My Lords, when this Bill was considered by the various powers that be in the House, including the Constitution Committee and the committee on the Bill itself, there was widespread concern from everybody who looked at it. They clearly saw that it was imprecise, not entirely intelligible and of a particular, difficult and complex scientific nature; I agree with that.
One of the problems I have in speaking to my amendments is that, to some extent, they must be probing, because my real problem is that the scope of this Bill is seen as one of the release of organisms into the environment. However, inevitably, the science behind that is of an essential aspect. I am very glad that the noble Lord, Lord Benyon, is answering for the Government, because I felt that his response to me at Second Reading was very helpful; it would have been good to discuss some aspects of this Bill, which we may still have time to do before Report.
To start, one of the really big issues, which I dealt with to some extent in my Second Reading speech, is the nature of precision breeding. As I explained, there is no such thing as precision in biology. Biology is not like physics, and it is certainly not like chemistry. It is a constant response to the environment in a way that does not apply to the other aspects of science. One of the issues here concerns the definitions that we are dealing with in this Bill and, to some extent, in my various amendments—forgive me for my very poor sight but I need to read the numbers; I cannot see otherwise—including Amendments 10, 11, 13 and 14.
One of my problems—it is a problem that many scientists have—is the nature of what is seen as gene editing and a genetically modified organism. There are many different ways of modifying an organism, be it animal or plant. I mentioned in my Second Reading speech that the first time this was done was by the injection of DNA into the egg by Jon Gordon. As we know, that resulted in many mutations and abnormalities in the animals, which were quite horrific to see; to some extent, that is one of the reasons for one of the later amendments that I have tabled for discussion. Moreover, with all the other methods that have been used since—whether it is gene insertion using electro-poration or gene insertion via various other methods,
such as using viral vectors and other vectors to carry the DNA into the nucleus—you get very big disruption of the genome.
It is perhaps not fully recognised that gene editing is not, as the noble Lord, Lord Benyon, kindly suggested, like taking a large paragraph of text and just replacing it with three or four different letters to make a new word. In fact, it is calculated that there are some 6.4 billion letters in the human genome—it is vast—and what is extraordinary is that the mutation of one single letter in that genome can result in a horrific disease.
The commonest genetic mutation affecting humans is probably cystic fibrosis, which until recently was a deadly disease. All you need to get cystic fibrosis is a deletion of three base pairs in the delta F508 part of the protein. That leads to a mutation that results in children being very severely handicapped, sometimes not growing or not able to digest their food and, in particular, having serious problems with their lungs. Consequently, not many of these children have a full life; they certainly do not have a full length of life and are often severely handicapped—even today, with modern so-called precision medicine trying to affect the genes, which is not nearly as successful as we would like.
That is just three base pairs out of those billions, and it is a good example of a very common genetic mutation that affects perhaps one in 20 of the British population. That means a one in 400 chance of a child’s father and mother both having it, in a family who would not suspect that they had that genetic disorder. Most genetic disorders are not anything like that common; some of them are extremely rare. None the less, they generally cause pretty devastating disease.
I am not suggesting for a moment that this necessarily applies directly to the Bill, but it is a very good model for trying to understand that, even with CRISPR-Cas9, for example, which is probably the main technology we are currently using for this kind of genetic modification, the so-called genetic editing is not exactly free of the chance of causing mutations. It is much less likely—for example, with Cas9 in plants, which is widely used, it undoubtedly causes mutations occasionally in the plant, and sometimes we do not know what the results of this mutation may be. Most of them will be completely harmless but some of them may change the way a gene affects, often quite severely, and its expression. By the word “expression”, we mean how a gene works. For example, a gene which expresses growth means that the organism will grow, and so on.
With regard to animals, we know that different species are very different in how they respond to even minor changes in their genes. Although CRISPR-Cas9 does not actually introduce DNA into the cells, it facilitates the introduction of DNA through the process of changing the RNA. That is the difference, but it is not entirely free of mutations. Mutations can occur occasionally at the point where the DNA is cut—that is, with a double-stranded cut in the DNA—or it can occur remotely across the vast genome that animals and plants have. They can be anywhere. Most of the time, that disruption will not necessarily be in a coding protein, but that does not mean to say that it will be free of any effect on the organism.
That is one of the serious issues that we did not really get to in our Second Reading discussion, and nor was it properly discussed in the House of Commons. I read the Hansard report of the debate, and it was quite deficient in many ways; it was not a very good debate in terms of the science.
The fundamental problem is the uncertainty that you may cause genetic modification—genetic mutation—that is unwanted and unreliable, and is not uncommon in plants with Cas9, which is part of the CRISPR process, in most cases. There are other ways of doing this: there is a process called TALENs and there is a process using nucleases, but we do not need to go into the detailed science. They all present problems in different ways of getting the DNA into a cell.
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Of course, one of the issues when we say “into a cell” is that we are talking about an animal at the beginning of its life. It is affecting not just the somatic cells—in the skin, brain, fat and muscles—but the germ cells. That means that any mistakes produced are heritable, and can be in completely unpredictable ways. This is one of the reasons for some of my later amendments, because heritability is clearly important as you want, first of all, to breed plants and animals that are free of risk. That is a fundamental difficulty in our discussion.
The evidence that CRISPR does not cause mutations is simply not clear. Often, the only way we can decide whether the genome remains “normal” is, in fact, by doing extensive research on the genome of that particular creature.
One of the other issues is that the Bill offers massive opportunity for better science. If we looked in greater detail at the way we manipulate plants and animals and funded it better, we would arrive at some useful conclusions that might help us with the genetics of a range of things, including medicine, gene therapy and all sorts of problems that affect the animal and plant kingdom. One of my concerns about the Bill is that we are simply releasing organisms but not studying them in detail before we do so or recording that. This subject will come up in later discussions on the Bill.
One of the issues dealt with in my amendments is the terminology, some of which is very strange. For example, in Amendment 13 I have suggested removing the word “stable”, because an organism’s genome being stable can mean various things. Does it produce progeny, or does stability mean that the genes function in a constant way, generally expressing the requirement you need? One of the problems we have with all genetic alterations is that, when you change the position of a gene in the genome or how it is printed, there is a risk that you may change expression. That is one of the reasons why multiple copies are sometimes included, an issue which is also addressed in the Bill. Sometimes, that will extend the gene’s effect—for example, increasing growth or, in some cases, decreasing it. That is one of the issues addressed in Amendment 13.
In Amendment 14 I have suggested removing the word “no” from Clause 1(5). This is partly to tease the Minister: I am changing just two letters, but arguing
that that completely changes the whole paragraph in a way that does not make it at all accessible.
My real criticism, which we have discussed and which I do not want to go on about at great length at this stage—there are many amendments on the Order Paper—is the lack of clarity on some of the issues. I do not think people understand what is being done, and they need to.
One of the biggest deficiencies that I hope the noble Lord, Lord Benyon, will take on board—it is not an amendment at this stage, by any means—is that we are not trying to get the public with us. Over 30 years ago, we saw a catastrophe for this kind of science. It affected so much science, which was brought into disrepute by the sudden release of genetically modified organisms, as people felt they would be dangerous to their health. Indeed, they might well be, and Members will be talking about these issues later on in the Bill. That resulted in a complete negation of GMOs, which were given a bad name. Of course, we are still producing GMOs, in effect, but in a slightly more precise, although not completely precise, way. The risks are still there, and we need to consider them.
Finally, the problem with propagation is that once you propagate organisms, you end up with all sorts of effects on the environment that you really do not expect. That will obviously come up later, and it is one of the concerns addressed in the amendments I have put down today. I beg to move.