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Issue 4: March 2007

Welcome to the March issue of the Human Tissue Authority’s e-newsletter. This issue provides important updates on a number of areas, including the new licensing requirements under the Regulations that transpose the EU Tissue and Cells Directive into UK law, changes to the process for late licence applications, and guidance on relevant material.

EU Tissue and Cells Directive (EUTCD)
 
Implementation of the Human Tissue (Quality and Safety for Human Application) Regulations 2007

This year the Department of Health will publish new Regulations to implement the detailed requirements of the EU Tissue and Cells Directive (EUTCD). These Regulations will make it an offence to carry out the activities listed below relating to tissue and cells for human application, without an HTA licence or an agreement with an establishment which has an HTA licence.

  • procurement
  • processing
  • storage
  • testing
  • distribution
  • import and export

Establishments that already hold an HTA licence to store material for human application will automatically be considered to be licensed for these activities under the Regulations. However they will be required to demonstrate that they meet the explicit additional requirements of the Regulations. We will be writing to Designated Individuals and Licence Holders in the next few weeks with more information.

Establishments that are carrying out these activities and do not currently have an HTA licence or a third party agreement with a licensed establishment, will need to register with the HTA. Arrangements for the registration process will be published on our website shortly.

Direct importation of human tissue for human application

Under the new Regulations it will be an offence to import or procure tissues and cells for direct use without approval from the HTA. This approval can only be given in rare and exceptional cases where there is a clinical necessity. The EC has advised the HTA that this provision was intended to allow the continued use of bone marrow and associated components for directed transplantation.

Regulation of donor lymphocyte infusions (DLI)

The European Commission has decided to amend the Blood Directive and the Tissue and Cells Directive at their next revisions to include donor lymphocyte infusions (DLI) within the latter. Until this happens the Commission has advised that establishments storing donor lymphocytes for infusion should be licensed / accredited by the Competent Authority for Tissues and Cells – the HTA in the UK. This is good news for the bone marrow transplant community who expressed significant concerns about DLI being included in the Blood Directive. The Commission informed the Competent Authorities on Tissues and Cells at a meeting on 8 February 2007. Read minutes of this meeting.

Late licence applications

It is now six months since the Human Tissue Act came fully into force. The HTA believes this is a reasonable amount of time for licensed establishments to become familiar with the requirements of the HT Act and to submit licence applications. For this reason, we are ending the transitional arrangements for late licence applications.

This means that from 1 March 2007, we will not take urgent action to issue a short term licence to late applicants. If an establishment has not submitted an application by 28 February 2007, it must suspend any activity it believes may be licensable under the HT Act until a licence is granted by the HTA.

Unlicensed establishments should apply for a licence.

After applying for a licence, establishments should allow between four and six months for the licensing evaluation and decision. During this time establishments should make alternative arrangements for any licensable activities that they were previously carrying out. This could include transferring the activities to an alternative HTA licensed establishment.

Further information about the changes to late licence applications.

Do I need a licence?

Review of licence fees

As explained on our website, the current HTA licence fee structure applies to this financial year (2006/07) only. In the light of our experience of licensing in our first year of operation, we have embarked on a review of the fee structure across all the sectors that we license.

From 5 February to 23 February 2007 we ran a licence fees consultation to allow all stakeholders to contribute to the development of the new fee structure. Many thanks to everybody who responded.

The Authority will be discussing the responses to the consultation at its March meeting and we hope to confirm the fee structure to all Designated Individuals and Licence Holders at the beginning of April. Information will also be available on our website.

Relevant material

We have recently published guidance on the definition of what the Human Tissue Act refers to as ‘relevant material’. The guidance divides potentially relevant material into three categories in order to help define whether or not it is relevant. These categories are: specifically identified material, processed material and bodily waste.

You can read the relevant material guidance on this website. We intend to expand the guidance to provide advice on specific examples of relevant material, and we are currently discussing with a group of stakeholders how best these might be set out.

Non-consensual analysis of DNA

Under the Human Tissue Act, it is an offence to analyse DNA without qualifying consent, with certain exceptions.

The HTA has published guidance on when, in exceptional circumstances, DNA analysis may be carried out for obtaining scientific or medical information about the person whose body manufactured the DNA, even if their consent has not been obtained. The guidance provides information about how applications can be made to the HTA to carry out non-consensual analysis of DNA.

You can read the non-consensual DNA analysis guidance on this website.

Adverse events notification system

The HTA has developed an online system for notification of serious adverse events and reactions linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells, which is currently being user-tested.

From 1 April 2007, establishments storing tissue for human application will be responsible for reporting serious adverse events and reactions relating to both the donor and the recipient to the HTA through the online system.

An internal HTA Steering Group and an external Working Group have been set up to support the implementation of the project. The external group consists of key stakeholders from the tissue banking field. Advice and guidance on how to report and investigate events and reactions will be provided to Designated Individuals at future training events.

We are evaluating its effectiveness before deciding whether it could usefully be rolled out to the other sectors we license.

For further information about adverse events reporting please contact Kristi Collins at kristi.collins@hta.gov.uk or 020 7211 3413.

Call for Specialist Assessors

The HTA has begun its programme of inspections of establishments storing tissue for human application (therapeutic tissue banks) and we are keen to recruit experts from the field to help us. Their role is primarily to advise the HTA staff who lead the inspection. We are also looking for individuals with experience of post mortem services.

So far we have had an excellent response to our call for Specialist Assessors. We have held three very successful training events and have recruited a number of professionals to help us with our schedule of inspections. The feedback has been positive, and Specialist Assessors who have been on an inspection have described the experience as informative and worthwhile.

Further information about the role of Specialist Assessors.

We will be running further one-day training and selection events for Specialist Assessors over the next few months. If you would like to attend one of these, please contact Kerri Treston at kerri.treston@hta.gov.uk or 020 7211 3427.

Live organ donation update

Organ donations

From 1 September 2006 to 27 February 2007, 262 reports from Independent Assessors (IAs) were submitted to the HTA, 255 of which have been approved. Two cases have not been approved, and five cases are awaiting more information before they can be adequately assessed. To date, only one case has been referred to a panel of HTA members for a decision.

The panel process was initiated because both the IA and the HTA Executive were unable to make a decision on a case in which there was conflicting evidence about the relationship claimed by the donor and recipient. Whilst the category of the relationship was stated as genetically / emotionally related, there were major inconsistencies in the donor and recipients’ accounts of the nature of the relationship, and the documentary evidence provided was not sufficient to give a clear indication of the true relationship between the parties. Consequently, this case was not approved.

The HTA has approved its first live liver lobe donation from adult to child. No applications involving adult-to-adult liver lobe donation have been received to date.

We are currently updating and reprinting our leaflet which provides information for people who are considering a living-donor transplant. If you would like to request copies of this in advance please email stuart.giblin@hta.gov.uk

Bone marrow transplants
 

From 1 September 2006 to 27 February 2007, 46 reports from Accredited Assessors were submitted to the HTA, all of which have been approved.

We have recently published a new leaflet providing information for people who are considering donating bone marrow or peripheral blood stem cells. This leaflet explains the role of the HTA in the assessment process. The leaflet can be downloaded from this website or printed copies can be ordered by emailing stuart.giblin@hta.gov.uk  . We will be sending an initial batch of copies to all stem cell coordinators shortly. The leaflet is also available in Welsh, Urdu, Gujarati, Punjabi, Hindi and Bengali on the website, and has been Crystal Marked by the Plain English Campaign.

Future events

Public Authority meeting

The HTA is holding a public Authority meeting in Birmingham on Tuesday 20 March. This is an opportunity to observe the Authority as it discusses its business. There are still a few spaces available at the meeting. If you would like to attend please register on this website. The agenda and papers for the meeting will be available on the website on 13 March.

Designated Individual training
 

The Designated Individual training days which were planned for 8 and 22 March have been rescheduled. The new training days will be sector-specific, and will allow us to provide more tailored advice and guidance to DIs. The dates will be published shortly on this website.

If you have any questions about DI training please contact Carly Tutty at di@hta.gov.uk or 020 7211 3438.

Coroners’ FAQs

We have recently published answers to the most frequently asked questions about coroners and how their activities relate to the HT Act. These include information about what should happen to tissue removed at a coroner’s autopsy. You can read the coroners' FAQs on this website.

Code of Practice on the import and export of human bodies, body parts and tissue

Many thanks to everybody who responded to our consultation on the Code of Practice on the import and export of human bodies, body parts and tissue, and who attended the consultation workshop in December. The consultation closed on 12 January and we received a large number of responses. The Authority is discussing the Code at its meeting on 20 March and we hope to publish the revised version shortly.

Better Regulation

On 8 January 2007, the Legislative and Regulatory Reform Act 2006 came into force. This ensures that regulatory functions comply with the five principles of better regulation, i.e. that they are transparent, accountable, proportionate, consistent, and targeted only at cases in which action is needed.

Since we were set up in 2005, the HTA has followed best regulatory practice as recommended in the Better Regulation Task Force and Hampton reports. This has included:

  • Developing a two-tiered licensing framework based on the assessment of risk – including use of self-assessment for initial licence applications followed by detailed desk-based evaluations, and conducting inspections according to risk.
  • Implementing a web-based system for licence applications, approvals of organ and tissue donation from the living, deceased body donation; and electronic evaluation.
  • Developing licensing standards and Codes of Practice in collaboration with stakeholders.
  • Continuing to provide feedback, advice and guidance, and education and training to the regulated sectors to drive up standards. 

Further information about the Legislative and Regulatory Reform Act is available on the Cabinet Office website.

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