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Jo Swinson (East Dunbartonshire) (LD)
The issue of making samples of human tissue available for use in medical research may seem obscure at first glance, but it has a huge impact on some of the other issues that we commonly discuss in this place, including the development of new medical treatments for common diseases, the safety of patients treated by the NHS, and the ever-controversial matter of scientific experimentation on animals. In today’s debate I shall discuss how increasing the availability of human tissue to the research community would be to our advantage, and shall suggest ways in which the Department of Health might help to make tissue samples more accessible.
I first became aware of the issue because of life sciences activity in my constituency. Glasgow is unfortunate in having one of the highest cancer rates in Europe, but that means that it has become a world-class centre of excellence. The Beatson research centre is based in my constituency, just outside Glasgow, and a new translational research centre is due to be built alongside it shortly.
The area is also a hub for other companies that work in the life sciences industry, such as the biomedical research company Biopta, which is based in Bearsden in East Dunbartonshire. Biopta uses fresh samples of human tissue to test new medical treatments before they get to the stage of clinical trial. Those tissue samples have been removed from patients during surgery and the parts not needed for diagnosis or therapy have been donated, with the patient’s consent, for use by researchers. Tissue is therefore not removed for the purposes of research; it is removed during surgical procedures anyway, most often to help in making a diagnosis, such as during a biopsy. A sample is taken, and in some cases an entire lump may be removed, but usually only a tiny amount of it is needed on a slide for diagnosis by examination under a microscope, and the rest is either incinerated or stored for use by researchers.
When I visited Biopta, the chief executive, David Bunton, explained the benefits of testing with human tissue. First, testing new treatments on tissue samples can help to protect those who volunteer as subjects in clinical trials from harm. I am sure that hon. Members have all seen adverts in newspapers, or perhaps in a doctor’s surgery or hospital, looking for people to give their time to participate in a study of a new medical treatment. Sadly, we have also all heard of clinical trials that have gone badly wrong, when people have become seriously ill; some have even died. By testing treatments on human tissue samples first, it is possible to rule out some potentially harmful treatments before they are tried out on human subjects in clinical trials.
Although there is no guarantee that a treatment that is tested on tissue samples and appears safe will not cause harm to a living person, currently the various techniques involving live tissue samples are the closest we can get to simulating the use of a particular treatment on a real patient. Basically all drugs are tested on human cell lines, but not all of them are tested on human tissue, whose reactions are closer to the behaviour of normal cells in the human body than cell lines in an artificial environment.
As well as posing a potential risk to the health of subjects, unsuccessful clinical trials also cost a great deal in time and resources. One of the biggest barriers to the development of new treatments for diseases is the huge costs and the financial risk involved in trialling treatments, as there is always a risk that they will not work. Many drug companies expect that nine out of 10 drugs taken forward will not reach production. That risk can never be eliminated, but the use of live human tissue samples can rule out some unsuccessful drugs before trials are carried out. That can reduce the costs.
Another reason for using human tissue samples is that it may reduce the need for experiments on animals. I shall touch only briefly on that point, but it is an issue on which many Members, like many of our constituents, feel strongly; other hon. Members may want to speak further about it. I accept that some testing on animals is still necessary for medical research, but of course we should pursue alternatives wherever possible, in line with the approach of replacement, refinement and reduction. Despite the benefits of tissue research that I have explained, vast quantities of residual surgical tissue are regularly incinerated as clinical waste. As a result, there is a shortage of human tissue samples for research.
Many of the diseases for which treatments could be developed by such research are common, and all hon. Members present for the debate will know someone who has suffered from them. Breast Cancer Campaign reports:
“There is a serious lack of access to breast cancer tissue available for breast cancer research. This access issue is hampering progress in breast cancer research: developing new treatments, finding the causes of breast cancer and discovering new breast cancer genes can only be achieved if breast tissue is available to scientists across the UK and worldwide.”
In this country one woman in nine will be diagnosed with breast cancer in her lifetime and 1,000 women and seven men die from it every month.
Another common disease for which no cure has been found is Parkinson’s disease, with which someone in the UK is diagnosed every hour. Researchers in the UK are looking to develop new drugs that could slow down, stop or even reverse the condition, and perhaps find a cure. According to Parkinson’s UK:
“A key challenge is that there is a shortage of human tissue, including intestinal tissue from the gut, available for research. There are then difficulties associated with obtaining it when it actually becomes available. We would therefore welcome any move to increase the amount of tissue which is retained for research purposes, including that which has been removed during surgery. For the first time, it would allow researchers to look at changes in parts of the body in people who are living with Parkinson’s.”
If tissue samples are to be used for research purposes, a number of things need to happen. First, the tissue donor needs to consent to the use of their tissue for the purpose of research. Secondly, tissue needs to be stored in an appropriate condition, and thirdly there needs to be a mechanism for making researchers aware of what tissue is stored where. As to consent, clearly it is important that patients should have the final say in how their tissue is used, but the current process for gathering consent is clearly not working. In a submission to the Academy of Medical Sciences, the Human Tissues Working Party, which includes a range of groups including the Safer Medicines Trust and Biopta, wrote:
“Respect for patients’ rights and wishes must always be paramount, and current regulatory requirements are very good at ensuring that anyone who may not wish to donate their tissues does not do so.”
However, the submission continues:
“The widespread desire amongst members of the public to contribute to medical research in this way frequently goes unfulfilled because many potential donors are not made aware of the possibilities of donation. The situation is often exacerbated by what is widely viewed as a complex and time-consuming bureaucratic process, time constraints amongst staff, a lack of appreciation amongst hospital staff of the importance of high quality tissues.”
Mark Tami (Alyn and Deeside) (Lab)
The hon. Lady has hit on the key point: often people are just not asked. As with cord blood, for example, I think that if the uses of the tissue and the benefits that can come from it are explained, people will say yes. However, people will generally be asked at a vulnerable time and may be nervous about what is happening and why, and that is an issue that should be addressed.
Jo Swinson
The hon. Gentleman is right. Often people are not asked, and the timing of the request is a question to be considered.
There is little public awareness of the need for live tissue, and it is fair to say that most people would never think of proactively offering to donate tissue samples for research. As the hon. Member for Alyn and Deeside (Mark Tami) has said, that is not uppermost in the mind of someone approaching a surgical procedure. Therefore, we need to ensure that patients are routinely asked whether they would like to donate.
Currently, it is up to each hospital trust to design and implement its own policy for gaining consent. Before a patient undergoes surgery, he or she will always be asked to sign a consent form giving the hospital the right to operate, and that would also seem like a good opportunity to ask for consent for the use of their tissue for research. Indeed, many hospitals do that, although many more do not.
Last year, I submitted a freedom of information request to every acute trust in England and every health board in Scotland, asking for a copy of their surgical consent forms. I found that, in England, 39% of hospital trusts have an option on their consent form for patients to donate tissue for research but that 61% do not. In Scotland, the situation is even worse—29% of health boards include it on their consent form, but 71% do not. Of those trusts that do not include the option on the form, some said that they had a policy of requiring their staff to ask patients verbally for consent; but others told me that they do not take tissue for research purposes at all.
The situation in Scotland is slightly different. Although the Human Tissue Act 2004 applies in Scotland, the Human Tissue Authority is responsible north of the border only for transplantation, not for regulating the use of tissue for research. However, the National Research Ethics Service is UK-wide, so I see no reason why procedures for gaining consent for the use of tissue cannot also be UK-wide; we would then have some consistency for those having operations, whether they live in Dundee or Doncaster.
The Human Tissues Working Party writes:
“Evidence suggests that the vast majority of patients agree to their surplus tissues being used in research. Moreover, they are equally happy for their tissues to be used by academic, biotech or pharmaceutical laboratories, as they understand that many players are required to bring new treatments to patients.”
Although no nationwide figures are available, research by the NHS Greater Glasgow and Clyde health board shows that only 5% of surgical patients in the area were being given the option to donate residual tissue. One way to increase that figure would be to standardise surgical consent forms across the country, ensuring that the option is always included. I discussed the idea last year with representatives from the Human Tissue Authority, but they argued that researchers and foundation trusts were likely to resent attempts to impose such a one-size-fits-all solution, as they all have different research systems in place.
Perhaps more importantly, the widespread view, articulated by the hon. Member for Alyn and Deeside, seems to be that when patients are about to undergo surgery, they may not be in the best frame of mind to make decisions about how their tissue might be used. They receive a great deal of information at this stage, including legal and medical information, which may be overwhelming; on top of that, they will understandably be nervous about undergoing surgery. Surgeons may also find it inconvenient. A surgeon at one London hospital told the Safer Medicines Trust that surgeons simply do not have time to explain to patients the benefits of donating tissue and simply tick the “no” box on behalf of their patients.
The Greater Glasgow and Clyde health board is taking a great interest in the matter, thanks particularly to the efforts of Professor Barry Gusterson at the university of Glasgow. It says that pre-surgical assessments could present the best opportunity to discuss the question with patients, and is now looking to make that standard practice. There is the potential, with IT developments, for patients checking in for pre-surgical appointments to be given information about tissue donation, and the opportunity at that point to click a box on the screen. However, we need to ensure that patients have information about what will happen to their tissue if they give consent. The health board has produced an information leaflet for patients that explains how and why tissue is stored by researchers, and for how long. That is a brilliant example of how information could be disseminated. I shall send the Minister a copy, and suggest that she share it with hospital trusts in England, Wales and Northern Ireland as an example of best practice.
The Scottish Government are working with schools to promote the benefits of joining the NHS donor register, giving information to young people about how the register works, and offering real life stories about people who have received transplants and the new lease of life that they now enjoy. A similar scheme could be developed for use throughout the UK to make people more aware of the research need for surplus surgical tissues.
In the longer term, we might even aim to reach the stage where hospital staff and the public are so well-informed about the need for surplus tissue for medical research that a system of presumed consent could be implemented. That would, of course, need to follow a national education campaign to explain the benefits of research on human tissue.
The debate about whether consent for organ donation should be opt-in or opt-out has been the subject of heated debate in this place. Indeed, my friend Dr Evan Harris, the former Member for Oxford West and Abingdon, introduced a Bill that would have brought in a system of presumed consent; under it, people would have to have opted out of it if they did not want to donate organs. In that case, of course, the debate was about organs for transplant rather than tissue for research purposes, which is slightly different, but we are still talking about measures that could save people’s lives. Personally, I would favour an opt-out system for tissue taken from live patients, as it would be less controversial; certainly, taking tissue post-mortem is more complex. I would welcome the Minister’s views on whether we could review the Human Tissue Act 2004, and whether the opt-in, opt-out question for live tissue samples might be considered.
The Department of Health carried out a review last year of the impact that human tissue legislation has had on the research community. It found that:
“the majority of participants report that human tissue legislation and subsequent regulation by the HTA had a negative impact on the research sector”.
That, of course, was not the intention of the legislation. The drive to ensure ethical practice is commendable—indeed, it is vital. However, 68% of respondents believed that it has made human tissues harder to obtain, and 61% believe that it has led to the disposal of potentially valuable tissue. Clearly, the use of human tissue for research must be subject to careful regulation to ensure a high standard of ethical practice, but that evidence suggests that the legislation may need to be reviewed.
Once consent has been granted and tissue has been removed, the question is how and where it should be stored in order to ensure that it is available for use by researchers wherever it is needed. Most tissue is stored in hospitals, and it can be difficult for researchers to find out what tissue is stored in which hospitals in various parts of the country, so that they can gain access to types of tissue that they need. There are more than 100 tissue banks in the UK, some publicly funded and some private, but scientists’ access to the tissue is seriously affected by its location—and their personal contacts—and some institutions are more willing than others to share their tissue stores.
Breast Cancer Campaign is in the process of setting up the first national tissue bank for breast cancer researchers in the UK. It will have a policy of equal access for researchers throughout the country. It is being funded through voluntary donations. As well as national tissue banks, there is another option for improving access to tissue samples; creating a database or online system would allow researchers to see what tissue there is and where, and to make requests for it. The national cancer biobanking organisation onCore has tried to set up a virtual network of tissue banks to share tissue with researchers across the country, but it has had limited success.
I maintain that the problem is not one of funding. Primarily, we need better co-ordination and implementation of the processes that need to be implemented, as well as greater awareness among health professionals and members of the public about the importance of human tissue research. Far too often, valuable tissue is incinerated rather than being collected for research purposes, even though collection is not difficult. It is a matter of spreading best practice, giving information to hospital staff and patients and making the gaining of consent part of the routine of surgical operations. When tissue is collected, it is not being made sufficiently accessible to researchers. I hope that the Minister will tell us whether the Department of Health is able to facilitate greater co-ordination across the NHS, and among academic and research institutions, to improve the sharing of information and clinical material such as human tissue.
I am sure that all hon. Members will agree that we should be doing all we can to speed up research into treatments for the diseases that I have mentioned, and the many others that I have not. I look forward to the Minister’s response.
Mr Russell Brown (Dumfries and Galloway) (Lab)
I attended this debate not intending to speak, but I congratulate the hon. Member for East Dunbartonshire (Jo Swinson) on securing it.
I wish to talk about the terrible condition of Parkinson’s disease. Yesterday evening I was making my way home and called my wife, as I routinely do. She informed me that a family member and good friend of ours, who is on holiday in Malta, had suffered an aneurysm, and is on a life-support machine until her family can get to her later today. I have known the lady for many years, and I know that she wants her organs to be donated to medical science, but tragically, she is hundreds of miles away from her family. That quickly brought home to me the fact that we need more research, and that more organs need to be donated to allow research to go ahead.
Parkinson’s disease, as we all know, is a terrible, debilitating condition. Every hour, someone in this country is told that they have Parkinson’s, and, if anything, the situation is getting worse. Parkinson’s UK is an admirable organisation doing its utmost to battle against the condition. Since 1969, it has spent over £45 million on groundbreaking research. At the start of the year, it was supporting 90 research projects worth over £15 million. Parkinson’s UK believes that it should be made easier for researchers to gain access to donated organs.
To be usable for research purposes, the brain must be harvested within 24 hours; however, all too often there are obstacles to that. For example, hospital staff are often reluctant to harvest organs without a death certificate—rightly so, on occasion. When someone dies over the weekend, there is often no one available to sign a death certificate, meaning that the organs, including the brain, cannot be harvested before they deteriorate and become totally unusable. When that happens, Parkinson’s researchers miss out on resources vital to developing better treatments and a cure. It also means that the wishes of the deceased, including those carrying donor cards, and their families simply cannot be followed. Parkinson’s UK is therefore calling for guidance for hospitals on the importance of harvesting organs, including the brain, quickly—within 24 hours—to avoid those obstacles. It also calls for greater public awareness of the importance of donated organs in medical research—an issue that the hon. Member for East Dunbartonshire raised.
The brain is the principal organ affected by Parkinson’s, and it is due to the death of specialised nerve cells in specific areas. However, the condition can also affect other parts of the body. There is emerging evidence, which the hon. Lady touched on, that early pathological changes found in the brain may start in the gut. The condition may actually start there and then spread to the brain. Much more research needs to be carried out in that area to investigate what is happening.
Parkinson’s UK funds a brain bank that makes it possible to look at changes that have happened in the brain once a person has passed away. However, it is also necessary to look at other organs, from people with and without Parkinson’s, particularly when they are alive, if at all possible. That would make it possible to correlate a person’s symptoms with any specific changes within the body; that is as important as looking at cells. A key challenge is the shortage of human tissue, including intestinal tissue from the gut, that is available for research. When it does become available, all too often there are difficulties associated with obtaining it. Parkinson’s UK would welcome a tissue database, as it would enable researchers to locate tissue more easily, thereby obtaining maximum benefit from it.
Mark Tami
Does my hon. Friend agree that we need the media to address research properly and to explain why it is being done? Too often, particularly in the tabloid press, we see headlines like “Frankenstein science”, and stories on experimentation for the sake of it, which has never been the case. Such language further undermines the likelihood of people giving consent; they would be more likely to do so if they were fully up to speed with why research was being carried out.
Mr Brown
I thank my hon. Friend for raising that point because I was going to come on to that issue. He made it abundantly clear that, regrettably, on too many occasions much of what we encounter day to day, especially in this arena, is driven by media hype and scare stories. His point is spot on. As the hon. Member for East Dunbartonshire said, the situation regarding presumed consent and everything surrounding it is delicate. New Members and those of us who were here previously will encounter over the coming months and years a significant amount of correspondence from people who are deeply concerned about organ donation and the provision of tissue. My hon. Friend the Member for Alyn and Deeside (Mark Tami) is right: when we tackle issues such as this one, we have to have open, honest and sensible adult debate, not driven by hype that, frankly, terrifies people.
I do not wish to say much more in my short contribution. Suffice it to say that the debate is very important indeed, and even that is probably an understatement. I have covered Parkinson’s disease, and I would like the Minister to address the issues surrounding that, the tissue database and how we overcome problems. I suspect that they occur too often, when the harvesting of organs needs to be dealt with very quickly—within 24 hours. How can we handle that better to ensure that we meet the wishes of those who want to give organs at the end of their life to save the lives of others and for research? Making that decision was a significant step for those individuals and we should do whatever is humanly possible to make it easier to respect their wishes.
Dr Julian Huppert (Cambridge) (LD)
I congratulate my hon. Friend the Member for East Dunbartonshire (Jo Swinson) on securing the debate. She briefly mentioned animal testing and I would like to pick up on that theme to start my comments. It is clear that further medical research is needed, and I have a background in that area. We heard movingly from the hon. Member for Dumfries and Galloway (Mr Brown) about Parkinson’s, and there are other areas where much greater research is needed, for which one needs some form of human-based model. That has led to the widespread use of animals for experimentation, which leads to concerns—ethical and practical.
The ethical concerns centre around how we should treat animals. While that is important and I very much share the deep concern, it has on occasion led to some extreme positions, which I do not think anyone in the House would support. There are sensible approaches to balancing the need for medical research, which leads to experimentation, with trying to avoid such experiments. I would like to highlight the Fund for the Replacement of Animals in Medical Experiments, which does a very good job in this area. It describes its position as anti-animal experimentation:
“FRAME believes that the current scale of animal experimentation is unacceptable, but recognises that the immediate abolition of all laboratory animal use is not possible. Essential medical research must continue, so that effective treatments for diseases that lessen the length and quality of human and animal life can be found. New products, including medicines and vaccines, and industrial and agricultural chemicals, must be adequately tested, in order to identify potential hazards to human and animal health, and to the environment.”
That nicely sums up the balance, and explains why we need to continue with this research. FRAME then goes on to say that it advocates the three R’s approach—replacement, reduction and refinement. As an aside, I notice that it is very traditional to use the three R’s whether we are talking about reduce, reuse and recycle or reading, writing and arithmetic.
There is a great deal of misunderstanding about animal testing. There is an idea that medical research organisations and pharmaceutical companies want to do animal testing, when in fact most of them would much rather not if alternatives were available. That might be for financial reasons if nothing else. A lot of work has been done to find different ways to test and develop new techniques. I am talking about work on humans, animal models and tissue. Recently, we have seen the idea of human on a chip, in which samples of different human tissues are put on a very small chip so that system interactions can be studied. There has also been work with stem cells and their derived tissues. There has been work in vitro and, increasingly, in silico—trying to use computational methods to work out what is likely to happen without having to perform real-life experiments—in which I was involved before I was elected to this place.
There are disadvantages to all those ideas. Testing on humans is risky; one has to be very careful about any intervention. We know that there have been some sad instances of severe illness and death when humans have tried out new therapies and medicines. We know that there are problems with animals; they often do not provide exactly the right systems. Drugs behave differently in some animals to the way that they do in humans. A lot of work has to be done on systems such as human on a chip, and most of the computational techniques still have a long way to go before they can truly be said to represent what is going on.
I do not want to breach the Haldane principles and suggest what research should be funded, but the topics that I have mentioned would be very interesting for the appropriate bodies to look at rather carefully—whether that is a funding organisation such as FRAME or the National Centre for the Replacement, Refinement and Reduction of Animals in Research. Support for such areas would be very gratefully received and would make a huge difference to many people.
Today we are talking about tissue, and tissue has a huge amount of potential. It occupies a very nice space in the hierarchy, between in vitro and in silico models and full humans with all the attendant risks. A number of tissue banks have been set up, including the UK Biobank. A large number of brain banks have produced some very nice work, typically post mortem, leading to results on Parkinson’s and Alzheimer’s. I shall mention, in particular, the Cambridge brain bank partly because it is in my constituency and partly because my mother was involved with it—as a researcher rather than as a donor. We should try to broaden the spread of these banks and create a proper network. Some of the brain banks have had problems with interacting with other banks and with transferring data. Things are also going on in this area with cancer banks. My hon. Friend the Member for East Dunbartonshire mentioned onCore, which is a national cancer biobanking organisation, and we need to have other such organisations.
There are issues not just with how we collect the samples and store the information, but over funding. Currently, there is not a viable commercial model for tissue banks or networks. From what I have heard, the banks have great difficulty in securing long-term funding. Banks cannot survive on project-based funding, because the value derives at the end of the process and not at the beginning, so there is a need for core funding to support such a network. They have to have a certain level of security.
Let me turn to the topic of consent. We have heard some discussions about whether we should have an opt-in or opt-out system. It would, I believe, be a great step forward if we decided on the opt-in model. If people were asked to opt in, we would see an increase in numbers. I would be concerned if we went to an opt-out system for tissue. There is not public acceptance of that, and I would prefer to get lots of people opting in.
The topic of organ donation was also raised. It is my strong belief that it should be on an opt-out basis, and I would have supported the Human Tissue Bill proposed by Dr. Evan Harris, the former Member for Oxford West and Abingdon. Why is there a difference between the two? One reason relates to public acceptability and the other to timeliness. While we benefit from having a larger and more thorough bank of information, individual instances of information missing are not critical; it is a general problem, but not a critical one. With organ donation, organs are individual lives, and there is a specific issue of timeliness. As my hon. Friend the Member for East Dunbartonshire mentioned, in the future we will be able to have an opt-out system for tissue. It will be nice to see a real acceptance of the benefits of research for everybody in this area.
There are also issues about the ease and clarity of consent. The advantages of a national system and how easily it can be established have been discussed. There are also questions about how much information should be stored with tissue, and that needs further thought. Should the data be anonymised? Should it be tied in to medical histories and to details of other phenotypes that were observed—other interactions that happened? Should it be tied in with a DNA profile from that tissue?
On that cue—I find it very hard not to talk about DNA as that is what I used to work on—let me say that there is an interesting asymmetry in the Human Tissue Act 2008 between DNA and tissue in terms of whose consent is required. The Human Tissue Act, which regulates tissue, stipulates that there is a hierarchy of consent before a tissue can be obtained from somebody who has died. Although we are mostly talking about tissue samples from those who are still living, post-mortem tissue is incredibly valuable as well. A spouse can refuse permission to use a tissue sample even though the benefit may accrue to those relatives who are biologically related. With DNA, there is no hierarchy of consent, and any relative can consent. Typically, the people who are asked are those with a genetic relationship. That gives rise to some interesting asymmetries, because it means that different people could be consenting for different aspects, whereas the DNA would typically be derived from the tissue. That will lead to problems in the future and we need to consider it. In general, DNA and the future of DNA technology and testing will be a topic that requires further thought from this House. It may be an appropriate topic at some stage for a debate such as this.
There have been a lot of drives for improvement as the cost of sequencing has plummeted—from costs in the order of billions for the first sequence down towards the £10,000 mark and heading very rapidly towards the £1,000 mark in the near future. That means that we are starting to see more and more projects in which everybody, or every baby at birth, is being sequenced. We will see some real effects on health—I hope that the Minister will be able to comment on some of those—both in research angles, through genome-wide association studies, and in areas such as personalised genomic medicine. I am sure that the Minister is aware of the House of Lords’ Select Committee report on the subject. Schemes are ready to be cascaded down through the NHS. For example, free foetal DNA testing allows Down’s syndrome screening at a very early age—at about six weeks into a pregnancy. A pinprick of blood is taken and the RNA is then sequenced. It is amazing that we can do that, and such a scheme is ready to go through the NHS in a matter of a few years.
In conclusion, let me support my hon. Friend and urge the Government to take action to support this work because it is in the interests of science and research, of reducing animal experimentation and of patients.
Mary Creagh (Wakefield) (Lab)
It is a pleasure to make my first outing as the shadow spokesman for public health under your chairmanship, Mr Benton. I congratulate the hon. Member for East Dunbartonshire (Jo Swinson) on securing such an important debate. Having listened to her this morning, I feel that I know a lot more about the subject. She is well known in the House for her campaigning work on this issue. Her early-day motion 212, which she tabled in the previous Parliament, attracted the support of 64 hon. Members, and I am sure that a version of the same early-day motion will make its appearance through the course of this Parliament.
It was interesting to hear about the hon. Lady’s strong constituency link with the subject. I was certainly unaware that her constituency was a hub for research into life sciences. I also want to congratulate her on her tenacity. Using the Freedom of Information Act to get the data on the hospitals is the work of someone who pays great attention to detail. In fact, she found that there are huge differences between hospitals. It might be interesting to drill down into the information that she has to see whether there are geographical differences, or differences between foundation trusts, in respect of how samples are collected. The challenge for Ministers is to try to get everybody up to the level of the best, and it is clear that there is a very long way to go to achieve that.
I congratulate the Minister, who has responsibility for public health, on her appointment. She has been in a shadow public health role since July 2007. She had a distinguished career in the NHS for 25 years, including working as a district nurse. She also worked in hospitals, in research and, of course, in palliative care, so I am very interested to hear her comments in this debate. Furthermore, she is possibly one of the very few Conservative MPs who has served as a trade union steward, for the Royal College of Nursing, so I will also be interested to hear whether she has any response to yesterday’s Budget. We welcome her, and her experience, to her new post. Her direct experience of front-line working in the public sector will no doubt stand her in very good stead.
I also want to congratulate the hon. Members who have contributed to today’s debate. I know that my hon. Friend the Member for Alyn and Deeside (Mark Tami) has a very strong interest in the subjects of cord blood and stem cell research; we have debated those issues together on many occasions. He raised a very important point about the general altruism that the public feel.
Most people want to make their own contribution and help to contribute to medical science. Unfortunately, however, the level of knowledge and debate on these types of issues is very low. Part of that is due to the “ick” factor—none of us likes to think of our precious bodies as, first, dying; secondly, being cut in any way, even after death; and, thirdly, being kept in a large fridge with medical scientists examining them. But in fact the reality is that that is how human progress, particularly progress in science, has been made for generations, even centuries.
I also congratulate my hon. Friend the Member for Dumfries and Galloway (Mr Brown) on his contribution to the debate. I send my condolences to the family of his friend who suffered such a terrible tragedy while on holiday and I wish them courage as they fly out to Malta.
My hon. Friend raised the very important issue of the practical barriers that exist in this area, even when hospitals systematically want to collect people’s brains after death. There are also the issues of the death certificate and the conflict that exists between the medical side and the research side. The hon. Member for East Dunbartonshire has really hit on an important issue here, which requires some constructive and creative thought.
Mark Tami
I thank my hon. Friend for her very kind comments. There is just one point that I want her to address; I am perhaps returning to the point that I made earlier about how we and the media view this issue. She knows that my particular interest in this area is with the Alder Hey hospital and with children—unfortunately, that interest derives from a personal experience. But the fact is that a lot of medical conditions, such as sarcomas, particularly affect children; indeed, in some cases, medical conditions only affect children.
Given that children are particularly affected by some conditions, it follows that the research into those conditions must focus on children, but we find such research difficult to accept. It is very difficult to accept research on adults, but research on children, which sometimes very unfortunately happens as a result of a child’s death, is even more difficult to accept. However, it is something that we really need to address. As I said, some medical conditions only affect children.
Mary Creagh
My hon. Friend makes a very important point. Actually, this is one of those issues where the answer of the child involved might be very different from that of a parent. I think that children can be incredibly wise.
Speaking as a mother, the thought of one of my children dying is beyond comprehension, or beyond the limits of my imagination. It would be wrong for someone to ask for a donation from a bereaved parent who was dealing with that level of stress and grief. The time for asking for donation is not at the point of surgery or of death; it is when people are feeling generous and altruistic, when they feel that donation is something that can help other people.
Actually, children themselves are incredibly generous and incredibly thoughtful. Obviously, it is different for babies and toddlers, but children from about the age of six or seven can start to work these things out for themselves. Perhaps there is a role for education in the classroom to get children to talk more seriously about these issues.
I know that the work that the Anthony Nolan Trust has done in increasing the number of people on the bone marrow register is incredible. In Huddersfield and Wakefield—my constituency covered part of Huddersfield until the last boundary change—we had a very brave campaigning journalist at the Huddersfield Examiner who, when he was dying in his mid-20s, launched a huge campaign, including writing a blog about his experience. Through that campaign, he engaged with a lot of young people to get them on to the bone marrow register.
The issue of donating tissue, or blood marrow, is a bit like that of blood donation. I have spoken to my staff about it and said, “The blood lorry is outside, off you go”. There are responses such as, “Well, I don’t fancy rolling up my sleeve and having someone stick a needle in me”. However, if I ask, “If you have an accident on your way home, or your child is ill, would you want blood for your child or yourself?”, the answer of course is, “Yes”. The time to do it is during a tea break or a lunch break from work and not when people are under stress and dealing with a huge range of emotions.
I also congratulate the hon. Member for Cambridge (Dr Huppert) on his contribution to the debate. It is clear that science has lost a great researcher, but science’s loss is certainly the House’s gain. While he was speaking, I had a quick look on my BlackBerry and perhaps after the debate he can explain to me what “nucleic proteins” are, or whatever it was that he was researching—I am not even sure that I have used the right word there—because I got lost after about the first sentence of his contribution.
Computational biology is clearly an emerging area of work in this field and the hon. Gentleman spoke very eloquently about its potential to reduce the need for experiments on animals and, in some cases, to replace high-risk human trials, which would be welcomed by all parts of the House. He also leaves us with the interesting image of a “human on a chip”, which is something that I will go away and reflect upon.
Using his own experience as a researcher, the hon. Gentleman raised the important ethical issue of the anonymisation of samples, and he is absolutely right to do so. Certainly, in any research that I have ever participated in, I have always been told that the donated material will be held completely anonymously and untraceably. Now, however, we are moving forward with this biobank. I was invited to take part in that project. I went along because I was interested and I asked, “Are more women than men coming along?” I was told that, yes, there were, so there were all the usual biases that exist. We come back to the altruism factor and it seems that women tend to be more altruistic than men. I will leave that point hanging; if anyone wants to intervene on me, I am happy to argue the point. [Laughter.]
Mark Tami
My hon. Friend is exactly right. Men are certainly less willing to become stem cell donors and bone marrow donors, because we are cowardly and do not like needles. That is a particular problem.
What we must do with bone marrow and stem cell research, as the work of the Anthony Nolan Trust shows, is to put fewer obstacles in the way of donors. When it comes to giving blood, I know from my own point of view that my reaction is really, “Argh”—giving blood really terrifies people. However, mouth swabs can be used to donate other material. If we can get people past that first stage and if they are then approached because they are a potential match, I think that people will say, “I am a potential match and therefore I will go to that next stage and give blood”. If we somehow phase people by saying, “You’ve got to give blood and you must have various tests for things”, then people are less likely to come forward.
Obviously, with bone marrow and stem cell donation, we are not talking about people who have died. It is one of the few areas where someone can save a life by giving something. It is not painful, it does not take that long and someone can actually save somebody else’s life. There are tens of thousands of people out there who do not even know that they are potential life-savers. This issue is not only about how we raise awareness, but how we—
Mary Creagh
Thank you, Mr Benton. I was listening with interest and totally agreeing with my hon. Friend. Most of us will not have the chance to save someone’s life in the normal way. The chance to be an everyday hero does not come to many of us, and most of us do not have the medical skills that would enable us to be one. However, a person can undergo a small surgical procedure to take bone marrow out of their hip, and someone else will be walking around as a result of their generosity to another human being. I find that profoundly moving.
We need to look at where the responsibility lies for raising awareness. We as politicians are in this room debating the matter, so we are fulfilling our responsibility.
We have heard of the difficulties that the media create in their coverage of these issues, some of which have been difficult. The Alder Hey and Bristol Royal Children’s hospital cases were seen as national scandals, and rightly so, but the scientific community has a huge responsibility in this area. This country has a problem with science. We have a framework that enables us to be world leaders in life sciences and all kinds of areas, and we have a population that is willing to run marathons, to do fun runs for breast cancer and cancer research and to work and raise money. Yet there is a gap.
Presumably, every one of the women who participated in the five-mile fun run in Wakefield—the race for life—did so because they knew someone who had died of or suffered from breast cancer. All those women could have been offered the chance to be screened for blood marrow donation or to talk about tissue sampling. The world of fundraising needs to work more closely with the world of research. I do not know how that would happen, but I think that the scientific community, whether it is researching genetically modified foods, cancer or Parkinson’s, has its own responsibility. However, it has not found its voice in this area.
We have an image of scientists working in their labs in white coats. It has been a long time since I have been in a research lab, so I do not know whether they still wear those coats, but they do not get on the telly. We tend to hear about sensational breakthroughs, but when we read the small print, we find that they are at least five, six or 10 years away. There is media sensationalism about what might be small steps at the beginning, yet no real conversation about the long, arduous and painful work that scientists have to go through to achieve a breakthrough. I agree with the hon. Member for East Dunbartonshire that there is not enough access to tissue samples, but there are difficulties at the interface between the two worlds.
My hon. Friend the Member for Alyn and Deeside mentioned cord blood collection. The Royal College of Midwives has specifically said to its members, “We do not want you to be distracted by cord blood collection while you are trying to deliver a baby.” Obviously, anyone who is assisting at a birth wants a happy baby and a happy mum. The cord blood thing comes much farther down the line. Certainly, that was my experience of giving birth, and I believe that it is probably the experience of most medical professionals.
The scientist is not in the room saying, “By the way, make sure you get the cord blood, and make sure you put it in the fridge quickly.” If a midwife is dealing with a baby that might be in respiratory distress or a mother who is in the middle of a haemorrhage, all other considerations rightly go out of the window. The midwife wants a safe delivery, and the researcher stands in the university lab and weeps as the precious cord blood heads off with the placenta to the incinerator. I do not know whether people still take the placenta home. I certainly was not interested in that; we are back to the “ick” factor.
There is a challenging conflict between the NHS professional who wants to deal sensitively with, for example, a cancer or Parkinson’s patient, and the colleague back at the lab who wants to know whether they have consent to do lab work on the tissue samples. We have heard some interesting suggestions today about how the medical process can support the collection of tissue. Most hospitals have introduced MRSA screening prior to surgical interventions, and that would be a good way of doing it.
The national patient care record—a national database with everyone’s details—is another possibility. The patient could sit with their general practitioner and go through organ and tissue donation. The information could be there in black and white on the computer screen for every medical professional who deals with them at any stage of their life. The decision could also be revoked at any stage.
Dr Huppert
As the hon. Lady knows, there has been a great deal of concern about uploading data. I hope she agrees that if what she is discussing is to happen at all, a huge amount of data safety and security, and a simple mechanism whereby people can opt out, will be needed. Ideally, they would opt into such a system, rather than being given a limited opportunity to opt out.
Mary Creagh
I agree with the hon. Gentleman. I know that Liberal Democrats have an antipathy to the national patient care record and have called for it to be scrapped, but it might represent an excellent opportunity to deal with this matter. Of course, people would have to opt in, and nothing I have heard today changes that.
The hon. Member for East Dunbartonshire asked whether people would opt in or opt out. We need to go back and look at consent, which is at the heart of this debate. As we have heard, the Human Tissue Act 2004 created the framework for the removal, storage and use of tissues and organs of the deceased.
We must remember the circumstances that gave birth to the Act. It came about because of public inquiries into the events at Bristol Royal and Alder Hey hospitals, where organs and tissues from children who had died had been removed, stored and used without consent. Scientists have been doing that for generations. I do not think that there is any question about that, and we can understand why they want to progress medical research. However, years—in some cases, decades—later, families discovered that the children who they thought they had buried had not been complete.
The series of moral, ethical and religious issues that came out of that practice had to be, and were, addressed by the Labour Government. The inquiries together with the Isaacs report, which focused on the retention of adult brains following coroners’ post-mortems, revealed that storage and use of organs and tissue without proper consent was commonplace. We as legislators had a duty to change that.
The chief medical officer concluded that the law needed to be changed. We had a wide-ranging public consultation, “Human bodies, human choices”, which set out proposals and led to the Act that created the Human Tissue Authority, which licenses and inspects institutions. The Act is based on the principle that consent should be given by the living. If that key principle is to be changed, it must be changed with a great deal of consent. I do not detect a groundswell of public opinion or hon. Members in this House wishing to reopen the consent issue, despite the efforts of Dr Harris, the former Member for Oxford West and Abingdon.
Jo Swinson
In the context of the legislation, I agree with the points that the hon. Lady makes about consent being vital. However, would she accept that the current problem is that many people would be happy to consent, but their wishes are not being fulfilled because they are not even being asked?
Mary Creagh
Absolutely. The hon. Lady makes a valid point, and systems, policies and processes are the only way. It is not laws or our passing Acts in Parliament that will make it happen. This is about the 60% of trusts that do not collect any form of tissue, but get rid of everything. It is about people being made aware—there is an educational side to this—and it is about having a system in place. If we want people to donate their organs, we have to make it as easy as possible, so that they can do it when they open a bank account or go to Boots pharmacy to pick up a prescription. Whatever it is, it has to be made easy.
Most people hope throughout their lives that they will not need a huge amount of surgical intervention. That is what we all hope for, is it not? I believe that the hon. Lady is right that most of those who are unfortunate enough to have repeated operations would like to help other people through medical research.
It is important to say that lifetime consent for a tissue sample is already possible under current legislation, and people may give “generic and enduring” consent for their own sample, but the hon. Lady may be trying to bring to the foreground lifetime consent for any medical research purposes. However, the law in such areas cannot and should not stand still, and we must renew the working of the existing law.
I was interested to hear the hon. Lady’s reference to the Human Tissue Authority’s evaluation of perceptions of how the legislation and regulations that flow from it have affected researchers. The Human Tissue Authority has said that it wants to ensure that researchers have access to high-quality samples by consolidating stocks throughout the sector; that brings us back to the idea of banks. It also wants to reduce the regulatory burden on the research sector by using open-ended rather than fixed-term licences, and moving to a risk-based approach to regulation rather than regulating everyone.
The hon. Lady will be interested to hear that the Nuffield Council on Bioethics is consulting on options for boosting the supply of organs and human tissue. It is clear that a problem is emerging as fertility sciences improve. There is a shortage of organs for transplant, as many hon. Members have said, and of sperm and eggs for donation. I prefer to refer to “sperm” rather than “gametes”, not least because I do not know how to pronounce that latter word. Let us call a sperm a sperm.
Transplant patients and women seeking fertility treatment may travel abroad, often to places where different rules apply or, in the case of organ donation, where there may be an illegal market. We must watch that carefully because moral and ethical considerations may be involved if inducements are offered, whether cash or paying funeral expenses for people who give their organs. Those are some of the issues being debated, and the consultation closes on 13 July. I put that on the record so that any hon. Members who want to participate in the consultation may do so.
New stem cells made by reprogramming adult tissue into induced pluripotent stem cells—iPS cells—which come not from human embryos but from adult skin cells, have been possible only since 2007, so science is already well ahead of legislation in this area. The iPS technique could lead to new breakthroughs for Parkinson’s disease, motor neurone disease, diabetes and paralysis, and that would obviously be very welcome.
Mark Tami
My hon. Friend referred to breakthroughs, and stem cells are one of the major areas where breakthroughs are happening. However, we must remember that much research comes to a dead end. Sometimes when we believe that it is going a long way, it does not. The Daily Mail and the Daily Express may say that drinking coffee prevents cancer, and also that it causes cancer. There is no “one size fits all” or one magical cure, so we must go down many routes, knowing that some will be a dead end.
Mary Creagh
I agree that there is no silver bullet, much as we would like one, and my hon. Friend is right about the red tops’ approach to eating—or not eating—yoghurt, strawberries, blackcurrants or whatever fruit or drink is fashionable. It would be impossible to live our lives by their diet rules, certainly in the House of Commons Tea Room. We need to understand better, and the hon. Member for Cambridge has a responsibility to his former colleagues in Cambridge to be a champion and an advocate in this place—he has already proved in this debate that he will be—in respect of the benefits involved and the management of people’s expectations.
I understand where the research is coming from. The hon. Member for East Dunbartonshire said that researchers are a bit cagey about sharing with other researchers where tissue is held. Someone doing a PhD who has put three or five years of their life into it does not want someone else from a different country or different research institution publishing six months before them; let’s face it, academics are as competitive as the rest of us. I know from my experience at Cranfield School of Management that we loved sharing our research at conferences, but we lived in dread of someone coming up with the same idea and publishing it a bit sooner. It is incumbent on researchers to work out ways and methods of sharing their research in this area.
Dr Huppert
The hon. Lady is making an important point. A lot of work is taking place on open-access data and open-access publishing with the safeguards that she correctly requires, so that people who have invested a lot of time and effort—for example, in building up a bank—get first priority. I hope that she is aware that many of the research councils are increasingly mandating that data should be made openly available.
The hon. Lady is correct about interaction with the media. She may agree that one problem is the shortage of good science journalists, with a few honourable exceptions.
Mary Creagh
I thank the hon. Gentleman for that intervention. I was not aware that the research councils were making open access mandatory, but logically it is right that that should be done. Researchers enjoy taxpayers’ money, so it is right that it should be shared for the common good. Most historic scientific breakthroughs have been made through people sharing building blocks with each other, rather than through working in splendid isolation.
The hon. Gentleman is right about science journalists. There is a paucity because they may make two, three or four times as much money working for a big pharmaceutical company. Writing for people who may not be interested or who may even be openly hostile to science may be less alluring than working for a big pharmaceutical company and being at the heart of breakthroughs.
The Human Tissue Authority website is incredibly useful in listing establishments that have human application, research application, post-mortem application, anatomy licences and display licences. I had not realised that the display of human bodies was regulated, but that was controversial a few years ago.
I hope that today’s debate will lead to solid proposals from the Minister. I look forward to hearing what she has to say. We must tread carefully if we are to maintain public confidence in these vital areas and public trust in the medical research community.
The Parliamentary Under-Secretary of State for Health (Anne Milton)
I welcome the debate, and congratulate my honourable colleague the Member for East Dunbartonshire (Jo Swinson) on securing this debate. Although we are not great in number, clearly the matter is important to some people, and this has been a brilliant opportunity to have a good run-around with some of the issues. My honourable colleague has worked extremely hard to promote the supply of quality tissue for research, and to encourage closer co-operation between everyone in the sector. If nothing else, the debate has highlighted the need for much greater co-operation.
Human tissue-based research is vital for advances in medical science. That is an obvious statement, but it needs to be reiterated. We want better and more effective treatments, and if that essential research is to flourish, everyone involved in procuring, storing and using tissue must work together. None of that work can take place without the generosity of people who are willing to allow their tissue to be used for the benefit of others. We can proceed only if we have their trust and confidence in what I believe is a difficult climate. The public’s trust of anyone outside their immediate family is low, so this is a good time to raise the matter.
My honourable colleague outlined some of the significant benefits of using human tissue. It allows for testing to reduce harm, reduces the need to use animals, and allows for placement refinement and reduction, which the hon. Member for Cambridge (Dr Huppert) also discussed at some length. I should point out that I am in the fortunate position of having a group of people to advise me, so I know all sorts of little facts that I did not know when I was an Opposition spokesperson. I should possibly have started my speech by congratulating the hon. Member for Wakefield (Mary Creagh) and thanking her for her kind comments.
My colleague the hon. Member for East Dunbartonshire said that the Human Tissue Act 2004 applied to Scotland, but I understand that there is separate Scottish legislation—the Human Tissue (Scotland) Act 2006. I am sure that she is aware of that Act, but I thought I would mention it for the sake of clarity.
The hon. Member for Dumfries and Galloway (Mr Brown) mentioned people who suffer from Parkinson’s. My mother-in-law suffered from Parkinson’s and, during my career, I have nursed many people who suffer from the illness, which is very cruel. Parkinson’s is very difficult not only for the individual to live with, but for those around them. Donated organs can clearly make a difference to research in that field, and I know that many people who suffer from Parkinson’s and their families look forward to a day when there is real relief from the symptoms and in time, I hope, a cure.
Of course, Parkinson’s is not the only illness, and there is possibly more publicity than ever for some of the severe, enduring and sometimes life-limiting illnesses that people have to go through. It is a shame that the opportunity is not always taken to highlight the difference that we can make as individuals who are not necessarily connected with people suffering from such illnesses. One of the ways that we can make a difference is by donating tissue.
The hon. Member for Dumfries and Galloway mentioned the tissue database. We are possibly in a fortunate position in the new coalition Government. I do not feel entirely responsible for what went on before I came into post, so this is a brilliant time to raise with Ministers some of the issues that hon. Members know create obstacles, particularly in relation to the subject that we are discussing today. This is an opportunity to raise issues, and I always welcome any feedback people can give me.
The hon. Member for Alyn and Deeside (Mark Tami) mentioned the need for media support. There is no doubt that the media have a huge role to play. The recent death from cervical cancer of a celebrity meant that the incidence of cervical screening shot through the roof. There is no doubt that the media have both a responsibility and, to some extent, a duty to raise some of the issues, as we all do.
Mark Tami
Further to the comments of the hon. Member for Cambridge (Dr Huppert), the problem is that the tabloid press provides a twisted, simplistic view of science, but the scientific press is too detailed and writes and speaks in a language that ordinary people do not understand. We need somehow to get a balance that crosses those two divides.
Anne Milton
I thank the hon. Gentleman for his intervention; he is absolutely right. I agree with the hon. Member for Wakefield—I call a sperm a sperm. The hon. Member for Cambridge strayed into areas that are way beyond me, but such matters are important. I welcome him to the House. At the last election, we lost a number of scientists and it is extremely important to have voices such as his in the House to inform journalists, particularly if there is not sufficiently extensive scientific journalism out there, although I am not in any position to judge on that matter. Such issues are important, and perhaps we should all take the opportunity to send a copy of this debate to our local press. That will perhaps highlight the issue of organ donation locally; we all have our responsibilities.
The issue of consent was raised. Legislation in that area was reviewed following revelations about the widespread retention of organs and tissue without the consent or knowledge of families, as the hon. Member for Wakefield mentioned. The Human Tissue Act 2004 makes it clear that consent is required for the storage or use of organs and tissue for research, whether they are taken from people during their life or after death.
As was mentioned, we know from talking to patients and their families that the vast majority of people are extremely supportive of tissue research and, when asked, will happily consent to their tissue being used. However, my colleague the hon. Member for East Dunbartonshire is rightly concerned that we should not waste opportunities to tap into that incredible good will. She suggested the use of generic consent for the retention of tissue, which could be sought at the same time as consent for other medical procedures—for example, surgery or a diagnostic biopsy. I entirely agree that people should be given the opportunity to donate tissue, but consent is not a straightforward issue.
I am not sure that a top-down approach is the best way to proceed with dealing with the matter. The good practice we seek cannot be imposed from the top, and history is littered with examples where a top-down approach simply somehow relieves professionals of their responsibility; they believe that they are no longer responsible for the matter. Increasingly, we find that organisations are tailoring their consent procedures to local needs; for example, there may be specialist clinics, where specific risks can be addressed. We are aware of successful and innovative approaches that have led to greater efficiency and a better experience for the patient or person. Innovative thinking must be encouraged and not constrained. I am often concerned about the latter happening with anything that takes a top-down approach.
Jo Swinson
I am sympathetic to what the hon. Lady is saying about enabling local decision making, but does she accept that there is a risk that if we have very different consent procedures across the country, it will hamper researchers and industry further? It would mean that when it came to accessing tissue samples, some would be available under certain consent rules and others would be available under others. That complexity is itself a real barrier and a problem.
Anne Milton
As with many things, it is a matter of balance. I heard my honourable colleague’s words about what the Department of Health must do. I do not know whether the Department of Health holds the solutions in this case. I really believe that the matter needs to be dealt with locally. Anyone who has first-hand experience of routine procedures knows that they can be quite unsettling for people. Most people about to undergo surgery are understandably nervous. The hon. Member for Alyn and Deeside expressed his visible concern about donating even blood. I suggest that he comes to see me afterwards—I will give him a talking to and get rid of his nerves.
We are dependent on the professionalism and humanity of health care professionals around the country, and we can draw on their experience to find the right time to discuss tissue research. Dealing with the issue is a question of trust—trust in the relationship between clinicians and patients, trust in local health organisations to provide the right information to people, and trust in health professionals to maintain the separation between treatment and research.
My colleague the hon. Member for East Dunbartonshire mentioned the fact that it might not be convenient for a surgeon to seek consent for tissue donation. I would suggest that it is not necessarily a matter of whether it is convenient; it is about whether it is appropriate. That is the difficulty. It is also true that clinicians can duck the issue and find it difficult to talk about. That also needs addressing. However, I do think that the solutions lie with the organisations and the clinicians, and should not come from the centre.
Mark Tami
The hon. Lady mentioned the issues of trust and getting information across on issues such as bone marrow donation and stem cells. However, there is also the matter of getting information across to minority communities, where levels of donation are very low. If, for example, a child is diagnosed with a particular condition, their odds of finding a donor are very slim compared with those of a child from the white population. We need to get information across to people and educate them about what is being done.
Anne Milton
I thank the hon. Gentleman for his intervention. It is interesting that this is the first time that we have referred to the differences between ethnic groups, and that is an extremely important matter, but there is a resource out there that we do not necessarily use, which is the faith leaders in communities, who can perhaps raise the issue. That is why we need to send tentacles out, perhaps even from this debate, to ensure that we get the messages across in many different settings. We mentioned children; perhaps the issue should be talked about in school.
Mary Creagh
The Minister says that this is not a matter for the Department of Health, but is she not even a little curious about which hospitals do systematically collect and process the material, and about the 60% or so that do not? I am very curious about that. Her Department could easily map, with the resources that it has, where the hot spots and cold spots are. It could use the transparency that we have under the Freedom of Information Act almost to shame the hospitals that do not do it, or it could at least have a conversation with those that do not do it systematically, perhaps because they are not attached to a university or because they are not teaching hospitals. We could examine how we could encourage hospitals to do it and educate the staff about the wider benefits to the community.
Anne Milton
The hon. Lady is right. I think that in the end it is the differences that will spread good practice and drive up standards and professionalism in this area. She is right to say that we must examine why some places are so good on this. One example that I heard about recently is that of a trust that sends combined, personalised leaflets about consent to treatment to patients along with pre-operative medication. My colleague the hon. Member for East Dunbartonshire mentioned that. That trust is giving patients the time and chance to think about their treatments in advance. That is the type of innovative practice that we want. I do not believe that a standardised form is the answer.
I would also have some misgivings about routinely seeking consent to use tissue for research unless we could be confident that there was a good chance of its being used. One of the key complaints from the families affected by organ retention scandals was that everyone tried to justify the practice of routinely retaining tissue in the name of research, when in fact most of the material had never been used. There is a test that is applied to children, called the Gillick competence. We do not often use the opportunities that we have to raise the issue with children, or to ask them what they want to do.
Let me clarify that there are no plans to revisit the question of an opt-out system. Certainly, on a personal level, I would not be happy with such a system. It would require an extensive information and education campaign, and there would be ethical and practical issues if people were able to opt out of some types of research but not others. No doubt some people would be happy to give tissue for some types of research but not others. Everyone feels so differently about the issue; it is a very difficult area.
My colleague the hon. Member for East Dunbartonshire also raised the prospect of a tissue database and mentioned the work undertaken by onCore. I understand that onCore was originally set up to collect and store tissue in a national bank for cancer research. It now focuses mainly on bio-banking activity, and that shift reflects the research community’s local initiatives.
I also understand that there have been excellent developments through the National Cancer Research Institute’s informatics initiative. For example, there is the oncology information exchange, a free-to-use computer portal for sharing information on resources for cancer research, including tissue collections.
At the heart of the debate is the issue of improving access to tissue for research. Some initiatives are under way, and there are some examples of good practice, but a common cause of concern is the complexity of the regulatory and governance regimes. A lack of confidence and misconceptions about requirements have meant that residual tissue from diagnostic procedures may be archived for purposes such as clinical audit, but not available for research. Perhaps the appropriate consent has not been secured or the licence to store tissue for research has not been obtained from the Human Tissue Authority. Either way, the effect has been to stifle research, which is not what we want. Researchers complain of local resistance to new research programmes because they are perceived as being too risky or beset with rules and regulations. Efforts are being made to help NHS organisations to overcome those perceptions.
The HTA, in collaboration with the National Research Ethics Service, has set out the licensing, ethical approval and consent requirements to enable diagnostic archives to operate as tissue banks. The HTA’s annual review tells the story of Guy’s and St Thomas’ NHS Foundation Trust, which was one of the first establishments to license its archive of diagnostic histopathology specimens as a research resource. A histopathologist from the trust said that
“support from the HTA was very helpful for us in approaching our Trust management with proposals to license our diagnostic archive for research and upgrade consent processes”.
That is precisely the type of collaborative and supportive approach that we want and it is typified by a joint enterprise between the HTA and the National Research Ethics Service, which has helped to open up access even further.
I look forward to the outcome of the consultation by the Nuffield Council on Bioethics. This is clearly a dynamic issue, and I personally would like to keep it as such. It is about raising awareness and about the role that we in this place can play in raising the issue in our constituencies and with a wider audience. That is not just down to the scientists or those with a scientific background in this place, although their expertise is very valuable. The media can play a role. The organ donation taskforce report raised the issue of awareness, and there have been a number of reasonably successful campaigns in the past year, but I cannot re-emphasise enough how important it is to have public trust and confidence in the systems in place. It is important that we do not have burdensome legislation. It is important to raise awareness among all types of clinicians in training and to raise awareness among members of the public. Possibly it is a question of just changing the culture, so that people think, “I can change what’s happening in the area in which I work.” Sometimes we perceive barriers when they do not exist.
We have raised the issue of the differences between men and women, so I suggest that the men go hence and give blood. It is true that there are gender differences. It is extremely difficult to get men to go to their doctor with symptoms, particularly concerning anything below the waist. It is an issue to get men to come forward and donate tissue and blood. It is important and perhaps incumbent on all of us at certain times in the year to seek an opportunity to demonstrate by example that we are prepared to do that.
I thank my colleague the hon. Member for East Dunbartonshire not only for her contribution, but for allowing us all to have quite a collaborative discussion about the issue. There is no single solution. The NHS, the research community, clinicians and Government agencies have a part to play. In particular, the Government have a role in facilitating, but at the end of the day, they cannot take action on the ground. I hope that I have been able to reassure my honourable colleague and other hon. Members that some progress has been made, and that the various initiatives allow us to be more optimistic about the future. I reiterate that my door is open, and officials in the Department would be pleased to hear from anyone with examples of attempts to make progress that have been frustrated by rules, regulations or bureaucracy that prevent research in this important area from going ahead.