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Liability and Redress on Biosafety Towards the Development of Rules at National and International Levels: 

Dr Philippe Cullet School of Law, School of Oriental and African Studies (SOAS), London & International Environmental Law Research Centre (IELRC), Geneva pcullet@ielrc.org www.ielrc.org Biosafety Forum on Liability and Redress, Kuala Lumpur, 29/8/2006 Liability and Redress on Biosafety Towards the Development of Rules at National and International Levels

Why discuss liability today?: 

Why discuss liability today? Development of genetically modified organisms (GMOs) and potential harm in national or transboundary context Adoption of the Cartagena Protocol on Biosafety, in particular Article 27 COP/MOP 1 decision to carry out mandate of Article 27 Individual countries understanding of the need for national liability regimes

Scope of biosafety legal regimes : 

Scope of biosafety legal regimes A complement to incentives provided for the development of biotechnology (for instance, patents) A part of a comprehensive biotechnology legal regime addressing environmental, health and socio-economic issues An effective biosafety regime includes: Regulation of GMO dissemination into the environment Liability/criminal sanctions in case of harm

Need for a liability regime for biosafety: 

Need for a liability regime for biosafety Aims of a liability regime: Compensation where harm takes place Prevention of harm (ensuring actors act responsibly) Implementation of precautionary principle Link with patent regime providing incentives for GMO development Patent liability

Other avenues to achieve similar aims: 

Other avenues to achieve similar aims Criminal sanctions For instance: Council of Europe Convention on the Protection of the Environment through Criminal Law, 1998 Dis/Incentives for introduction of GMOs through use of biosafety clauses in intellectual property law

National and/or international regimes?: 

National and/or international regimes? Need for the adoption of an international regime where transboundary impacts Need for the adoption of a national liability regime that Addresses domestic issues Complements the international regime Provide a framework to address problems that may arise with non-parties to the Biosafety Protocol

Need for a separate liability regime: 

Need for a separate liability regime International level State responsibility an insufficient response in case of environmental harm Existing international liability regime are sectoral – little prospect for an international liability convention National level General framework usually insufficient Existing national laws indicate that a separate regime is feasible and necessary

Existing civil liability regimes provide appropriate starting point: 

Existing civil liability regimes provide appropriate starting point States have consistently adopted a similar set of principles to address environmental harm through civil liability Biotechnology’s harm may not be clearly established yet but the central role of the precautionary principle in biotechnology regulation confirms the need to follow existing principles

Basic principles for an international liability regime: 

Basic principles for an international liability regime Strict liability Liability channeled exclusively to the person commercialising/exporting Limitations may be placed on amount and duration (with subsidiary state responsibility) Payment to prescribed limit supported by insurance

Principles (ctd): 

Principles (ctd) Different types of damages covered such as: Environment Health Socio-economic (e.g., loss of organic certification)

Domestic level: example of Switzerland: 

Domestic level: example of Switzerland Adoption of a biosafety law as part of an overall compromise on the development of biotechnology Like in most other countries, environmental law is sectoral, complemented by an umbrella Environmental Protection Act (1983) Proposal to adopt an amendment to EPA to address biosafety. Parliament made the conscious choice to adopt a separate biosafety law, for reasons including the need to adopt a separate liability regime to address specificities of biotechnology

Swiss liability regime – main features: 

Swiss liability regime – main features The ‘person subject to the notification or authorisation requirement’ is liable for damages caused Strict liability where injured party is consumer or farmer Environmental harm to be compensated Environmental damage to common lands: Local government allowed to claim damages Burden of proof simplified in favour of affected party Prescription of 30 years from time GMO marketed or occurrence of event causing damage (3 years from time party becomes aware) Compulsory insurance may be imposed by central government

The Swiss regime in perspective: 

The Swiss regime in perspective Switzerland, a small country surrounded by several other countries, yet adopting a national comprehensive biosafety law Switzerland, a country hosting some of the major MNCs interested in the development of biotechnology as well as a strong organic farming constituency and anti-GMO lobby groups The gene technology act shows that a balanced legal regime including a strict liability regime is possible in all countries

Conclusions: 

Conclusions A liability and redress regime is a necessary part of a balanced biosafety legal regime The adoption of a liability does not imply that harm will occur but provides incentives to ensure all actors act responsibly A binding liability regime needs to be adopted at both the national and international levels The adoption of an national regime does not need to be linked to the adoption of an international regime