which provide assurance that standards are being maintained.
• 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. As outlined in the Strategic Review section, in this three year period our development goals will focus on building resilience, agility and overall sustainability through a programme of more significant organisational change activity, alongside a plan of continuous improvement.

Innovation

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.

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. We will continue to strengthen our regulation through implementation of the recommendations from our recent review of risk in the Human Application sector.

In living organ donation, we are seeing increasingly complex cases and wider use of the UK living kidney sharing scheme, placing pressure on staff resource. Although we have made good progress in increasing the numbers of Independent Assessors, the sustainability of the Independent Assessor framework remains a significant strategic issue, and we will implement further measures to bolster this during 2019/20.

Legislative change

This strategic period will see significant changes to our legislative framework. 

The Organ Donation (Deemed Consent) Act 2019 received Royal Assent on 15 March 2019; when the new law comes into force it will change the legal basis for consent for deceased organ donation in England. Close engagement with public and professional stakeholders will remain a key priority as we make amendments to our Codes of Practice to support the introduction of the new system.

As the Competent Authority for two sets of EU Directives, the HTA will continue to work closely with central Government to prepare for the UK’s planned exit from the European Union, translating any legislative changes into operational practice as smoothly as possible in order to minimise disruption for our licensed establishments.

Improving compliance

Although in general we see a high level of compliance in licensed establishments, we are continuing to see an increase in the number of shortfalls against standards on inspection. We will use the data and information 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, and make better use of, automation and technology to manage the data and information we hold, in order to ensure we identify trends and prioritise and target resources effectively across the organisation.

Organisational change

In addition to seeking continuous improvements to processes, this strategic period will see us invest significant resources in developing our people, business technology and estates planning. 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.

Influencing others

We will reflect our experience of regulating across diverse sectors in submissions and dialogue on the future of regulation, particularly in the context of the Government’s Industrial Strategy and EU Exit. We will be available to offer advice and guidance to colleagues across government and those we regulate as and when it is needed and work in partnership with innovators to advise, guide and shape best practices to drive consistent implementation.

Development objectives

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, or 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.
• Begin work on implementing 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 an organisational change programme.
• Prioritise engagement with stakeholders as we develop amended Codes of Practice to support the implementation of deemed consent in England.
• Continue to implement the recommendations from our evaluation of risk across the human application sector and amend our approach as necessary.
• Further implement measures to improve the sustainability of the Independent Assessor framework.
• Continue to work with central Government and our licensed establishments to prepare for the UK’s planned exit from the EU.
• Continue to develop approaches to engaging with Designated Individuals and licensed establishments as a key tool in ensuring compliance.
• Develop tools to improve how we prioritise and plan regulatory activities and manage resources, including more effective use of information and data.
• Continue to upgrade and develop core business systems, website, and online portal to better meet business needs and the needs of stakeholders.
• Continue to use our unique position to advise the Government in matters relating to our remit.

People

Our staff are our key asset and are fundamental to successful delivery of our objectives. Our staff survey gives us great reassurance that the HTA is a good place to work, but offers insight into areas we can improve. More fundamentally, in order to achieve our vision to be a more resilient and sustainable organisation by 2021, our People Strategy has undergone a fundamental review.

We will develop proposals for widening the pool for recruitment outside London and the South East, and continue to build on the work we have done to remodel induction and training to allow staff to become competent more quickly and be less dependent on location.

As a small, expert regulator, it is imperative that we retain the specialist skills of staff for longer, which is challenging with current financial restraints. 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.

Estates

Our People Strategy, as outlined above will largely drive our approach to estates. We continue to control accommodation costs as far as possible by sharing office space; however, our current lease expires in 2021 and we have undertaken work with the Department of Health and Social Care to identify suitable future accommodation. We would expect these proposals to solidify early in 2019/20.

Expanding our workforce outside London and the South East over this period gives us the opportunity to develop as an organisation that works remotely by design, whilst ensuring that our culture and connectivity are maintained. As well as allowing us to increase the geographic pool from which we recruit, this may also produce rental savings that could be reinvested to address emerging business needs.

Business technology

Our business technology has never been more crucial to the success of the organisation and underpins much of what we set out to achieve. Our new strategic vision will require development of IT architecture, which is not dependent on location, in preparation for a future office move. 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.

Finance

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 sharing 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. To inform this we will undertake a more fundamental review of our fee model in 2019/20.

In 2019/20 we hope to be successful in securing approval for our business case to fund our organisational change programme. This will be funded via accessing existing reserves and will not necessitate an increase in licence fees or Grant-in-Aid. Robust oversight and governance of the change programme will ensure that these funds are used prudently to achieve tangible benefits for our stakeholders.

Deployment objectives

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:

• Act on the feedback provided by our staff  to address key issues of concern
• Build on the remodelling of our training and induction programme
• Identify and strengthen the capabilities we will need to achieve success over this strategic period
• Develop more formal arrangements for greater use of home working to support our recruitment strategy 
• Give greater priority to information management and risk, ensuring that we comply with our requirements under relevant Data Protection legislation
• Implement the recommendations of the shared services review with HFEA to improve the resilience of both organisations
• Improve our video conferencing, online meeting, and collaboration capabilities
• Produce an options appraisal for different models of working as an organisation, which puts our staff at the heart of what we do
• Plan for an office move by March 2021

Accountability

The Authority is made up of a Chair and eleven Members:

• Nine 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 Authority is made up of both lay and professional Members and currently includes an organ donor and a transplant recipient. 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 Authority’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.

Authority members also fulfil a valuable role in contributing to project work and the HTA’s advisory groups, as well as providing counsel on a range of emerging issues. While the Executive implements this strategy by way of business plans, there are a number of mechanisms in place by which the Authority steers, scrutinises and reviews performance.

The Authority 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 Authority to hold the Executive to account for the HTA’s performance.

Standing items reported to the Authority include:

• Chief Executive’s report – to provide an overall assessment of the HTA’s performance and strategic risks
• Delivery report – to provide assurance on the delivery of regulatory activities
• Development report – to provide assurance on the delivery of development activities
• Deployment report – to provide an update on the deployment of resources

The board meetings also provide the main means by which the Authority sets the direction on issues of strategic importance that emerge over the course of the year.

The Authority is supported in its work by two standing committees:

• Audit and Risk Assurance Committee
• Remuneration Committee.

The Executive also holds quarterly accountability meetings with the Department of Health and Social Care to review progress with delivery of key performance indicators and the management of strategic risks.