Issue 15 February 2009
Welcome to the February 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 more than 4500 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 about training for Designated Individuals in the human application sector and our next public Authority meeting. You can also find out how to take part in our project to evaluate the impact of human tissue legislation and regulation on research.
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.
Consultations
Consultation on proposed new licence fee structure
Our consultation on the proposed new licence fee structure will run until Thursday 5 March. If you wish to respond, please make sure that you do so by this date.
You can find out more about the proposed fee levels for your sector, and details of how to respond to the consultation, in the consultations section of our website.
If you have any questions about the consultation process please contact Morounke Akingbola, Head of Resources: morounke.akingbola@hta.gov.uk
Website evaluation
In 2008 we completed an evaluation into how we can improve our website. As part of this project we carried out an online survey and interviewed people from the different sectors we regulate. The results were extremely informative and you can read a summary of the main findings and next steps on our website.
Events
Public Authority meeting, 17 March 2009
The HTA holds two public Authority meetings every year, one of which takes place outside London. Our next public Authority meeting will be held on Tuesday 17 March in Manchester.
This event provides an opportunity to observe the Authority as it discusses its business. The main agenda items for discussion at the meeting will be the HTA’s revised codes of practice and new licence fee structure.
Places at the meeting are limited and will be allocated on a first-come, first-served basis. If you would like to attend, please register by Friday 27 February.
Once your place at the meeting has been reserved, you will be sent a confirmation letter and agenda at the beginning of March. The papers for the meeting will be available to download from this website one week before the meeting.
Designated Individual training – human application sector, 25 March 2009
The HTA is hosting a one-day training event for Designated Individuals (DIs) who work in the human application sector. This event will take place on Wednesday 25 March in Birmingham.
The DI training event will provide information on current issues within the human application sector, such as the role of the DI, our inspection process, developing robust third party agreements, reporting serious adverse events and reactions, and recent changes to our licensing methodology. It will also be an opportunity for DIs to network with colleagues working in the sector and meet HTA staff.
Please register on this website to show your interest in attending this training event. There are 80 places available with priority going to DIs who have not participated in HTA training. We will contact registrants at the end of February to confirm whether they have been allocated a place.
Licensing and inspections
Moving from fixed term to continuous licences
In 2008 we held workshops with the licensed sectors to discuss renewal of licences. Following the feedback given at these workshops, we have made a decision to change from a fixed-term licensing system to a continuous licensing system for establishments. The continuous licensing system will be supported by a new sector-specific compliance monitoring framework.
We will shortly be writing to licensed establishments to let them know about the move to a continuous licensing system. This communication will be followed by a Notice of Proposal to vary the licence, which will be sent to all Designated Individuals and Licence Holders in April 2009.
DIs and licensed establishments do not need to take any action as a result of this change.
Inspections update
Since the HTA began licensing in 2006, we have completed 654 phase one (desk-based) inspections and 219 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.
Hampton Implementation Review
The HTA is regulated by the Department for Business Enterprise and Regulatory Reform (BERR) and is required to comply with the Statutory Code of Practice for Regulators. Through evidence gathering and interviewing staff, the Better Regulation Executive carried out a ‘Hampton Implementation Review’ of the HTA between 3–5 December 2008 to assess how well we are following the principles of Better Regulation. These encourage best practice and continuous improvement. The report will be available on the BERR website when it is published.
Information for the human application sector
Advanced Therapy Medicinal Products
In March 2008 the HTA issued a joint statement with the Medicines and Healthcare products Regulatory Agency (MHRA) on the relationship between the Advanced Therapy Medicinal Product (ATMP) Regulation 2007 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
In order to provide more information on this issue for people working in the human application sector, we have now published frequently asked questions and definitions of the key terms related to the ATMP Regulation.
Regulation of acellular material
We have recently revised our policy regarding the regulation of acellular tissues and cells for use in human application. You can read the revised policy on this website. This policy does not affect or change the regulation under the Human Tissue Act of licensable activities involving relevant material.
Regulatory route map for clinical application of stem cells
The HTA has participated in the production of a regulatory route map for stem cell research, which has been developed by the Department of Health with the support of regulatory bodies and the Gene Therapy Advisory Committee. The route map is intended to be a reference tool for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. An interim version of the map will be available on the our website shortly. A more detailed, web-based ‘UK Regulatory Route Map for Stem Cell Research and Manufacture’ will be available by the end of 2009.
Information for the research sector
Impact of human tissue legislation and regulation on research
We are currently running a significant project to assess the impact of human tissue legislation and regulation on tissue-based research. This project is being carried out by an independent research company, Opinion Leader, on behalf of the HTA. The aim is to review how recent human tissue legislation has impacted on the research community and how it has been implemented by the HTA. Responses will feed into a future review of the Human Tissue Act and inform the HTA’s advice and guidance.
This project will involve interviews with individuals associated with establishments licensed by the HTA to store tissue for research, but also look beyond licensed establishments to get a truer picture of the impact on the whole community of human tissue research. Opinion Leader would therefore also like to speak to individuals who do not have an HTA licence (for example, because they have project approval from a research ethics authority, or use tissue banks).
We would appreciate your contribution through a 15 minute telephone interview. As an alternative, an online version of the survey can be completed on this website. All interviews will be confidential.
If you feel that this project is relevant to you and want to take part, please email hta@opinionleader.co.uk or phone 020 7861 3802 with your name, telephone number, institute and position and someone will get back to you.
If you have any questions about the project please ring Joanna Bibby-Scullion at Opinion Leader on 020 7861 3080. If you would like to speak to someone at the HTA, please contact Daisy Thomas, Head of Communications, on 020 7211 3417 or email daisy.thomas@hta.gov.uk
We hope that you will consider taking part in this important research project.
Information for the organ and bone marrow transplant sector.
Organ donations from living people
From 1 April 2008 to 31 January 2009, 870 reports from Independent Assessors (IAs) were submitted to the HTA, 866 of which were approved. One case is currently awaiting more information before it can be adequately assessed, and three reports are to be referred to panels for decision. Since 1 April 2008, 28 cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and incapacitated adults
From 1 April 2008 to 31 January 2009, 51 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved.
Introduction of EU directive on organ donation
On 8 December 2008, the European Commission adopted a proposal for a Directive on organ donation. In parallel to provisions in place for tissues and cells, the Directive is intended to ensure the safety and quality of organs through the introduction of common standards across Europe. The HTA has been working with the Department of Health and other organisations to ensure that the requirements of the final Directive are implemented proportionately in the UK.
You can read the draft Directive on the European Commission website.
In March 2008, the HTA gave evidence to the House Of Lords Select Committee on the European Union’s inquiry into ‘communication on organ donation and transplantation: policy actions at EU level’, which considered the possible costs and benefits of EU action in this area.
Download the Select Committee report ‘Increasing the supply of donor organs in the EU’.
Recent media stories about human tissue
More brain tissue needed for medical research
A commentary on the Guardian website by Professor James Ironside, HTA Authority Member and Professor of Clinical Neuropathology at the University of Edinburgh, explains why more brain tissue is needed for medical research. The commentary also describes the role of the HTA’s regulation in ensuring the public have confidence that the wishes of the deceased are respected.
Professor Ironside took part in a press conference hosted by the Science Media centre, on behalf of the charity Autism Speaks. The day after the conference, 11 new donors registered their willingness to donate their brains to medical research after their death.
Revised policy on acellular material
On 18 February we issued a media release about our revised policy on regulation of acellular material. Read the media release.