Human Tissue (Availability)

Jo Swinson Excerpts

Wednesday 23rd June 2010 Westminster Hall

[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.

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[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.

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[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.