Liability and Redress:Overview and General

CommentsAsia Regional Workshop

on theCartagena Protocol on Biosafety

September 7-8, 2010Daewoo Hotel, Hanoi, Vietnam

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.”

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

Comparing Attributes

Administrative Civil

◦ 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

Comparing Attributes

Administrative Civil

◦ 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

Comparing Attributes

Administrative Civil

◦ 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”

Comparing Attributes

Administrative Civil

◦ 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

Comparing Attributes

Administrative Civil

◦ 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

Comparing Attributes

Administrative Civil

◦ 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

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

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

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.edu1-405-325-4784 (ph); 1-405-325-0389

(fax)I will be glad to answer questions from

conference participants.

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)

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)