Quotes and endorsements
A series of quotes from the HTA media briefing on 30 August 2006.
Health Minister
Rosie Winterton, Health Minister, said: “The Human Tissue Act coming fully into force on 1 September is a huge milestone. The Human Tissue Authority has played a key role in bringing activities involving the use of human organs and tissues into a regulatory framework that builds on best practice, in many cases for the first time. I am sure that both professionals and the public will have confidence in the knowledge that these activities will be carried out in a system that promotes high professional standards and provides proper protection for the rights of individuals and families."
Transplants
Keith Rigg, Consultant Transplant Surgeon at Nottingham University Hospitals NHS Trust and HTA member said: “The opportunities that the Human Tissue Act brings for both deceased donor and living donor transplantation are welcomed and it is hoped that the wishes of both deceased and living potential donors can be met. The Human Tissue Authority has been working in close partnership with the transplant community to ensure the regulatory framework is in place to enable a smooth transition to the Human Tissue Act and for transplant activity to continue uninterrupted. The opportunity to undertake paired and altruistic living donation for the first time in the UK has been eagerly awaited by many and it is anticipated that these programmes will soon be up and running across the UK.”
Living donation
Lisa Burnapp, Consultant Nurse at Guy's and St Thomas' NHS Foundation Trust in London, on the newly permitted forms of transplantation (altruistic and paired / pooled), said: "The benefits of transplantation are well established. These new initiatives extend the range of options available for people who are waiting for a kidney transplant; increasing choice for patients and maximising the opportunities for successful transplantation. This is a new and exciting era in the UK."
Keith Rigg, Consultant Transplant Surgeon at Nottingham University Hospitals NHS Trust and HTA member said, “The HTA has been working in close partnership with the transplant community to ensure a smooth transition to the Human Tissue Act so that transplant activity can continue uninterrupted. The opportunity to carry out paired and non-directed altruistic living donation for the first time is very welcome as this will increase the number of living donors in the UK. We anticipate that a small number of people will want to take advantage of the new arrangements within the first twelve months of the system becoming operative and hope that the numbers will grow in future years.”
David Clark, who suffers from polycystic kidney disease, said: “Thanks to the Human Tissue Authority which was set up to regulate living donor transplants, paired donation can take place in the UK. It brings hope to me and others who are in such desperate need of having a new kidney. This and the possibility of altruistic stranger donation should help to address the shortage of organs available. Anything that can help must be a good thing. In a few years time I hope this will be as common in the UK as it is starting to be in other countries.”
David Clark and his wife Lindsey, are considering the option of paired / pooled living donor kidney transplant, when this option becomes available after 1 September 2006.
Timothy Statham OBE, Chief Executive of the National Kidney Federation, a UK-based charity for kidney patients, said: "The donation of a body organ from one person to another is a truly selfless and thoroughly altruistic act. The National Kidney Federation warmly welcomes the Human Tissue Act and in particular the recognition that such ‘gifts of life’ can, and will, take place between strangers”.
Deceased donation
Adrian McNeil, Chief Executive of the Human Tissue Authority, said, “The implementation of the Human Tissue Act should mean that more organs will be available from deceased donors. Steps can now be taken to preserve the organs from people who have died until their wishes are established, or, if their wishes are not known, consent is obtained from their family. People will be reassured that their wishes expressed while they were alive are now more likely to be followed.”
Chris Rudge, Transplant and Managing Director of UK Transplant said: “There is a critical shortage of donated organs and many more people could receive a life-saving transplant with the donor’s wishes being given priority. The Human Tissue Act makes it clear that the wishes of the deceased must be put first. NHS staff are aware that we have a duty to respect the wishes of a patient after their death and if someone has expressed a wish to donate, they should do whatever they can to ensure that those wishes are fulfilled.
“If the family or those close to the person who has died object to their donation, for whatever reason, healthcare professionals will discuss the matter sensitively with them and encourage them to fulfil the dead person’s wishes. We know that in most cases families will agree to donation if they know that was their loved one’s wish. There may, nevertheless, be circumstances where it would be inappropriate for donation to go ahead.”
Research and pathology
Professor Alex Markham, Chief Executive of Cancer Research UK said: Research using human tissue is essential if we are to improve our understanding of cancer and develop more effective cancer treatments. Cancer Research UK is hopeful that this new regulatory framework will give researchers the support they need to carry out their work. We welcome moves by the Human Tissue Authority to engage the research community in understanding their obligations under the new legislation. This will be crucial to ensure that the good quality research, for which the UK is rightly renowned, continues unimpeded to the benefit of all patients.
Professor Colin Blakemore, Chief Executive of the Medical Research Council, said: “Research on human tissue samples is crucial for the development of new treatments and new approaches to disease prevention. It is important that the public should have confidence in the regulations that govern such research, but it is essential to achieve a reasonable balance between the prevention of possible abuse, and the facilitation of this vital research. The Medical Research Council was pleased to be closely involved in the consultation on the Human Tissue Act and we will continue to work with the Human Tissue Authority to ensure that research of huge potential benefit to the public will be able to continue within the law and with minimal cost and delay”.
Dr Mark Walport, Director of the Wellcome Trust, said: “Medical research is vitally dependent on the use of human tissue to understand the causes and effects of disease. The Human Tissue Authority has a challenging job to regulate the use of tissue fairly and cost effectively and we look forward to working closely with them to ensure the burden on researchers is not disproportionate or excessive”.
Professor Finbarr Cotter, Centre for Haematology, Barts and the London Medical School, said: “The Human Tissue Act should be viewed as an aid to all research and transplant healthcare staff. It provides protection and guidance for the fulfillment of patients and families expectations. The Act is a simple and caring concept that provides the patient and relatives with a voice. This can only strengthen the essential bond of trust between patient and clinician. For the medical profession it does require a slight change in culture and forethought that we have sometimes lacked. However, thinking and planning ahead has to be beneficial. All research now will go forward with the willingness and support of those consenting to the use of their tissue. This can only be reassuring to those making use of this tissue and enhances the research and transplantation process. An independent, active and responsive Human Tissue Authority is the pivotal link providing the necessary functional links for all, to ensure the process can be trusted and evolve together with patient and researcher perceptions and cultures. This is a truly important and empathetic piece of legislation that benefits us all”.
Belinda Seeto, Project Manager, Human Tissue Resource Centre at Barts and The London NHS Trust and Queen Mary’s School of Medicine and Dentistry, said: “In response to the Human Tissue Act, we at Barts and The London NHS Trust and Queen Mary’s School of Medicine and Dentistry have set up a centralised Human Tissue Resource Centre (HTRC) to ensure compliance with the Act and with the Human Tissue Authority’s Codes of Practice as they affect scientific research using human tissue. This is clearly a crucial area for an academic teaching hospital and medical school. As the Designated Individual for Research responsible for ensuring compliance of the HTRC with the new legislation, I have liaised closely with the Human Tissue Authority over the past few months and have found their advice invaluable. In practice they have adopted an approach which is most helpful and supportive, both in terms of helping us understand the spirit of the legislation and in answering specific questions about policy and practice. They have been interested in our operation, listened carefully to our concerns and responded with practical advice”.
Professor Adrian Newland, President of The Royal College of Pathologists, said: “I was very pleased that the College were encouraged to be actively involved in the development of the Human Tissue Bill and that many, although not all, of our concerns were taken into account in its progress to the Act. Our continuing input into the Authority should give confidence to our members that the pathology community are actively involved in the implementation of the Act and that this is not purely legislation imposed from outside. I see this as a further step in restoring public confidence in the use of human tissues and hopefully will support the revitalisation of tissue-based clinical research.”
“My own personal experience of the licensing of banks storing tissue for human application by the HTA has been encouraging and I have every confidence that the scheme will work smoothly with minimal disruption”.
Professor James Ironside, Professor of Clinical Neuropathology at the University of Edinburgh and HTA member said "Medical research is critically dependent on studying diseases in human tissues. The regulatory framework of the Human Tissue Authority will give researchers confidence that this essential work can take place with consent from the patient or relatives, and give the public confidence that medical research is based on the principle of consent".
Professor El-Nasir Lalani, Professor of Molecular and Cellular Pathology at Imperial College London and Honorary Consultant Histopathologist at Hammersmith Hospitals Trust, and HTA member, said “Our understanding of disease processes and the development of new therapies is critically dependent on the availability of human tissues for research. The Human Tissue Authority’s regulatory framework aims to provide a balanced approach of meeting the needs of the research community whilst maintaining public confidence”.
Professor Sir James Underwood, Professor of Pathology at the University of Sheffield and Consultant Histopathologist to the Sheffield Teaching Hospitals NHS Foundation Trust, and HTA member, said "Patients, their families and the public can now have greater confidence in the arrangements for storing and using human tissue for research and education. Licensing and Codes of Practice have also created a framework in which post mortem examinations can be performed to fully and reliably determine causes of death, the extent of disease and the safety and effectiveness of new treatments."
Dr Simon Best, Chairman, BioIndustry Association, said: “The BIA welcomes the introduction of the Human Tissue Act which provides a regulatory framework that will ensure that essential medical research using human tissue can continue to deliver new treatments for patient benefit. Public confidence in the Act and in the Human Tissue Authority as a transparent and trustworthy regulatory body will be key. We hope that this will result in greater participation in research which ultimately benefits patient health. The BIA was delighted to be involved in the development of the Human Tissue Bill and the consultation on the Human Tissue Act and looks forward to continuing to work with the Human Tissue Authority.”
Nursing
Ruth Musson, Pathology Specialist Nurse at Queen’s Medical Centre in Nottingham, and HTA member said “Nurses are on the front line in dealing with the dying patient and are often the first point of contact for bereaved families. The Human Tissue Act presents a fundamental change in that a patient can state their wishes about what happens to their body after death, and can also nominate a representative to make decisions on their behalf, neither of which can be overturned by other family members. Nurses play a crucial role in identifying potential donors of organs and tissues both for transplantation and research ensuring that the wishes of the deceased are reflected in practice. We need to ensure that nurses are fully informed of the requirements, so that patients and their families have trust in the systems in place so that the work of professionals can proceed with confidence, with the health benefits we all want”.
Anatomy
Dr D Ceri Davies, Reader in Neuroscience at St George's Hospital Medical School, London and HTA member, has been a licensed teacher of anatomy for over 20 years and is a member of the Council of the Anatomical Society of Great Britain and Ireland. He said: “The Human Tissue Act builds upon the firm foundations of previous Anatomy Acts to facilitate the essential training of medical and paramedical professionals and to maintain public confidence in the way in which these activities are carried out”.
Museums and public display
Dr Kate Robson-Brown, Senior Lecturer in Biological Anthropology and Graduate Dean of Arts at the University of Bristol, and HTA member said: "Across the UK, institutions such as museums and universities hold collections of human remains which are of immense value to medical and anthropological research and teaching. The Human Tissue Authority will provide a regulatory framework within which researchers, lecturers, students and the public can continue to learn from and work with these collections in an environment of mutual respect".
Patient and family groups
David and Hazel Thewlis, said: “The Human Tissue Act has provided a new foundation for the people of this country, and the Human Tissue Authority is working hard to provide Codes of Practice for those who implement the Act. Let us all remember that consent was the cornerstone of the Act, and this must colour all of the work of the Human Tissue Authority”.
David and Hazel Thewlis are representative of those affected by events at Alder Hey.
Michaela Willis, Chief Executive of the National Bereavement Partnership and Human Tissue Authority member, said “As a member of the Human Tissue Authority and a bereaved mother, it is especially important to me to see the Human Tissue Act coming into force. The fundamental principal that underpins the Act is consent. Consent is such a simple word that means so much, especially to the bereaved. The Act came about after much public debate, and I truly believe that this has enabled better communication between the public and professionals. In turn this has enabled the Human Tissue Authority to develop a regulatory system that the public can have confidence in”.
Claire Rayner, President of The Patients Association, said “Anyone who has ever observed the misery caused by a wide range of chronic human diseases – such as Muscular Dystrophy, Multiple Sclerosis, Diabetes and many others – will surely agree that any research that can provide remedies or prevention for such ills has to be encouraged.
“The Human Tissue Act will among other things enable this important research to be carried out. So this alone deserves all the support that people can give it”.
Tissue banks for human application / therapy
Professor John Armitage, University of Bristol and Director of Bristol Eye and Heart Valve Banks, said: “Many patients benefit every year from tissue transplants, greatly improving their quality of life and, for some, saving lives. The Human Tissue Authority has worked closely with tissue banks to implement the standards and licensing requirements of the EU Tissues and Cells Directive, whose purpose is to assure the safety and effectiveness of tissue transplants for patients”.
Dr Mark Lowdell, Director of Cellular Therapeutics at the Royal Free and University College Medical School (Hampstead) said: “Haematopoietic stem cell transplantation and associated cellular immunotherapy are now routine procedures in many centres throughout the UK. The implementation of the Tissue and Cells Directive by the HTA has continued to uphold the current standards of best practice in this field whilst minimising the administrative burden. The willingness of the HTA to engage in dialogue and training with this sector facilitated the ongoing development of these standards nationally”.
Ruth Warwick, lead consultant for tissues at the National Blood Service and President of the British Association for Tissue Banking, said: "The Human Tissue Authority's two briefs with regard to tissues for transplantation – to ensure the highest standards in consent for donation to protect donors and their families and secondly, to ensure safe and efficacious transplants for recipients is being fulfilled by close dialogue with the Professionals working in this important area. Initially the Department of Health established a group of stakeholders to work together to ensure that the developing European regulation was pertinent and able to facilitate safety and sufficiency of tissues for transplant. The HTA then went on to ensure an extensive consultation exercise to ensure their Codes of Practice relating to consent were pertinent. Current work streams include the provision of training to ensure that tissue and cell banking facilities and their staff are well prepared to meet the needs of the regulation. This collaborative way of working between the regulated sector and the regulators is welcomed by the profession".