In science fiction, human genetic engineering is nothing new for almost a century. In the book “Brave New World” different castes of embryos are fertilized by the state for the purpose of social stability. In the movie “Gattaca” it is the norm for doctors to make DNA-profiles of thousands of fertilized eggs and to select the best egg, not only on the basis of genetic diseases, but also on psychological characteristics.

Nowadays, a lot of the elements of these science fiction stories are no longer fiction. In vitro fertilization (IVF) makes it possible to fertilize an egg outside the body. The technique of pre-implantation genetic diagnosis (PGD) profiles the genes of embryos prior to implantation. Combining these techniques makes it possible to select the best of a few fertilized eggs. Moreover, last April, scientists in China successfully edited human genes for the first time ever.[i] The success rates were, (un)fortunately, very low: from the 86 embryos, 71 survived and from them the genomes of only 28 embryos were edited. The technique needs to be further developed, because the success rate has to be near 100 percent, but the first step has been made.

At first, PGD was used to target severe diseases. Nowadays, parents often use it for sex selection or to screen treatable diseases. Most than likely, in the future, it will be possible to choose characteristics as eye-color or hair-color of your child. Less probably, it may be possible in the future to identify genes on, for example, intelligence and homosexuality.[ii] If these predictions become true, it will be possible to design your baby to your own wants, “designer babies” will be born.

At this moment PGD can only profile the genes of both parents. If both parents do not carry a blue-eye gene, then their baby cannot have blue eyes. Princeton professor Lee Silver predicts that in the future it could be possible that parents can buy every kind of (artificial) genes in order that their baby, in this situation, can have blue-eyes.[iii] Then, the whole genetic profile of a fertilized egg can be modified. When other genes, like higher intelligence, can be bought, this will have an enormous impact on society. It will lead to a greater gap between rich and poor people, since these gene modifications more than likely will cost a lot of money. Eventually, the rich could modify into a new kind of human species. The poor people, still sharing a lot of genes with the new human species, could be acknowledged in the same way as we acknowledge chimpanzees now. Of course, this is a far-fetched example of a situation of human genetic engineering. Despite the risks for society as we know it, forms of genetic engineering have great potential to treat genetic diseases. Therefore, many scientists believe that it still is of great importance to further develop these techniques. However, I believe that the risks of genetic engineering for society should not be underestimated and that these kinds of situations could be prevented through regulations.

In this light, the question arises if designed babies are possible within the current legal framework of the Western World.

Within the chosen legal frameworks, legislation on PGD and human genetic modification will be described. The legal frameworks I use in this study are the United Kingdom, the United States of America, the Netherlands. I have chosen these frameworks, because I believe that these will give a good image of the Western World. Secondly, an analysis of if, and so yes, under which circumstances genetic modifications on humans are possible, will be given. Thirdly, recommendation regarding legislation on modifications of the human genomes will be given. Lastly, in the concluding remarks, the research question will be answered.

1        Current Legal Framework

1.1      United Kingdom

The United Kingdom’s approach to research on human genomes is heavily geared towards scientific freedom. They want to be world leaders in the area of new genetic technologies. [iv] Their regulation on PGD has been described as “one of the most liberal regulatory mechanisms in the world”.[v] The Human Fertilisation and Embryology (HFE) Act regulates the creation and use of human embryos outside the body. These practices are actually prohibited, but the Human Fertilisation and Embryology Authority (HFEA) may grant licenses that allow these kinds of practices. Embryo testing is an activity that may be licensed by the HFEA, but only if it fulfills one or more of the purposes mentioned in Section 11, paragraph 1ZA of the HFE Act. Some of these purposes are to establish whether the embryo has a gene, chromosome or mitochondrion that may affect its capacity to result in a live birth, when there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, and when there is a particular risk that any resulting child will have or develop a gender-related serious disability, illness or medical condition. In the case of a gene, chromosome or mitochondrion abnormality, there has to be a significant risk that the person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition. In the case of a gender-related medical condition, the medical condition has to affect only one sex or it has to affect one sex significantly more than the other. Section 11, paragraph 1ZB states that a license cannot be granted to any practice designed to secure that any resulting child will be of one sex rather than the other. Regarding modifications in genes the HFE Act states that nuclear or mitochondrial DNA of any cell of the egg, sperm or embryo may not be altered, otherwise it is not (a) permitted egg, sperm, or embryo.[vi] Besides, an embryo is not permitted if cells have been added to it other than by division of the embryo’s own cells.[vii] Non permitted eggs, sperm or embryos may not be placed in a woman.[viii] However, regulation may provide that an egg and an embryo can be permitted “even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease”.[ix]

1.2      United States

At this moment, there is no federal regulation about the use of PGD in the United States of America. There are three federal agencies that could impact laws at the federal level about PGD.[x] These are the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Center for Medicare and Medicaid Services (CMS). The CDC are currently not required to report data on the use of PGD. Thus, there is no information available on what methods are being used, in which cases, on whom, and how often.[xi] Regarding the FDA, laboratory instruments that are used at genetic tests could fall under the jurisdiction of the FDA. The genetic tests that are used by most US clinics, do, however, not fall under FDA authority. According to the Genetics and Public Policy Center, there is confusion about the jurisdiction of the FDA on genetic testing in general, and that is the reason the FDA does not regulate the use of genetic devices for PGD or exercise authority over the PGD technology.[xii] The CMS has authority over clinical laboratories. However, it is still unclear whether clinics that perform IVF and PGD are clinical laboratories. Therefore, this authority cannot regulate PGD practices.[xiii]
Regarding state regulation, there is also nothing arranged about PGD technology and activities.

1.3      The Netherlands

The Dutch Regulation on PGD determines that PGD is possible in one center, the Academic Hospital Maastricht. The Regulation contains requirements in the annex that must be met for the use of PGD. First, there has to be a serious individual risk for a severe genetic disease or illness. The age on which the disease usually occurs, plays a role too. When the disease occurs at a later age, the breach of life and the treatment perspectives will be weighted differently, than a situation where the disease occurs at young age. The possibilities of (preventive) treatment also play a role. The physical and mental effects of treatments will be taken into account. Each PGD case will be treated individually and according to the circumstances of the case, PGD will be permitted or not. There are strict requirements to fulfill and since it is an individual decision, it will be uncertain whether or not a couple qualifies. Besides the Regulation on PGD, the Dutch Embryo Act also regulates some relevant subjects. Article 24 (g) prohibits intentional modifications in the genes of the cells that are used to fertilize. Moreover, Article 26 prohibits activities to determine the sex of the future child, except for situations when there is a serious risk of a severe gender-related genetic disease.

2        The Possibilities of Human Genetic Engineering

If the predictions of professor Lee Silver come true, then the whole genetic profile of an embryo can be modified. The question arises if it is possible to modify the human genomes within the current legal framework. In China, it is possible, but is it also possible in the Western World?

It is very remarkable that the United States do not have any regulation in the field of PGD and that there is no federal authority that monitors PGD technology or activities. According to MIT Technology Review, there is a genetics center in the United States that tries to modify the human genomes, but they do it secretly.[xiv] Thus, in the United States every kind of genetic modification will be possible.

The regulations in the United Kingdom and the Netherlands are very much alike. In both countries PGD is only allowed for health purposes and the requirements that have to be fulfilled are detailed. Regarding human genetic modification, in the Netherlands it is explicitly prohibited in The Dutch Embryo Act. Therefore, it will not be possible to modify the human genomes in the Netherlands. The HFE Act prohibits non permitted eggs, sperm or embryos to be placed in a woman. Non permitted eggs, sperm and embryos are, inter alia, altered nuclear or mitochondrial DNA of any cell of the egg, sperm or embryo. Notable is that the HFE Act mentions an exception to this. Namely, regulation can provide that an egg and an embryo can be permitted even though their nuclear or mitochondrial DNA is altered. Regulation has to prescribe the circumstances and process in which situation this is allowed. This exception is only allowed in the occasion to prevent the transmission of serious mitochondrial diseases. In the United Kingdom, modification of the human genomes is possible, but only in specific circumstances that have to be described in laws. It is most likely that in this situation it will not be possible to modify the genes for cosmetic purposes. Most probably, human gene modification will only be possible in situations of severe diseases.

3        Recommendations

Since modification in human genomes has a great potential to solve many diseases and can contribute in a great way for better health of mankind, I believe it is important to further develop these techniques. Regulation plays an important role in this, because this kind of research can be prohibited by regulation. However, doing this kind of research while nothing is regulated about it can be dangerous. The situation described in the introduction, where only rich people have access to genome modification, will have a lot of implications for society. Besides, a lot of countries provide embryos with certain rights, because they will develop in human beings or are already considered as human beings (the opinions differ), which makes research on embryos not easier.

Leaving all the ethical opinions on embryo research and ethics aside, I believe that no regulation at all is not good, but neither is a prohibition on genetic modification. It is advisable to define what the borders should be on genetic modification. Is the purpose to create a whole new evolutional mankind with the best genes possible? Or is the purpose to discard genetic diseases and improve the health of all humans? In my opinion, it is very important to make the advances of the technique to discard genetic diseases available to all. However, this is easier said then done. Less developed countries may not have the tools and/or knowledge to apply these techniques on their people and who will regulate that whole mankind has access to these techniques? Organizations like United Nations have a lot of member states, but not all states in the world. Besides, who will bear the costs hereof? Will governments bear the costs or insurance companies or individuals themselves? It will be easier to achieve this on nation level, than worldwide. Availability for all on nation level is a good start, but eventually it will be for the better if the whole world can benefit from human genetic manipulation. Thus, making the technique available to all will not be easy, but with some determination it, most certainly, will be possible. But, first things first, the technique of genetic manipulation has to be further developed and the borders thereof should be determined in legislation. There also has to be room for research on genetic modification on humans, but within the borders of human rights. The way the United Kingdom regulates this is, in my opinion, a good way. A law has to specifically define the circumstances and processes that are being used for the modification and the purpose of the modification. In this way, the borders are explicitly defined in which circumstances genetic modification on humans is possible. If this technique is made available to everyone, then the health of whole mankind is brought to the next level and genetic diseases will, eventually, no longer exist. Moreover, society will not be harmed. It will be a win-win situation.

4        Concluding Remarks

The legal frameworks of the United Kingdom and the Netherlands are more alike than the framework of the United States. It seems that in the United States everything is possible in the fields of human genetic modification, because there is no regulation in this field. In the United Kingdom modifying human genomes could be possible, but the process in order to make it possible is not an easy one. Regulation has to be established and specific circumstances and processes have to be prescribed. In the Netherlands it is very clear, human genetic modification is prohibited.

In view of the health prospects for humans of genetic modification, the United Kingdom has the best legislation. There, the borders of human genetic modification and its purpose can be defined in laws. Prohibition or no regulation on this subject will not harm mankind’s health. Prohibition on human genetic modification makes it impossible to discard genetic diseases and no regulation will do harm to society. But, in my opinion, it is of most importance that the techniques to discard genetic diseases should be made available to all. This will not be an easy task, but it is important. To achieve this worldwide will be very difficult, but it is certainly achievable on nation level.

The outcomes within the legal framework of the Western World are very different. Therefore, the answer to the question if designed babies are possible, depends on the country. More specifically, in the Netherlands it certainly is not possible. In the United States designer babies are possible. In the United Kingdom designer babies could be possible, but most probably it will not possible to design your baby to your own needs. It is for a reason that it must be prescribed in regulation under which circumstances and with what process the modification is allowed. Modification on the human genomes is also possible in the United Kingdom, but only under specific circumstances and specific purposes defined in legislation. Regarding the United Kingdom’s opinion on PGD, it will be probable that the only purposes allowed will be to discard genetic diseases. Designing a baby to your own needs will probably not be possible.


[i] DNA-disaster or medical miracle? Chinese researchers modify human genome. April 23, 2015. (accessed June 24, 2015).

[ii] Tuhus-Dubrow, R. “Designer Babies and the Pro-Choice Movement.” Dissent 54, no. 3 (2007): 37-43.

[iii] BBC. Designer Babies – Comments by Princeton professor Lee Silver. September 26, 2006. (accessed June 24, 2015).

[iv] Government White Paper. “Our Inheritance, Our Future.” Cm 5791, 2003.

[v] Brownsword, R. “Biotechnology and Rights: Where are we Coming From and Where are we Going.” In Human Rights in the Digital Age, by M. and Murray, A. Klang, 230. Great Britain: Glasshouse Press, 2005.

[vi] Section 3ZA Human Fertilisation and Embryology Act.

[vii] Section 3ZA, paragraph 4(c) Human Fertilisation and Embryology Act.

[viii] Section 3, paragraph 2 Human Fertilisation and Embryology Act.

[ix] Section 3ZA, paragraph 5 Human Fertilisation and Embryology Act.

[x] Genetics and Public Policy Center. “Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos.” Washington, D.C., 2004.

[xi] Snelling, J. and Henaghan, M. “Choosing Genes for Future Children: Chapter 5 – Law and Regulation.” Human Genome Research Project, 2006.

[xii] See Genetics and Public Policy Center. “Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos.” Washington, D.C., 2004 and Snelling, J. and Henaghan, M. “Choosing Genes for Future Children: Chapter 5 – Law and Regulation.” Human Genome Research Project, 2006.

[xiii] Snelling, J. and Henaghan, M. “Choosing Genes for Future Children: Chapter 5 – Law and Regulation.” Human Genome Research Project, 2006.

[xiv] DNA-disaster or medical miracle? Chinese researchers modify human genome. April 23, 2015. (accessed June 24, 2015).