Human Tissue (Availability)

Anne Milton Excerpts

Wednesday 23rd June 2010 Westminster Hall

[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.