Written by Luisa Antunes.
Genome-editing techniques have advanced tremendously in recent decades, especially since the development of CRISPR‑Cas9 by Nobel laureates Jennifer Doudna and Emmanuelle Charpentier. Such technological advances allow precise and targeted alterations to human DNA in a manner that is more efficient, more flexible and relatively less expensive than previous strategies. Coupled with artificial intelligence, this revolutionary technology could open a new field of precision medicine that includes a wide diversity of applications, ranging from uncovering therapeutic options for several allergies to potentially eliminating cancer, curing immunological diseases, antimicrobial resistant infections, cystic fibrosis, sickle cell anaemia and more.
Yet, proposing to alter the human genome conjures images of science fiction and past echoes of eugenics. Associated concerns allude not only to ethics, but also to safety, economic and political implications. What is the limit between a genetic modification aimed at treating a disease and a cosmetic alteration designed to modify a physical aspect of the consumer? Will genome editing replace the lucrative market of plastic surgery? What is the potential sociopolitical impact of unequal economic access to precision therapeutic medicine? Could international technological and regulatory differences carry geopolitical repercussions in the global arena?
To map the scientific and legal framework of genome editing in humans and support policy-makers in their understanding of its technical development and potential impact, the European Parliament Science and Technology Options Assessment (STOA) Panel commissioned a study entitled ‘Genome-editing in humans: A survey of law, regulation and governance principles’. The report was written by Professor Ana Nordberg, of the Faculty of Law, Lund University (Sweden) together with Doctor Luisa Antunes, policy analyst at STOA.
The study provides an overview of genome-editing technologies, the associated potential and risks, followed by a comparative analysis of regulatory frameworks in the European Union and worldwide, and options for political action.
In sum, genome-editing legislation can be introduced either in existing EU regulations (vertical approach), or through specific legislation (horizontal approach), and alternative governance mechanisms can also be explored. In any case, legal harmonisation facilitates the navigation of all stakeholders involved in a currently fragmented EU legal landscape. Moving forward, a few policy options can be envisaged:
- Resilience mechanisms could be included in legislation to ensure continued correspondence between legislation and ongoing scientific advancements. Terms such as somatic v germline, hereditable genome editing, modifying genetic identity, andhuman enhancement are vague, scientifically outdated and could be updated.
- Somatic as well as germline applications can pose social and ethical risks. A multi-level, risk-based approach could be used to determine what interventions to ban. The prohibition of genetic eugenics could extend to somatic applications.
- Assisted reproduction techniques are often linked with the treatment of serious diseases. Scientific criteria used to determine disease seriousness could be harmonised.
- Legislation on reproductive travel and wellness tourism varies by country. Corresponding EU law could apply extraterritorially.
- Genome-editing needs to account for fundamental rights and freedoms. Subjects of illicit practices should be treated as victims and be allowed to refuse body-invasive activities, whilst also respecting their privacy, life, integrity and autonomy.
- Counterfeited services are an intellectual property rights and public health issue. Genome editing could be introduced in existing legislation, including artificial intelligence (AI) legislation, and ethical licensing could be considered.
While genome editing provides great expectations for medicine, several ethical, social and legal questions remain to be addressed and regulatory and governance mechanisms are greatly needed in the EU.
The study was presented at a STOA panel meeting on 7 April 2022, and fostered fruitful discussions between the panel members present, who also raised questions with Professor Ana Nordberg:
Christian Ehler (STOA Chair, EPP, Germany): What is the most urgent legislative measure to be taken?
Professor Nordberg: It is urgent to adapt legal rules so that research on assisted reproduction is not delayed. Secondly, it is important to increase regulation on non-therapeutic uses (somatic interventions). The market for cosmetic products is huge and consumers are not very particular about which products they use, so this is a problematic legal area, which could be subject to further regulation. When patents expire, there will be a strong opportunity to explore the cosmetic products market, so regulation should already be in place. This issue links to questions of medical wellness and reproductive tourism to countries outside the EU.
Pernille Weiss (EPP, Denmark): How can we measure the seriousness of disease in respect to genome editing in assisted reproduction?
Professor Nordberg: There is an ongoing debate on the meaning of disability, which medical criteria are usually used to define. However, such criteria might differ from the patient’s own understanding of their condition. The patient’s view should also be taken into account.
What are the links between genome editing and the proposed artificial intelligence act?
Professor Nordberg: Artificial intelligence can be very helpful in disease diagnosis. Associated with genome editing, it can help correct certain diseases. However, genome editing could also be used to modify traits with no therapeutic objective. It could therefore be considered in the proposed artificial intelligence act.
Maria-Manuel Leitão-Marques (S&D, Portugal): How can we create flexible legislation that can be adapted to such a fast-evolving scientific area? Do you see a parallel with the proposed artificial intelligence legislation? If so, do you think a risk-based approach, as used in the artificial intelligence act proposal, could be adapted and applied to this area?
Professor Nordberg: The field is evolving very fast. Legislation will therefore need to be flexible, adaptive and resilient.
There is a clear parallel with the proposed legislation of artificial intelligence. The study favours a risk-based approach, which already exists in the legislation of pharmaceutical product evaluation and marketing authorisation. Legislation could take the perspective of ethical and social risks and implications, as well as being patient-based. It is also important to add the possibility of flexible legislative definitions, such as annexes, which can be revised easily if the technology moves forward, so that any legislation will not be outdated in just a few years. This can also be seen in the proposed artificial intelligence act.
Ivars Ijabs (Renew, Latvia): What is the threshold between genetic eugenics, which are prohibited, and self-enhancement?
Professor Nordberg: The distinction between eugenics and self-enhancement is very complex. It is therefore difficult to consider concepts such as ‘human enhancement’ in legislation. Human dignity, human autonomy, human agency, are concepts that might be better choices to use in legislation.
It is important to establish boundaries on the definition of eugenics. For instance, private actors can be considered to use a form of eugenics, regardless of the outcome, if they operate outside of the normal informed consent given by an individual subject to an intervention. It is therefore extremely important to prohibit and maintain a ban. Prohibition, in my view, should be clearly extended to private actors.
What is the role of public opinion in EU policies on this issue? As with genetically modified organisms, the EU’s commitment on genome editing in humans seems to be rather conservative. How do we make this democratic participation compatible with the further development of techniques that would improve human life?
Professor Nordberg: There is no single public opinion on elective interventions, but rather a question of public ‘opinions’, since there are many and these depend quite significantly on context. Non-therapeutic (elective) somatic interventions could be regulated. For example, at times, the same people who are very concerned about the safety of a vaccine are then very happy to be subjected to cosmetic modifications, for instance in a beauty salon, without knowing if there are any safety precautions. Legislation in this field is lacking.
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