THE BIODIVERSITY ACT OF BHUTAN,WATER SHEEP YEAR 2003

The Biodiversity Act of Bhutan, 2003

Royal Government of Bhutan
Ministry of Agriculture

The Biodiversity Act of Bhutan, 2003

CONTENTS
PREAMBLE..........................................................................................................1
1.

Title, Enactment, Commencement and Extent................................................................................. 2

2.

Purpose and objectives ....................................................................................................................... 2

3.

Scope .................................................................................................................................................... 3

4.

Exemptions. ......................................................................................................................................... 4

CHAPTER 2 ACCESS TO GENETIC RESOURCES AND BENEFITSHARING CONDITIONS OF ACCESS ................................................................55.

Prior Informed Consent. .................................................................................................................... 5

6.

Authorization Procedure: Application.............................................................................................. 5

7.

Application for Access Permit ........................................................................................................... 58.

Confidentiality..................................................................................................................................... 7

9.

Conditions for the Grant of Access.................................................................................................... 8

10.

Conditions for benefit sharing ...................................................................................................... 9

CHAPTER 3
VARIETIESA SUI GENERIS SYSTEM FOR THE PROTECTION OF PLANT
11

11.

Conditions of Protection. ............................................................................................................ 11

12.

Novelty........................................................................................................................................... 11

13.

Distinctness. .................................................................................................................................. 11

14.

Uniformity/ Stability/ Identifiability........................................................................................... 11

15.

Certificate of Origin..................................................................................................................... 12

16.

Rights conferred. .......................................................................................................................... 12

17.

Acts requiring the rights holder’s authorization. ...................................................................... 12

18.

Exceptions to the rights conferred. ............................................................................................. 13

19.

Duration of the rights................................................................................................................... 13

20.

Exhaustion of the rights............................................................................................................... 13

The Biodiversity Act of Bhutan, 2003

21.

Compulsory Licenses. .................................................................................................................. 14

22.

Other requirements for granting compulsory license. .............................................................. 14

23.

Derogation from exceptions......................................................................................................... 14

24.

Persons entitled to file applications. ........................................................................................... 15

25.

Examination of application. ........................................................................................................ 15

26.

Denomination. .............................................................................................................................. 1527.

Interface with seed certification system. .................................................................................... 1528.

Interface with patent law............................................................................................................. 15

29.

Nullity of breeder’s right ............................................................................................................. 15

30.

Cancellation of breeder’s right ................................................................................................... 16

CHAPTER 4

PROTECTION OF TRADITIONAL KNOWLEDGE....................17

31.

Applicability. ................................................................................................................................ 17

32.

Customary uses............................................................................................................................. 17

33.

Rights owners. .............................................................................................................................. 17

34.

Material form not required. ........................................................................................................ 1735.

Duration. ....................................................................................................................................... 17

36.

Additional rights........................................................................................................................... 17

37.

Application.................................................................................................................................... 18

38.

Appraisal of application............................................................................................................... 18

39.

Proposed agreement..................................................................................................................... 18

40.

User agreement and prior informed consent ............................................................................. 18

41.

Advice of Competent Authority .................................................................................................. 18

42.

Inventory of Traditional Knowledge. ......................................................................................... 19

CHAPTER 5
43.

OFFENCES AND PENALTIES .................................................20

Offences......................................................................................................................................... 20

The Biodiversity Act of Bhutan, 2003

44.

Penalties ........................................................................................................................................ 20

45.

Revocation of access permit ........................................................................................................ 21

46.

Determination of liability............................................................................................................. 22

47.

Protection of action taken in good faith. .................................................................................... 2248.

Jurisdiction. .................................................................................................................................. 22

CHAPTER 6 RULES AND REGULATIONS, AMENDMENTS,
INTERPRETATION AND DEFINITIONS. ...........................................................23
49.

Rules and regulations................................................................................................................... 23

50.

Amendments. ................................................................................................................................ 23

51.

Interpretation ............................................................................................................................... 23

52.

Definitions ..................................................................................................................................... 23

The Biodiversity Act of Bhutan, 2003

PREAMBLE
Noting the provisions of the Convention on Biological Diversity on thesovereignty of the States over their genetic resources and the need to promote
the conservation and sustainable use of these resources as well as the fair andequitable sharing of benefits arising from its utilization;
Recalling the numerous decisions of the Conferences of the Parties and other
Bodies of the Convention on Biological Diversity promoting and encouraging
the Parties to implement legal, administrative and policy measures to regulate
access to genetic resources and benefit sharing;
Recognizing that access to genetic resources is currently unregulated in theKingdom of Bhutan;
Realizing the value of biological and genetic resources in the development of
products, compounds and substances that have medicinal, industrial andagricultural and related applications;
Whereas it is necessary to protect and encourage cultural diversity giving due
value to the knowledge, innovations and practices of local communities in
Bhutan;Aware of the fundamental principle that prior informed consent and mutuallyagreed terms for benefit sharing shall be secured before access can take place;
The National Assembly of Bhutan hereby adopts this Act.

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1

CHAPTER 1
TITLE, ENACTMENT, COMMENCEMENT, EXTENT, PURPOSE &OBJECTIVES, SCOPE AND EXEMPTIONS
1.

2.

Title, Enactment, Commencement and Extent.
a.

This Act shall be called the Biodiversity Act of Bhutan, 2003.

b.

Be it enacted by the National Assembly at it’s 81st session on the…. day of the …. month of the Water Sheep Year corresponding to….day of the …. month of 2003.

c.

It shall come into force in the year of the Water Sheep Year, the ….
month, the …. day, corresponding to the …. day of …. month,
2003.

d.

It shall extend to the whole of the Kingdom of Bhutan.

Purpose and objectives
This Act shall have the following purposes and objectives:a.

To ensure national sovereignty of the RGOB over genetic resourcesin accordance with relevant National and International Law.

b.

To ensure the conservation and sustainable use of the biochemicaland genetic resources.

c.

To promote the equitable sharing of benefits derived from the useof genetic resources.

d.

To promote technology transfer and capacity building at thenational and local levels, including the building of scientific andtechnological capacity relevant to the conservation and sustainable
use of biological diversity.

e.

To recognize and protect Traditional Knowledge, innovation andpractices of local communities associated with biodiversity.

f.

To regulate and facilitate the process by which collectors may
legally obtain genetic resources.

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3.

g.

To prevent illegal access to genetic and biochemical resources andassociated Traditional Knowledge.

h.

To recognize and protect the farmers’ and breeder’s rights.

i.

To make plant varieties subject to property rights.

j.

Ensure that plant breeders are able to recover the cost from usefulimprovements and innovations, and continue to do so.

k.

Provide legal recognition of varieties which are not protectable
under the internationally existing patent and/or plant breeders rights
laws and thereby recognize farmers’ plant variety improvements
and innovations and provide a means of sharing benefits derived
from the use of farmers’ or traditional varieties as breeding material
for commercial purposes.

l.

To promote access to foreign sources of improved plant varieties to
Bhutanese farmers.

Scope
a.

This Act shall apply to all the genetic and biochemical resources
including wild, domesticated and cultivated species of flora andfauna, both in-situ and ex-situ conditions found within the territoryof Kingdom of Bhutan.

b.

The procedure and conditions provided by this Act shall apply even
if the genetic resources for which access is sought are located inprotected areas or government reserved forests.

c.

The provision of this Act shall apply to the Traditional Knowledge,
innovation and practices associated with biodiversity.

d.

The Traditional Knowledge includes any knowledge that generally
fulfills one or more of the following conditions:
i)
ii)
iii)

Is or has been transmitted from generation to generation.
Is regarded as pertaining to a particular traditional group,
clan and community of people in Bhutan.
Is collectively originated and held.

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4.

Exemptions.
This Act shall not apply:a.

Where the biological material is used as a commodity for the
purpose of direct use or consumption as determined by theCompetent Authority, based on the processes and end use ofgenetic resources, in accordance with the provisions of the Act.

b.

To access, use and exchange of biological and genetic resourcesamong local communities resulting from their traditional andcustomary practices.

c.

To access of human genetic resources.

d.

Where the Competent Authority may determine plant and animal
genetic resources access, which will be governed by Special Rules
and Regulations or Conditions such as those established bymultilateral systems for access and benefit sharing, especially in thecase of plant genetic resources for food and agriculture, in
accordance with the international law.

e.

To varieties for which patent protection is available.

f.

To the prevention of the commercial exploitation, which isnecessary to protect public order or morality including prejudice tothe environment, the general interest or traditional rights of farmers.

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CHAPTER 2ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING
CONDITIONS OF ACCESS
5.

Prior Informed Consent.
Access covered by this Act shall be subject to the prior informed consent
of the Competent Authority of Bhutan, representing national interests andthe interests of the local communities harbouring, cultivating, developing
and maintaining the biological diversity concerned.
In case of access to Traditional Knowledge, innovation and practices of
local communities, the procedure and conditions set out in Chapter 4 andChapter 1, Section 3 of this Act shall also apply.
In both cases, the Authorized Agency is responsible for processing theapplications and monitoring the Permits granted.

6.

Authorization Procedure: Application
The applicant shall submit an application for access to the Authorized
Agency in accordance with Section 7. In the event the Authorized Agency
is satisfied that the application for access complies with the requirement
under Section 7, such an application may be submitted to the Competent
Authority to arrive at a decision to grant or refuse a permit in accordancewith Sections 7 and 9.
For duly registered ex-situ collections the Regulations of this Act may set
special procedures for access authorization.
Likewise, the requirements of this Act will be determined in a different
way for commercial and for non-commercial applications.

7.

Application for Access Permit
To enable the Competent Authority to arrive at a decision to grant orrefuse a permit, the applicant shall include the following information,
when submitting an application for access to genetic and/or biochemical
resources or associated Traditional Knowledge covered by this Act:a.

Provide a description of the applicant including their legal status,
place of residence and a list of all entities and individuals,

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5

which will be involved in the access activities and their respective
responsibilities.
b.

Describe the applicant’s technical and financial capability to
conduct the access activity and previous biological resource
collection activities within Bhutan and elsewhere.

c.

Identify the kind of genetic and biological resources it is seeking.

d.

Identify the purpose and fields of the access activity and the
purpose for which access is requested including the type and extent
of research, teaching or commercial intention and use expected to
be derived from it. For a different purpose, the applicant shallsubmit a separate application.

e.

State the potential use and anticipated benefits of the accessedmaterial and how the results will be shared.

f.

Identify the nature of the legal rights the applicant may seek overthe collected resources, derivatives of the collected resources, andinnovations that are derived from those resources, including any
intellectual property rights.

g.

Indicate agreement to abide by the conditions set out by theCompetent Authority for collection activities. This includes
appropriate arrangements with the Authorized Agency to facilitate
the collection mission, including establishing provisional routes,
estimated timing, types of material collected and quantities andidentification of methods of collection (sampling, harvest andstorage methods).

h.

The identification of the national institution or institutions, which
will participate in the researchi.

Indicate agreement to bear all costs involved in collection,
including participation of at least one government official of the
RGOB in the collection mission.

j.

Provide information about existing or proposed contracts between
the applicant and any third party relating to the use of any
information and products resulting from the access activity.

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k.

Provide information on the primary destination of the resources andany expected subsequent destinations of the resources.

l.

Provide information on the arrangements made within Bhutan tofacilitate the collection mission.

m.

Indicate plans, if any, for cooperation with national institutions,scholars, scientists, students, farmers and farmer groups in Bhutan
in the field mission and/or its follow-up activities.

n.

Provide information on intended distribution of the germplasm
collected and list actual or potential beneficiaries.

o.

Demonstrate that the collection/access activity will have no
negative environmental impact.

p.

Provide information on the prior informed consent of the relevant
stakeholders when necessaryq.

The economic, social, technical, scientific, environmental or any
other benefits that are intended or may be likely to be accrued to thecountry and an indication of the types of short, medium and longterm benefits to be shared with the RGOB and other relevant
stakeholders as well as the proposed mechanisms and arrangements
for benefit sharing.

r.

All information provided shall be supplied in English or Dzongkha.

s.

An application shall be affixed with an affidavit.

7.1.

The applicant shall be informed in writing of the decision taken within 30
days of receipt of the application by the Competent Authority.

8.

Confidentiality.
The Authorized Agency shall protect all the information deemed
confidential as per the Act, such as trade secrets or other forms ofintellectual property rights.

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9.

Conditions for the Grant of Access.
Competent Authority, through the Authorized Agency, may grant access
if in addition to Section 10, the following minimum requirements are
satisfied:a.

The applicant agrees to bear all costs relevant to the collection,
including costs of participating staff identified by the Competent
Authority.

b.

The applicant agrees to deposit with the Authorized Agency
duplicates of each sample collected and the associated informationon collection sites of collected materials gathered from farmers’
field or government forest.

c.

The applicant agrees to inform the Competent Authority, throughthe Authorized Agency, of all findings from subsequent researchand development on the collected samples in accordance with theterms of the Material Transfer Agreement or Contract signed
between both.

d.

The applicant shall not transfer the resources accessed or associatedTraditional Knowledge to any third party without the authorizationof the Competent Authority.

e.

The applicant shall notify the Competent Authority prior toapplying for intellectual property rights relating to the collectedmaterial or intellectual property rights relating to an invention,
which is based on associated Traditional Knowledge obtained in
Bhutan.

f.

The applicant agrees to benefit sharing conditions negotiated inaccordance with Section 10 below. These conditions shall becontained in an appropriate Material Transfer Agreement orContract Agreement signed between the applicant and theCompetent Authority.

g.

The applicant agrees to submit a full report to Authorized Agency
on completion of the collection activity, including sites ofcollection, number of samples collected and associated information
gathered.

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10.

h.

During collection, the collector should systematically record
common passport data and describe plant populations, its diversity,
habitat and ecology in detail.

i.

The applicant agrees that, the acquisition of germplasm must not
deplete populations or farmers’ seed stocks, in order to avoid
genetic erosion.

j.

If appropriate, the applicant agrees to bear the cost ofenvironmental impact assessment and abide by the Environmental
Assessment Act, 2000 of Bhutan.

k.

The applicant shall abide by the relevant laws of the country, local
customs, traditions and values.

l.

In addition to the requirements laid down in Section 9(a) to Section
9(k), the competent authority and the local community or person
may where it is deemed necessary or appropriate require thecollector to comply with additional requirements.

Conditions for benefit sharing
Upon fulfilment of all the conditions described above, the Competent
Authority may grant access if one or more, when relevant, of thefollowing minimum conditions for benefit sharing, which are to be
included in the Material Transfer Agreement or Contract Agreement to besigned between the Competent Authority and the Applicant. These
conditions may also be considered in any Material Transfer Agreement orContract Agreement to be signed between the applicant and any otherrelevant stakeholder.
a.

A flat fee and upfront payments.

b.

The sharing of the research results and relevant information.

c.

Royaltiesd.

Milestones payments.

e.

Recognition as a partner in intellectual property ownership of
products derived from the supplied material.

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f.

Joint research activities.

g.

Concessionary rates or free supply of commercial products derived
from the resources provided.

h.

Transfer of technologies.

i.

Training and capacity building.

j.

The acknowledgment of the origin of the genetic resources in any
publication resulting from the research activities.

k.

Donation of equipment to national institutions.

l.

Other benefits, monetary or non-monetary.

10.1. The Competent Authority shall issue a Certificate of Origin, which states
that, the procedures and conditions for granting access to the applicant havebeen met.

Biodiversity Act of Bhutan, 200310

CHAPTER 3
A SUI GENERIS SYSTEM FOR THE PROTECTION OF PLANT
VARIETIESPart I:
11.

CONDITIONS FOR PROTECTION

Conditions of Protection.
Plant variety protection shall be granted for plant varieties that are novel,
distinct, identifiable, uniform and stable.

12.

Novelty.
The variety is novel if at the date of filing of the application, the materialof the variety has not been sold with the consent of the applicant or her/his
successor in title, for purpose of exploitation of the variety:

13.

a.

For longer than one year for commercial varieties.

b.

In case of varieties bred and developed by farmers and only
cultivated within limited areas of the country for longer than 10
years.

Distinctness.
The plant variety is distinct if it is clearly distinguishable from any othervariety whose existence is a matter of common knowledge at the time offiling of the application.

14.

Uniformity/ Stability/ Identifiability.
a.

Uniformity;
The variety is uniform if, subject to the variation that may be
expected from the particular features of its propagation andreproduction, it is sufficiently uniform in relevant characteristics.

b.

Stability;
The variety is stable if its relevant characteristics remain
sufficiently unchanged after repeated propagation.

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c.

Identifiability;
The variety is identifiable if it can be identified by a person skilledin the art of such identification, recognized by the Competent
Authority.

15.

Certificate of Origin.
A Certificate of Origin of the plant variety under this chapter may berequired at the discretion of the Competent Authority.
Part II:

16.

17.

RIGHTS CONFERRED

Rights conferred.
a.

Entitlement to the right conferred under this Chapter shall vest in
the person(s) who (jointly) bred and developed the plant variety orin her/ his or their successor(s) in title.

b.

Where the person who bred and developed the plant variety is an
employee, entitlement to the Right conferred under this Chapter
shall be vested in the employer, unless otherwise agreed.

c.

Where an application has been filed by a person who is not entitled,
the person entitled may submit a request to the Competent
Authority for assignment of the application. Where the right has
already been granted to the person not entitled, the person entitled
may file an objection for the restitution of the title.

Acts requiring the rights holder’s authorization.
The following acts in respect of material of varieties shall require therights holder’s authorization:
a.
b.
c.
d.
e.

Producing or reproducing (multiplication)marketing.
Offering for sale, selling or other marketing.
Exporting.
Importing.
Stocking for the purpose of a – d.

Biodiversity Act of Bhutan, 2003

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18.

Exceptions to the rights conferred.
a.

Farming (farmers’ rights)

The Competent Authority may restrict breeder’s rights in relation to plantvarieties protected by these provisions in order to permit small farmers, as
defined in the regulations of this Chapter or at the discretion of theCompetent Authority, to propagate seed which they have harvested on
their holding and to exchange that seed with others on a non-commercial
basis.
b.

Breeding (breeder’s exemptions).

The rights conferred on right holders in Section 16, shall not apply to acts
done for the purpose of breeding other varieties and shall not apply to any
acts in respect of such other varieties provided these other varieties havenot been essentially derived from a protected variety.
19.

Duration of the rights
The plant variety protection shall last 20 years from date of grant of theright and 25 years for trees and vines.

20.

Exhaustion of the rights
The right conferred in Section 16 shall not extend to acts concerning any
material of the protected variety or any material derived from suchprotected variety, which has been sold or otherwise marketed by theholder with her/ his consent, unless such activities:a.

Involve further propagation of the variety in question.

b.

Involve an export of material, for the purpose of propagation, into a
country that does not protect varieties of the plant genus or species
to which the variety belongs.

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21.

Compulsory Licenses.
Any person may, by means of an application filed to the Competent
Authority, seek the grant of a Compulsory License in respect with the
Rights conferred under this Act. A Compulsory License shall not be
granted unless one or more of the following conditions are fulfilled:

22.

a.

It is necessary to safeguard public interest.

b.

It is necessary due to insufficient supply by the rights holder of thesubject variety.

c.

It is necessary since to high a proportion of the plant variety offered
for sale by the right holder in Bhutan is being imported and not
produced in the country.

d.

That the right holder is not prepared to grant a license on reasonable
commercial terms.

Other requirements for granting compulsory license.
The Competent Authority shall act in compliance with the general laws
and regulations in granting or refusing a compulsory license. In particular,
the Competent Authority shall:a.

Offer opportunity to the right holder to be heard and to respond to
all assertions of the applicant of the compulsory license.

b.

Hear interest groups and national professional organizations in thefield concerned before granting or refusing a compulsory license.

22.1. Any decision of the Competent Authority to grant or refuse a compulsory
license, or on the amount of equitable remuneration thereof, shall be
subject to appeal to a court of law.
23.

Derogation from exceptions.
Private contracts, to the extent that they impose restrictions on the use of
the material of the variety, or parts thereof, in conflict with the exceptions
set out in Section 18 shall be unenforceable.

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Part III:24.

MISCELLANEOUS

Persons entitled to file applications.
Any natural or legal person may file an application for a right considered
under this Chapter.
The regulation shall set the information and requirement the application
form must contain including the procedures of application.

25.

Examination of application.
The variety shall undergo, under the supervision of the Competent
Authority, an examination based on the results obtained by the applicant.

26.

Denomination.
The denomination of a protected variety shall be its generic designation in
a way that the variety may be identified. The denomination may consist of
any suitable word, combination of words, combination of words andfigures or combination of letters and figures, provided that thedenomination allows the variety to be identified.

27.

Interface with seed certification system.
The Rights conferred under this Chapter shall be separate from themeasures taken by the RGOB to regulate the production, certification andmarketing of material of plant varieties or the importing or exporting ofsuch material.

28.

Interface with patent law.
Notwithstanding any patent rights restricting the use of material of thevariety or parts thereof, the exceptions as set out in Section 18 shall apply.

29.

Nullity of breeder’s right
The Competent Authority shall declare a breeder’s right null and voidwhen it is established that:a.

The conditions laid down in Sections 11, 12, 13 and 14 were notcomplied with at the time of the grant of the breeder’s right,

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b.
30.

The breeder’s right has been granted to a person who is not entitledto it.

Cancellation of breeder’s right
The Competent Authority may cancel a breeder’s right if the conditions
laid down in Sections 11, 12, 13 and 14 are no longer fulfilled.
Furthermore, the Competent Authority may cancel a breeder’s right
granted by it if, after being requested to do so and within a prescribedperiod:a.

The breeder fails to provide the Competent Authority with theinformation, documents or material deemed necessary for verifying
the maintenance of the variety.

b.

The breeder fails to pay such fees as may be payable to keep hisright in force.

c.

The breeder fails to propose, where the denomination of the variety
is cancelled after the grant of the rights, another suitable
denomination.

Biodiversity Act of Bhutan, 200316

CHAPTER 4
PROTECTION OF TRADITIONAL KNOWLEDGE
Part I:
31.

CONDITIONS FOR PROTECTION

Applicability.
This Chapter applies to Traditional Knowledge that was in existence
before the commencement of this Act or is created on or after thecommencement of this Act.

32.

Customary uses.
The customary use of Traditional Knowledge among the local
communities does not give rise to any criminal or civil action for liability
under this Act.

33.

Rights owners.
The owners of Traditional Knowledge are the holders of the rights in the
Traditional Knowledge.

34.

Material form not required.
The rights exist in Traditional Knowledge whether or not the Traditional
Knowledge is in material form.

35.

Duration.
Rights conferred by this Chapter continue in force in perpetuity and are
inalienable.

36.

Additional rights.
The Rights in Traditional Knowledge are in addition to and do not affect,
any rights that may subsist under any intellectual property laws.

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Part II:
37.

PROCEDURES

Application.
The applicant shall obtain the prior informed consent of the traditional
owners of the Traditional Knowledge for use of Traditional Knowledge
for a non-customary use.
The Regulations shall set the information and requirements theapplication form must contain.

38.

Appraisal of application.
The owners of the Traditional Knowledge must decide whether:

39.

a.

To reject the application.

b.

To accept the application and enter into negotiations for a written
authorized user agreement in relation with the application
containing the appropriate benefit sharing arrangements.

Proposed agreement.
Before entering into an authorized user agreement the owners of theTraditional Knowledge must submit the proposed agreement forcomments to the Competent Authority.
The Competent Authority has the final right to approve or deny the
proposed user agreement based on the national interest of the country.

40.

User agreement and prior informed consent
If the applicant and the traditional owners enter into an authorized
agreement, the owners of the Traditional Knowledge are deemed to havegiven their prior informed consent to the proposed use. A final copy of theagreement must be forwarded to the Competent Authority. If a copy is notprovided the user agreement is null and void.

41.

Advice of Competent Authority
The Competent Authority, upon request, may provide advice to theowners of the Traditional Knowledge during the negotiations of the user
agreement or during the processing of the access application.

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42.

Inventory of Traditional Knowledge.
The Authorized Agency in collaboration with the owners of theTraditional Knowledge will carry out an inventory and documentation of
Traditional Knowledge. The Regulations shall set the terms andconditions for applicants for the access of the information inventoried.

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CHAPTER 5
OFFENCES AND PENALTIES
43.

Offences.
The following acts shall constitute an offense under this Act.
a.

In-situ or ex-situ collection of genetic resources without access
Permit.

b.

Non-compliance of conditions for grant of access as provided in
Section 9.

c.

Non-compliance of the conditions for benefit sharing as provided in
Section 10.

d.

Breach of confidentiality as provided in Section 8.

e.

Non-compliance with the traditional knowledge rights as provided
in Chapter 4.

f.

Failure to comply with any other provisions of this Act orRegulations.

43.1 Civil liability
Beside the offences mentioned in the Section 43, any violation of material
terms and agreement in respect to this Act shall be treated as a breach ofcontract.
44.

Penaltiesa.

Whoever,
i)
ii)
iii)

Conducts in-situ or ex-situ collection of genetic resources
without access Permit, orFails to comply with or contravenes the provisions of Section
10 or Section 11, orFails to comply with or contravenes with Chapter 4 of theAct, shall be punishable with imprisonment for a term whichshall not be less than one year but which may extend to 3
years or with fine which shall not be less than 2 years

Biodiversity Act of Bhutan, 200320

equivalent of the minimum daily wage rate but which may
extend to 6 years equivalent of minimum daily wage rate
provided in the Chathrim for wage rate and recruitment
agencies and workman’s compensation, 1994 or with both.

45.

b.

The Authorized Agency shall take appropriate measures to provide
for confiscation of such genetic resources collected incontravention of the provisions of this Act and impose liability on
the person deemed guilty to pay damages.

c.

Where the Authorized Agency contravenes the provisions ofSection 8, the Authorized Agency shall be liable to compensate forthe damage caused by the contravention with a fine equivalent tothe compensation paid for the damage.

d.

Whoever contravenes any of the provisions of this Act or rules andregulations issued there under, for which no penalty has beenelsewhere provided under this Act, shall be punishable withimprisonment for a term which may extend to 3 months or with finewhich may extend to 6 months equivalent of minimum daily wage
rate as provided in Chathrim for wage rate, recruitment agencies
and workman compensation, 1994.

Revocation of access permit
Access permits may be withdrawn by the Competent Authority under anyof the following circumstances:a.

When the collector has violated any of the provisions of this law.

b.

When the permit was obtained by providing false or misleading
information under Section 8.

c.

When the collector has failed to comply with the conditions of theaccess permit and the Material Transfer Agreement or Contract
Agreement.

d.

For reasons of public interest, including the protection of theenvironment and biological diversity.

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46.

Determination of liability.
The determination of liability for offences committed under this Act shalltake the following factors.

47.

a.

Magnitude of the offence.

b.

Frequency of the offence.

c.

Actual or potential impact on the plant genetic resources.

d.

Culpability of the offender.

e.

The extent of the achieved or intended economic advantage fromthe offence.

Protection of action taken in good faith.
No suit, prosecution or other legal proceeding shall be against theCompetent Authority or the Authorized Agency or any member or
employee thereof in respect of anything which is done or intended to bedone in good faith in pursuance of this Act or the rules and regulations
made there under.

48.

Jurisdiction.
a.

A court of law or any specialized court or tribunal, which may beestablished by the RGOB having original jurisdiction shall hear the
disputes under this Act.

b.

When any other law also covers the penalties for offences
committed under this Act, the penalty shall be determined as per
this Act.

Biodiversity Act of Bhutan, 200322

CHAPTER 6
RULES AND REGULATIONS, AMENDMENTS, INTERPRETATION
AND DEFINITIONS.
49.

Rules and regulations.
In accordance with the provisions of this Act, the Competent Authority
shall have the power to formulate and adopt rules and regulations for the
implementation of the Act.

50.

Amendments.
When necessary the National Assembly of Bhutan shall amend the Act.

51.

Interpretation
In case of differences, in interpretation of this Act between Dzongkha andEnglish, the interpretation in Dzongkha text shall be final and binding.

52.

Definitions
In this Act, unless the context requires otherwise;a.
Access: means obtaining, collecting, utilizing and/or exporting
genetic or biochemical resources covered by this Act for purposesof conservation, research, bioprospecting or commercial use.
b.

Applicant: means a natural or legal person seeking access togenetic or biochemical resources.

c.

Authorized Agency: means the body designated as Authorized
Agency by the Competent Authority under this Act.

d.

Biochemical Resources: means any material derived from plants,
fungi, animals or micro-organism, which contains specificcharacteristics and special molecules.

e.

Bioprospecting: means the systematic search, classification andresearch of new sources of chemical compounds, genes, proteinsand microorganism for commercial purposes with real or potential
economic value, which are found in biodiversity.

Biodiversity Act of Bhutan, 2003

23

f.

Competent Authority:
Agriculture of RGOB.

g.

Compulsory License: means the mechanism through which theRoyal Government of Bhutan or any Third Party, without theconsent of the owner of the intellectual property rights, and after
compliance with due process is entitled to use the protected plantvariety for reasons of public interesth.

Collectors: means any natural or legal person, entity or agent
obtaining access to genetic and biochemical resources or associatedtraditional knowledge under authority given by the Competent
Authority.

i.

Essentially derived varieties: means varieties that are geneticallysimilar to an existing variety, except for one or a few characters.
Such a variety can, for instance, be obtained through natural or
induced mutation, or a soma-clonal variant, the selection of avariant individual from plants of the original variety, resulting fromback -crossing or from transformation by genetic engineering.

j.

Genetic resources: means any material derived from plants,
animals, fungi or microorganisms which contains functional unit ofheredity.

k.

Material: means vegetative and reproductive material for the
purpose of commercial exploitation.

l.

Plant variety: means any variety of all the plant species found in
Bhutan.

m.

Prior informed consent: means the procedure through which the
RGOB and other stakeholders, as the case may be, properly
supplied with all the relevant information, allow access to their
genetic and biochemical resources or associated Traditional
Knowledge, under mutually agreed terms.

n.

RGOB: means Royal Government of Bhutan.

o.

Right holder: means natural or legal person who owns theintellectual property rights on a plant variety.

Biodiversity Act of Bhutan, 2003

means the Head of the Ministry of

24

p.

Sui Generis System: means a system of its own kind for theprotection of plant varieties.

q.

Traditional Knowledge: means the knowledge, innovation andpractices of local communities relating to the use, properties, values
and processes of any biological and genetic resources or any part
thereof.

Biodiversity Act of Bhutan, 2003

25