Jump to navigation

Issue 1 July 2006

Welcome to the first issue of the Human Tissue Authority e-newsletter ‘Current issue’. This issue marks the launch of our new website which means that establishments needing a licence under the Human Tissue Act 2004 (HT Act) can apply for licences online.

The website provides the definitive guide to licensing for post-mortem services, anatomy schools, establishments storing tissue for research, and sites displaying human material, such as museums, all of which must apply for a licence online by 31 August 2006, in order to comply with the new legislation.

As well as applying for a licence on the website, you can also find out whether you need a licence, pay licence fees, register to attend HTA events and respond to our consultations. The site provides clear guidance about the licensing process, as well as frequently asked questions and a glossary of terms.

The site also provides information and guidance on regulation of living donor organ transplants and implications of the Human Tissue Act for the transplant community.

The website redevelopment followed a user-centred approach – stakeholder representatives took part in testing the site, and their feedback informed the way the site was developed.

Thank you to all those involved, not only in the website development, but also in developing our licensing standards and our Codes of Practice.

Codes of Practice

We have now published our first six Codes of Practice on the removal, storage, use and disposal of human tissue and organs. The Codes – which have received Parliamentary approval – provide advice and guidance to practitioners and lay down the standards expected. The Codes have gone through an extensive consultation process with professional and patient groups. We received more than 100 responses to our online consultation and more than 100 people took part in workshops held across the UK.

The six Codes of Practice are:

  • Code of Practice 1: Consent
  • Code of Practice 2: Donation of Organs, tissue and cells for transplantation
  • Code of Practice 3: Post mortem examination
  • Code of Practice 4: Anatomical examination
  • Code of Practice 5: Removal, Storage and disposal of human organs and tissue
  • Code of Practice 6: Donation of allogenic bone marrow and peripheral blood stem, cells for transplantation.

A rationale document explaining the major changes made as a result of the consultation are published alongside the Codes. The HTA will issue further Codes of Practice and additional guidance later in 2006.

Designated Individual training days

Designated Individuals (DIs) have a key role to play in implementing the requirements of the HT Act. They are the people under whose supervision the licensed activity is authorised. The DI might be a head of department, clinician, scientist or manager. What is important is that it is someone in a position to ensure that activities are conducted properly, by people who are suitable to carry out those activities, and that all the necessary requirements are complied with.

We have been running a series of training days for DIs across the UK, which have been well-received by the 300 people have attended so far. All DIs need to complete HTA-accredited training (online or otherwise) within 12 months from the date of the licence, or other period we specify.

Further information and guidance about the roles of the DI and Licence Holder is available on the website.

Living-donor transplants

The HTA is responsible for approving transplants from living donors whether or not they are related to the recipient. We are working with UK Transplant to ensure the appropriate systems are in place to support these transplants across the UK.

We have trained and accredited more than 100 Independent Assessors who will make local recommendations for approval of living-donor transplants. There has been good take-up of the training and stimulating sessions.

Our Code of Practice on donation of organs, tissues and cells provides guidance on the circumstances in which live donation of ‘transplantable material’ (from both related and unrelated donors) can take place. A separate Code does the same for bone marrow transplants.

The HT (Scotland) Act 2006 has provisions on living donation almost identical to those in the HT Act. We will have responsibility for approving all forms of living donation involving Scotland.

We have published a new leaflet providing information for anyone considering a living-donor transplant. The leaflet is available to download from our website and can be ordered by calling 020 7211 3400. It is also available on our website in Welsh, Urdu, Gujarati, Punjabi, Hindi and Bengali.

We will shortly be publishing a guide for transplant teams and Independent Assessors on the new processes for approval of living-donor transplants. This will be available on our website at the end of July.

Consultations

The consultation on our Code of Practice on public display of human bodies, body parts and human tissue has now ended. The public display provisions of the HT Act start on 1 September 2006, and this Code will provide guidance the sector needs to comply with the requirements. Thank you to everybody who responded to this consultation; and particularly to everyone who attended our lively consultation workshop – your comments have been invaluable in shaping the final version.

We will shortly be consulting on a Code of Practice on the import and export of human bodies, body parts and tissue. Further information will be available on our website in due course.

The Department of Health is currently consulting on draft Regulations to transpose three EU Directives covering donation, procurement, testing preservation, storage and distribution of tissue and cells for human application, into UK legislation. Electronic copies of the consultation documents are available from www.dh.gov.uk/consultations. The closing date for responses to the consultation is 13 October 2006.

Publications

We have produced a leaflet providing an introduction to our work and responsibilities. It is designed primarily for those medical, scientific and other professionals who work in the areas we regulate, but it may also be of interest to a wider audience. You can download copies of the HTA leaflet from our website or order hard copies by calling 020 7211 3400. A leaflet for our public stakeholders will be published in September 2006.

Our first Annual Report and Accounts (2005/06) will be available on the website from 20 July 2006.

 

(Apologies if you received this e-newsletter more than once, this was due to technical problems with the first issue, which have now been resolved.)