Human Tissue Authority

The regulator for human tissue and organs

Help to shape the HTA’s licence fees structure

Issue date: 
25 July 2016

From 25 July to 30 September 2016 the HTA is asking for our stakeholder’s views on proposed changes to the licence fees structure.

The HTA is the regulator of human organs and tissue. We were established as an executive agency of the Department of Health under the Human Tissue Act 2004, which covers England, Wales and Northern Ireland, to regulate activities relating to the removal, storage, use and disposal of human tissue and organs. We also give approval for organ and bone marrow donations from living people.

We make sure that the 850+ licensed organisations (main licences and satellites) across the six sectors; Public Display, Organ Donation & Transplantation, Human Application, Post Mortem, Research and Anatomy, store and use human tissue and organs, do so safely, ethically and with proper consent. We do this by licensing and inspecting organisations, ensuring that they meet standards on: consent, governance and quality systems, premises, facilities and equipment, and disposal. When organisations do not meet these standards, we work with them to help them improve. The regulation work we do is fully funded by the licence fees paid each year.

The HTA is committed to reviewing and streamlining processes, including the way we charge licence fees, in order to keep licence fee income as low as possible. We have made significant efficiency savings since 2010, which we have passed on to establishments by reducing fees.

Six years on from the last review, there have been changes in the HTA’s licensing and inspections process and some regulation costs have increased. The scope for cost cutting is now less given new pressures such as the introduction of EU directives, Brexit implications and the Better Regulation Agenda. We are looking at the fees structure again to ensure the impact of these changes is reflected and that we minimise any unnecessary burden for our licensed organisations in a fair and transparent way.

Allan Marriot-Smith, Chief Executive of the HTA said: “We are committed to making sure that people continue to have confidence in the safe and ethical use of human tissue and organs. Our licensing and inspection model is fundamental to our work. Since 2010, when the fees structure was last reviewed, there have been many changes within the sectors that we regulate and to the way we licence and inspect organisations.

We want to take this opportunity to listen to professionals working in these sectors, in order to implement changes to our fees structure that are fair and understood, and provide value for money, whilst ensuring we protect the public’s interest.  

We urge all those who have an interest in the fees that we charge to respond to this consultation and let us know what you think”

The changes to the fees structure that we are proposing are:

  • Different application fees across sectors
  • Charging the same fee to all establishments in the Public Display sector
  • Charging different fees within the Organ Donation & Transplantation (ODT) sector based on the number of different organ types
  • Within the Human Application sector, introducing an additional fee for establishments that have five or more different tissue types
  • Charging different fees within the Post Mortem sector based on the activities establishments undertake
  • Changing the banding for all sectors’ satellites to two groups (1-4 satellites and 5+ satellites)

You can view the consultation page here.

Notes

  • Licence fees constitute approximately 73% of the HTA’s total income (£3.3m in 15-16)
  • The HTA is recognised as an effective and successful regulator. Our regulation is underpinned by close working relationships with our stakeholders, and supported by a risk-based and proportionate approach.
  • The HTA’s approach is to review our fees structure approximately every five-six years, and to set fees annually based on the income required. The current fees structure was put in place in 2011/12 following review in 2010. However, since then there have been changes in the HTA’s licensing and inspections process, such as our approach to inspecting satellites, and it is timely to review the fees structure to ensure the impact of these changes is reflected. 
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