Gene editing and the integrity of the genetic identity — are new legal tools required?
Mutagenesis is a set of techniques allowing the modification of the genome of a living organism without the insertion of foreign DNA. Emerging mutagenesis techniques include gene editing through clustered regularly interspaced short palindromic repeats (“CRISPR”).[1]
Cas9 is an enzyme that uses CRISPR sequences as a guide to recognize and cleave specific strands of DNA, which, together with CRISPR sequences (“CRISPR/Cas9”), comprise a technique that could be used to edit genomes within organisms.[2]
CRISPR/Cas9 and all effective mutagenesis techniques paving the way for genome editing, hold both great promise and immense risk.
CRISPR/Cas9 and all effective mutagenesis techniques that pave the way for genome editing, hold both great promise and immense risk. While they could be used to present new treatments for a range of diseases including cancer, cystic fibrosis, haemophilia and Duchenne muscular dystrophy, they also give rise to significant ethical and legal issues, which have yet to be exhaustively debated.[3]
As genome editing implementations unfold, particularly those spearheaded by CRISPR/Cas9, addressing such ethical and legal issues will become imperative.
In the UK, the Human Fertilization and Embryology Authority gave a team of scientists in London the license to edit genes in human embryos in 2016.[4] In the US, a new method of repairing a disease-causing mutation and preventing it from being inherited by succeeding generations was demonstrated in research published in 2017 and which was based on tests on donated clinical-quality human eggs.[5] Chinese scientists appear to have used CRISPR/Cas9 to genetically engineer the cells of cancer and HIV patients.[6]
Also in China, but far more alarmingly, a scientist announced in November 2018 that he had created the world’s first genetically edited babies by altering a gene in the embryos, before having them implanted in the mother’s womb, with the goal of making the babies resistant to HIV infection.[7] A number of other planned CRISPR/Cas9 implementations, involving the editing of living human cells, have surfaced in media coverage of companies active in the discussed field.[8]
While a number of jurisdictions already feature a legal framework in relation to genetic intervention, such frameworks were developed prior to the advancement of highly advanced genome editing techniques such as CRISPR/Cas9. National and supranational legislators and judges may be increasingly called upon to determine whether existing legal frameworks suffice to address the new possibilities and implementations unleashed by the latest technologies, or whether new approaches are required.
Illustratively, at an EU level, primary EU law prohibits eugenic practices, as part of the right to the integrity of the person, under the Charter of Fundamental Rights.[9] Directive 2001/18/EC on the release of genetically modified organisms into the environment (the “GMO Directive”) is seen as relevant to genome editing following a Judgment of the Court of Justice of the European Union (the “CJEU”) of 25 July 2018.[10] The CJEU held that organisms obtained by the new techniques of directed mutagenesis are genetically modified organisms (“GMOs”) that are subject to the obligations laid down by the GMO Directive. However, Union law does not appear to regulate genome editing for the prevention or treatment of disease.
The CJEU held that organisms obtained by the new techniques of directed mutagenesis are genetically modified organisms (“GMOs”) that are subject to the obligations laid down by the GMO Directive. However, Union law does not appear to regulate genome editing for the prevention or treatment of disease.
The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (the “Oviedo Convention”) contains express provisions on the discussed topic. Under Article 13, the Oviedo Convention prohibits modifying genomes to introduce genetically modified children and only allows genome editing interventions for diagnostic or therapeutic purposes.
The wording of Article 13 of the Oviedo Convention can serve as a prism through which the urgent issues emerging from the deployment of techniques such as CRISPR/Cas9 could be addressed. Human genome editing has two aspects: the genetic modification of living human beings and that of unborn human beings. The latter is prohibited under the Oviedo Convention, even where such purported modification would be aimed at preventing disease.
However, the technologies presently under development may lead to the prohibition on genetic modification of unborn humans being revisited in some jurisdictions. Moreover, even in those jurisdictions where genome editing of descendants is prohibited, the possibility of modifying genomes of living humans raises the issue of mutagenetic ‘succession’, namely whether descendants of humans whose genes have been edited will be genetically impacted by such editing.
Moreover, even in those jurisdictions where genome editing of descendants is prohibited, the possibility of modifying genomes of living humans raises the issue of mutagenetic ‘succession’, namely whether descendants of humans whose genes have been edited will be genetically impacted by such editing.
It is suggested that benchmarks are required to inform any discussion on a potential regulatory response to technologies such as CRISPR/Cas9. A legal construct of genetic identity could be formulated, to be utilised as a legal benchmark against which any genome editing will be assessed.
A debate would be necessary, drawing on genetics, medicine, law, sociology and philosophy, to determine whether the regulatory intervention and the optimal normative order addressing genome editing could be linked to the extent to which any introduced technique impacts genetic identity.
The legal notion of a genetic identity could be formulated on the basis of a consensus aligned with shared constitutional traditions and fundamental rights regimes, the notion of genetic identity in science the possibilities of scientific research in the field of genome editing.
The legal notion of a genetic identity could be formulated on the basis of a consensus aligned with shared constitutional traditions and fundamental rights regimes, the notion of genetic identity in science the possibilities of scientific research in the field of genome editing.
The time is ripe for a sophisticated debate, which will strive to arrive at a consensus on whether a legally defined genetic identity should be enshrined in our legal orders, which could be invoked to prevent genetic anarchy.
[1] Barrangou R (2015) “The roles of CRISPR-Cas systems in adaptive immunity and beyond” Current Opinion in Immunology 32: 36–41
[2] Zhang F, Wen Y, Guo X (2014) “CRISPR/Cas9 for genome editing: progress, implications and challenges” Human Molecular Genetics. 23 (R1): R40–6.
[3] For a discussion of the ethical issues in genome editing, see, generally, Rodriguez E (2016) “Ethical Issues in Genome Editing using Crispr/Cas9 System” J Clin Res Bioeth 7:266.
[4] “UK scientists gain licence to edit genes in human embryos”, Nature, 1 February 2016, https://www.nature.com/news/uk-scientists-gain-licence-to-edit-genes-in-human-embryos-1.19270
[5] Hong Ma, Nuria Marti-Gutierrez, et al. “Correction of a pathogenic gene mutation in human embryos” (2017) Nature volume 548, pages 413–419.
[6] “China, Unhampered by Rules, Races Ahead in Gene-Editing Trials”, Wall Street Journal, 21 January 2018, https://www.wsj.com/articles/china-unhampered-by-rules-races-ahead-in-gene-editing-trials-1516562360
[7] “Chinese Scientist Claims to Use Crispr to Make First Genetically Edited Babies” The New York Times, 26 November 2018, https://www.nytimes.com/2018/11/26/health/gene-editing-babies-china.html?module=inline.
[8] “Crispr gene editing ready for testing in humans”, 5 March 2018, Financial Times, https://www.ft.com/content/d6a773a0-cece-11e7-947e-f1ea5435bcc7
[9] Article 3.2, Charter of Fundamental Rights of the European Union. It should be noted that the explanatory notes to the Charter note that the reference to eugenic practices, in particular those aiming at the selection of persons, relates to possible situations in which selection programmes are organised and implemented, involving campaigns for sterilisation, forced pregnancy, compulsory ethnic marriage among others, all acts deemed to be international crimes in the Statute of the International Criminal Court adopted.
[10] C-528/16, Confédération paysanne and Others, Judgment of 25 July 2018; ECLI:EU:C:2018:583
Image credits: DocWise LLC.
