(pt 1)

9 Nov 2005 : Column 73WH

Westminster Hall

Wednesday 9 November 2005

[Mr. Joe Benton in the Chair]

Medical Research (Regulation)

Motion made, and Question proposed, That the sitting be now adjourned.—[Mr. Heppell.]

9.30 am

Dr. Ian Gibson (Norwich, North) (Lab): It is a pleasure to speak under your chairmanship, Mr. Benton. It is a first and I welcome the opportunity to introduce the debate. It is clear that not many people will show particular interest in the subject. Regulation must be one of the most boring issues in Parliament, yet I hope to prove that many problems are associated with it. Moreover, I am sure that many hon. Members have other things on their minds today that are perhaps more pressing than what we are discussing today and do not regard regulation as being as important as some of us believe it is.

I wondered about the vagueness of the title of the debate because various people telephoned to ask me what I would talk about. The subject is wide ranging and difficult to home in on. I will concentrate on regulation because it crosses various Departments, especially the Department of Health and the Department of Trade and Industry. People are charged with operating the regulations and drawing them up. It is a huge activity throughout many Departments. Although the issue is a quagmire and many people hate regulation, there is no doubt that it is necessary in many circumstances, mainly because the public expect it. It exists for the safety of the public in many cases and we must have good regulation if we are to establish new research, new technologies and new ideas.

I was struck by those who have been lobbying about   such matters. Many people are worried about regulation. I mean not only drug companies, but organisations such as Cancer Research UK, which said that the

It went on to say that regulation

and that European legislation has a great effect in this country. We all remember the big debate about how clinical trials were carried out in Europe, and how the proposals from Brussels were curtailing the innovative work that is undertaken in this country.

I have received letters from organisations such as Kidney Research UK. While welcoming the opportunity to undertake medical research, it must have the freedom to work without unnecessary regulatory burdens. It said that adequate safeguards must be

A year or so ago, the Human Tissue Bill was introduced. It provoked much debate and many professionals were upset by the restrictions that were
9 Nov 2005 : Column 74WH
being brought in by regulation. They said that that would make it difficult for them to hold on to tissues and to reclaim them without consent. Matters concerning who obtained consent created a huge debate within the academic community, as well as much activity and lobbying in both Houses. The Parkinson's Disease Society regards stem cells as a potential great way forward to controlling problems. It is worried about the regulations that might be attached. Patient groups as well as the pharmaceutical industry are concerned about regulations and their potential to inhibit progress.

It is clear that medical research has contributed so much not only in this country, but throughout the world. We have learned so much about diseases and we   are learning more. There is no doubt that there will be more drugs to treat cancer, Alzheimer's disease and other diseases. There will be a huge explosion of effort in medical research and stimulation, and we do not want that to be inhibited by fearsome regulations that put people off filling in the forms or whatever bureaucracy is associated with such regulations.

The position is becoming interesting and the Government should be examining when regulation is necessary and when it is not. Such questions need to be   dealt with at some point not in a piecemeal way, but generally. It is hard to draw up hard-and-fast rules, but   that does not mean that we should not attempt to do so. We want to encourage innovation in research. There is great potential for patient benefit and faster success to find cures for many diseases.

I am pleased that a DTI Minister is replying to the debate because such matters have a huge effect on our economy. Research and development, and the young people whom we train to work in our industries, have made a difference in terms of what we can discover. Not only do we employ those people, but we create a knowledge-based economy, which is one of the Government's prime targets. For that we should be   grateful. It has taken a long time for it to be acknowledged, but, thankfully, now we are there, with 10-year innovation plans and so on to help things happen. Yet there is still a concern—perhaps not a worry—that some of the regulations associated with the new technology may inhibit the development of our economy. I shall spell that out a little more.

Medical research is not simply Nobel prize-winning research into a new gene, disease, drug or treatment. It also relates to the care of patients. We must recognise that research can be done into the kinds of bed people are in, palliative care and the circumstances in which people live. We want an evidence-based society that treats the patient from the early diagnosis, at which we are getting better with many diseases, through to when we care for them in our communities. That will enable us to realise that many diseases will be associated with people late in life and will be chronic, and that there will be a patient's journey from the early stages to the later ones. Much research is undertaken into that, but it is not highly prized or recognised. People feel that it is not Nobel prize-winning stuff. However, it is still important. Therefore, we need innovative ideas across the board.

Some hon. Members may be confused by the title of the debate. Research is regulated. There are health and safety conditions and laws that must be obeyed. It has sometimes been hard to operate in that environment if people have not been trained properly to understand
9 Nov 2005 : Column 75WH
that the research that they do in their white coats in the laboratories demands care and attention. I refer not only to their own behaviour with others but to the materials that they work with, be they chemicals, gases or anything else. Some of those materials could become available to people who have other plans for them. Therefore, there must be continuing regulation at that level. However, I am concerned about the regulation after that, and today we should try to address the regulation that helps our economy and develops new techniques. I want to give some examples of that.

Do we have enough regulation and do we need it at   all? I do not have a hard blueprint in relation to those   questions, but I can see that people can be over-zealous or under-zealous. I shall speak later about human embryology. The hon. Member for Salisbury (Robert Key) and I were members of the Select Committee on Science and Technology last year when it looked into the regulation of assisted reproduction technology and, gosh, we have the scars on our backs to remind us of those debates, because it is a vehement issue. The body that operates the legislation relating to that, the Human Fertilisation Embryology Authority, was very much in our sights. I shall cite that regulator as an example later.

The Government brought stem cell research into the parliamentary domain and allowed it to go ahead in this   country. Now the argument is whether we are developing the technology fast enough and whether we will be ready for it when it happens. Members will know that Christopher Reeves, who played Superman, supported the work going on in this country, as opposed to the work that was not going on in the United States, which was inhibited by religious fervour. A Republican Government, who in many ways were against science, technology and innovation, were making it very difficult. Therefore, this country is ahead of the game.

With Richard Branson, Sir Christopher Evans and others, I sit on the Stem Cell Foundation, which has been considering a mechanism to ensure that, as the discoveries fall off the bench, the peer-reviewed papers and so on do not simply stay at the Royal Society and other such institutions, but are used to cure motor neuron disease, Parkinson's and Alzheimer's. There is tremendous potential, but getting money fast-tracked is   a real problem and one with which we have not yet dealt.

Regulation is not the only consideration. We have laws in place, but we also need to know how to develop the research. Regulation could be part of ensuring that   we take the public with us when we start to do experiments, particularly those that involve animals. It is necessary to go through a regulatory process using animals. We all know about animal activists, or terrorists, and the way in which we have had to legislate and to draw up regulations to prevent their activities but to allow an open debate about their beliefs.

This country is doing well on stem cells—for example, in getting legislation and regulations in place and in starting to introduce products that will help people in   the marketplace. That is difficult, as those people are not just constituents. They wear other hats as well. They are members of the public, patients and, indeed, citizens, so it is difficult to address such questions.
9 Nov 2005 : Column 76WH

I sit on various committees for public understanding—the Royal Society and this and that organisation. Everybody means well and wants to get information to the public, but there is still a difficulty in getting scientists and medics to come out of their ivory towers and to talk about things in a language that the public can understand and feed into, thereby creating the feeling that the work   is valued. Without that, we will run into more debates such as the ones on the measles, mumps and rubella vaccination—still going strong—genetically modified products and telecommunication masts, where knowledge does not get into the argument. The media and the political activity of other groups take over the debate and determine what happens to many products. These things are all mixed up but necessary: the legislation, the regulations and the interaction with all the   different forces from industry to the public. How we make such interaction happen is important, and we still have much to learn.

There is a plethora of regulatory and advisory agencies in this country. Sometimes, I think that there are too many. They cross each other's agendas and have turf wars, almost like Government Departments. The war itself becomes bigger than the actual manifestation of the research in the communities and in the world. A great deal of effort and potential are lost.

Let us consider drugs, for example. People from the pharmaceutical industry—very powerful, emboldened, wanting to get their products to market—always want to talk about regulation. They talk about bureaucracy and too much red tape. Such talk can go too far. We do need some regulation, but perhaps the case can be made now and again that we stretch it too much. However, regulations evolve—they do not last for ever. In five or 10 years, the regulations that we make now may change because of, for example, new information.

There are deep-seated problems with public understanding of what some regulatory agencies are about. I have a quote about the United States Food and Drug Administration, which is known as

that is, food industry products. That is the biggest part of its mission but not the only part. Its other mission is to be

Sometimes regulatory agencies get muddled up by taking on only their major responsibility, perhaps because of limits on time or resources, but I do not know of any agency that does not have to carry out several major activities. As I shall explain later in discussing the HFEA, there is a case for distinguishing between them.

Of course, strengthening the work on the safety of medicines is extremely important. However, innovation, openness, communication and information, which help   to embolden and to strengthen, for example, the European Network for Drugs and Drug Addition, which meets occasionally, are also important, so there is a regulator looking at that across the board, as well as looking at the safety of medicines. What would be interesting to know is how much effort, relatively, is put into those particular two activities in the States and here.

The pharmaceutical industry says that the development of a drug is still an art, which is interesting—a matter of intuition, luck and trial and error, instead of what it should
9 Nov 2005 : Column 77WH
be, a mechanical process driven by science-based facts or   probabilities. Lack of those insights at the start of   the   development process exposes novel drugs to unforeseen obstacles. We often glibly say that research and development is all that needs to happen, but the process is much more sophisticated and difficult to operate than that.

Medical research feeds into the process, and we need   to make sure that we understand that, although regulated, the use of something may not happen right   away. Seeing the benefits may take time, but we might need the regulations in place. For example, penicillin took a long time to get into use, likewise for   recombinant DNA technology with therapeutic proteins and monoclonal antibodies, which were discovered at Cambridge but, sadly, developed in the United States. The new stuff coming along—cells, tissues, genes, therapies and stem cells—are at early stages yet, but how do we react to those discoveries?

The example of stem cells is a good one. There was good pressure from the academic community and, particularly, from the patient associations—those for Parkinson's, Alzheimer's and others—to wake the Government up to the fact that we needed regulation, that we needed to talk about it and to expose it to the public.

That was a good example of something being taken up, but quite often we sit back and wait for something to happen. GM technology, for example, had been around a long, long time. Scientists, academics and medics said that we would not need any regulation, the public would love GM, which was going to be good for   them. Well, we learned the lesson the hard way. Newspapers took up Frankenstein stories, exposing lies to the community, such as GM technology and plants giving us this and that disease.

As people know, the argument about the MMR vaccine is still raging on. Journalist Melanie Phillips has taken an anti-science view or, rather, has taken some scientists' view against that of others. We have to see things coming and have the regulation in place, or not, depending on the situation. We cannot wait and say that all the research will find its own level. We have to provoke things and know what the problems might be. We do not have to put them in hard order, but we must have some discussion.

If a pharmaceutical company tries to develop things today, it will have to deal with EU legislation, testing directives, paediatric regulation and tissue engineering regulation. It will remember that we have the Human Tissue Act 2004 and a regulator, the Human Tissue Authority, which was set up to handle questions after Alder Hey. That was a reaction to a situation that we should have seen coming, but which happened because of exposure in the media and a national scandal. That is not how we should use the excellence of knowledge, research and what we discover, nor how we should get   them into the legislative, regulatory and parliamentary processes.

I want to talk briefly about several of the regulators. For example, we all know about the National Institute for Health and Clinical Excellence. I am not going to go on about NICE—we are all a bit fed up with NICE and the stories on Herceptin, which just keep going on and on. I am not sure that NICE is the best organisation in the way that it works, but the principle of having evidence-based medicine cannot be argued against.
9 Nov 2005 : Column 78WH

How NICE operates is up for grabs at the minute. I   asked a question the other week on what the value of NICE was. The Minister told me, but she did not say that the NICE organisation was brilliant—she said that the principle was brilliant. I agree, but we have to look around. We do not need to throw brickbats at NICE, which is an evolving organisation. It may be hard to push, shove and kick it but Ministers and Governments can help with legislation and regulation. We are moving towards a fast-track process and I predict that within a year NICE will have sub-committees. One will deal with cancer drugs, another with drugs for mental health and so on. We are going to be invaded by all the new potential coming out of research. There is a huge feeling that we are not really ready for it and that, if we breathe on Herceptin, it will go away. It will not. That organisation has a list of about 30 cancer drugs, and the suspicion is that all of them will be useful in helping people with certain types of cancer. I will not go on too much about that.

What I want to go on about in particular relates to some of the other authorities. The Human Fertilisation and Embryology Authority has a dual role. It considers several things at the same time. It has two principal functions: it is a regulator and an advisory body. It is   charged to keep under review information about embryos and, as the Human Fertilisation and Embryology Act 1990 states:

Hon. Members will know that that provision is mainly concerned with the technology of in vitro fertilisation, which changes almost daily in terms of how embryos can be created.

Regarding stem cells, there is a provision concerning the embryo: how long should an embryo be kept before it is killed, and is it a live being after 14 days or not? Now, the process can be carried out without having to destroy an embryo at all. That is true of mice at the moment, but you can bet your bottom boots that they will be able to do it with human eggs as well. We always start such processes with animals, then the process moves on. Nuclear transplantation started off with frogs, ended up in Dolly the sheep and can now be done with human beings. That is an inevitable process, which we should welcome but be ready for and ready to handle.

We are ready in some ways. We have considered human cloning and said that we should not allow it. We have jumped ahead there, but that is because of stem cell research. The technology and science of medicine moves on so fast that we are always lagging behind. We often get caught by media scares, patient groups or other groups making the case.

There is a problem with regulators having a dual function. The regulator's role allows it to work within the Act and to discharge its duties accordingly. Its advisory function challenges it to find fault with the legislation on behalf of the Government. That is an ambiguous position. It is a double-handed position, and one role does not always sit easily with the other. The Select Committee was quite light about it compared with Lord Winston, who would abandon the HFEA overnight. He said that it had no useful function and was a pain, and he is considered to be a world expert in this
9 Nov 2005 : Column 79WH
arena. He suggested that the functions should be separated in two new regulatory bodies. I give that not as an example of something I want to argue, but as an example of how we have to adapt when we consider something in depth in relation to new research and discoveries.

There are many more agencies that have been important in the sphere of health. The regulators are amazing; they spring out of the woodwork all the time. The Minister will probably be able to give examples of where that has happened in his field of expertise. I shall just use the one of health because I mentioned the HFEA. Bodies have been set up for clinical standards, medicines, health care products, equipment and the conduct of health care professionals. The current vogue in politics is to merge those bodies. I mentioned, for example, the Human Tissue Authority, which was set up   a year or so ago by the Government. The intention is to merge it with the HFEA because there is so much cross-function. Considering the bare bones of their job descriptions, it should be possible to find common territory, so that we do not duplicate things. Turf wars could emerge; even if they do not, the process of getting the product into the market could be delayed.

The Medicines and Healthcare Products Regulatory Agency has been attacked quite savagely by people in this Chamber. It was set up in 2003 and it replaced the Medical Devices Agency and the Medicines Control Agency, one of which was concerned with technologies such as stents for heart disease and the other one of which was concerned with drug products. Within that context, it promotes public health, patient safety and health care products that meet appropriate standards of   safety, quality, performance and effectiveness. That is another example of taking two bodies and putting them together so that they function in the same building to tackle the same problems: health and the standards that have to be met.

Another body, the Commission for Healthcare Audit and Inspection, came on the scene about the same time. The HFEA suddenly had to talk to it too, because, again, there was a lot of overlap, although there are differences in function. One body is concerned only with IVF and assisted reproduction. However, the general care and interaction with the public and patients is much the same in both instances. So, again, much more could be done about that.

I am not going to say anything about ethical committees and issues of morality. They often get put at the bottom of the agenda, if there is time to get to them. It is essential that they should be the top one or two items on the agenda. We cannot worry about that because we do not understand ethics. That is true. On our Select Committee, gosh did we argue about ethics. I   still do not know what they are and we did not get very far. I do not think that we were going to persuade each other what an ethical position was, but did we argue.

Now, if we are like that, what must it be like on some of those committees? However, there are important, serious questions to be asked and they must be incorporated. Patients can be involved or it can be members of the public, but their view must be taken into consideration. I made that point about the joining together of committees and so on.
9 Nov 2005 : Column 80WH

Many complaints are emerging in some areas, not just about regulations, but about having the necessary staff. I am not going to talk about radiographers and radiologists and all the boring stuff that we have been through. I want to talk about clinical people who work in universities and who are interested in clinical infection. They find it difficult to get others interested in that. These people are interested in infectious diseases and, gosh, do we know about those. We are hearing about bird flu just now, as well as AIDS, tuberculosis, malaria, antibiotic-resistant infections and so on. The official bodies complain that there are not enough people studying those things and that the people who are teaching do not have time to do proper research into those areas.

There is a point to be made about regulation in that context, too. There must be enough people to know what kind of research is going on and to subject it to critical scrutiny. Microbiologists and virologists in this country think that they are being left behind. That would mean that, if we had an epidemic of some kind, we would have to buy in the expertise and obtain the knowledge. We must consider problems such as that at the same time.

I have talked about several bodies, how they have merged together and how that has been valuable. Remember that the endgame in all this is to reduce the risks to public health. The process must be seen to be   transparent. It must be based on scientific and medical evidence to support risk management. Sometimes, people have to know what the risk is and there are ways of handling that. If the public are given the knowledge, they can say, "Well, I'll take the risk," or "I'm not taking the risk." I do not know what makes the public choose one rather than the other, but I know this: if we do not ask them early enough, they will get confused messages from the media and others and the whole thing could go wrong. That is important.

I have already given a few examples of how regulation can tee people off in terms of innovation. The great thing in this country is that young people who work in these fields have superb ideas. That is why I care about people who are doing medical microbiology and virology. They have so much information and dedication, and the hours that they work are almost as long as those of MPs.

Someone who works on AIDS at Oxford worked in my office in Parliament for three days the other week. After she left at six o'clock at night, she said to one of the other interns, "I am going back to the lab tonight to carry on my work." That is the kind of dedication that we have. I do not want to talk about such people's career prospects, but they are making the innovation and product culture very much a part of the British way of life. We do not have to leave the US or Europe to do it all the time, and we do not have to be inhibited by the way in which they carry out research.

I do not want to go on about the HFEA, or others who I have mentioned who are worried about it, such as Lord Winston. There is turmoil, however: on the one hand, there are good messages about what is being done;   on the other, there is fear. Can we get rid of the organisation? Do we need to? It may be good that people think that their work will not get on to the market. They do not do it to become millionaires; they get a pride out of doing it, and that is important. We
9 Nov 2005 : Column 81WH
have much to learn not only in the area that I have emphasised, but in others. I have no doubt that the Minister will have something to say about that.

The Select Committee's report about legislation addresses the question of how much regulation we need. I shall not be able to find the quotation I had from the competitive fifth force, the body in the Minister's Department which considers such matters. However, it produced a report on regulation in which it said that there is a time for regulation when public concern requires it; there is a time also when one needs to evolve existing legislation and regulation and join the bodies that take care of it, because knowledge moves on; and there is a time for no regulation at all.

Most of medicine is not regulated. Why should assisted reproduction in vitro fertilisation have a regulator all to itself? What about all the other activities in the health service? That is the reason that Lord Winston does not like the HFEA. One could spend one's whole life analysing the health service and setting up regulators, but it would be inhibitory. Sometimes, one must trust people to set up their own ethics committees. They have concerns, ethics and morality, and they are certainly concerned to ensure that the products we produce are regulated and respected.

Many regulators are respected. It is a good job that they exist, because there are charlatans out there trying to cut corners. There is no doubt about that, and regulation cuts it down.

10.3 am

Martin Horwood (Cheltenham) (LD): I congratulate the hon. Member for Norwich, North (Dr. Gibson) on securing the debate on this important topic. It is dear to   my heart, and the hon. Gentleman should not apologise for it being dear to his. I used to work with and for several medical research charities, and this is an important subject for Parliament to debate. It is risky for politicians, as it includes ethics and morality, which lead us to the grey area between party politics and private conscience in which tempers run high and party Whips are strangely unwilling to provide their usual gentle guiding hand.

I agree wholeheartedly with the hon. Gentleman that   careful attention to the evidence and a rational argument must guide us through this unfamiliar territory. When strongly held personal and religious beliefs lead people to believe only the evidence that suits them, sensible debate begins to go out the window. The least excitable participants in the debate on regulation are those in the business community. As I am sure that the Minister will shortly tell us, it employs significant numbers of people in medical research in the UK. One managing director of a pharmaceutical company told me yesterday that there is much to be positive about in Britain's commercial position in medical research. He sees Britain as

in medical research and says that it scores more highly than most other EU countries. He also said that a positive Government and regulatory environment is essential to that success and spelled out nine areas of concern.

I will not list them all but will make the Minister aware of a few. They include competition from the US   market and, increasingly, from China, India and
9 Nov 2005 : Column 82WH
eastern Europe, as well as the climate of fear that is still being created by violent animal rights campaigners who are now beginning to target small suppliers. Even in a large medical research charity I remember the siege mentality among researchers that was created by the most violent campaigners. Even when we were not   commissioning research involving animal models, we would never say that for fear of starting a process by   which animal campaigners could narrow down and   identify the charities that were. The managing director I talked to was from Eisai UK. He cited a lack   of well trained science graduates, the unrealistic expectations of potential academic partners in terms of intellectual property and the slowness of negotiating agreements and clinical study protocols with NHS hospital trusts. Those were all issues for him. Perhaps predictably, he grumbled a little about NICE's role in judging the cost-effectiveness of medicines in addition to all the other regulatory bodies involved in the industry. I cannot agree with him there and I agree with the hon. Gentleman. My experience in the area of Alzheimer's is that NICE's decisions are not always right, but it is right in principle to have a body to direct prescribing in the NHS on evidence-based lines.

The managing director of Eisai warned specifically about one aspect of a recent new proposal from NICE to evaluate new medicines at their launch. He was worried that that might delay the entry of products into the market and lose us one of our competitive advantages over many other EU countries. It affects the nature and quality of evidence available on which to make an assessment if one dives into the process so early because there is none of the grubby market-based learning from the drug in the market.

Charities have similar concerns about the balance between the proper need for regulation and a system that is manageable and proportionate to the risks involved. The hon. Gentleman mentioned what Cancer Research UK had said to the Select Committee and others. It suggested three measures to reduce bureaucracy, simplify processes and increase productivity such as a common system of reporting to reduce duplication and free up time for research. It suggested that application processes should be simplified to address delays and inconsistencies. It suggested simplifying and expediting the ethical review process for clinical research, which would reduce the time taken to start research programmes, making that process as quickly navigable as it believes it is in other countries.

CRUK acknowledges that although the regulatory regime for medical research in this country is not perfect, it is of a higher standard than in other European countries, which is a matter of pride. It is also worried about the EU clinical trials directive and particularly how its UK incarnation, the Medicines for Human Use (Clinical Trials) Regulations 2004, has impacted on the   non-commercial sector, pushing up the cost of clinical   trials and perhaps damaging recruitment. In theory, that should apply equally in all EU countries and there is a thought that we might be gold-plating the regulations. I am not sure whether that is so, but perhaps the Minister could pay attention to that. I hope that he will bear in mind the concerns of both the charity and the commercial sectors.
9 Nov 2005 : Column 83WH

It is a tribute to the 20-year-old legislation that set up the Human Fertilisation and Embryology Authority that it has largely succeeded in coping with astonishing and often controversial new developments in reproductive medicine. It has combined a willingness to   allow effective, important research to proceed and to grow with an understanding of public sensitivities. The novel use of embryonic material is one of the most sensitive areas and the authority is absolutely right to keep that under review. It should remain clearly within the authority's remit, and that should not have to be brought before judges, or even politicians, too often. The way in which the debate in the United States has been debased by politicians influenced by religious fundamentalism should give us all pause for thought. The result is that scientists such as Stephen Minger of   King's college, London, and Roger Pederson of Cambridge, have come from the United States to this country, and that is a matter for quiet national pride.

It would be wise to amend the Human Fertilisation and Embryology Act 1990 to make clear the authority's competence in areas of study that were not really foreseen 20 years ago, such as the creation of embryos for the purpose of treatment using stem cell lines. That, as the hon. Gentleman mentioned, holds enormous promise for potential therapies for diseases such as Alzheimer's, Parkinson's and Huntingdon's disease.

It has been suggested that the authority's remit could be extended to the licensing of clinical trials. It argued that that would have the advantage of encouraging a smooth transition from research to treatment under the same regulator and the same legislation; but, of course, from the point of view of clinical trials, it would be adding yet another regulatory body into the mix. Perhaps it would be wiser if the HFEA were simply asked to issue guidance to the ethics committees already responsible for regulating clinical trials. We are in a new   landscape in terms of awareness of issues such as children's welfare, patient safety and personal freedom of information. Those issues may have implications for the wording of legislation and the composition of the authority itself.

Public opinion is, in broad terms, generally on our side; a recent MORI poll conducted for the HFEA earlier this year showed how far we have come since the   first test-tube baby was a matter of such huge publicity and controversy. The recent poll showed some public concern about unforeseen consequences, and even about risk to future generations, but more than 70   per cent. of respondents agreed that human embryo research can improve the quality of life of future generations with inherited diseases, and can enable scientists to increase their understanding of how the human body works. Fewer than 10 per cent. disagreed.

The same cannot be said of the use of animals in medical research; on that subject, opinion is much more polarised, and there is significant public and political disquiet. On regulation, opinion varies. Some people would like us to go towards a free-for-all, and would allow very light regulation of animal research, but others want to ban it completely. Opinion is so polarised that each side in the debate has taken to almost cartoon characterisation of the other. I have been at meetings in the medical research community where anyone who had
9 Nov 2005 : Column 84WH
the faintest notion of animal welfare or animal rights was characterised as being in the same camp as violent car bombers. On the other side, it seems that it is sometimes claimed that animal research has contributed absolutely nothing to human welfare, has only harmed and killed people and has impeded medical research. The truth, as ever, is somewhere between the two.

I commend to hon. Members, and to the Minister, the recent report by the Nuffield Council on Bioethics. It is a little bit of light reading at 334 pages. I confess that I   have not read every page of it yet, but from what I   have read, it seems a thoughtful and impressively thorough examination of just about every nook and cranny of the animal research debate, including the issue of the need for regulation. It gives no comfort to antagonists on either side who are in search of a quick win. For those who ask, "What has animal research ever done for us?", it gives chapter and verse. In basic biological research, it explains: how research with dogs helped to identify the biological basis of narcolepsy; how animal studies revealed the role of autoantibodies in the life-threatening disease myasthenia gravis and contributed directly to better diagnosis and treatment; and how patching the eyes of newborn cats revealed the risk of patching newborn children with one lazy eye. Children with this condition now have each eye patched alternately, saving many of them from blindness in one eye.

In the study of diseases, the most famous example is that of variant Creutzfeldt-Jakob disease—a rare, fatal and fast-moving form of transmissible spongiform encephalopathy that affects mainly teenagers. Studies with mice proved the transmissibility of scrapie between sheep species through abnormal proteins known as prions. Those led in turn to experiments that showed the transmissibility of the bovine variety of spongiform encephalopathy—BSE—to primates. The process linking BSE to human variant CJD was therefore clear. The rest, as we know, is political history.

The report also explores the use of animals for   pharmaceutical research and toxicity studies. It acknowledges that there is controversy, complexity and genuine limitation in both those fields, but in the end it supports their validity as well.

The notorious failure of pharmaceutical research methodology in the case of thalidomide provides a good example of some of the problems involved. Animal trials failed to predict the adverse effects of the drug on the   unborn children of pregnant humans. However, the animal models used were not pregnant. Subsequent experiments showed that had they been, the same limb deformities might have been detected in mice, rats and other animals, and the alarm bell would have been sounded.

Is there no case to answer for animal research and no   need for tighter regulation or, perhaps, for any regulation? Yes, there is. Showing that some animal experiments work for humans does not necessarily make it the right thing to do and does not even show that most research using animals is necessary or beneficial to humans.

A recent article in the British Medical Journal is pretty damning. Its authors are not animal rights protestors, but professors from the London School of Hygiene and Tropical Medicine, the Centre for Perinatal, Pediatric,
9 Nov 2005 : Column 85WH
and Environmental Epidemiology at the Yale university school of medicine, and the department of clinical neurosciences at Edinburgh university, along with a research fellow from the department of social medicine at Bristol university. They said:

Examples were given in the article and work on that investigation is urgently needed.

Even if animal experiments are well designed and prove to be beneficial, it is not always clear that they are   really necessary. The Nuffield report quotes a 2003   study, where head restraint devices were implanted in the heads of rhesus macaque monkeys under anaesthetic and metal coils were then surgically implanted into their eyeballs so that their eye movements were recorded. The purpose of the study was to learn more about the way primates perceive other primates' faces. The pressure group Europeans for Medical Progress, with which I have some issues, claims that similar experimental outcomes have been achieved using human volunteers wearing adapted contact lenses. Even if they had not, many of us would instinctively recoil from the use of intelligent creatures, such as monkeys, in that way for research unconnected with any life-threatening disease.

That raises the moral question of whether we have the right to conduct experiments on animals and, if so, on which ones and causing what degrees of harm, distress, discomfort or pain. The Nuffield report bravely ploughs into the moral, philosophical and scientific arguments, quoting Aristotle, Immanuel Kant and others along the way; it is a fantastic read.

My view is that is nearly impossible to draw a categorical moral dividing line between humans and other animals, especially as science reveals more and   more characteristics that we have in common with a few of the most intelligent animals, from tool use to altruistic behaviour and the capacity for language. In other words, some animals must have some rights, but it would take the most pious Jain religious belief or the most extreme support for animal rights to place us on the same moral level as a fruit fly. Lines have to be drawn and moral boundaries marked out across what is essentially an evolutionary and biological continuum.

The Nuffield report makes no real stab at that almost impossible task, but it concludes simply, powerfully and perhaps rather surprisingly:

9 Nov 2005 : Column 86WH

The report's authors go on strongly to support the three Rs of reduction, refinement and replacement. They argue for much more promotion of best practice and say:

It encourages the UK to take a leading role in the development of alternatives and recommends that each   research application proposing the use of animals should show how the three Rs have been considered and on what grounds any possible alternatives to animal use have been rejected. Interestingly, the Royal Society for the Prevention of Cruelty to Animals has tackled the other end of the research process and suggested that all published research papers from studies using animal models should include information on how the three Rs had been complied with and on the fate of the animals involved.

The Nuffield report also suggests public opinion research, which might start to draw the animal research debate into the admittedly rather fragile kind of public consensus enjoyed in the field of embryology, and away from the current, extremely polarised, views. Those and other recommendations on regulation in the report go well beyond the status quo, and I recommend them to   the Minister.

10.21 am

Robert Key (Salisbury) (Con): I congratulate the hon.   Member for Norwich, North (Dr. Gibson) on securing this debate, which is extremely important. He has done the House a service in raising this important issue. I had the good fortune to serve with him on the Science and Technology Committee during the previous Parliament. It was an exciting experience, to say the least, to do something that this House should do far more—take a lead in the area of science.

Medical research is fundamental to the well-being of   all of us in this place, the whole country and, increasingly, the whole world. One of the best reports produced by the hon. Gentleman's Committee was that   on science in international development. It showed the significance of the British research effort for worldwide well-being. We had many more, slightly exotic, excursions into the realms of scientific research under his excellent chairmanship.

I am not a scientist. However, I have the honour of   representing a lot of scientists; there are more than 1,000   scientists and science researchers in my constituency. Most work near Salisbury, at Porton Down, which has two establishments: the Defence Science and Technology Laboratory and the Health Protection Agency. A lot of very important research is done there that has a huge spin-off into medical research, with everyday applications to extremely complex diseases—and to some simple ones as well.

Science is politically neutral. It is what we do with it that matters. When science, or an issue in science, is overlain by moral or ethical considerations, as in the
9 Nov 2005 : Column 87WH
case of human reproductive technology, for example, the decision on where to draw the line has to be taken by Parliament as a whole, not by the loudest pressure groups—or, for that matter, by Whitehall Ministers. It is often perceived in this country that to be pro-science is to be anti-green, but that is no more true than saying that good greens are anti-science.

Often in the United Kingdom, there is an assumption that science is bad, dodgy, difficult and something that we really do not want to know about unless we have to. That is most unfortunate, because it is not true of other nations, where the whole concept of science is often thought of very differently. Perhaps the old days, when scientists in this country were extremely respected because they knew so much more than the rest of the community, have gone. Sadly, that respect is not there as it used to be.

If we go to other countries such as Finland or France, we still find that there is a great deal of respect for scientists—research scientists in particular—specialising in anything from nuclear energy, to GM crops, to medical research. In those countries, the place of the scientist in the community is different from the position that we have arrived at.

What has gone wrong? One of the things that has gone wrong is to do with British politicians. We should take a lead, and not run for cover every time science is mentioned. It is significant that only four Members of Parliament are taking part in this important debate. That does not do us much credit, although it gives those of us who are present a little longer to say what we want to say, which is no bad thing.

When considering medical research, debating policy options, scrutinising legislation or deciding how to vote on difficult issues, we must first understand and properly assess the nature of risk. The hon. Member for Norwich, North mentioned that. That is fundamental. There is now an assumption in the public mind that it is possible to achieve a risk-free status for almost everything, and that things should not be done if politicians or scientists cannot guarantee that. If we try to justify doing something by saying, "Well, there is a risk, but we have assessed it and we have made the decision to go ahead," we immediately have the tabloid press, for example, down on our heads. Anyone who has ever been in a ministerial position knows what can happen if they dare to put their head above the parapet and say that they have assessed the risk of doing something and that they   want to take the public with them.

Public opinion can be gullible if the public are not well informed. That is another major problem in our country, because we do not have nearly enough science education. The right attitude towards science is inculcated at an early age in many societies. The teaching profession—I was a teacher for 16 years—tries hard in respect of science education, but it is an uphill task to try to persuade people to take science in schools seriously.

We have heard again today, from the hon. Member for Cheltenham (Martin Horwood), about how British industry complains that there are not enough good science graduates. Why are there not enough good   science graduates? Because not enough people
9 Nov 2005 : Column 88WH
study it at school. Why do too few people study it at school? Because science does not have a high enough status, it is too difficult and we do not encourage schools to take it more seriously for pupils at a tender age.

I asked a group of young professional people aged between about 25 and 35 if it was true that Brits cared little about science. They said that most of us, including journalists, were, to use their words, apathetic, ignorant, indifferent, misinformed and gullible when it comes to science. In their opinion, science is taken for granted until something goes wrong, when the media have a field day. There is open season for pressure groups and lobbyists, and then we enter the fantasy world of Frankenstein food, designer babies and grey goo.

Later, I attended a seminar of chief executive officers   of blue-chip, science-based companies, a brace of vice-chancellors from science-oriented universities and a few politicians. The subject of the seminar was the state of science education. I expected to get an ear bashing from the industrialists about the paucity of postgraduate science education and so forth. Instead, with one voice, I was told that the most pressing need is for more and better science education for all, from key stage 1 right through life. That is a challenge that we politicians must meet.

One of the areas where we come across that problem is in medical research, in the regulation of that and in the nature of the science budget. The science budget describes a delicate relationship or partnership between the Office of Science and Technology at the Department of Trade and Industry, other Government Departments, business and industry, charities, which have an important role to   play, international sources, including the European Union, and, of course, the regional development agencies in the United Kingdom, which also have an important role to play in the delivery of the science budget. They all meet as what is called the Funders' Forum.

One of the problems is that the Government see themselves as the main driver of innovation and research in the UK, simply because they are the biggest customer. That is not unreasonable; 10 per cent. of our gross domestic product is spent on goods and services to do with research. However, the trouble is that, although the Government are a good spender, I am not sure that they are the best judge of research and innovation agendas. Therefore, the relationship between Ministers and science is probably wrong.

For example, when the DTI published its last five-year programme for science, it said that the Cabinet would define the "grand challenges" facing public policy in   which scientific research can play a major role in establishing the way forward and that that work would be based on departmental proposals. I wonder whether that introverted and interventionist approach can deliver the global advantage so necessary for UK science and innovation and the economic prosperity so necessary for   our nation, particularly where medical research is concerned.

We should follow the good practice of the hugely successful system in the United States, where the federal-funded, fully independent National Science Foundation is responsible for granting research funding, with the exception of medical research funding, which is administered by the independent National Institutes of
9 Nov 2005 : Column 89WH
Health. The foundation gives the private sector and medical research charities a much bigger role in determining where research should go.

In biotechnology and pharmaceuticals, British science is ahead of the game. The spin-out of research through innovation to production is remarkable and much to be encouraged. However, as we heard from the hon. Member for Cheltenham, there is still unfinished business in relation to the use of animals in research. The targeting of scientists and their families by extremists is completely unacceptable, as is the economic damage done to the biotechnology sector by threats to trade suppliers, financiers and insurers. None of that is justified or in the national interest. It is driving global enterprise out of the UK.

I pay tribute where it is due to the Government in taking steps to improve the situation, but we must go further if we are to encourage British scientists to stay in difficult sectors of medical research. We must also challenge and remove burdensome regulation when we can. As the hon. Member for Norwich, North said, there is an enormous burden of regulation. He said that more regulators creep out of the woodwork all the time. Therefore, we face a huge challenge.

To turn to specifics, it is true that the United Kingdom has been at the cutting edge of medical research. Many of the methods used for large-scale clinical trials were developed in the UK, largely because of the nature, size and scale of the national health service. Other countries that do not have a comparable health service cannot get their hands on the numbers—the captive audience—necessary to do the work.

I mentioned the work done at the Health Protection Agency and the DSTL at Porton Down, but there was also the work done until the 1980s by the Common Cold Research Unit in Salisbury. It did not find the cure for   the common cold, but it laid the foundation for important virology work, which led to British expertise in coping with AIDS. That was an unexpected roll-out of science, which often happens when scientists, almost by accident, come across something that can change the world.

I also think of the work on the defence side at Porton Down, which has led to the treatment of wounds. It has been of enormous benefit around the world, not only to the British military, which is the prime purpose of the establishment, but to everybody else. The work at the   DSTL on the detection of chemical and biological agents has been of enormous significance throughout the world, as has the development of protection against those agents through suits and breathing apparatus. It is significant that not only do the military now train people at the Defence Nuclear Biological and Chemical Centre at Winterbourne Gunner, also in my constituency, but,   at the Police Nuclear Biological Chemical and Radiological Centre. Every police force in the UK now receives training in those subjects. Therefore, the basis on which we invest in science in this country can have significant spin-offs throughout medical research and everyday life.

Last year, there was a row between the Medical Research Council and the National Institute for Medical Research. It symbolised so much of what had gone wrong with medical research. I congratulate the hon. Member for Norwich, North on the skill and ruthlessness with
9 Nov 2005 : Column 90WH
which the Science and Technology Committee, of which I was a member, pursued an inquiry. That report did much to heal the wounds and to point the way forward for two world-class institutions. It was a remarkable example of the good work of a Select Committee.

I happened to be strongly opposed to us getting into that murky water, but the hon. Gentleman was right. It helped to resolve a conflict between those two excellent organisations, and the latest reports are most encouraging.

In June 2003, the Department of Health produced an encouraging document, "Our Inheritance, Our Future: Realising the Potential of Genetics in the NHS". It was a remarkable document, and it foresaw some problems facing the national health service's attempt to integrate genetics, which has not worked out as well as we hoped. The Government have failed to secure the necessary funding to develop research within the NHS. The nation cannot afford not to do that work.

The Government pledged that they would spend 1.5   per cent. of the total NHS budget on research. They have delivered just 0.96 per cent. That has meant a lack of training opportunities and poorly defined career structures. The lifetime financial rewards in clinical academia are not attractive, and they are certainly less attractive than private sector opportunities. The result was that the number of clinical academics fell by 12   per cent.

The good news, however, is that the Medical Research Council is working to find a new focus in clinical research, and I congratulate Colin Blakemore on his energy and enthusiasm in steering the MRC down that channel. Getting those scientific bodies moving in the right direction must be like steering a flotilla of large tankers through the English channel.

What can Parliament do? I have already said that Select Committees have a role. It is their duty and that   of Parliament as a whole not only to reflect public opinion, but to delve into the real world, to shine a torch into obscure corners of science and technology and to make sensible and practical recommendations. Sometimes they should be for policy changes and at other times for more research, but always for more open   debate. The Science and Technology Committee made an important contribution in the previous Parliament when it produced its report on human reproductive technology.

That report was groundbreaking. The hon. Member for Norwich, North said that we bear the scars of that report on our backs, and we certainly do. It was a brave report. It sought to continue the Warnock, gradualist approach to research. Research will always be way ahead of public opinion and knowledge, but we must try to bring the scientists feet out of the clouds and put them firmly on the ground.

The Government's response, published in the middle of August, was encouraging. It set out a number of positive results. I shall not go into them all, but will the Minister consider one significant point about the future of medical research? I know that the report is from the   Department of Health, but if he could look into the matter I should not expect an answer today.
9 Nov 2005 : Column 91WH

The Select Committee recommended that there should be

The Government acknowledged that. They intended that primary legislation would set out the

They also believed that they should give

You and I know, Mr. Benton, that secondary legislation will never give Parliament a greater role in anything if we cannot even debate whether we approve the content of a statutory instrument. We still need to challenge the Government on the policy-making role in that case. There is a lot of work to be done.

The Government said that they would create a regulatory authority for tissue and embryos. That would require primary legislation, so they must present to Parliament in due course their proposals for the role, remit, composition and powers of the authority. My question for the Government is: when? We cannot let the matter drag on for many more years. When will we see the   primary legislation?

We were encouraged that the Government concluded by saying that they would take the recommendations into account in drawing up the new legislation and that they would expect to include most, if not all, of them. That was a big compliment to the hon. Member for Norwich, North. The Select Committee that he chairs has produced a report and the Government have said   that they will include most, if not all, of its recommendations.

It has been a bit of a canter round the course this morning, but it has been an important debate. It is significant that all three of us who have spoken so far have tackled different angles of medical research. I look forward to hearing what the Minister has to say.

10.41 am

The Parliamentary Under-Secretary of State for Trade   and Industry (Barry Gardiner) : It is a pleasure, Mr.   Benton, to speak under your chairmanship. The hon. Member for Salisbury (Robert Key) just said that the debate has been quite a canter. I am afraid that, in the 19 minutes that remain in which to respond to the many questions, it may turn into more of a gallop, but I   shall do my best.

My hon. Friend the Member for Norwich, North (Dr.   Gibson) said that this was perhaps one of the most boring subjects to come before Parliament. The speeches that we have heard this morning have eloquently given the lie to that suggestion. I remember arriving in the House several years ago and being advised by an older colleague that, if I wanted to be taken seriously by the House, I ought to try to become an expert in something. My hon. Friend certainly is a good exemplar of an expert in something: medical research and the regulation thereof. He has an air of expertise and the House always listens to him carefully and with great respect, sometimes quaking as it does so.
9 Nov 2005 : Column 92WH

Before I try to respond to many of the important points raised, I want to set out the Government's position on the issue of regulation in general and on the necessary regulation of medical and clinical research in particular. The Government are at the forefront of the drive to improve the European Union regulatory environment, which is a key issue for the current UK   presidency. Better regulation plays a key role in   improving UK and EU competitiveness. The Government's better regulation agenda involves scrutinising all current legislation for unnecessary bureaucratic burdens and introducing simplification and deregulation, as envisaged by the Hampton review and the Better Regulation Task Force reports.

We are also ensuring that the right stakeholders are appropriately engaged with emerging policy proposals and that our position on key EU measures is best designed to meet UK objectives, including the Lisbon and regulatory reform goals. All regulatory and enforcement proposals will be challenged. I thought that, at one point, my hon. Friend sounded like an Old Testament canonical prophet from Ecclesiastes. He was looking for a quotation, and I thought that this might be the one he was looking for, but I changed my mind: "A time to regulate and a time not to regulate."

Of course, many fear that better regulation is an excuse to deregulate. Let me say this clearly and without hesitation: it is not so. Carefully drawn-up regulation improves the health and quality of people's lives throughout Europe. It guarantees the rights and safety of employees, protects consumers and conserves the environment. Legislation also underpins the markets and can create new business opportunities.

I was struck by the remarks of the hon. Member for   Salisbury, who spoke specifically about the need for regulation, the need to look at the effects on business and the fact that this is a matter not simply of science but of important business. That remark was echoed by the hon. Member for Cheltenham (Martin Horwood). Let us be clear: better regulation does not mean sacrificing high standards. However, it must be proportionate, accountable, consistent, transparent and targeted. The DTI works to maintain the best possible business environment for bioscience companies. It is crucial that society and the Government clearly understand the issues and set the regulatory framework within which the industry can innovate, be competitive and develop effectively.

That means influencing many complex and technical EU directives and regulations, and working with our European partners to ensure that those directives and regulations are based on sound science and that the requirements are measurable and enforceable. The UK has the largest biotechnology industry in the EU and is   regarded as a pace setter in competitiveness in that   sector. The DTI hosted a UK EU presidency biotechnology conference in October this year, which was attended by delegates from almost all member states. A session on regulation considered the way in which the EU clinical trials directive had been implemented by member states and what lessons could be learned for the implementation of future directives. The October conference came up with proposals to be discussed as part of the mid-term review of the EU strategy for life sciences and biotechnology.
9 Nov 2005 : Column 93WH

Hon. Members spoke about the gold-plating of regulations. It is essential that, in working with our EU   partners, we ensure that there is a level playing field throughout the Union and that gold-plating is not going on. That can best be done by carrying out the proper impact assessments and the correct consultation procedures at an early stage, so that we get things right in the first place and roll them out accordingly.

The hon. Member for Salisbury spoke of Government interference in science and, in particular, of prioritisation. I have to confess that I found his comments about what he saw as the centralised approach of this country and the US approach strange. However, he went on to acknowledge, as did my hon. Friend the Member for Norwich, North, that this country enjoys a research capacity, particularly in human fertility and stem cell research, that far exceeds that of the United States, precisely because of the political interference there. Although the Office of Science and Technology sets the overall strategic objectives and priorities for the science budget in the UK, research councils are independent bodies and prioritise their particular areas. Of course, they are delivering plans that are developed in line with Government strategy, but, on the whole, our system has worked well and stands up against that of the United States.

If the UK is to take full advantage of the opportunities for creating wealth and improving the   quality of life offered by scientific discovery and technological development, it is crucial that we develop new approaches to bring scientists and the public together in a constructive dialogue to explore emerging issues. We need to build on the already widespread positive attitudes to science in the UK to ensure that the public, the broad science community and policy makers feel comfortable in handling issues raised by science and technology and that they feel a joint sense of purpose in ensuring that the full benefits of science and technology are realised.

The UK is among the world leaders in both industry and academic medical research. The Government have   consistently shown that we have big ambitions for   medical research to maintain the UK strengths in pharmaceutical and biotechnological research and development. However, we will not succeed if we do not meet or exceed international regulatory standards for good clinical practice and public expectations of safety, security and privacy. This country's future in medical research depends on making the best use of highly talented people and the unique potential of the NHS as a platform for superb quality clinical research to bring benefits to patients.

We must have high standards and businesslike systems to support doctors, researchers and the industry to allow them to do their jobs properly. We cannot forget the vital part that patients play in medical research by making available their bodies, samples and medical records, which are the basis of all research. If patients have no confidence in medical research, they will simply not volunteer. That is why in the past five years we have overhauled the regulation and management of medical research, clinical trials, human tissue and mental capacity research, and the process will continue as science develops into new areas such as nanotechnology and stem cells.
9 Nov 2005 : Column 94WH

The Government recognise that the changes are a big challenge for everyone. It is in all our interests that the UK takes the lead and sets an example to others in developing a sensible, robust, risk-based approach to regulation. That goes with our reputation for leadership in this area.

Many changes derive from European measures to harmonise markets. In principle, they should make life more predictable for industry and academics alike. However, it is uncomfortable to adjust to new procedures. Transition brings uncertainty if there is long debate among regulators about the details and, of course, no one welcomes the extra cost of complying with new inspection and quality systems. The regulation of pharmaceutical clinical trials is an example.

The EU issued a directive in 2001, which followed years of effort by the industry to agree on common standards for trials in Europe, the USA and Japan. The principles behind the directive seemed to be well understood and not so different from a regime we have operated under since the Medicines Act 1968. The European Parliament extended the standard protections to academic trials and early phase trials, from which the UK had previously been exempt, but the directive allowed three years for the Commission to work out the   subsidiary guidance, and for member states to implement the proposals. Therefore, why are we continuing to hear concerns?

Member states and the Commission took a long time debating the details. The Commission's subsidiary directive on good clinical practice came out after the deadline for member states to implement the parent directive. A number of member states have yet to implement it. We are far from achieving harmonisation across Europe and there are lessons for future legislation. Finally, the EU seemed to take inspection and monitoring standards that were right for new medicines and apply them to other trials with different risk profiles. Why is that important? It is not just because it is a nuisance for researchers.

There is some good news from the experience of regulating clinical trials. The UK took a leading role in arguing for a more flexible, risk-based approach. Officials worked with the Medical Research Council to explore and to respond to researchers' concerns. The EU is now preparing more appropriate guidelines for academic trials and the UK is pressing it to draw lessons from all this. That is important, because there is more harmonising legislation on the way, affecting research on children's medicines, tissue-engineered products, and the use of so-called physical agents such as devices for imaging.

Dr. Gibson : Is it the Minister's understanding that in Europe the precautionary principle is operated much more vehemently than in this country? That can lead to an inhibitory situation.

Barry Gardiner : I understand the point that my hon. Friend is making. That is why I emphasised earlier that the measures that we take in regulation must be proportionate. It is only by ensuring that there is proper consultation and that the appropriate risk-based regulation is put in place that we will get this right.
9 Nov 2005 : Column 95WH

This Government rightly give a high priority to protecting individuals who volunteer to take part in clinical research. We make no secret of the fact that we want to ensure that properly conducted and approved research can go ahead with the minimum of delay and with the maximum respect for the patient's rights and privacy. We all acknowledge that, if the process is disproportionate, there are costs beyond making research expensive. One cost is delayed development of better, safer treatments; another is less evidence about existing treatments, when the public expect more reliable advice on safety and effectiveness.

Those dilemmas are not new. They are at the heart of every debate about medical research. With each change in the law, it is the job of Government and Parliament to take great care not to add complexity when what we want is robust systems that protect people from risk across the whole of medical research.

The overwhelming majority of doctors and researchers place the patient at the centre of all decisions about clinical research. There are well understood checks and balances in the system of research ethics committees, hospital and NHS governance systems and, ultimately, the research funders such as the Medical Research Council.

Unfortunately, there are occasional researchers who seek to circumvent the controls and, as has been mentioned, they receive most publicity in the press. That tarnishes the rest of the research community. Sometimes, as with the recent Human Tissue Act 2004, those events highlight flaws in the legal system, which has been overtaken by progress in research. This Government have taken decisive action to prevent unacceptable practice, but at the same time they have listened to patients and researchers about how to strike the correct balance. We will go on listening.

It is a credit to hon. Members on both sides of the House that the Human Tissue Act enjoyed the broad support of all parties in its final form. The new legislation introduces a coherent framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of tissues and organs from the deceased, for specified health-related purposes and public display. The Act will help to protect the rights and expectations of patients and their families, while allowing vital medical research to flourish. On Second Reading of the Human Tissue Bill, my hon. Friend the Member for Norwich, North, said:

The Department of Health and the NHS have issued consolidated guidance on research governance in the NHS, and research governance is now one of the core NHS standards. In the past, researchers have had difficulty in obtaining ethical review of proposals for NHS research, but a national system of ethical review is now in place and it is backed by a managed booking system and a common electronic application form. As a result, the time scale for obtaining ethical review has
9 Nov 2005 : Column 96WH
been dramatically reduced. Following the report of a   review of NHS ethics set up earlier this year by Lord   Warner, we can look to further improvements in the ethical review process as we progress to a smaller number of larger, better-trained research ethics committees.

The Government have also driven initiatives to aid researchers in obtaining approval for research by NHS   trusts. In the summer, the Department of Health consulted on a new strategy for research in the NHS. The proposals include a number of bureaucracy-busting measures: national advice structures to provide reliable advice on regulatory measures; better local support for   researchers through national networks; much more joint working and standardisation in research governance procedures; and better use of IT to streamline information flows.

Those measures will have a parallel effect to those introduced for ethical review and standards of decision making, and the time scales for clearance by NHS trusts will improve dramatically. To secure the clinical research potential offered by the NHS, the Government announced in 2004 the establishment of the UK Clinical Research Collaboration, with a commitment of a £100   million increase in NHS research and development funding by 2008.

The UKCRC brings together the major stakeholders that influence clinical research in the UK, particularly in the NHS. The ultimate goal underpinning the initiative is to create a clinical research environment that will benefit patients and the public by improving national health, increasing national wealth and enriching world knowledge. The collaboration will achieve that by building up a research work force, streamlining the regulatory and governance processes and co-ordinating future clinical research funding.

The Government were grateful for the report on human reproductive technologies and the law, produced under my hon. Friend's chairmanship. The report was highly detailed, but not without controversy, as such issues touch on the essence of what it is to be human. We made clear in our response, published in August, where we agreed or disagreed with its recommendations and where we felt that consultation with the wider public was necessary.

I am sure that parliamentary time will be made available to debate that report at an appropriate time. Many of its recommendations dealt with detailed aspects of the regulation of in vitro fertility services. The Government are consulting on a range of issues covered by the Human Fertilisation and Embryology Act 1990 and the closing date for comments is 25 November.

The consultation document includes a section on the regulation of research involving embryos, sperm and eggs, and poses a number of questions on which the Government are seeking the views of the public. Any changes to the 1990 Act as a result of the consultation would require primary legislation and therefore provide Parliament with an opportunity to consider these important matters. My hon. Friend raised the issue of the regulation of embryonic stem cell research, and he has done a sterling job of keeping the Government alert to the prospects and pitfalls of such research—for example, he led a debate on it in March this year.
9 Nov 2005 : Column 97WH

I am grateful that my hon. Friend pointed to the need for more investment in translational research to move stem cells from the laboratory to the clinic. I am delighted to record his foresight. Shortly afterwards, the Chancellor of the Exchequer in his Budget speech made similar points when he established the UK stem cell initiative, a high-level review, chaired by the former director of research and development at the Department of Health, Sir John Pattison, who is charged with developing a vision and strategy for UK stem cell research over the next decade. The initiative is due to report back to the Government shortly. We eagerly await its report and recommendations on the future of that area of medical research in the UK.

Next Section IndexHome Page