Human Tissue Authority

The regulator for human tissue and organs


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.


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. 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.

In living organ donation, wider use of the UK living kidney sharing scheme continues to place pressure on staff resource. We have made good progress in improving the resilience of our Independent Assessor system and we will continue to examine the way in which we as the Authority undertake approvals.

Legislative change

The Organ Donation (Deemed Consent) Act 2019 came into force in England on 20 May 2020, changing the legal basis for consent for deceased organ donation in England. We have worked closely with the sector to revise our Codes of Practice to reflect the changes in legislation. Close engagement with public and professional stakeholders will remain a key priority as the changes come into effect.

Following the UK’s exit from the EU, we are continuing to work closely with the Department of Health and Social Care to ensure preparations are in place throughout the transition period and assess any implications for our regulated sectors.

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 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, 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.

As an organisation, we have responded effectively to the recent move to remote working, minimising the impact of the changes on our staff and their ability to deliver our regulatory functions. We will continue to build on the work we have already done and any learning we can use from this as we move to new ways of working in the future.  

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, and in sharing our experiences of adapting in response to the COVID-19 pandemic. 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.
  • 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 an organisational change programme.
  • Prioritise engagement with stakeholders to support the implementation of deemed consent in England.
  • Continue to develop the use of our data and intelligence functions in the management of risk.
  • Continue to work with central Government and our licensed establishments to support cross-organisational work on the UK’s future relationships with the EU and the rest of the world.
  • 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.
Last updated on: 10 Nov 2020