Human Tissue Authority

The regulator for human tissue and organs

HTA self-assessment against the Regulators’ Code

The Regulators’ Code came into statutory effect in April 2014. It provides a principles-based framework for how regulators should engage with those they regulate.

The HTA's full self-assessment against the Regulators' Code and 12-month action plan

Below is a summary of our self-assessment including key action points:

Regulators should carry out their activities in a way that supports those they regulate to comply and grow

The HTA has sought to further reduce costs and regulatory burden and strengthen engagement amongst the sectors we license and activities we regulate. Our regulation is proportionate to risk, for example low risk sectors are subject to less frequent inspections. We have also established joint inspections and information sharing protocols with other regulators.

We regularly seek to evaluate and learn from feedback from those we license and regulate. We then encourage and promote compliance by sharing advice and guidance and learning from these interactions. 

Regulators should provide simple and straightforward ways to engage with those they regulate and hear their views

ExplainingThe HTA engages with its stakeholders in a variety of ways. We have set up a new Stakeholder Group to consider fee-setting and regulatory issues across all sectors. We also manage a number of specialist groups like the Histopathology Working Group and Transplant Advisory Group. We constantly seek to involve licensed sectors in the development of regulatory policy, through the groups above and through workshops, events, consultations, surveys and the HTA’s e-newsletter. We also hold a three-yearly independent survey of professionals. The results of this evaluation are published in full and impact on our strategic plans.

Regulators should base their regulatory activities on risk

The HTA regulates six diverse sectors; our starting point is that some are inherently more risky than others and this informs our regulatory approach. We seek information and updates from each sector which feeds into our new risk model. We also remain flexible and make adjustments to our regulatory activities where necessary.

Regulators should share information about compliance and risk

We have agreements in place with CQC, HRA and HFEA, and are working towards an agreement with MHRA, which include how data will be shared.  This means that we are able to work together with other regulators when concerns are raised; reducing the burden on establishments and ensuring public confidence is maintained.

In organ donation and transplantation we partner with NHSBT to keep the burden of reporting to a minimum and ensure that learning is shared with the sector.

Regulators should ensure clear information, guidance and advice is available to help those they regulate meet their responsibilities and comply

The HTA’s aim has always been to support establishments to become compliant rather than solely dealing with non-compliance. This approach has enabled us to develop positive and productive working relationships with those we regulate. 

The HTA has a statutory duty to provide advice and guidance.  We provide a large amount of information on our website, in many different formats, for example through FAQs, leaflets, codes of practice and sector specific publications. We work closely with establishments to ensure compliance and provide advice about each stage of the licensing and inspection process. We encourage establishments to report serious events and incidents and work together to ensure appropriate corrective action is taken. 

We also answer almost 3000 individual enquiries a year.

Regulators should ensure that their approach to their regulatory activities in transparent

The HTA has service standards for many of our regulatory activities including answering enquiries, handling complaints, processing licensing variations, producing and publishing inspection reports and assessing living organ donation cases. These are monitored via HTA key performance indicators. Reports on key performance indicators are published on our website.

Relevant HTA policies on licensing and inspection processes and complaints are published on our website.

Summary of actions

  • The HTA is implementing a licensing and inspection review that will examine whether our processes in these areas can be more efficient and effective.
  • During 2015 we will begin to review our codes of practice and licensing standards with input from stakeholders.
  • We are enhancing our website and e-newsletter to make it easier for professionals and the public to access HTA advice and guidance.
  • We will evaluate the effectiveness of our updated risk model which was introduced last year.
  • We will review the arrangements we have in place with other regulators.
  • We will publish a consolidated set of our service standards, which are easy to locate and access.

For further news and updates about the HTA’s progress against the Regulators' Code, please sign up to our e-newsletter.

Last updated on: 28 Jul 2015