Human Tissue Authority

The regulator for human tissue and organs

Strategic review

In preparing this strategy, the HTA has undertaken a fundamental evaluation of the extent to which our current 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 focussed on evaluating our future operating environment and whether our resources are optimally aligned to where the risks are greatest.

An assessment of the evidence provides 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 future 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, as well as potential changes to organ donation policy and the outcomes of 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.

This strategy is therefore focussed 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.


By sustainable, we mean taking a new approach to recruiting 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, burnishes our reputation as an expert regulator and actively supports the Industrial Strategy for Life Sciences.

Year 1 of this strategy represents a transition between the previous 3 year strategy and the new priorities. Our 2018/19 business plan will therefore reflect the trade-offs between current and emerging business needs.

In order to meet the challenges ahead we require a fresh 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 - 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.
Last updated on: 23 May 2018