Petra De Sutter

Fertiliteitsexperte, senator & parlementslid voor Groen in de Raad van Europa

Ethics, Europe, Sexual & reproductive health

We should all be interested in the ethics of genome editing

Sinds 30 november 2015 werk ik in de Raad van Europa aan het ethisch kader voor het genetisch modificeren van menselijke embryo’s. De wetenschap gaat snel vooruit, dus ben ik bezorgd over de ethische grenzen van de genetische technologieën.

Op 12 oktober 2017 werd mijn rapport ‘The use of new genetic technologies in human beings’ aanvaard in het parlement van de Raad van Europa. De aanbevelingen van het rapport gaan nu naar alle ministers van de lidstaten van de Raad van Europa, zodat zij ze op nationaal vlak kunnen navolgen.

Dit was mijn tussenkomst:

Dear President
Ladies and gentlemen,

Medical technologies are advancing at a very rapid pace. Especially genetic technologies are changing medical practice rapidly.

Today a couple at risk for a severely genetically affected child has different possibilities. They can go for prenatal diagnosis and interrupt the pregnancy. Or they can have their embryos tested and select only embryos which are not affected.

But tomorrow, we will be able to screen for other diseases, which are less severe. Or for medical conditions which affect people only later in life, such as diabetes or colon cancer. This is much more controversial.

And the day after tomorrow we could go even further. Some modern-day philosophers like the Australian Julian Savulescu plead for a revival of the old concept of eugenics, now called enhancement, leading to designer babies. He believes this will be necessary for the survival of humankind. I suspect most of us here present would not endorse this view. I certainly don’t.

Where to draw the line?

Genetic technology has very recently entered in a new era. We now can not only select embryos after screening, but modify them. The new CRISPR-Cas-9 technique allows to cut out a piece of DNA and replace it with another, in an easy, cheap and effective way. Many applications are underway in different fields of medicine, and they are not raising ethical questions, because they deal with somatic cells, such as blood or other tissues.

It gets something quite different when dealing with sperm, eggs or embryos. In that case you do not only modify the embryo, but also all descendants ever to be born from that individual.

Does this seem scary to some of you?

Let us examine why you would or should indeed be scared.

First of all the technique seems effective, but mistakes are certainly possible and maybe even likely at this stage of development. These mistakes may be off-target, thus affecting other pieces of DNA than the ones you would want to modify. With unpredictable side effects.

It therefore is today clearly inadmissible to consider transferring a modified embryo into a womb and let a child be born. Everybody agrees to that.

But there is another reason not to want this technology to develop without any regulation or legislation. Even if it would be safe, who will decide what can be modified in the genome of a particular embryo and what not?

Consensus guidelines by different scientific bodies, such as the Hinxton ethics, as well as the US National Academy of Science, the European Society of Human Genetics and others — have advised that editing the human germ line can be justified for the scientific purpose of research into fundamental biology.

But they also say that substantial basic research is needed to check the safety, accuracy and feasibility of genome editing as a potential clinical tool. Therefore, clinical applications can be considered only after strong research groundwork has been done, and only then for cases that are deemed acceptable after careful examination of alternatives and further societal debate. This is what the scientific community says.

Dear colleagues, we must have no illusions, these developments will go on, and genetically modified babies will be born in some countries, possibly in member states of the Council of Europe. It has recently happened for the so-called three-parent-child. A first child has been born in Mexico, a second in Ukraine. If this will happen again with genetically modified children, let us please think about what is acceptable and what is not.

Colleagues, our work here really matters. A recent scientific publication in EMBO reports regrets that the present report reaffirms the Oviedo ban on germline genome editing in humans. The authors consider especially our paragraph 5.1 to be outdated and in sharp contrast with recent international scientific developments. I understand their opinion. Scientists are interested in the science, but we should also be interested in the ethics of it. To quote Rabelais: « science sans conscience n’est que ruine de l’âme ». In English science without conscience is only the ruin of the soul.

Where does this leave us?

Dear colleagues, for us, it is actually clear. We do have the Oviedo convention. This is the first and still the only legally binding international treaty in bioethics. The Oviedo convention is clear: article 13 states that the transfer of a genetically modified human embryo, leading to the birth of a child, is NOT allowed.

Fundamental research is possible, but the red line is the birth of a genetically modified child. It however leaves open the possibility of amendments in article 32 after appropriate public discussion as stated in article 28.

As you know the Oviedo convention, which – by the way – will celebrate its 20th anniversary in a few weeks, has been ratified by only 29 member states. The states which did not ratify it, did this for different reasons than for the issue we discuss today. That is why this report urges member states to ratify the Oviedo convention in the first place, but if they do not, to at least put in place legislation to ban the establishment of a pregnancy after genome editing of the embryo. As you can see from the recommendations, this report also asks to put in place a broader regulatory and legal, – because it has to be binding – , framework to define which medical indications would be acceptable and which would not. Why these three propositions, would you ask?

Ladies and gentlemen, you should read these recommendations as three different levels of regulation. Plan A is the ratification of the Oviedo convention. For those member states that refuse to do so, perhaps for other reasons, there is a plan B, namely at least banning the transfer of a genetically modified embryo and establishing a pregnancy. The framework proposed in this report under paragraph 5.4 is a plan C.

Ladies and gentlemen, we should have a broad discussion with all stakeholders and come to a common conclusion. Only in this way we can avoid what I would call “genome editing tourism”, patients who travel to other countries where is possible what is not allowed in their own country, or as in the Mexico case, scientists traveling to more permissive countries to do things they could not do in their own country. We can see this already today for many other treatments in reproductive medicine, such as egg donation or surrogacy, and this is not what we want.
I will conclude by referring to a recent editorial in the scientific magazine Nature which states the following: regulators, funders, and scientists need to continue working together to define the details of the path forward for germline genome editing, so that the valuable resources and tools now at our disposal are used with good judgement.

Dear colleagues, I would add politicians to that list. We have a huge responsibility in taking the right decisions in regulating this rapidly evolving field. Thank you for supporting this report.

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Thema door Anders Norén