Draft Rules and Regulationsof theBiodiversity Act of Bhutan, 2003
Presented by
Ugyen Tshewang, Program Director
The National Biodiversity Centre
Ministry of Agriculture
Royal Government of Bhutan

Presentation Overview
Overview of Bhutan’s Biodiversity Act,
2003
 Status of development of Bhutan’s
Biodiversity Rules & Regulations
 Clarification of issues & concerns Implementation considerations
 Next stepsWhy did Bhutan pass the
Biodiversity Act, 2003 ???
Bhutan is a biological ‘hot spot’ & has a hugebase of Traditional Knowledge
 Many research firms have expressed interest in
bioprospecting in Bhutan There is a need to protect against exploitation
while also gaining shared benefits by allowing
regulated access Bhutan is a party to the CBD & hopes to becomea member of WTO (which requires countries tohave their own laws on biodiversity & plantvariety protection)
Summary of Bhutan’s
Biodiversity Act, 2003
Bhutan’s Biodiversity Act approved by the
National Assembly in August 2003
 Specific authorization to adopt
implementing Rules & Regulations
approved by the National Assembly in July
2004
 Draft Rules & Regulations now underdevelopment & review
Biodiversity Act in a Nutshell:Six Chapters
Ch. 1: Purposes, Objectives, Scope Ch. 2: Biodiversity Access & Benefit Sharing
 Ch. 3: Plant Variety Protection
 Ch. 4: Protection of Traditional Knowledge
 Ch. 5: Offences & Penalties
 Ch. 6: Amendments, Interpretation, Definitions
Purposes & Objectives
Ensure nat’l sovereignty of RGOB
over genetic resources existing in
Bhutan consistent with CBD
 Ensure the conservation, sustainable
use, and equitable sharing of
benefits derived from Bhutan’s
genetic resources and associatedTraditional KnowledgePurposes & Objectives cont’d
Promote tech transfer and scientificcapacity building at nat’l & local
levels in Bhutan relating to theconservation & sustainable use ofgenetic resources Recognize & protect uses of
Traditional Knowledge associatedwith biodiversityPurposes & Objectives cont’dRegulate & facilitate legal access togenetic resources existing in Bhutan Prohibit & penalize illegal taking &use of genetic resources & related
Traditional Knowledge existing in
BhutanPurposes & Objectives cont’d
Recognize & protect farmers’ & plant
breeders’ rights
 Protect plant varieties & promote
Bhutan’s access to foreign sources ofimproved plant varieties
Biodiversity Act, 2003:
Some points to keep in mind . . .
The biodiversity law is cross-cutting• Environmental considerations• Cultural & scientific considerations• Property rights considerations• Economic considerations• Trade & investment considerations

No ‘cook-book’ answers . . .
 Buts sets course of action to follow
Biodiversity
Rules & Regulations
Organized according to Biodiversity Act Four main substantive sections
• Introduction• Access & Benefit-Sharing• Plant Variety Protection• Traditional KnowledgeAppendix (forms to implement Rules)

Biodiversity
Rules & Regulations:Introduction
Preliminary• National Scope• Effective Date (???)
 Definitions• Incorporated from Biodiversity Act• More incorporated from CBD• Some new: “Commercial Use”


Biodiversity
Rules & Regulations:Introduction cont’d
Official Procedures / Notifications• Discretionary authority of Ministry of Agriculture Forms & Annexes• Discretionary authority of Ministry of Agriculture(“necessary or appropriate”)
 Applications, Permits & Certificates• Authorizations granted to ‘Authorized Agency’• ‘Authorized Agency’ to be designated by MOA
Review of Issues on
Access&Benefit-Sharing

Biodiversity Act, 2003:
Access & Benefit-Sharing
Access to Bhutan’s biodiversity now
requires ‘Prior Informed Consent’(PIC) ‘PIC’ obtained & access authorizedthrough Access Permit Applicants must submit an Access
Permit Application to the RGOB
consistent with the lawBiodiversity Act, 2003:
Access & Benefit-Sharing
RGOB (‘Authorized Agency’ to be
determined by the Agriculture Ministry) Permit application requirements &access conditions specified by the law
 Benefit-sharing required as a conditionof access (case-by-case basis) 30-day decision in writing on permit
application (approval, revision, denial)Rules & Regulations:
Access & Benefit Sharing
Biological specimen collection prohibited w/opermit issued in compliance with Rules
 Access Permit required to• “Obtain” / “Collect” / “Utilize” / “Export” . . .
• “Genetic or Biochemical Resources” . . .
• “Existing in Bhutan” for . . .
• “Conservation” / “Research” /Bioprospecting” / “Commercial” Uses

But, note ‘exceptions’ !!!

Rules & Regulations:
Access & Benefit SharingPermit Application = “Prior Informed Consent”• Applicant’s info (name, address, legal status, roles)• Applicant’s tech & financial capabilities• Applicant’s prior biospecimen collection experience• Description of biospecimens to be collected• Research purposes / objectives• Potential uses of research results• Compliance acknowledgement / agreement• Other info required by RGOBRules & Regulations:
Access & Benefit Sharing

‘Access Permit Application’ Formalities• Language (Dzongkha or English)• Legibly written / typed / printed• Signed by applicant(s)• Signature(s) constitute certification of legal
compliance• Fees to be paid / submitted with application

Rules & Regulations:
Access & Benefit Sharing

How will an Access Permit Application beprocessed & reviewed ???
• The ‘Competent Authority’ (Minister/MOA)
needs to designate the ‘Authorized Agency’ toprocess biodiversity Access Permit Applications
as intended by the Act• The Authorized Agency will consult with ascientific review committee to evaluate
applications


The review committee will be comprised ofrepresentatives from relevant MOA and otheragencies as appropriate

Rules & Regulations:
Access & Benefit Sharing
The Competent Authority through the
Authorized Agency may approve, require
revisions / additional information, or denyan Access Permit Application
 The Biodiversity Act requires theCompetent Authority to notify theapplicant of its decision w/in 30 days ofreceipt of the Access Permit Application
Rules & Regulations:
Access & Benefit Sharing‘Permit Approval’ conditioned on
finding of no adverse impact on• Public health / safety• Environmental / scenic / cultural values• Natural / cultural resources• Scientific research• RGOB management responsibilities• Equitable allocation / use of resources• Avoidance of conflict

Rules & Regulations:
Access & Benefit SharingPermit Denial• Based on finding of adverse impact on
ONE or more factors required for Permit
Approval• Explanation provided in writing toapplicant (upon applicant’s request)Amendments / Reconsideration• Must be in writing• Must provide all information requested
by RGOBRules & Regulations:
Access & Benefit Sharing
Benefit-Sharing
 Can be required for . . .
• Specimen collection and use (‘up-front’)• Commercial use of research results(‘downstream’)‘Unauthorized Commercial Use Prohibited’(legally binding & enforceable !!!)

Rules & Regulations:
Access & Benefit Sharing

Benefit-Sharing Options• Two Types . . .
Monetary Non-Monetary• Short-term (‘now’) / Long-term (‘later’)• Package approach (mix of monetary andnon-monetary benefit provided now andlater (all subject to negotiation!))Rules & Regulations:
Access & Benefit Sharing

Monetary Benefits• Access (‘permit’) fee / specimen collection payments• Cooperative Research Project Budget (cost-sharing)• Milestone payments (eg, IP applications / IP grants)• Royalties
Creditable annual ???
 Product-specific ???
 ‘Value-added’ ???
 ‘Know-how’ (TK) ???
• Other ???

Rules & Regulations:
Access & Benefit Sharing


Non-Monetary Benefits• Scientific information / data
• Joint IP ownership options (negotiable)• Joint R&D activities (tech transfer)• Technical training / licensing / capacity-building• In-kind transfers of equipment / material• Acknowledgement of Bhutanese origin• Other ???

Rules & Regulations:
Access & Benefit Sharing

Benefit-Sharing: Non-Compliance Penalties• Legally binding & enforceable permit condition(essential ‘trigger’ mechanism)• Sale or transfer of specimens, components,
products or research results developed from
specimens or their components is PROHIBITED
w/o approval (‘license’) from RGOB
• Non-Compliance Penalty
20% non-compliance payment (on gross revenues)
 Damages / injunctive relief
 Other (specified in Act)

Review of Issues
on theProtection of
Plant Varieties

Biodiversity Act, 2003:
Plant Variety ProtectionEstablishes legal protection forplant varieties that are• Novel• Distinct• Identifiable• Uniform• Stable

A type of ‘IP’ protection specificallyfor plant breeders only

Biodiversity Act, 2003:
Plant Variety Protection
Plant Breeders’ Rights obtained byfiling an application with the Ministryof Agriculture Any natural (‘individual’) or legal(‘corporation’ / ‘partnership’) person
may file an application
 Application requirements &procedures to be established by
Rules & Regulations
Biodiversity Act, 2003:
Plant Variety ProtectionRights protected: Requires recognizedplant breeder’s authorization for• Production or reproduction of protected
plant varieties for commercial marketing• Offering for sale, selling, or marketing• Exporting• Importing• Stocking for any of the foregoing
purposes

Biodiversity Act, 2003:
Plant Variety Protection

Exceptions guaranteed for• Farmers’ Rights
Allows small farmers to propagate seed
they have harvested on their own land
 Exchange seed with other farmers on
non-commercial basis
• Breeders’ Exemptions
Allows breeders to conduct research
activities for purposes of breeding new(‘not-essentially-derived’) varieties

Biodiversity Act, 2003:
Plant Variety ProtectionPlant Breeders’ Rights guaranteedfor• 20 years from date of grant of right(for most plants)• 25 years for trees & vines

Plant Breeders’ Rights can benullified & cancelled if law violated

Rules & Regulations:
Plant Variety Protection
Rules & Regulations establish theapplication procedures & guidelines required
to implement the Plant Variety Protection
provisions of the Biodiversity Act
 Includes detailed guidelines to determine
eligibility based on new varieties that are• Novel• Distinct• Identifiable• Uniform• StableRules & Regulations:
Plant Variety Protection

Detailed procedures required for• Review of applications• Challenging applications / rights• Revocation of rights

Intended to comply with UPOV standards
and practices
 Requires substantial human & institutional
capacity to implement (!)
 Next steps ???
Putting
Traditional Knowledge
in context ofBiodiversity Act / Rules & Regs

Biodiversity Act, 2003:
Traditional Knowledge
Biodiversity Act recognizes & establishes
enforceable legal rights in TK associatedwith biodiversity in Bhutan Procedures for Protection of TK• ‘Prior Informed Consent’• Two-step application processDocumentation• Authorization for TK Inventory /Documentation Activities

Biodiversity Act, 2003:
Traditional Knowledge
Biodiversity Act defines TK as “knowledge,
innovation and practices of local
communities relating to the use, properties,
values and processes of any biological andgenetic resources or any part thereof”
 Biodiversity Act applies to TK in Bhutan• Existing before the Act• Created after the ActTK in material form (‘tangible expression’)
not required

Biodiversity Act, 2003:
Traditional Knowledge
Continued “customary use” of TK by “local
communities” not affected by TK provisionsof the Biodiversity Act
 “Customary Use” and “Local Communities”
not defined by Biodiversity Act
 Biodiversity Act provides that “Owners” of TK
are the “Rights Holders”
 But, the term “Owners” is not defined !
Biodiversity Act, 2003:
Traditional Knowledge
Access-applicant must obtain PIC of TK
rights holders (‘owners’) for use of TK for
any non-customary use
 PIC accomplished through an “application”
to be defined by the Rules & Regulations
 If access application accepted, a ‘user
agreement’ must be negotiated & approved• Protects rights of TK owners• Authorizes access & defined use of TK

Biodiversity Act, 2003:
Traditional Knowledge
Biodiversity Act authorizes the ‘Authorized
Agency’ to conduct TK “inventory” and“documentation” activities in collaboration
with TK owners
 Procedures for TK documentation notdefined (but limited to TK “relating to theuse, properties, values and processes ofany biological and genetic resources or any
part thereof”)
 ‘Access’ to documented TK to be defined in
Rules & Regulations
Rules & Regulations:
Traditional Knowledge

Establishes two-step procedure toaccess Traditional Knowledge (TK)
for any non-customary use• Requires ‘application’ that must be
accepted by relevant TK owners• If ‘application’ accepted, requires
additional negotiation of written
authorized user agreement (must be
approved by TK owners and Ministry ofAgriculture)

Rules & Regulations:
Traditional Knowledge
Application contents and requirements
specified in Rules
 Required information submitted onstandardized TK application form (similar
to ABS Permit Application)
 Application form first submitted to
Authorized Agency to verify identity of
relevant TK owners before being
submitted to relevant TK owners forconsideration
Rules & Regulations:
Traditional Knowledge

TK owners have option to• Reject PIC application (“right to say ‘No’”)• Accept application

Acceptance of application triggers
negotiation for “written user agreement”
with appropriate benefit-sharing terms
and conditions
 Competent Authority may provide advice
during review of access application or
negotiations of draft TK user agreement
Rules & Regulations:
Traditional Knowledge
Owners of TK must submit draft TK “useragreement” to Competent Authority for“comments”
 “Competent Authority” defined by
Biodiversity Act as “Head of Ministry ofAgriculture / RGOB”
 Competent Authority may approve,
request revisions, or deny proposed user
agreement based on “nat’l interests”
Rules & Regulations:
Traditional Knowledge
Approved TK “user agreement”
means that PIC requirement issatisfied Copy of final approved TK user
agreement must be filed with theCompetent Authority
Rules & Regulations:
Traditional Knowledge
Biodiversity Act also authorizes the‘Authorized Agency’ to conduct TK“inventory” and “documentation” activities
in collaboration with TK owners
 Procedures for TK documentation notdefined (but limited to TK “relating to theuse, properties, values and processes ofany biological and genetic resources orany part thereof”)
Rules & Regulations:
Traditional Knowledge
TK documentation procedures may
supplement TK access & use procedures toprotect TK owners’ proprietary interestsand ensure compliance with access & use
agreements
 TK documentation requires specialized
human & institutional capacities toaccomplish TK-protection objectives (!)
Rules & Regulations:
Traditional Knowledge


TK Documentation Objectives• ‘Defensive’ objectives, such as

Prevent others from claiming IP rights involving use of
documented TK
 Prevent others from using TK in unauthorized,
unintended or inappropriate ways
 Preserve TK in documented form for future generations• ‘Offensive’ objectives, such as

Develop IP rights in TK as basis for new potential
economic opportunities
 License use of documented TK for limited purposes Manage TK dissemination to broader public (including
other TK owners)Rules & Regulations:
Traditional KnowledgeBasic Issues for TK Documentation• TK documentation has potential benefits
for TK owners if properly managed• TK documentation also has potential risks
to TK owners’ cultural, economic and IP
interests• Documentation does not automaticallyguarantee legal protection for TK (but canbe part of a strategy of protection)

Rules & Regulations:
Traditional Knowledge

Potential Benefits of TK Documentation• Documentation process may help refine IPinterests of TK owners• Documented TK and related resources may
create new economic opportunities for TK
owners• TK ‘preserved’ through documentation /saved from loss

Rules & Regulations:
Traditional Knowledge

Potential Risks of TK Documentation• Potential for misappropriation (copying)of documented TK and associatedresources (‘piracy’)• Potential for misuse of documented TK
contrary to objectives of TK owners• Potential loss of confidentiality
associated with TK

Implementation Considerations /Next Steps

Review, revision, and finalization of Rules &Regulations• Draft TK regulations to be discussed through consultative
workshop• Other sections of draft Rules & Regulations discussed at MOA
workshop in November 2003
• Completed final draft of Rules & Regulations to be submitted
to the BMB for reviewThe ‘Competent Authority’ (Minister/MOA) needs todesignate the ‘Authorized Agency’ to process
biodiversity & TK access applications as intended by
the ActImplementation Considerations /Next Steps

Discussions with potential applicants
concerning development of pilot
project proposals to allow evaluationof the Rules & Regulations and build
technical & scientific capacity
required to implement & achieve theobjectives of the Act

Biodiversity Act, 2003:
Offences & Penalties


Biodiversity Act specifies six offences
under the law• Unauthorized collection of biodiversity• Non-compliance with permit conditions• Non-compliance with benefit-sharing• Breach of confidentiality requirements• Non-compliance with TK rights• Non-compliance with any other provision of
the Act or Rules & Regs

Biodiversity Act, 2003:
Offences & Penalties


Penalties for violations of the Act or Rules& Regulations• Imprisonment• Fines• Confiscation of material collected• Damages• Revocation of permitsPenalties determined on case-by-case basis

Biodiversity Act, 2003:
Amendments, Interpretation, Definitions
Biodiversity Act subject to amendment by
the National Assembly Dzongkha text determines interpretationof legal requirements
 Definitions
• Some adapted from CBD• Others unique to Bhutan (‘RGOB’, etc.)• Govern implementation of the Act and Rules &Regulations

Thank You&
Tashi Delek