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Legal consideration of new technologies always faces the challenge that the law can only react with a time lag. When scientists work on new methods and processes, politicians must first become aware of this work and then conclude that there is a need for legal action. As a rule, it is then examined whether: the existing laws are sufficient to regulate the new technology in question, the existing law needs to be amended or a completely new framework needs to be developed. The relevant processes are therefore politically driven, predetermined by certain procedural rules and complicated by the fact that the relevant laws must strike a fair balance between the rights and interests of a wide range of stakeholders. All of this means that legislative procedures at national and European level regularly take years and sometimes even decades.

Regarding genome editing, the situation is further complicated by the fact that "gene scissors" such as CRISPR/Cas9 and comparable methods can be used in both the plant sector (the so-called "green" sector) and the human medical sector (the so-called "red" sector). However, completely different legal requirements apply to both areas. This is not only because of the fields of application but also because the legal interests protected in each case differ considerably. The European Court of Justice has established that genome editing and all other so-called new gene technologies (NGTs) are subject to the applicable gene technology law of the European Union. This means that the precautionary principle in Article 191 of the Treaty on the Functioning of the European Union (TFEU) must be observed and the Deliberate Release Directive 2001/18/EC and the Contained Use Directive 2009/41/EC must be applied. However, current deregulation efforts are facing concerns because the European Court of Justice has recently pointed out the considerable risks of NGTs in the aforementioned decisions and has formulated further strict limits that the legislator must not violate. 

In the "red" sector, the European Union's pharmaceutical law is particularly relevant. One example is regulation (EC) No. 1394/2007, which lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products. In addition, certain fundamental human rights are more important in the "red" sector than in the "green" sector. This is because genome editing in humans not only potentially shifts the boundaries between medically indicated therapy and non-medically indicated enhancement, but also raises previously unanswered questions. For example, it raises unanswered questions in relation to “designer babies” or, more fundamentally, germline interventions (i.e. where DNA is inserted into the reproductive cells). In particular, the rights laid down in the Charter of Fundamental Rights of the EU and the European Charter of Human Rights of the Council of Europe play a central role in clarifying these issues. 

In contrast to the "green" sector, the protection of genetic data in accordance with the General Data Protection Regulation 2016/679/EU (GDPR) plays an important role in the "red" sector. However, as health data protection is currently to be reorganised by the so-called European Health Data Space, new considerations and legal assessments are also constantly required.

The legal framework for genome editing is therefore extremely complex, multi-faceted and, above all, never entirely rigid. To sum up, there are three reasons for this: the framework overlaps with other regulatory areas, the case law of the courts, and, last but not least, legal policy activities mean that the legal framework must always be kept up to date.

Author:

Prof. Tade Spranger, University of Bonn