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Home / Healthcare & Medicine / Fertility & Birth / Making Babies in the 21st Century / Regulating the future

Regulating the future

Interview with Juliet Tizzard of the HFEA about the regulatory situation in the UK when it comes to genome editing.
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One of the key features of the law in the UK is that there is a very clear separation between embryo research and treatment. So what you can do to embryos in a research setting in a laboratory and what you can do to embryos for treatment that will make babies. And the law was modified in 2009 to allow genetic modification of embryos in a research project. And has always been the case in the UK, you can only do research on embryos until 14th day of development and under a license.
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So again research is strictly regulated, but as long as you operate within the law you can modify embryos and do a number of things to them that helps advance knowledge of human biology and potential applications in treatment. And so it is in that context that we as a regulator allowed one of our research laboratories to include gene editing in their research project. And really all we did was to apply the the questions that the law asks us to think about. Which is, is the use of embryos necessary? Is the use of embryos desirable? Could this research be done without using human embryos? And our answer from taking scientific advice was that it wasn’t possible.
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So gene editing in the context of embryo research at the moment for our laboratory doing this in the UK, is to understand the early development of the embryo. How that will be applied in future I don’t know. We will see what other research applications we get. I think it was remarkable for other countries looking at the UK as is often the case when we come first to a particular issue is lots of people worry about how this will get out of control and how it could possibly be monitored but we are quite confident in the UK because of the regulation we have that we can allow a research laboratory to do gene editing, and have no concerns that this will be applied in a clinical setting in the UK because it is illegal.
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It would be a criminal offence to do so. And so we can make that separation between research and treatment very clearly. The law doesn’t allow any kind of genetic modification of embryos, which are going to be used to make a baby, that is very clear. And, again, it would need to change the legislation would need to change in order to make that happen if there were valid reasons for doing so. Government departments are notoriously distant from the population.
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And when you have a regulator like the HFEA, and there are many regulators in the health sector in the UK now you are able to have a much closer dialogue with the public as well as patients and donors and donor-conceived people about the developments that are happening or about the change that you might want to make. And that kind of open and frank conversation between the regulator and the public at large is crucial I think.
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It was really what parliament intended by passing this legislation, it was a pact between the research community and society, which is there is a framework within which you can do this, there is a regulator to keep an eye day-to-day on what you are up to, but within that please push ahead, please advance, please develop new treatments and new understanding of disease and fertility etc. And so that pact is crucial to the way that we regulate fertility treatment in the UK. And it works very well. And having a regulator now allows that kind of closeness between the fertility sector and the public, which isn’t really possible to achieve just by having the law alone.

In this interview, Juliet Tizzard of the HFEA explains the difference between embryo research and embryo treatment. This separation is what allows research on genome editing to develop in the UK.

The UK is almost unique in this way, as many countries around the world have not made this distinction, and so they have not allowed genome editing for research.

This distinction allows new techniques to be developed in the laboratory, so that it can be tested and safeguarded, and is one of the ways in which the HFEA is able to support novel research in the area of gene editing and other fields.

For discussion: If you come from a country other than the UK, please share how you think this technology would be received in your country. In doing so, please explain why you think it would be received in that way.

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This content is taken from UCL (University College London) online course
Making Babies in the 21st Century
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