Human Tissue Authority

The regulator for human tissue and organs


To make the right investment to continuously improve delivery

The HTA has always been active in seeking ways it can advance public confidence and better target its regulation.

Over recent years, the Government has introduced a range of measures which place obligations on regulators to reduce regulatory burdens and to support innovation and economic growth. There is undeniably a tension between reducing regulatory burdens and the delivery of statutory duties which protect public confidence. The HTA will manage these tensions by maintaining right-touch regulation focussed on risk while simultaneously identifying opportunities for reducing regulatory burdens and potentially, the costs of compliance where risks are lower. There are also opportunities for clarifying compliance requirements, whether these are new or existing requirements. As there is no review of the human tissue legislation currently planned, any such changes will take place within the constraints of the current legislation.

Early in the period covered by this Strategy, the Department of Health will publish the findings from the Triennial Review of the HTA undertaken during 2015. Our response to the recommendations from the Review will also be built into our development programme.

Over the last five years, the HTA has made significant efficiency savings. Although we actively seek opportunities to reduce our costs, the scope for cost savings is now more limited than it was. Our focus for the next three years will be to look for ways of improving systems and processes to allow us to do more with the resources we have. Our licensing and inspection review (completed in 2015) identified a range of targets for improvement.

As all of our activity is aimed at maintaining public confidence, there is also more we can do directly in pursuit of improving public confidence, both alone and in partnership with other regulators and public-facing bodies. Our aims in this regard are to produce better public-focussed information which reaches a wider audience. There is also more we can do to involve the public in informing and assuring our regulatory approach and the decisions we make. 

Our Development objectives for 2016-2019 are to:

  • reduce regulatory burdens where risks to public confidence are lowest
  • make it clearer how to achieve compliance with new and existing
  • regulatory requirements
  • make continuous improvements to our systems and processes
  • take opportunities to better inform and involve the public

In the period covered by the strategy, we will:

  • build on the outcomes of the licensing and inspection review and other known improvement targets to produce an HTA Development programme. Potential projects within this programme will be judged on their contribution towards Development objectives and will include:
    • introduction of the EU Coding and Import Directives
    • introduction of revised Human Tissue Act licensing standards –––review of the Human Application inspection cycle to better target risk
    • Designated Individual Development
    • review of the inspection process
    • Independent and Accredited Assessor Development
  • ​refine our processes to further improve the timeliness and quality of enquiry responses
  • work with partners to develop and more widely communicate public-facing information which improves understanding of what we do, what to expect from those we regulate, and which promotes informed consent. Examples are likely to include:
    • Summary guides to the HTA Codes of Practice
    • Public guides to the research, body and brain donation
  • improve arrangements for the public to inform and assure our regulatory approach
  • seek further opportunities to collaborate with others to reduce regulatory burdens, clarify regulatory pathways and involve the public
  • act on the recommendations of the Triennial Review of the HTA (due to report in 2016
  • undertake a fundamental review of our fees structure to ensure it remains sufficiently aligned with our regulatory activity
  • strengthen our arrangements for horizon scanning and accessing external expertise, in particular on scientific trends and developments, to better inform policy development and strategic planning
  • actively seek opportunities to reflect and shape thinking on the future of regulation in the health sector
  • continue to upgrade and develop our Customer Relationship Management (CRM) system, website and portal to better meet business needs
Last updated on: 31 May 2016