Biotechnology ranges from traditional genetic engineering to the development of personalized medicine and synthetic biology, which modifies biological systems using a modular principle. Thanks to CRISPR-Cas9, DNA can be edited in a targeted manner, while biotechnological processes are increasingly being used in industrial production – whether for the manufacture of medicines, artificial organisms or even drugs. But where innovations sprout, there are also legal and ethical pitfalls.
Biotechnology not only opens up unimagined medical and economic opportunities, but also harbors considerable risks, particularly in the area of crime. I summarize this new dimension of criminally relevant offences under the keyword “BiotechCrime “.
Biotechnology as a new playing field for crime
Traditionally, biotechnology has been the field of work of research laboratories and pharmaceutical companies. However, with the increasing democratization of knowledge – keyword “biohacking” – and easy access to genetic engineering, new dangers are emerging. Even today, genetic material that can be used to produce biological substances previously reserved for high-security laboratories can be obtained with a simple online order. While cybercrime has long been an established threat, a new category of crime is now emerging: crimes that result directly from the use of biotechnological methods.
Biotechnology and criminal law: current and foreseeable challenges
Biotechnology leads to criminally relevant issues in various areas. I have selected a few specific future scenarios and will then look at the combination of cybercrime and biotechnology.
1. production of illegal substances through synthetic biology
One example of biotech crime is the genetic production of anaesthetics. Scientists have already shown that modified yeast cells can synthesize morphine or other opiates from simple sugars. While pharmaceutical research is aiming to produce drugs in a safe and controlled manner in this way, there is a risk that criminals will also use this technology. If synthetic drugs can be produced in home laboratories using simple means, this could undermine existing drug laws and drastically increase the availability of illegal substances.
2. (Privates) Biohacking
Do-it-yourself biology has long been a reality. Biohackers are experimenting with the genetics of microorganisms and plants in private laboratories. The focus will initially be on the construction kits, the genetic engineering kits: Depending on the specific“DIY kit“, genetic engineering law may apply. This is always the case if the “DIY kit” contains genetically modified organisms (GMOs) or if GMOs are produced with it. According to Section 8 (1) sentence 1 of the Genetic Engineering Act (GenTG), such genetic engineering work may only be carried out in genetic engineering facilities, i.e. in suitable, officially supervised laboratories under the supervision of a competent project manager. Anyone who orders DIY kits and uses them outside of genetic engineering facilities risks a fine of up to fifty thousand euros in accordance with Section 38 (1) No. 2 GenTG. If GMOs are released when the DIY kits are used, there is even a risk of imprisonment for up to three years or a fine under Section 39 (2) No. 1 GenTG. The German authorities have been warning about this for years, so the issue is on their radar!
While much of this work is ultimately harmless – such as examining one’s own DNA or cultivating fluorescent bacteria – the question arises as to what happens when someone modifies dangerous pathogens. Theoretically, a highly dangerous pathogen such as an engineered influenza virus could be cultivated with well-equipped home laboratory equipment and the appropriate knowledge. While chemical weapons and explosives are already comprehensively regulated, biological warfare poses a threat that is difficult to control.
3. import of DIY kits
The import of DIY kits is a separate problem: It has long been possible to order genetic engineering kits from abroad on the internet that already contain genetically modified organisms (GMOs) that are not approved for marketing. Some of these genetic engineering kits are part of online courses on the subject of “biohacking”. Anyone who orders such kits and does not carry out legally permitted genetic engineering work in an officially supervised laboratory is committing an administrative offense:
By placing an order, the GMOs contained in the corresponding genetic engineering kits are placed on the market as soon as they enter Germany. This already constitutes an administrative offense according to § 38 para. 1 no. 7 GenTG. Such shipments can therefore be confiscated by customs. In addition, a fine of up to fifty thousand euros may be imposed.
4. data protection and genetic identity
The digitalization of biotechnology is accompanied by a massive collection of genetic data. Companies such as 23andMe or AncestryDNA analyze the genetic material of their customers – often combined with the possibility of revealing genetic relationships. But what happens when such data falls into the wrong hands? The case of the data leak at 23andMe, in which genetic information of thousands of people was accessed, shows the dangers. Identity theft takes on a new dimension when not only personal but also genetic identities can be misused.
unauthorized interventions in the human germ line5. unauthorized interventions in the human germ line
The possibility of using CRISPR technology to modify genes brings with it ethical and legal challenges. While interventions in the human germline are strictly prohibited in most countries, one case has already been reported in China in which embryos were genetically manipulated. Such cases raise the question of how illegal genetic modifications can be proven and punished under criminal law. The boundaries between medical progress and punishable genetic manipulation are blurred and pose completely new challenges for lawyers.
Biotechnology and cybercrime: complex requirements
An interdisciplinary and cross-sector strategy is required for the early detection and prevention of biotech crime. Particular attention should be paid to the link between biotechnology and cybercrime, as the two areas of biotechnology and information technology are increasingly merging. This is because modern laboratories and biotechnological infrastructures are increasingly digitalized in the sense of being networked – and therefore more susceptible to cyber attacks. The focus is particularly on medical devices and hospitals, research databases, DNA synthesis and automated laboratory processes that are vulnerable to attack through digital control. In addition to these classic scenarios, the risk of digital platforms being misused to develop and distribute dangerous biological constructs must also be taken into account. In particular, instructions for the production of dangerous organisms can be distributed or hacked directly as DNA code and sent to synthesis laboratories, as we already know from 3D printing.
- Misuse of cyber infrastructure in biotechnology: Attacks on medical devices, hospitals and company databases can be identified as particularly relevant future crimes. The potential for blackmailing people by hacking implants such as pacemakers must be of acute concern.
- Different perspectives on biotechnology misuse: The field of vision must not be narrowed down to the classic threat scenarios such as state-directed misuse or industrial espionage – in fact, there is a wider range of possible scenarios for which one cannot afford to wait for them to even exist from a regulatory perspective.
- Need for preventive measures: Increased public education on biotechnology safety and targeted financial support for safety measures is absolutely essential.
- Synthesis of biological weapons or illegal substances: With the increasing spread of CRISPR-Cas9 and other genetic engineering methods, the risk of biotechnologies being used for criminal purposes is growing. Cyber capabilities provide decentralized attack structures for terrorist organizations that only distribute instructions and blueprints for the creation of dangerous substances to local cells.
Criminal law orientation around biotechnology
So far, criminal law has only dealt with biotechnology on a selective basis. Traditional laws such as the Narcotics Act (BtMG) or the War Weapons Control Act (KWKG) cover some aspects of biotech crime, but developments in synthetic biology require new regulations.
The focus is currently on genetic engineering and stem cell research, which are caught between scientific progress and regulatory limits. In Germany, the Genetic Engineering Act (GenTG) and the Stem Cell Act (StZG) regulate the framework conditions for dealing with these technologies. Both laws contain consequences under criminal law and fines for violations of the statutory provisions in order to contain risks to people, the environment and fundamental ethical values.
The aim of the Genetic Engineering Act is to protect life, health and the environment from the potential dangers of genetic engineering processes. It sets out clear requirements for safety measures, particularly for genetic engineering work in laboratories and for the release of genetically modified organisms. Anyone who carries out genetic engineering work or places genetically modified organisms on the market without the required authorization may be liable to prosecution. Particularly serious violations, for example if considerable damage is caused through negligence or intent, can be punished with a prison sentence. Data protection also plays a role: information about genetic engineering processes or facilities is subject to special confidentiality obligations, and failure to comply with these is also sanctioned. At the same time, the law provides for extensive provisions on fines in order to punish violations without direct criminal consequences and thus achieve a preventive effect.
In addition to genetic engineering, stem cell research also raises sensitive issues that go far beyond technical progress. The Stem Cell Act generally prohibits the import and use of embryonic stem cells, but makes exceptions for research purposes possible under strict conditions. One of the prerequisites for approval is that the stem cells used were not created specifically for research, but come from surplus embryos that were no longer needed as part of artificial insemination. In addition, their derivation must not have violated fundamental principles of the German legal system. Violations of the Stem Cell Act can be punished with severe penalties. Violations of the Embryo Protection Act, which is also relevant in the context of stem cell research and criminalizes, among other things, the deliberate creation of embryos for research purposes, are particularly serious.
The Trade Secrets Protection Act also plays a role in the illegal use of biotechnological innovations – for example, if stolen research or research data is used for illegal purposes. Questions of responsibility and liability in biotechnology remain unanswered. Who is liable if a genetic manipulation has unexpected side effects? Is the biohacker who experiments with CRISPR in his laboratory responsible for unintended mutations? Such questions require new legal considerations.
Society is faced with a crucial question: how can we enable innovation in biotechnology without opening the door wide to crime and abuse? At the same time, researchers, whether in science or industry, must be aware of the criminal law risks associated with this work. Compliance alone will not help, even if good compliance structures are essential.
Conclusion: “Biotechnology criminal law”?
Biotechnology is developing rapidly – faster than criminal law can keep up. While traditional criminal offenses such as drug trafficking, data misuse or terrorism can also cover biotechnological offenses, there is often a lack of specific regulations for new offenses. Technological progress raises the question of whether we need our own “biotechnology criminal law” that takes into account the special risks of this science.
Our law firm specialises in criminal defence, white-collar crime and IT law / technology law. Note our activity in digital evidence in IT security and software law.