Human Tissue Authority

The regulator for human tissue and organs

Launch of draft HTA Codes of Practice and Standards

Introduction

The HTA is updating its Codes of Practice and Standards. Click here to see news and sign up for webinars to learn more.

The current Codes of Practice last underwent a major review in 2009. Since then, there have been a number of changes to the way we regulate and interpret our governing legislation. 

By reviewing the Codes of Practice and associated Standards, we aim to ensure that:

  • the Codes and Standards reflect our current interpretation of the law and regulatory practice;
  • the Standards are fit for purpose; and
  • the Codes and Standards make our regulatory requirements clear, while minimising regulatory burden where possible.

In September 2014, the Authority agreed proposals to produce a new streamlined set of Codes, which would be underpinned by a set of principles drawn from the Human Tissue Act. Between 1 September and 30 October 2015, the HTA ran a wide-reaching public consultation on the proposed changes to its Codes of Practice and Standards. The consultation provided an opportunity for all those with an interest in the HTA’s regulatory activities, be they professionals or members of the public, to inform the development of the revised Codes and Standards.

Below are the post-consultation Codes of Practice and Standards and the analysis of the public consultation which highlights the changes made to the Codes and Standards following the consultation.

The revised Codes of Practice and Standards (below) will remain draft until next year. We are publishing the draft documents now to make sure that the professionals we work with have ample time to familiarise themselves with the new documents before they come into force. We are aiming to bring the revised Codes and Standards into effect by April 2017 after they have received Ministerial and Parliamentary approval. All Designated Individuals and Independent and Accredited Assessors are asked to continue to work to the HTA's current Codes and Standards until then.

Later this year, we will put in place a training package to support Designated Individuals and others to ensure they are up-to-speed by the time the Codes and Standards come into force. 

 

The post-consultation draft Codes of Practice and Standards with consultation analysis

Rationale

The Codes have been revised to provide a clearer flow of information, and there are now fewer documents that establishments need to refer to. The Codes of Practice on Disposal (Code 5) and Import and Export (Code 8) have been incorporated into the sector Codes so that all relevant sector information is contained within the respective Code (underpinned by Code A, which all sectors must follow). The restructure means that establishments will need only to follow Code A plus their relevant sector Code(s) and Standards.

Current progress and next steps

A consultation on the draft Codes and Standards was carried out in September-October 2015. We have analysed the responses and have reviewed the draft Codes and Standards taking your comments into consideration. The draft Codes and Standards were submitted for Parliamentary approval in October 2016 and will be launched from 3 April 2017.

In the run up to April, when the new Codes and Standards will come into effect, we will be sharing key information with you.  Click here to see news and sign up for webinars to learn more  

The pre-consultation drafts of the codes can be viewed here.