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Overview of regulatory issues

Watch Juliet Tizzard on the history of PGD in the UK and the regulatory criteria that form the basis of PGD.
In Britain PGD first came in to use, in fact it was the world pioneer in 1990/1991, which was just when the legislation here was going through parliament. And in fact the ability to test embryos for genetic diseases to help those couples have disease free babies was something that parliamentarians were really struck by and very supportive of. Arguably more supportive than infertile couples who needed help from a clinic. And as those 25 years have rolled by we are now offering PGD in the UK for close to 400 relatively rare genetic diseases for people who know they have a risk of having a child with that disease. So it has opened up enormous possibilities for those couples.
And what is interesting about it, I think that 25 years ago there was lots of discussion about designer babies, about eugenics, about slippery slopes and about this kind of testing really getting out of control being offered for, non-serious diseases. Perhaps even just characteristics of humans that we might find desirable. And, that hasn’t happened. Now whether that hasn’t happened because we’ve got good close regulation in the UK or because the technology hasn’t particularly, hasn’t advanced to a point where this is actually a technology you would choose to have a baby through, I don’t know. But we do monitor it very closely in the UK. If you are offering a PGD service you have to run it through an IVF practice.
You need to have a licence from us. And have the right practitioners in place to do it. So, entry to the market if you like is quite strictly controlled here. And anybody who wants to offer PGD for a new condition that hasn’t been tested for in the UK needs to apply to us. And what we do is we look at that disease and we ask ourselves Is there a significant chance, that a child born into this family will have a serious genetic disease? That’s the question that the legislation asks us to think about.
And, in a way that is easy for something like Duchenne Muscular Dystrophy, something that affects children young and is very debilitating and shortens lives, causes pain etc. And where there is a high risk of that appearing. It is arguably more controversial in something like a hereditary cancer where the onset is much later in life, and where there isn’t 100% chance that you will get that cancer. And that applies to people who’ve got the BRCA1 or 2 gene in the family. We have allowed PGD for those conditions.
And that is because we don’t think that seriousness and high chance of having a disease necessarily means you have to have a 100% chance of it appearing and it doesn’t necessarily mean it has to appear early in life because the impact on those families, of knowing that you have, or those individuals of knowing that you have that disease more than likely coming your way is an enormous burden to bear. So we took the decision that a rounded judgement of seriousness and significant risk allowed us to offer PGD for things like hereditary cancers like bowel cancer and breast cancer too. So, again, the numbers are relatively low.
There are, you know, a few hundred PGD cycles happening each year in the UK. There are 60,000 IVF cycles. So it is really a drop in the ocean compared to fertility treatment in its standard sense. But is an important service for people who’ve got those kinds of diseases in their family. Now whether that will expand in the future, I don’t know. I think that the lessons of the past suggest that the advance of these technologies is much slower than we think they will be regardless of the restrictions and the legislation. As I said our law doesn’t allow us to offer PGD for things that aren’t serious diseases.
So the law would need to change and there will need to be a strong appetite for that change to happen before we thought about offering it for characteristics or enhancements. I think that is an interesting debate to have but, at the moment we have to regulate against the legislation. And there doesn’t seem to be enormous demand to go beyond that kind of use at present.

Over the last 25 years, PGD has come a long way. From being able to test for only a few condition, PGD can now be used to test for over 400 hereditary conditions.

The criteria that are used for whether or not a conduction can be screened for include whether the child will grow up to have a debilitating condition, and whether the condition can be helped with current medicine.

Although the pace of change has been slow, over the years there has been an expansion of what constitutes a serious condition, and testing for risk genes like BRCA mutations that increase a person’s risk of cancer, is now licensed in the UK.

One reason why the pace of change has been slow might be because, in the case of PGD, IVF is required. This involves removing eggs from the woman’s ovary, fertilising the egg with sperm in a laboratory dish and implantation, which is both costly and invasive.

Yet, with the introduction of non-invasive prenatal testing, this might be about to change. Now, it would be possible to test the growing fetus for a number of genetic abnormalities early in pregnancy

For your discussion: What do you think the arrival of prenatal testing using cell-free DNA (like NIPT) will be on the uptake for screening? Do you think we are on the cusp of a searching in genetic profiling in early pregnancy?

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