The legality of fixing genetic disorders in embryos
DNA editing methods have advanced to the point that they could be used on human embryos to correct gene mutations that cause numerous diseases at the earliest stages of life. While there are ethical issues to address about such technology, the legality of this is not often discussed. Current laws and regulations are examined to understand the current legality of editing the DNA of embryos for medical purposes for Europe and its member states.
What questions & challenges are raised?
Many diseases, such as cystic fibrosis, sickle cell anaemia and Huntington’s disease, are caused by mutations in the DNA of genes inherited from parents. The announcement in 2012 of CRISPR-Cas9 as a new DNA editing tool has opened up a real possibility to correct disease-causing genetic mutations at the earliest stages of life and prevent them from being passed on to subsequent generations. Two different teams of researchers have genetically modified human embryos in China, and researchers in the UK and Sweden have been given approval to study using CRISPR technologies for correcting genetic disorders in human embryos. There has been a great deal of discussion about the ethics of modifying the DNA of human embryos, including what kind of genetic modifications, if any, should be allowed. But is modifying the DNA of a human embryo legal? What are the current regulations on this? In his recent paper, Dr Iñigo de Miguel Beriain from Universidad del Pais Vasco examines the current legislation in Europe relevant to modifying a person’s DNA and discusses its interpretations and implications.
What background and points are discussed?
Dr de Miguel Beriain begins by noting that there is limited EU legislation directly discussing genetic modification in humans. This is likely because most regulations were written before DNA editing technologies like CRISPR-Cas9 were available. Dr de Miguel Beriain found relevant pieces of legislation in EU policies, laws of individual countries and in the Oviedo Convention, a legal framework prepared by the Council of Europe and ratified by most of the EU states. One clear and unified stance across all Europe governments and legal policies is a ban of editing human genes and DNA for eugenic practices (preferential selection of human traits to ‘improve’ a population). The EU’s ban against eugenics is stated clearly in The EU Charter of Fundamental Rights. The only other legal documents from the EU related to editing human DNA are two EU directives. One directive states that human DNA modifying procedures are not patentable and the second directive prohibits the use of medical products for gene-therapy clinical trials that could edit DNA inherited by future generations. Dr de Miguel Beriain suggests that these regulations don’t directly address the legality of editing DNA mutations in the human genome for the prevention of disease. The position of The Oviedo Convention is much clearer. It prohibits modifying DNA of human embryos or human reproductive cells with the aim of producing DNA-edited children, even if the intention is to prevent, diagnose or treat diseases. Almost all countries in the EU, with the exception of Belgium, have also adopted similarly worded state-level regulations. Dr de Miguel Beriain notes that this ban does not include editing human DNA in early embryos, sperm or eggs for research purposes. While the Oviedo Convention may allow editing embryo DNA for research purposes, many countries have strict regulations on research using human embryos. For example, many countries only permit researchers to use discarded embryos from in vitro fertilization treatments. Dr de Miguel Beriain points out that what is not clear in all these legal regulations is whether treatments intended for curing a disease in a person are permitted if the treatments also inadvertently affect the DNA passed on to children. This would include chemotherapy and radiation treatments used for cancer treatments, which can inadvertently introduce new genetic mutations into an individual’s DNA.
What insight and direction does this give for research policies?
Dr de Miguel Beriain shows that some aspects of legislation are quite clear, whereas others need to be reviewed and better articulated. Of particular importance is that legislation should clarify treatments that unintentionally alter DNA passed on to children. Also, countries should address and better define the intentions of treatments being used. For example, Dr de Miguel Beriain suggests that using DNA-editing treatments to treat or prevent a disease in an embryo are intended for treating the immediate embryo. Although the treatment may alter the genetics passed on to the next generation, that was not the intended use. Dr de Miguel Beriain states that another topic current regulations don’t appropriately address is DNA editing in foetuses and already-born humans. Dr de Miguel Beriain explains that current regulations aim to preserve human ‘genetic identity’, but it is not clear what that is. Is correcting a DNA mutation to prevent a genetic disorder changing a person’s genetic identity? Perhaps most importantly, Dr de Miguel Beriain emphasises that legal policies should be revised periodically, as is stated in the Oviedo convention. Review of legislation provides the opportunity for uncertainties to be addressed and policies to be adapted based on the latest understanding of science and medicine.