By Andrea J. Trozzo

Biotechnological advances, namely gene editing, have left the confines of science fiction to enter our medical reality. They provide impressive opportunities, both for the treatment of existing illnesses and for those with inheritable diseases to have their own genetic children. However, the responses of the global community have been mixed, with concerns raised surrounding the legal, political, and regulatory implications of moving gene-modification technologies from the laboratory to the clinic.

Described in layman’s terms as the ability to change the sequence of the genomes of living cells, gene editing is a rapidly-developing area of biotechnology with widespread application. The medical industry has applied gene editing to the communicability of viruses, such as Lyme Disease and Zika, by engineering infected mosquitos and mice whose DNA prevents transmission. The livestock industry could see the implementation of gene editing to make animals resistant to infection, thus reducing the use of antibiotics. Gene editing of cows and chickens may enable both the removal of the genetic roots of allergens in livestock by-products as well as allow greater yield for a lower cost. Some literature has even suggested the gene editing of ‘organ-donor pigs’ to decrease the likelihood of tissue being rejected by human patients.

These applications would arise from a process known as somatic gene editing. Somatic gene editing allows scientists to modify various types of cells and tissues (internally or externally) and return them to the patient as a form of transformative therapy. Scientists are currently using and developing this form of gene editing as a method of treating diseases caused by a single mutated gene, including sickle cell disease and HIV.[1] While somatic gene editing corrects the patient’s affected cells and tissues, offspring would not inherit such corrections.

However, beyond somatic gene editing lies the world of germline gene editing. The controversial human applications of germline gene editing, particularly to foetuses and early life, have caught the attention of legal professionals worldwide. This process involves the protection of a child from inheritable diseases, such as Alzheimer’s, by altering the genetic components of early-stage embryos.[2] Unlike somatic gene editing, germline gene editing alters the whole of the embryo’s DNA – therefore, offspring would inherit the modified DNA and any corrections.

Unsurprisingly, such techniques have triggered alarm, particularly in those who point to the applicability of germline gene editing to create ‘designer children’. Should such practices become mainstream, parents would be able to select a child’s eye and hair colour, physical fitness and endurance indicators, and ‘edit’ their child for genetic mutations such as Dwarfism and Down syndrome.

With rapid advances made in recent years following the discovery of Clustered Regularly Interspaced Short Palindromic Repeats/Cas9 system (CRISPR-Cas),a means of repairing individual genes and strands of DNA far more efficiently than previously thought possible, successful germline genetic modification has become feasible. Experiments have already begun –in April of 2015, China’s Sun Yat-sen University published a study describing the use of CRISPR to edit the DNA of nonviable human embryos.

Consequently, the question turns from a scientific to a legal one. How does the law regulate the use of such gene editing techniques to ensure compliance with both ethical norms and safety standards?

One of the primary issues to be discussed is the need for research prior to widespread implementation of such gene editing procedures. This is to be encouraged for the purposes of identifying and resolving uncertainties surrounding such practices in human embryos, particularly those relating to effectiveness, success rate and accuracy, and long-term impacts. However, such research raises an important legal and ethical issue: human embryos will have to be cultured specifically for research purposes. As identified by the Netherlands Commission on Genetic Modification (COGEM), “surplusembryos (embryos left unused after an assisted reproduction treatment, which in principle should be destroyed) could be used in fundamental research, for example on early embryonic development, or in preclinical research into the safety of new reproductive techniques. However, these embryos will not be sufficient”.[3] Therefore, research on germline gene editing will interfere with the earliest stages of human life and bring to light questions of i) whether it is morally acceptable to create human life solely for the purpose of experimentation and ii) the legal protections of such embryos.[4] With the current state of English criminal law refusing to recognize a foetus as a human being, and the Canadian Assisted Human Reproduction Act prohibiting the creation of human embryos solely for research, what rights of protection will be vested intrinsically in the human embryo?[5] Will it be afforded greater protection as it develops, or will the social and moral duty of developing gene editing techniques outweigh the embryo’s right to protection? And how would this be reconciled with, or distinguished from, current practices in assisted reproduction whereby a greater number of embryos are produced than are ultimately implanted in the uterus?

Some bioethicists have also expressed concerns surrounding the legal implications of the inability to obtain consent for gene editing from future generations, as the decision to endure the unknown long-term effects of the treatment are made on the embryo’s behalf.[6] Although the argument can be made that there already exists in the law the permission for parents to make decisions affecting their potential future children through processes such as IVF, the decision to conceive must be separated from the decision to genetically modify. Therefore, germline gene editing’s creation of a new strand of the issue of informed consent must also be addressed by law and regulation.

A final issue is raised by the current status of laws restricting genetic modification internationally. Experimentation and research on human embryos (up to 14 days old) is currently governed by the Human Fertilisation and Embryology Authority, which states that such research is “permitted where i) appropriately justified, [and] ii) supported by rigorous scientific and ethical review”.[7] However, the editing of embryos in a clinical context is strictly prohibited under UK law. A similar approach is found in the Netherlands, whose Embryo Actstrictly prohibits the implantation of embryos containing a modified nucleus in the uterus, and in the Canadian Assisted Human Reproduction Act’s prohibition of germline engineering.[8] The key question therefore becomes how such acts should be amended and whether/how an international consensus can be achieved to prevent medical tourism. If, for example, the law is to restrict the clinical application of germline gene editing to solely the prevention of ‘serious’ diseases, how will ‘serious’ diseases be classified and differentiated from i) ‘less serious’ diseases and ii) human enhancement? If gene editing is not thusly restricted, how can the law react to prevent germline gene editing from “creating classes of individuals defined by the quality of their engineered genome”?[9] Will the NHS provide funding to parents seeking germline gene editing (and what criteria will qualify parents for this funding), or will it become a disparity-expanding practice only accessible to the wealthy?

It is therefore clear that gene editing is a topic that requires much discussion, and currently presents more legal, ethical, and regulatory questions than answers. The next several years will likely see germline gene editing reach the forefront of biomedical law, at which point lawmakers and policymakers worldwide will be forced to examine the aforementioned issues. For now, interested parties must be content with the ‘wait and see’ approach.

 

 

[1]https://wellcome.ac.uk/what-we-do/our-work/uk-legislation-and-regulation-governing-use-gene-editing

[2]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5544380/

[3]COGEM/Health Council of the Netherlands. Editing Human DNA: Moral and social applications of germline genetic modification. March 2017.

[4]https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/349/34909.htm

[5]A-G ref (No 3 of 1994) [1998] AC 245, http://laws-lois.justice.gc.ca/eng/acts/a-13.4/

[6]https://www.genome.gov/27569225/what-are-the-ethical-concerns-about-genome-editing/

[7]https://wellcome.ac.uk/what-we-do/our-work/uk-legislation-and-regulation-governing-use-gene-editing

[8]http://laws-lois.justice.gc.ca/eng/acts/a-13.4/

[9]https://www.genome.gov/27569225/what-are-the-ethical-concerns-about-genome-editing/