“Clustered regulatory interspaced short palindromic repeats”, better known as CRISPR-Cas9 (pronounced as “crisper”) is one of the biggest biotech inventions that has the potential to change the human race, as we know it, forever. The function of CRISPR-Cas9 as gene editing tool is described by the Nuffield Council on Bioethics (UK) as “…the alteration of a selected DNA sequence in a living cell by cutting the DNA molecule at a chosen point and either removing existing elements of the genome or deliberately introducing a new sequence.” The editing of genes through this method offers the possibility of treatment for debilitating genetic disorders, the improvement of fertility treatments and the successful treatment of haemophilia, sickle-cell anaemia and muscular dystrophy, to name a view.
In addition to CRISPR’s significant therapeutic possibilities, its further significance lies in the fact that any alterations to “germ cells” (sperm and egg cells) will be inherited by future generations. Although the alteration of defective genes to prevent or cure genetic diseases is a definite benefit of CRISPR technology, the Centre for Genetics and Society (USA) has warned that this technology may give rise to so-called “designer babies” which will further divide populations into “haves” and “have-nots” depending on their connections and financial means. Sex selection for “non-medical” reasons to avoid having a child with a sex-linked diseases is already allowed in countries such as Belgium, Canada, China, Germany, India, Netherlands, Russia and the United Kingdom (amongst other), whilst strictly prohibited in Austria, New Zealand, South Korea, Switzerland and Vietnam. Section 57(1)(a) of the South African National Health Act 61 of 2003 strictly prohibits the manipulation of any genetic material of human gametes, thereby prohibiting not only sex selection, but also gene editing in general in respect of reproductive cloning of human beings.
Although CRISPR technology is not yet available as medical treatment, and will not be for a number of years until its safety and efficacy has been sufficiently proven in clinical trials, thorough consideration of the legal-ethical issues involving this technology became pressing when China published research in April 2015, announcing that they have created the first genetically modified human embryos. In reaction the National Institutes of Health (NIH) confirmed their long standing concerns about the safety of the technique and the ethical implications of altering genes that will be passed to future generations of humans and reaffirmed their ban on research that involves gene editing of human embryos on 29 April 2015.
In September 2015 these issues became critical when Dr Kathy Niakan of the Francis Crick Institute (London) submitted the first application to the UK Human Fertilisation and Embryology Authority (HFEA) to pursue genome editing research in viable human embryos. A research proposal the Executive Director of the Centre for Genetics and Society (USA), Dr Marcy Darnovsky, called “…a troubling and provocative move.” Contrary to prohibiting legislation in other countries, no similar legal protection exists in the USA which raises his fear that by allowing this kind of research it will “…open the door to a world of genetically modified humans.”
Subsequently an International Summit on Human Gene Editing, hosted by the National Academy of Science, National Academy of Medicine, Chinese Academy of Science and The Royal Society was held in December 2015 to discuss future and implications of human gene editing and address the need for universal guidance in view of the different sets of rules governing this technology in different countries. This summit resulted in multi perspective and organised debate which concluded in the following consensus statements:
- It was agreed that basic and pre-clinical research on genome editing should continue to further study this technology and to investigate its potential benefits and risks, especially in view of science’s current limited knowledge of human embryology. It was also agreed that researchers that do use editing on human embryos to modify early embryos of germlines should not allow these to be used to establish a pregnancy;
- Although changes to somatic cell genomes, such as the editing of genes for sickle-cell anaemia in blood cells, are not passed on from one generation to the next, the risks of possible off-target effects of inaccurate editing must still be assessed in clinical trials;
- The clinical uses of gene editing in germline cells which will allow the prevention of genetic disease or potentially enhance human capabilities are ultimately passed on to subsequent generations. The summit acknowledged their obligation towards generations which will ultimately carry these genetic alterations and the idea that once these alterations have been made, it will be near impossible to remove those changes which can lead to social inequalities and associated moral and ethical considerations;
- The need for an ongoing forum, inclusive across all nations to include a broad range of perspectives to discuss future research and clinical uses was also established.
Substantive and clear answers to all the legal and ethical questions arising from human gene editing will not be available as long as this technology keeps on developing and research results keep on evolving.
On 1 February 2016, the UK HFEA approved Dr Niakan’s above application to edit the genomes of human embryos for research purposes with view of eventually developing treatments for infertility, although genome editing will not form the basis of such therapy.
Active debate regarding human genome editing is thus ongoing, important and exciting! Please contact writer hereof at the below e-mail address with your questions and comments in this regard.
by Marietjie Botes