Human Tissue Authority

The regulator for human tissue and organs


To deliver the right mix of activity to maintain public and professional confidence

The HTA aims to be a right-touch regulator which complies with the principles of better regulation, and supports the Government’s aims with regard to deregulation.

That means that we focus our regulation on those establishments which carry out activities with inherently greater risk to public confidence if standards are not maintained, and those which we have assessed as being at the greatest risk of non-compliance. This approach means that we target our resources at those areas which have the greatest impact on our overall goal.

We undertake licensing as required by legislation to a set of licensing standards, which are aligned with our principles and designed to promote public confidence. Assurance that standards are being met is achieved through a variety of mechanisms.

HTA inspections take place in each sector according to the legislative requirements and the regulatory risk in that sector, as well as the risk specific to each establishment. The HTA’s current approach is to work with an establishment to schedule an inspection at a mutually convenient time. We recognise the significant level of compliance and transparency across our sectors and believe that this approach enables us to reduce the burden of the inspection without increasing the risk of non-compliance. We do, however, have a right of entry to licensed establishments (except those in the transplantation sector) and, where we believe it is justified to do so, will conduct a short-notice or unannounced inspection.

We also place reporting requirements on licensed establishments to inform us of incidents and events posing the highest risk to public confidence and patient safety. This allows us to take appropriate action, should things go wrong, and to ensure that lessons learnt can be shared.

We have a statutory duty to give advice and guidance to establishments. We place great emphasis on this so that we can bring them to compliance in partnership, rather than dealing solely with non-compliance. This approach has enabled us to develop strong links with representatives of the sectors we regulate. This means we are able to engage with them about issues across the sector and gain a better understanding of the challenges they face and, in turn, inform our regulatory policy development. Similarly, it gives them a better understanding of our requirements. It also means that we use significant regulatory action when appropriate and in the public interest.

The living donation assessment regulatory framework acts as a deterrent to donors and recipients entering the living donation programme with reward as a motivation. It also provides independent protection to donors, to avoid the rare cases where a donor is pressured to act against his or her wishes. The system relies on donor and recipient interviews undertaken by a group of independent and accredited assessors who are predominantly volunteers who we train, accredit and support in order to fulfil our statutory functions.

We have structured communication with professionals, the public and strategic partners to ensure that there is confidence in HTA regulation and in the services being regulated. Our approach is to ensure that relevant, high quality information is available on demand to these groups via our website and to target information to specific audiences via a range of channels. We involve these groups to ensure we make decisions which reflect, as far as is possible, the operational realities faced by professionals and the concerns of the public. We also provide the public with the information they need to understand what they should expect from the services we regulate and to allow them to make informed decisions about using these services.

Many HTA licensed establishments are also regulated or accredited by other bodies. The HTA recognises the impact that this can have on an establishment, so structured collaborative working with other bodies is also an important feature of our strategic approach to minimise regulatory burdens.

Our Delivery objectives for 2016-2019 are to continue:

  • to deliver right-touch regulation and high quality advice and guidance, targeting our resources where there is most likelihood of non-compliance and greatest risk to public confidence
  • to be consistent and transparent in our decision-making and regulatory action, supporting those licence holders who are committed to achieving high quality and dealing firmly and fairly with those who do not comply with our standards
  • to deliver effective regulation of living donation
  • to inform and involve people with a professional or personal interest in the areas we regulate in matters that are important to them and influence them in matters that are important to us
  • to maintain our strategic relationships with other regulators operating in the health sector

In the period covered by the strategy, we will:

  • undertake and publish reports on a programme of site visits and inspections which meet the aims of the HTA and licensed establishments and which provide assurance to the public that standards are being maintained
  • ensure that, where there are shortfalls against standards, these are rectified within agreed timescales
  • reach decisions on living organ donation cases to agreed service standards and in a way which provides the necessary protections
  • provide high quality responses to enquiries from professionals and the public
  • actively communicate with the public and professional stakeholders about matters within our remit using a wide variety of channels
  • seek to exert influence in Europe and internationally in matters relating to the regulation of organ donation and transplantation and tissues and cells for human application 


Last updated on: 31 May 2016