Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012

Lord Winston Excerpts

Thursday 13th December 2012 Grand Committee

[Lord Winston]

My Lords, first, I declare an interest as animal licence-holder for more than 40 years; I think I am almost the longest holder of a licence in London. I work at Imperial College where animal research is conducted. I am a member of a research council which from time to time may need to support the use of animal research for specific validation in engineering, and I am also chairman of a spin-out biotech company, although I do not take any income from that company. Clearly all companies are aiming eventually to make a profit, although I doubt that this one will, but it is still exploring various patents that involve techniques that will be tested on animals.

I am grateful for the clarity of the Minister’s assessment of the directive, which was very helpful. I want to add a personal note of thanks to the Home Office, which has been exemplary in the way it has helped me from time to time with licence applications. In recent years, we have seen a much greater recognition of the need to collaborate and care for the way that we ensure that the law is properly enforced, and I feel very confident in the officials with whom I have dealt.

With that preamble, I express some concerns about this directive and about how we might go ahead. In particular, I am concerned about the three Rs. The three Rs have been around for a very long time. When they were first considered, nobody appreciated where the limitations of the reductions or replacements might be. For example, when the three Rs were first proposed, nobody considered that cell culture is a very limited model for many needs in medicine. Cells in culture do not always perform or behave in the same way as cells do inside an intact organ or, even more importantly, an intact total person or being. A rodent that is alive and well, in which the cells are functioning without changes altering how the genes express or how the cells are growing normally in that organ, is fundamental to medicine. To some extent replacement, reduction and refinement are a bit of problem in cell culture.

When one looks at organ culture, human organs unquestionably do not react completely normally. The classic example is the isolated liver. It was hoped that it might replace the liver of people in liver failure, but those livers do not react in the same way. They cannot because they are not subject to all the homeostatic control mechanisms that go on inside an intact organ.

When computer modelling was first envisaged, it was also thought to be a very good way of replacing animals in research. It has become apparent in the past three or four years that computer models fall way short of what is needed. They cannot predict how animals in the intact state would behave. Many of the invertebrate species, in which we can work, are not always ideal models either.

We have to accept that there is going to be a need to continue, particularly in rodents. In my view, there are some reasons for considering that not only should that work continue but it may need some degree of amplification. The reason why I say that is as follows. First, I am very concerned about the issue of the backbone of British science, which, as every research council will tell you, is the PhD student. That is the person who does the mainstream experimental work that we hope will lead to our understanding of medicine and our improvements of treatment, and of course contributes to the British economy with novel and innovative ideas. There is no question, from my experience and that of many other people, that PhD students are increasingly reluctant to go into important areas of medicine and biology where animal research is being used, not because they disapprove of that research but because they are concerned increasingly about the delay, when they have a finite time—now rigidly defined because of fees and so on—of three years to complete their PhD. For a PhD student to delay starting experimental work is a massive problem.

Many PhD students do not see this work as anything other than laudable. It is worth bearing in mind, since we sometimes forget, that most scientists are actually very altruistic people; they go into an area of work because they believe that they are going to do some good. They certainly do not want to harm animals, or indeed people. However, there is concern. I have one person in my own lab who refused an area of research because she felt that it was seen publicly as being disreputable; it was felt to be not very acceptable to the public as it involved mice. That individual ended up doing work, which was actually very good science, in a different area of biology that did not involve animals, but it took a long time. That was a typical switch that we often see in young scientists, and I am a bit concerned about that.

Further, as noble Lords will appreciate well, there is the issue of the fear among experimentalists about their risk of being attacked. Unfortunately, not enough of the community are prepared to put their head above the parapet, and we need to do more to encourage my colleagues to stand up and be accountable.

The second issue, apart from the PhD students, is the real issue that it is an important aspect of our economy. I have no doubt that we have to be stringent and careful about how we use animals, and we have to be utterly humane. That is an essential component of any work; certainly, as a doctor, I feel that that is important, just as it would be in treating a patient. As I think my noble friend on this side will say, we in Britain feel that our regulations are probably more stringent than most of Europe, and we are probably far further down the road of being sure that we are running a proper shop in our universities and other laboratories. However, 11% of our GDP comes from manufacturing. Although we are losing some of our great pharmaceutical companies, big pharma and biotech is an important area where we still lead the world, and those companies need animal work. It is fair to say that there is hardly a single drug that any of this in this Room have taken that does not depend on some animal research. The exception would be aspirin and, I think, digitalis, but I cannot think of any others; all the rest will at some stage have had animal research to prove their efficacy, their safety and that their long-term effects were not a problem.

That is one reason why this has to continue, and another is vaccinology. People may say that with modern genetics, reverse vaccinology, where you tailor a vaccine descending on the genome of what you are trying to combat, is the answer, but the modern techniques of making vaccines all use intact animals at some stage, so that also needs to be factored in.

I do not want to go on for too long because it would be wrong to do so, but I just want to draw attention to a couple of other points. First, one of the great areas of medicine which is really advancing and offers hope for better treatment is genetics. There, the greatest single model probably is the modified mouse. That has been a massive advance in the past few years—of course, since the three Rs. Increasingly, we are needing to look at mice whose genes are not working in the way that they would normally work because of cancer or other issues. They are absolutely essential to animal research. While we have to make certain that these animals do not suffer undue pain and are humanely treated, it would be unthinkable to allow more patients to die because we are not prepared to look for new drugs that might combat a condition which will kill one-third of the human population of the United Kingdom eventually.

On transplantable organs, I note the directive and its issue on transplantation but we also have to bear it in mind that every 15 minutes around the world someone is put on a transplant list. Most people on a transplant list will not get an organ. For every one person put on a list, there are probably five others who do not even get there. One of the great hopes is still xenotransplantation. The idea that we might not be able to engineer pigs for their organs when they are killed absolutely humanely, and much more humanely than, for example, in farming, is something we need to bear in mind.

We need to be clear in Europe as regards this technology, in which we lead in this country and may want to continue to produce. I have to admit that my company is involved in that technology, so I have a vested interest. I am not speaking because of that vested interest: I believe passionately that it is worth doing.

Let me conclude by arguing that one of the things that we need to do is to get a sense of reality about the three Rs. We need to recognise, for example, that every research university is doing animal research and that we need to have more people putting their heads above the parapet. It would be really helpful if the Government could encourage more public engagement. We note that they had many responses from the public but I suspect that even those came from people with a very narrow view of animal research—either very pro or very opposed to it.

From various polls, including a fairly recent MORI poll, it is clear that most people still do not really understand, first, how stringent and well conducted our regulations are and, secondly, the value of the research that is going on. We should be trying to focus more of our attention on that.

[Lord Alton of Liverpool]

My Lords, as the noble Lord, Lord Taylor of Holbeach, has told us, these draft regulations are intended to tighten the regulations on the use of animals in scientific research in the less well regulated European Union countries, particularly to improve animal welfare. I declare an interest as I serve on my university’s ethics committee, which oversees any Home Office licences required for such research, which, I might add, is undertaken for all the ethical reasons described by the noble Lord, Lord Winston.

Let me begin by welcoming the tightening of animal welfare legislation that the EU directive requires. I also welcome the instances of more stringent protection of animals in these regulations than is required by the EU directive, particularly the retention of the UK special protection for cats, dogs and horses; I find it surprising that that is not required in the directive.

Before turning to my concerns, perhaps I may pick up on a point mentioned by the Minister when he talked about three Rs—replace, reduce and refine. Perhaps when he comes to respond, he will amplify slightly on the question of replacement and to tell us what it is that he thinks that animals, such as the rodents described by the noble Lord, Lord Winston, should be replaced with. The Committee will not be surprised to know that I am particularly concerned about the use of human embryos.

However, during the proceedings on the Human Fertilisation and Embryology Act 2008, the noble Lord, Lord Hunt of Kings Heath, who spoke several times during those proceedings, made abundantly clear what became known almost in shorthand as the Hunt test. If alternatives existed to the use of human embryos, they should always be used. There is potential here for conflict: if they were to be used for replacement for animals, how does that accord with the so-called Hunt test that was used during those proceedings.

My concerns in this legislation to improve animal welfare centre on the importance of ensuring that other areas of legislation therefore do not suffer. There are a number of major concerns about this on which I will ask the Minister for reassurance. I return to some of the questions raised during the passage of the HFE Act, and in subsequent Questions I asked of the noble Earl, Lord Howe, on 20 July 2011. In a Written Answer he confirmed that some 3.1 million human embryos had been created since the passage of the 1990 legislation, and that 1.4 million of those had been discarded. To put it another way, for every baby born by IVF, 30 human embryos are destroyed. In a further reply that day, the noble Earl said that 150 animal/human hybrids had been created over the three years up to July 2011; that is obviously the question that I will centre on in my remarks today. I will also partly focus on replacement, which I referred to. I hope that as he comes to reply today, the noble Lord, Lord Taylor of Holbeach, will be able to tell us what the numbers of animal/human hybrids created in the United Kingdom have been since that was authorised; and also the total number of human embryos that have been destroyed or experimented upon since the passage of the 1990 legislation.