ENVI II

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Committee on Environment, Health and Food Safety II (ENVI II)

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?

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Eva Thorshaug (NO)

Topic at a Glance

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Hi all! My name is Eva, I’m the Chairperson of the Committee on Environment, Health and Food Safety II and together we will be discussing a topic that has sparked controversy from its very apparition – human genome editing. Genome editing gives scientists the ability to change an organism’s DNA and allow genetic material to be added, removed, or altered at particular locations in the genome, making it possible to treat genetic diseases. This has raised a number of questions such as whether it is ethical to use the technology to irreversibly change the human gene pool irreversibly as well as concerns about the potential misuse. In the absence of an international moratorium or a comprehensive, international convention covering the issue, states have been left to regulate research and application mostly for themselves. But as researchers in some countries such as China are now taking great strides in editing DNAs – far beyond what the World Health Organization (WHO) has advised – the need for European countries to take a stand on this topic has become clear. Should research on human embryos be allowed? If so, what legal frameworks need to be in place internationally? These, and more, are all questions we will address and where you, through the European Youth Parliament, will be able to voice your opinion

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.

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Context

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.

Topic Analysis

Individual

The greatest effect of research on and potential application of germline modification is felt on the individual level by improved health and living conditions. Most significantly, corrections of genetic mutations in early embryos could prevent hereditary diseases such as Huntington’s disease, painful heart conditions and even treat eye disease to name a few. Recent developments also show that germline modification could eventually enable better adjustment of humans to the environment such as prevention of allergies and enhancement of human capabilities, for example better eyesight. 

Despite the medical opportunities that genome modification offers, there are still concerns regarding the irreversible nature of genome editing and the greater societal impacts it could have. It is feared that once germline editing is fully developed, the blurred line between treatment and enhancement would make it hard to identify and prevent unacceptable uses of the technology. As such, concerns are that germline modification could fundamentally change society, bringing about old practices of eugenics and changing societal views of diversity and disabilities.

National

Since individual countries have their own policies regarding research and potential clinical applications, there is quite the discrepancy between Member States when it comes to legislation and public opinion. Research on embryos is allowed in 15 Member States, forbidden in 4 and undefined in 8. With regards to potential clinical applications, many countries have banned or restricted germline modification while in others the legal situation remains ambiguous. National governments also differ in their approaches to a possible solution. Some countries, such as France, are pushing for a re-evaluation of the existing ban and the restrictive policies arguing that freedom from regulation is necessary in order to pursue research and explore therapeutic applications. Similar calls have also been made in Germany. Others, such as the Netherlands and Luxembourg, have not signed or ratified the Oviedo Convention in part because of the limits it puts on embryo research.

https://www.researchgate.net/publication/338854778_Editing_Human_DNA_Moral_and_social_implications_of_germline_genetic_modification (page 40)

European

Through the 2014 Clinical Trials Regulation, the EU has restricted the research on germline modification. The regulation states that “no gene therapy trials may be carried out, which result in modifications to the subject‘s germline genetic identity”. However, opposition to the restrictive nature of the Oviedo Convention and EU Clinical Trials Regulation in general has gained traction in the European scientific community in past years. Scientists are claiming that the ban on germline editing is outdated and overly restrictive, arguing that it will hamper promising research for germline gene therapy. Those in favour argue that the risk of loosening European legislation is simply too big, potentially stigmatizing humans and allowing for a eugenic expansion of definitions of healthy, disease, and disability.

International

Internationally, the debate ranges from policy proposals such as an international ban on heritable genome editing to more laissez-faire attitudes. Members of the scientific community have spoken in favour of an international moratorium which was eventually proposed at the International Summit on Human Gene Editing in 2015. Such an effort would entail a temporary postponement on clinical use of germline modification until relevant safety and ethical issues are resolved as well as a broad societal consensus about the appropriateness of application is reached. The conclusion from that very same summit was also that safety and ethical issues need to be resolved first and that a broader, more participatory public debate is deeply needed.

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?