1. Liability and Redress: Overview and General Comments Asia Regional Workshop on the Cartagena Protocol on Biosafety September 7-8, 2010 Daewoo Hotel, Hanoi, Vietnam

2. Definitions & Distinctions Liability – legal responsibility for harm Redress – the remedy or relief to address the harm Three Separate and Distinct Spheres ◦Patents  Not part of the Cartagena Protocol on Biosafety ◦Regulation  Main focus of the Cartagena Protocol  Biosafety laws ◦Liability and Redress  Article 27: “The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing process in international law on these matters, and shall endeavour to complete this process within four years.”

3. Liability Regimes Three types of liability regimes ◦The Article 27 charge: “ … adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress …” ◦Administrative liability ◦Civil liability ◦Criminal (Penal) Liability  Not seriously discussed in Article 27 negotiations  Article 25 – Illegal Transboundary Movements  Fines, Imprisonment, Punishment ◦No liability regime option under Article 27

4. Comparing Attributes AdministrativeCivil ◦Public harms ◦Governmental response to protect the public interest ◦An administrative system ◦Private harms ◦Personal response to protect a private interest ◦A judicial system  Domestic law  Common law (Case law) systems  Civil law (Code) systems

5. Comparing Attributes AdministrativeCivil ◦What are the harms?  Environmental damage  Social Structure Damage ◦ Health ◦ Welfare  Recall that biotechnology products will already have regulatory approval ◦ Presence alone cannot count as public harm – authorized products ◦ Unanticipated harms ◦What are the harms?  Personal injury  Personal Property Damage  Personal Economic Damage  Personal Values Damage ◦ Aesthetic ◦ Religious/Moral ◦ Cultural ◦Personal, Property & Economic damages are usually labeled “traditional damages” ◦Coexistence

6. Comparing Attributes AdministrativeCivil ◦Who can bring a claim for harms? (Standing)  Competent Administrative Agencies  Public Participation ◦ Requests for action ◦ Citizen initiated claims ◦Who can bring a claim for harms? (Standing)  Person(s) personally suffering the harm  Persons or groups asserting a claim in the “public interest”

7. Comparing Attributes AdministrativeCivil ◦Who is potentially responsible?  Developer  Permit Holder  Exporter/Importer  User  State of Origin (State responsibility)  Joint and Several Liability ◦Who is potentially responsible?  Same alternatives (policy choices) as administrative system

8. Comparing Attributes AdministrativeCivil ◦On what basis is a particular party responsible?  Causation ◦ But for causation ◦ Direct (proximate) causation ◦ Burdens of Proof  Who  What degree ◦ Presumptions  Standard of Liability ◦ Strict liability ◦On what basis is a particular party responsible?  Causation – same alternatives (policy choices) as administrative system  Standard of Liability ◦ Intentional Harm ◦ Fault based – negligence or failure to abide by expected standards ◦ Strict liability – without regard to fault – ultrahazardous activities

9. Comparing Attributes AdministrativeCivil ◦What is the appropriate redress (remedy)?  Restoration (recall, removal)  Remediation (mitigation)  Replacement (comparable functions and services)  State action; Responsible Party action  Compensation may be an alternative, secondary redress. ◦Financial Security  Responsible Party Assets  Insurance  Compensation Funds  Bonds ◦What is the appropriate redress (remedy)?  Monetary damages ◦ Compensation to the injured private party is the primary goal.  Injunctions  Costs ◦Financial Security  Same alternatives (policy choices) as administrative system

10. Comparing Attributes Administrative ◦Defenses  Beyond control of the responsible party – excused reasons  Authorized actions -- justified reasons ◦Time Limitations  Absolute – so many years from approval  Incident-related – so many years from actual or implied knowledge by the claiming party Civil ◦Defenses  Same alternatives (policy choices) as the administrative system; and plus  State of the art  Reasonable care ◦Time Limitations  Same alternatives (policy choices) as the administrative system

11. Final Comments International Rules and Procedures ◦Binding international law  Adoption  International courts ◦ Domestic courts and administrative agencies ◦Why a unique international legal regime?  Exemplary record of agricultural biotechnology  Regulatory approval Domestic Law ◦Domestic laws and procedures ◦Domestic laws and procedures as presently adequate  New Zealand Royal Commission Report 2001 ◦Guidelines for domestic laws and procedures

12. Thank You Drew L. Kershen, Earl Sneed Centennial Professor of Law, University of Oklahoma, College of Law, Norman, OK 73019-5081 U.S.A. dkershen@ou.edu 1-405-325-4784 (ph); 1-405-325-0389 (fax) I will be glad to answer questions from conference participants.

13. References Article Stuart J. Smyth and Drew L. Kershen (2006) “Agricultural Biotechnology: Legal Liability Regimes from Comparative and International Perspectives,” GLOBAL JURIST ADVANCES, Vol. 6, No. 2, Article 3 http://www.bepress.com/gj/advances/vol6/iss2/art3/ (opens in a new window)http://www.bepress.com/gj/advances/vol6/iss2/art3/ (opens in a new window) Working Paper Kershen, Three Separate and Distinct Spheres: Patents, Regulation and Liability (Conference Paper 2009-2010), http://jay.law.ou.edu/faculty/kershen/articles/three spheres.pdf (pdf, opens in a new window) Book Stuart Smyth, A. Bryan Endres, Thomas Redick & Drew Kershen, INNOVATION AND LIABILITY in BIOTECHNOLOGY: Transnational and Comparative Perspectives 224 pp. (Edward Elgar Publishing, March 2010)