With recent developments in medical technology, genome editing opens up the possibility of heritable modification of our genetic composition, to either heal a genetic illness or alter physical traits. How should the EU approach these new possibilities in the field of research and practical application?
Committee on Environment, Health and Food Safety II (ENVI II)
Eva Thorshaug (NO)
Topic at a Glance
The field of genome editing has experienced major growth in the past couple of years, with the latest developments enabling scientists to make irreversible changes to the human DNA. While research is moving fast, action on the part of national and international institutions seems to have fallen behind. The topic of genome editing opens up crucial ethical and practical questions that need to be addressed by current legislation for the development to continue in the safest way possible.
Ever since the discovery of the CRISPR/Cas9 technology and its ability to edit the human DNA in 2012, research in the field of genome editing has rapidly accelerated. While the application of this newfound germline technology opens up major fields of research, the most potent use of the technique is also the most controversial one – tweaking the genomes of human embryos in order to eliminate genetic diseases and alter physical traits. The technique offers promising prospects in terms of preventing previously untreatable diseases and even enhancement of human abilities, for instance better eyesight, but it also provokes safety concerns en ethical questions. Most notably the fact that genetic changes of this kind are irreversible, meaning they will be inherited by the next generations. Furthermore, aside from off-target effects and unknown long-term consequences, potential misuse of the technology could potentially be fatal.
The progress in the field of genome editing has been formidable in recent years, yet the public debate en political framework seem to be lagging behind. Recent developments in China have revealed major discrepancies in national and international legislation which are often unclear and outdated. In the absence of an international moratorium temporarily prohibiting further activity until more ethical and legal guidance is in place, there is genuine concern about the potential implications of unregulated research. The field of genome editing offers an array of possibilities both in terms of scientific progress and practical application. However, the disparity between the science itself and the surrounding legal and ethical framework presents a growing issue which requires immediate action.
Relevant Policy Measures and Legal Framework
Many of the security concerns and ethical dilemmas that debates on genome editing entail have been difficult to regulate within the current institutional framework or lack thereof. Despite various attempts over the past couple of years, an adequate overall legal framework has not yet been established. As views and public debate on genome editing vary both among and within countries the results have been a variation of public policies. Said policies are either permissive, unclear, outdated or prohibitory, but rarely cohesive.
Nevertheless, attempts have been made at the European level to regulate the industry and provide guidance to national governments. The Council of Europe’s Oviedo Convention is the only international legally binding instrument concerning the protection of human rights in biomedicine and its purpose is to prohibit the misuse of innovations in biomedicine. On the topic of genome editing, this has translated into a prohibition of germline genetic modification and the creation of human embryos for research purposes. In other words, the Convention only permits germline editing for the purpose of prevention, diagnosis or therapy. The framework outlined in the Convention provides the minimum common standard that parties must follow, leaving it up to states to legislate further upon ratification, as per Article 27 of the Oviedo Convention. This also means that the effective implementation of the Convention lies primarily with the States themselves. Only 35 out of 47 members of the Council of Europe have indeed signed the Convention. The implementation of these principles into national law has been limited as only 29 of the signatory countries have ratified the Convention.
While international bodies such as the World Health Organization (WHO) and the EU make recommendations and set the criteria for safe and ethical genome editing, the national governments decide whether and how to adopt the proposed regulatory frameworks. An important element in this landscape is the variation of national legislation governing embryo research among European countries. On the one side of the spectrum, some countries like Austria, Germany, Italy forbid all research using human embryos. On the other side, a limited number of countries like the United Kingdom, Belgium and Sweden allow the creation of human embryos for research purposes. This divide in national legislation illustrates how the possibility of irreversibly changing the human gene pool has brought up several ethical questions. These questions have in turn been difficult to reconcile into a common legislative and political framework, as discussed below.
Further Research and Questions
When you embark on your own research, try to focus on the key practical concerns that need to be addressed. The lack of a common legally binding framework is one of them. The fact that some countries are advancing their research with disregard for agreed-upon best practices is another. Researching action that can be taken under the current framework of the Oviedo Convention is also advised. Finally, do not forget to take into account the ethical concerns that lay the foundation for the discussion on this topic. They are, after all, what provoke the most reactions.
You are encouraged to think about the following five questions when researching the topic further:
- What kind of framework needs to be in place to avoid blurring the line between treatment and enhancement by use of genome editing?
- What can be done to address the discrepancies in national legislation?
- What could be the dangers should a common international framework not be introduced?
- What role could and should the EU take on in addressing the issue on an international level? What tools does it have at its disposal?
- What are the concerns brought forward by groups championing disability rights when it comes to genome editing and how can their unease be reconciled with the desire to research further?