Human Tissue Authority

The regulator for human tissue and organs

Introduction from the Chief Executive

During 2017, the HTA undertook a fundamental review of its strategy. This exercise gave us considerable reassurance that the public and professionals think we are on the right track with our regulatory approach. As a result, the fundamentals of our regulatory approach, which have served the public and our licensed establishments well, will remain unchanged. At the same time, the review also identified a number of emerging issues that we need to address in addition to our core regulatory business.

Specifically, we continue to see novel uses of human tissue and the emergence of new business models that bring regulatory challenges and require new ways of thinking. As a result, we are increasingly called upon to give advice and guidance on issues that are beyond our formal regulatory remit, but which nevertheless require us to provide a leadership role to ensure that public confidence is maintained.

In addition, we wish to make an active and positive contribution to national policy developments. Over the next year, we would expect to work closely with the Department of Health and Social Care to help shape the proposals to introduce opt-out consent for organ donation in England. We will also have a part to play in the delivery of the Life Sciences Industrial Strategy and in preparations for the UK’s exit from the European Union. In both of these areas our expertise and history of effective collaboration will support the development of appropriate, risk-based approaches to regulation, which balance public confidence and patient safety with building a prosperous UK economy.

These challenges will require us to operate in a more sustainable way by 2021, building in greater resilience and agility in the face of greater complexity and uncertainty in our external environment. These concepts are described in detail within this Business Plan.
We will over the next three years, need to effect significant changes to our operating model, which will involve:

  • Moving towards a workforce that increasingly works remotely by design, allowing us to increase the geographic pool from which we recruit and producing savings on our accommodation costs that could be reinvested to address emerging business needs.
  • Making better use of data to make the right regulatory interventions with the right establishments at the right time.
  • Designing business processes and business technology in a way that best supports this new way of working.

This new operating model will require a renewed focus on high quality leadership, management and staff development to ensure a cohesive organisational culture focussed on the continued delivery of excellent regulation that protects public and professional confidence.

This Business Plan describes what we will do during 2018/19 to ensure that we continue to build our reputation as a highly effective regulator, and the building blocks we intend to put in place as we embark upon our organisational transformation.

I look forward to continuing a productive working relationship between the HTA and our stakeholders to ensure that the public’s confidence in the removal, storage and use of human organs, tissues and cells is maintained.

Allan Marriott-Smith
Chief Executive

Last updated on: 22 May 2018