Biodiversity Act, 2003

Link to law: http://www.nationalcouncil.bt/assets/uploads/docs/acts/2014/BiodiversityEng2003.pdf

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Biodiversity Act of Bhutan 2003_English_

The Biodiversity Act of Bhutan.

Water Sheep Year 2003

!

Royal Government of Bhutan

Ministry of Agriculture

CONTENTS Page

PREMBLE 1

CHAPTER 1

TITLE, ENACTMENT, COMMENCEMENT, EXTENT, PURPOSE &
OBJECTIVES, SCOPE & EXEMPTIONS 2

1. Title, Enactment, Commencement & Extent 2
2. Purpose and Objectives 2
3. Scope 3
4. Exemptions 4

CHAPTER 2

ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING 5

Conditions of Access 5

5. Prior informed consent 5
6. Authorization procedures: application 5
7. Application for access permit 5
8. Confidentiality 7
9. Conditions for the grant of access 8
10. Conditions for benefit sharing 9

CHAPTER 3

A SUI GENERIS SYSTEM FOR THE PROTECTION OF PLANT
VARIETIES 11

PART I: Conditions of Protection 11

11. Conditions for protection 11
12. Novelty 11
13. Distinctness 11
14. Uniformity/Stability/Identifiability 11
15. Certificate of origin 12

PART II: Rights Conferred 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
21. Compulsory license 13
22. Other requirements for granting compulsory license 14
23. Derogation from exceptions 14

PART III: Miscellaneous 14

24. Persons entitled to file application 14
25. Examination of application 15
26. Denomination 15
27. Interface with seed certification system 15
28. Interface with patent law 15
29. Nullity of breeders’ rights 15
30. Cancellation of breeder’s rights 16

CHAPTER 4

PROTECTION OF TRADITIONAL KNOWLEDGE 17

PART I: Conditions for protection 17

31. Applicability 17
32. Customary uses 17
33. Rights owners 17
34. Material form not required 17
35. Duration 17
36. Additional rights 17

PART II: Procedures 18

37. Application 18
38. Appraisal of application 18
39. Proposed agreement 18
40. User agreement and prior informed consent 18
41. Adivce of the competent authority 18
42. Inventory of traditional knowledge 19

CHAPTER 5

OFFENCES AND PENALTIES 20

43. Offences 20

Civil liability 20

44. Penalties 20
45. Revocation of access permit 21
46. Determination of liability 22
47. Protection of Action take in good faith 22
48. Jurisdiction 22

CHAPTER 6

AMENDMENTS, INTERPRETATION & DEFINITIONS 23

49. Amendments 23
50. Interpretation 23
51. Definitions 23

Preamble

Noting the provisions of the Convention on Biological Diversity on the
sovereignty 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 and
equitable 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 the
Kingdom of Bhutan;

Realizing the value of biological and genetic resources in the development of
products, compounds and substances that have medicinal, industrial and
agricultural 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 mutually
agreed terms for benefit sharing shall be secured before access can take place;

The National Assembly of Bhutan hereby adopts this Act.

CHAPTER 1

TITLE, ENACTMENT, COMMENCEMENT, EXTENT, PURPOSE &
OBJECTIVES, SCOPE AND EXEMPTIONS

1. 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
6th day of the 5th month of the Water Sheep Year corresponding to

4th day of the 8th month of 2003.

c. It shall come into force in the year of the Water Sheep Year, the 5th
month, the 6th day, corresponding to the 4th day of 8th month, 2003.

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

2. Purpose and objectives

This Act shall have the following purposes and objectiv s:

a. To ensure national sovereignty of the RGOB over genetic resources

in accordance with relevant National and International Law.

b. To ensure the conservation and sustainable use of the biochemical
and genetic resources.

c. To promote the equitable sharing of benefits derived from the use

of genetic resources.

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

e. To recognize and protect Traditional Knowledge, innovation and

practices of local communities associated with biodiversity.

f. To regulate and facilitate the process by which collectors may

legally obtain genetic resources.

g. To prevent illegal access to genetic and biochemical resources and
associated 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 useful

improvements 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.

3. Scope

a. This Act shall apply to all the genetic and biochemical resources
including wild, domesticated and cultivated species of flora and
fauna, both in-situ and ex-situ conditions found within the territory
of 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 in
protected 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) Is or has been transmitted from generation to generation.
ii) Is regarded as pertaining to a particular traditional group,

clan and community of people in Bhutan.
iii) Is collectively originated and held.

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 the
Competent Authority, based on the processes and end use of
genetic resources, in accordance with the provisions of the Act.

b. To access, use and exchange of biological and geetic resources

among local communities resulting from their traditional and
customary 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 establihed by
multilateral systems for access and benefit sharing, especially in the
case 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 is

necessary to protect public order or morality including prejudice to
the environment, the general interest or traditional rights of farmers.

CHAPTER 2

ACCESS 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 and
the interests of the local communities harbouring, cultivating, developing
and maintaining the biological diversity concerned.

In case of access to Traditional Knowledge, innovati n and practices of
local communities, the procedure and conditions set out in Chapter 4 and
Chapter 1,Section 3 of this Act shall also apply.

In both cases, the Authorized Agency is responsible for processing the
applications 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 accordance
with 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 or
refuse 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 iividuals, which
will be involved in the access activities and their respective
responsibilities.

b. Describe the applicant’s technical and financial c pability 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 typ and extent
of research, teaching or commercial intention and use expected to
be derived from it. For a different purpose, the applicant shall
submit a separate application.

e. State the potential use and anticipated benefits o the accessed

material and how the results will be shared.

f. Identify the nature of the legal rights the applicant may seek over
the collected resources, derivatives of the collected resources, and
innovations that are derived from those resources, including any
intellectual property rights.

g. Indicate agreement to abide by the conditions set out by the

Competent 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 and
identification of methods of collection (sampling, harvest and
storage methods).

h. The identification of the national institution or institutions, which

will participate in the research

i. Indicate agreement to bear all costs involved in colle tion,
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.

k. Provide information on the primary destination of the resources and
any expected subsequent destinations of the resources.

l. Provide information on the arrangements made within Bhutan to

facilitate 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 necessary

q. The economic, social, technical, scientific, environmental or any
other benefits that are intended or may be likely to be accrued to the
country and an indication of the types of short, medium and long
term 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 d cision 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 of
intellectual property rights.

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 information
on collection sites of collected materials gathered from farmers’
field or government forest.

c. The applicant agrees to inform the Competent Authority, through

the Authorized Agency, of all findings from subsequnt research
and development on the collected samples in accordance with the
terms of the Material Transfer Agreement or Contract signed
between both.

d. The applicant shall not transfer the resources acessed or associated

Traditional Knowledge to any third party without the authorization
of the Competent Authority.

e. The applicant shall notify the Competent Authority prior to

applying for intellectual property rights relating to the collected
material 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 in

accordance with Section 10 below. These conditions shall be
contained in an appropriate Material Transfer Agreem nt or
Contract Agreement signed between the applicant andthe
Competent Authority.

g. The applicant agrees to submit a full report to Authorized Agency

on completion of the collection activity, including sites of
collection, number of samples collected and associated information
gathered.

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 f

environmental 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 the
collector to comply with additional requirements.

10. 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 the
following minimum conditions for benefit sharing, which are to be
included in the Material Transfer Agreement or Contract Agreement to be
signed between the Competent Authority and the Applicant. These
conditions may also be considered in any Material Tr nsfer Agreement or
Contract Agreement to be signed between the applicant and any other
relevant stakeholder.

a. A flat fee and upfront payments.

b. The sharing of the research results and relevant information.

c. Royalties

d. Milestones payments.

e. Recognition as a partner in intellectual property ownership of

products derived from the supplied material.

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
have been met.

CHAPTER 3

A SUI GENERIS SYSTEM FOR THE PROTECTION OF PLANT
VARIETIES

Part I: CONDITIONS FOR PROTECTION

11. 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 of the
application material of the variety has not been sold with the consent of
the applicant or her/his successor in title, for pupose of exploitation of
the variety:

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 l nger than 10
years.

13. Distinctness.

The plant variety is distinct if it is clearly distinguishable from any other
variety whose existence is a matter of common knowledge at the time of
filing 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 and
reproduction, it is sufficiently uniform in relevant characteristics.

b. Stability;

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

c. Identifiability;

The variety is identifiable if it can be identified by a person skilled
in 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 be
required at the discretion of the Competent Authoriy.

Part II: RIGHTS CONFERRED

16. 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 or
in 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 agr ed.

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 th right has
already been granted to the person not entitled, the person entitled
may file an objection for the restitution of the title.

17. Acts requiring the rights holder’s authorization.

The following acts in respect of material of varieties shall require the
rights holder’s authorization:

a. Producing or reproducing (multiplication) for commercial

marketing.
b. Offering for sale, selling or other marketing.
c. Exporting.
d. Importing.
e. Stocking for the purpose of a – d.

18. Exceptions to the rights conferred.

a. Farming (farmers’ rights)

The Competent Authority may restrict breeder’s rights in relation to plant
varieties protected by these provisions in order to permit small farmers, as
defined in the regulations of this Chapter or at the discretion of the
Competent 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 thse other varieties have
not 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 the
right 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 such
protected variety, which has been sold or otherwise marketed by the
holder 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.

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:

a. It is necessary to safeguard public interest.

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

subject 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.

22. 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 nd to respond to

all assertions of the applicant of the compulsory license.

b. Hear interest groups and national professional organizations in the
field 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 hereof, shall be
subject to appeal to a court of law.

23. Derogation from exceptions.

Private contracts, to the extent that they impose re trictions on the use of
the material of the variety, or parts thereof, in co flict with the exceptions
set out in Section 18 shall be unenforceable.

Part III: MISCELLANEOUS

24. Persons entitled to file applications.

Any natural or legal person may file an application f r 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 denomi ation may consist of
any suitable word, combination of words, combination f words and
figures or combination of letters and figures, provided that the
denomination allows the variety to be identified.

27. Interface with seed certification system.

The Rights conferred under this Chapter shall be separate from the
measures taken by the RGOB to regulate the production, certification and
marketing of material of plant varieties or the importing or exporting of
such material.

28. Interface with patent law.

Notwithstanding any patent rights restricting the use of material of the
variety 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 void
when it is established that:

a. The conditions laid down in Sections 11,12,13 and 14 were not

complied with at the time of the grant of the breedr’s right,

b. The breeder’s right has been granted to a person wh is not entitled
to it.

30. Cancellation of breeder’s right

The Competent Authority may cancel a breeder’s right f 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 prescribed
period:

a. The breeder fails to provide the Competent Authority with the

information, 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 his

right 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.

CHAPTER 4

PROTECTION OF TRADITIONAL KNOWLEDGE

Part I: CONDITIONS FOR PROTECTION

31. Applicability.

This Chapter applies to Traditional Knowledge that was in existence
before the commencement of this Act or is created on or after the
commencement 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 n t 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 t and do not affect,
any rights that may subsist under any intellectual property laws.

Part II: PROCEDURES
37. 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 requir ments the
application form must contain.

38. Appraisal of application.

The owners of the Traditional Knowledge must decide wh ther:

a. To reject the application.

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

39. Proposed agreement.

Before entering into an authorized user agreement the owners of the
Traditional Knowledge must submit the proposed agreement for
comments 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 have
given their prior informed consent to the proposed use. A final copy of the
agreement must be forwarded to the Competent Authority. If a copy is not
provided the user agreement is null and void.

41. Advice of Competent Authority

The Competent Authority, upon request, may provide advice to the
owners of the Traditional Knowledge during the negotiations of the user
agreement or during the processing of the access applic tion.

42. Inventory of Traditional Knowledge.

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

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 a 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 or
Regulations.

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 of
contract.

44. Penalties

a. Whoever,

i) Conducts in-situ or ex-situ collection of genetic resources
without access Permit, or

ii) Fails to comply with or contravenes the provisions of Section
10 or Section 11, or

iii) Fails to comply with or contravenes with Chapter 4 of the
Act,

shall be punishable with imprisonment for a term which shall not be
less than one year but which may extend to 3 years or with fine
which shall not be less than 2 years 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.

b. The Authorized Agency shall take appropriate measures to provide

for confiscation of such genetic resources collected in
contravention 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 of

Section 8, the Authorized Agency shall be liable to compensate for
the damage caused by the contravention with a fine equivalent to
the compensation paid for the damage.

d. Whoever contravenes any of the provisions of this Act or rules and

regulations issued there under, for which no penalty has been
elsewhere provided under this Act, shall be punishable with
imprisonment for a term which may extend to 3 months or with fine
which may extend to 6 months equivalent of minimum daily wage
rate as provided in Chathrim for wage rate, recruitment agencies
and workman compensation, 1994.

45. Revocation of access permit

Access permits may be withdrawn by the Competent Authority under any
of the following circumstances:

a. When the collector has violated any of the provision f 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 theconditions of the
access permit and the Material Transfer Agreement or Contract
Agreement.

d. For reasons of public interest, including the protection of the

environment and biological diversity.

46. Determination of liability.

The determination of liability for offences committed under this Act shall
take the following factors.

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 from

the offence.

47. Protection of action taken in good faith.

No suit, prosecution or other legal proceeding shall be against the
Competent Authority or the Authorized Agency or any member or
employee thereof in respect of anything which is done r intended to be
done 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 be
established 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.

CHAPTER 6

AMENDMENTS, INTERPRETATION AND DEFINITIONS.

49. Amendments.

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

50. Interpretation

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

51 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 purposes
of conservation, research, bioprospecting or commercial use.

b. Applicant: means a natural or legal person seeking access to

genetic 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 specific
characteristics and special molecules.

e. Bioprospecting: means the systematic search, classification and

research of new sources of chemical compounds, genes, proteins
and microorganism for commercial purposes with realor potential
economic value, which are found in biodiversity.

f. Competent Authority: means the Head of the Ministry of

Agriculture of RGOB.

g. Compulsory License: means the mechanism through which the
Royal Government of Bhutan or any Third Party, without the
consent of the owner of the intellectual property rights, and after
compliance with due process is entitled to use the protected plant
variety for reasons of public interest

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

i. Essentially derived varieties: means varieties hat are genetically

similar 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 a
variant individual from plants of the original variety, resulting from
back -crossing or from transformation by genetic engineering.

j. Genetic resources: means any material derived from plants,

animals, fungi or microorganisms which contains functional unit of
heredity.

k. Material: means vegetative and reproductive materi l 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 the

intellectual property rights on a plant variety.

p. Sui Generis System: means a system of its own kind for the
protection of plant varieties.

q. Traditional Knowledge: means the knowledge, innovati n and

practices of local communities relating to the use, properties, values
and processes of any biological and genetic resources or any part
thereof.