Issue 11 June 2008
Welcome to the June issue of the Human Tissue Authority’s e-newsletter.
The e-newsletter is the main way that we communicate changes to our regulatory policy and so is essential reading if you work in one of the sectors that we regulate. We now have 4000 subscribers. We also use the e-newsletter to let you know about new advice and guidance, and important updates to our website.
This issue includes information for organisations that carry out procurement of tissues and cells, which need to apply for an HTA licence by 5 July. It also includes new guidance for the post mortem sector on the removal of tissue from deceased children.
Read on to find out the latest on the revision of our codes of practice, including how you can have your say on the revised versions by taking part in our consultation. We also announce the appointment of four new Authority members – the first new members to join since the HTA was set up in 2005.
If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items that you would like to see in future, please contact us at enquiries@hta.gov.uk
Information for the human application sector
Licensing of procurement organisations
In April we contacted all establishments currently licensed by the HTA for human application, as well as NHS Chief Executives, maternity units and private hospitals across the UK, to give an update on the licensing of procurement by the HTA.
Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation. By 5 July 2008 all organisations that carry out procurement will need to have applied for an HTA licence or have a third party agreement in place with an HTA licensed establishment.
The HTA does not expect procurement organisations to be fully compliant at the point of application for a licence in July 2008. The HTA’s approach is to work with licence applicants to identify deficiencies and offer advice and guidance about how best to meet them. We will therefore work with licence applicants to agree a timeframe for meeting the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations.
You can find out more about the licensing requirements on this site.
Organisations that need to be licensed must complete a compliance report licence application form.
If your organisation requires a licence and does not apply by 5 July, you will not be able to carry out the activity of procurement until you have submitted an application, the HTA has evaluated it, and has issued you with a licence for this activity. This process can take up to three months.
We will be announcing the licence fees for procurement organisations soon. When we do so, we will update the fees and payment page.
For further advice, please read the frequently asked questions or email enquiries@hta.gov.uk
Position statement on regulating human embryonic stem cells lines for human application
In May 2007 the HTA, Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products Regulatory Agency (MHRA) issued a joint statement on the regulation of human embryonic stem cell lines which are going to be used for human application (patient treatment). This statement has recently been updated to incorporate the HTA’s extended remit under the Quality and Safety Regulations.
You can read the updated statement.
Information for the post mortem sector
Guidance on removal of tissue from deceased children
From April 2008, removal of pathology specimens from deceased infants and children in the Accident and Emergency (A&E) departments for microbiological, biochemical and toxicological testing is a statutory requirement defined in the Government’s 2006 publication Working Together to Safeguard Children (WTtSC). The practice may also take place in other areas of a hospital, for example special care baby units or paediatric wards.
Removal of material from a deceased person to determine the cause of death is a licensable activity under the Human Tissue Act 2004 (HT Act) and must take place on licensed premises.
On receipt of a written request from a licensed establishment, the HTA will extend the Trust's pathology / post mortem licences to include the A&E department, provided that the department is located on the same premises as those specified on their licence. Where the removal takes place on other premises, for example on a children’s ward located in a different hospital within the Trust, a satellite licence arrangement may be required.
Removal of tissue from the deceased for the purpose of determining the cause of death can only take place under the authority of the coroner (or, in the case of hospital post mortems only, with appropriate consent). Removal without such coronial authorisation would be unlawful.
More information is available on this website.
Information for the anatomy sector
As mentioned in the April e-newsletter, we are currently undertaking a review of all data that we collect to ensure we only gather information that is necessary for our regulatory activities. This includes the Anatomy Online Submission System (AOSS) and anatomy forms.
Once we have completed the review, we will contact the anatomy sector and update this website.
If you have any questions about the review, please contact Kristi Adams, Head of Regulation, kristi.adams@hta.gov.uk or 020 7211 3413.
Information for the organ and bone marrow transplants sectors
Organ donations
From 1 April 2008 to 29 May 2008, 151 reports from Independent Assessors (IAs) were submitted to the HTA, 149 of which were approved. Two cases are currently awaiting more information before they can be adequately assessed. Since 1 April 2008, four cases have been referred to a panel of HTA members for a decision. More information can be found in our IA bulletin.
Bone marrow donations
From 1 April 2008 to 29 May 2008, 11 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved. More information can be found in our AA bulletin.
Codes of practice revision
We are currently completing a review of our codes of practice, which provide advice and guidance to professionals. The codes have been revised to reflect our experience of regulation. There will be a full public consultation on the revised codes which will run from August until mid November 2008.
The consultation versions of the codes will be available on our website from August. We are also planning to hold consultation workshops for professionals that work in the sectors regulated by us.
Inspections update
Since the HTA began licensing in 2006, we have completed 546 phase one (desk-based) inspections and 157 phase two (site-visit) inspections across our five licensed sectors. Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information.
More information about inspections.
New Authority members
Four new Authority members have recently been appointed to the HTA. Three by the Secretary of State and one by Ministers in the Northern Ireland Executive. These are the first new Authority members to join since the HTA was established in 2005. Authority members meet with senior HTA management approximately 10 times a year to shape HTA strategy and policy. The new members are:
Jodi Berg, Independent Complaints Reviewer.
Brian Coulter, Northern Ireland representative.
Pamela Goldberg, Chief Executive of Breast Cancer Campaign
Catharine Seddon, producer of film documentaries and magistrate
Future HTA events
On 18 September 2008 we will be holding our next public Authority meeting and annual report-back event in London. If you would like to attend these events, please register online in July.
Recent media stories about human tissue
Cord blood collection
On 30 April the HTA issued a press release on the new rules for cord blood collection. This relates to the requirement for procurement organisations to apply for an HTA licence by 5 July.
This story was covered by the Times, the Independent and the BBC website, as well as by specialist media such as the British Medical Journal, the Health Service Journal and Nursing Times.
BBC website
The Times
Nursing Times (free to register)
Better Regulation
In striving to be a model, modern regulator, the HTA applies the principles of best regulatory practice, which are enshrined within our primary legislation. The HTA has built a firm regulatory foundation based on these principles, to ensure our regulatory activities are:
- transparent
- accountable
- proportionate
- consistent
- targeted only at cases in which action is needed.
The Better Regulation Executive (BRE) and National Audit Office (NAO) work together to review the performance of regulatory bodies in applying these key principles. The reviews are described as Hampton Implementation Reviews.
In 2007 BRE and NAO conducted Hampton Implementation Reviews of five regulators:
- Food Standards Agency
- Office of Fair Trading
- Health and Safety Executive
- Environment Agency
- Financial Services Authority
The HTA has been identified as one of three health regulators that will have a Hampton Implementation Review during the 2008/09 business year.
More information about the work of the BRE is available on its website.