Concept and Principles of Genetic Product Liability
Die Genetic Product Liability (Liability for Genetically Modified Products) refers to the legal responsibility for damages that may arise from the use or dissemination of genetically modified organisms (GMOs) and products derived from them. It represents a specific area of product liability characterized by the particular risks and uncertainties of genetic engineering. The regulations on genetic product liability aim to comprehensively consider both consumer interests and environmental protection, while also regulating innovation in the field of biotechnology.
Legal Basis of Genetic Product Liability
Product Liability Act (ProdHaftG)
The German Product Liability Act (ProdHaftG) forms the central statutory basis for claims for damages resulting from defective products, including genetically modified products. According to § 1 ProdHaftG, the manufacturer is liable without fault (‘strict liability’) for personal injury and property damage caused by a defective product. Liability also extends to intermediate products, such as genetically modified plants or microorganisms, if they enter the economic cycle.
Genetic Engineering Act (GenTG)
The Genetic Engineering Act (GenTG) contains supplementary provisions for activities involving GMOs and, in addition, provides for special liability rules (§§ 32 et seq. GenTG). According to § 32 GenTG, the operator of a genetic engineering facility or a release is liable, even without fault, for damage caused by GMOs. This strict liability especially covers damage to human health, but also certain property or environmental damages.
Scope of Application of Genetic Product Liability
Genetic product liability applies in particular to the following areas:
- Agriculture: Liability for damage caused by genetically modified crops, contamination damage to adjacent agricultural areas, and the consequences of unintended spread.
- Food Production: Liability for health damage caused by the consumption of foods containing genetically modified ingredients.
- Environmental Damage: Liability for impairment of ecosystems due to the release of GMOs into the environment.
Requirements for Genetic Product Liability
Defectiveness of the Product
Liability requires that the product had a defect at the time it was placed on the market. Such a defect may exist in the design, manufacture, or in insufficient information/instructions. In the case of GMOs, unknown or long-term consequences of genetic modifications must particularly be considered.
Causal Connection
There must be a causal link between the GMO product used and the damage that occurred. The burden of proof generally lies with the injured party. However, the Genetic Engineering Act provides for a reversal of the burden of proof (§ 33 GenTG) in certain cases in favor of the injured party.
Damage
There must be measurable damage to persons, property, or the environment. Pure financial losses are not covered by the Product Liability Act, though economic losses resulting from property or personal injury are included.
Scope and Upper Limits of Liability
Liability under the Product Liability Act is limited to certain maximum amounts (§ 10 ProdHaftG), for example, 85 million euros for personal injuries. The GenTG provides its own upper limits of liability, which are particularly relevant in cases of environmental damage.
Special Features of Liability in Genetic Engineering
Strict Liability
A characteristic of genetic product liability is generally the strict (non-fault based) liability. This accounts for the fact that the risks and damages associated with genetic products are difficult to foresee and may only become apparent after a considerable period.
Reversal of the Burden of Proof
In cases of the release of GMOs into the environment, the Genetic Engineering Act provides for a reversal of the burden of proof: If, for example, a GMO is released in agriculture and this results in damage, it is presumed that the damage was caused by the GMO, unless other causes are proven.
Insurance Requirement
The Genetic Engineering Act mandates insurance for certain operators to ensure that potential claims for damages can be met (§ 37 GenTG).
International Aspects and European Law
EU Genetic Engineering Law
Liability for GMOs is not fully harmonized within the European Union. The Product Liability Directive 85/374/EEC regulates strict liability for defective products and forms the basis for national product liability law of the Member States, including Germany.
Cartagena Protocol
At the international level, the Cartagena Protocol on Biosafety establishes a framework for the transboundary handling of living GMOs. Liability issues, however, are partly left to national legal systems.
Distinction from General Product Liability
While general product liability covers all defective products, genetic product liability applies exclusively to damages resulting from genetically modified organisms or their derivative products. It is characterized by particular hazard potentials and higher liability requirements, as the risks of genetically modified products are often difficult to assess and may extend to third parties or the environment.
Discussion and Case Law
Judicial decisions on genetic product liability often concern the scope of liability in cases of cross-border contamination, the burden of proof in rare damage scenarios, and the attribution of damage in complex productions. Special focus is placed on cases where the risks of genetic modifications cannot be conclusively assessed from a scientific perspective.
Literature and Further Information
Further information on genetic product liability can be found, among others, in commentaries on the Product Liability Act and the Genetic Engineering Act as well as in relevant legal publications on environmental and liability law.
See also:
- Product Liability
- Genetic Engineering Act
- Environmental Liability
- EU Product Liability Directive
- Cartagena Protocol on Biosafety
Frequently Asked Questions
In which cases does genetic product liability apply under German law?
Genetic product liability applies under German law when a genetically modified product causes damage to third-party legal interests and this damage can specifically be attributed to the particular characteristics or risks of the genetic modification. In principle, liability is independent of the manufacturer’s fault (strict liability). The most relevant legal frameworks are the Genetic Engineering Act (GenTG) as well as, in some cases, the Product Liability Act (ProdHaftG). Liability may include property damage—such as damage to other agricultural products—or also financial damage such as crop loss, as well as, under certain conditions, personal injury. A prerequisite for a claim for damages is that the causal link between the genetically modified product and the damage can be proven. In complex cases of proof, the GenTG provides for facilitated burdens of proof in favor of the injured party.
Who is liable under German law for damages caused by a genetic product?
Primarily liable is the operator of the genetic engineering facility who releases or places the genetic product on the market, and in some cases also the manufacturer of the genetic product. According to § 32 GenTG, the holder of the authorization for release or market placement is a principal liable party. If a damaging event is repeated, depending on the circumstances, other persons, such as distributors or refiners of genetically modified products, may also be held liable if they are independently involved in the release. Several liable parties are jointly and severally liable. The special liability provision of the GenTG takes precedence over product liability claims where they concern the same damage.
To what extent is the compensation obligation limited within the scope of genetic product liability?
The compensation obligation under the Genetic Engineering Act is limited in amount: for property and financial damages, there is a statutory limitation of the liability amount to 85 million euros per incident (§ 33 para. 3 GenTG). This cap does not apply to personal injury, such as health damage or fatalities, although here as well restrictions under the ProdHaftG may apply (§ 10 para. 1 ProdHaftG sets approximately 85 million euros for personal injury per event, but varies depending on the injured party). The compensation obligation is also excluded if the damage was caused by force majeure, especially natural disasters.
What requirements apply to the proof of causal connection?
As a rule, the injured party bears the burden of proof for the origin and causality between the genetic product and the damage sustained. However, the Genetic Engineering Act provides for an easing of the burden of proof: If the damage occurs to a protected legal interest and in an area where genetically modified organisms have been released, it can be presumed that the genetic product was the cause, provided no other plausible causes can be considered. The operator may exonerate himself by proving that the damage was in all likelihood caused by another source.
Are there insurance requirements for operators or manufacturers of genetic products?
Yes, the Genetic Engineering Act obliges operators of genetic engineering facilities or those placing genetic products on the market to take out liability insurance (§ 34 GenTG). The insurance must adequately cover the potential liability risks arising from the particular dangers associated with handling genetically modified organisms. Without proof of such insurance, neither the release nor the market placement is permitted. The scope of insurance must cover the maximum compensation obligation under the statutory liability caps.
What special duties of care exist for manufacturers and distributors of genetic products?
In addition to liability, manufacturers and distributors of genetic products have extensive monitoring and due diligence obligations. These include, among others, ongoing monitoring of products after their release or market placement, taking measures when new risks become known, documentation and reporting obligations to authorities, and extensive obligations to inform potentially affected parties. Breach of these obligations can lead to fault-based liability or shift the burden of proof in favor of the injured party.
How long do liability claims exist in connection with genetic products?
The statute of limitations for liability claims in connection with genetic products is governed by the special rules of product liability law and the Civil Code (BGB). In principle, claims for damages expire within three years from knowledge of the damage and the liable party (§ 195 BGB). In addition, there are ultimate limitation periods (‘cut-off periods’) of ten years from the date the product was placed on the market, as regulated in § 13 ProdHaftG. In the case of irreversible damage developments, where the connection to genetic products only becomes apparent late, extended limitation periods may apply, provided special statutory provisions so require.
