PROTECTION OF TRADITIONAL KNOWLEDGE, GENETIC RESOURCES AND EXPRESSION OF FOLKLORE ACT: SUBSIDIARY LEGISLATION

"agent" means a legal practitioner or person registered as a patent agent under the Patents Act, 2016, or a trade mark agent under the Trade Marks Act;

"appropriate institution" has the meaning assigned to the word in the Act;

"certificate of registration" means a certificate of registration issued under regulation 8;

"compulsory licence" means a licence issued under regulation 17;

"counter-statement" means a response to an objection for the registration of traditional knowledge or expressions of folklore;

"holder" has the meaning assigned to the word in the Act;

"licensing agreement" means an agreement concluded by the holder of an expression of folklore to authorise or licence the use of the expression of folklore; and

"Nagoya Protocol" means the Nagoya Protocol on Access and Benefit Sharing which entered into force on 12th October, 2014 and was ratified by Zambia on 20th May, 2016.

PART II
APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

3. Registration of traditional knowledge or expressions of folklore

(1) A person who intends to register traditional knowledge or expressions of folklore shall apply to the Registrar in Form I set out in the First Schedule on payment of the fee set out in the Second Schedule.

(2) The Registrar shall cause a notice of the application for registration of the traditional knowledge or expressions of folklore in Form II set out in the First Schedule to be published in the Gazette, newspaper of general circulation in the Republic or other media.

4. Objection to application for registration of traditional knowledge or expressions of folklore

(1) A person may, within 60 days of the date of the publication of the notice of the application for traditional knowledge or expressions of folklore, lodge an objection with the Registrar in Form III set out in the First Schedule on payment of the fee set out in the Second Schedule.

(2) The Registrar shall, within 14 days of receipt of an objection made under sub-regulation (1), serve the applicant with a copy of the objection.

(3) An applicant shall, within 30 days of receipt of the objection, lodge with the Registrar a counter-statement in Form IV set out in the First Schedule, stating the grounds relied on in support of the application for registration.

(4) Where an applicant does not lodge the counter-statement under sub-regulation (3), the application shall be deemed to have been abandoned.

5. Request for further particulars

(1) The Registrar may, where the Registrar requires further particulars in relation to an application or an objection, request an applicant or the person that lodged the objection to provide further particulars within 60 days, in Form V set out in the First Schedule.

(2) A person who fails to provide further particulars as required under sub-regulation (1) shall be deemed to have abandoned that application or objection.

6. Determination of an objection

(1) The Registrar shall, within 60 days of receipt of the counter-statement or further particulars, determine an objection and communicate the decision of the Registrar to the applicant and the person who lodged the objection.

(2) Where the Registrar is of the opinion that an objection ought to be determined by an appropriate institution, the Registrar shall refer the objection to the appropriate institution and notify the parties accordingly.

(3) The appropriate institution referred to in sub-regulation (2) shall determine the objection and communicate its decision to the Registrar within 60 days of receipt of the objection.

(4) The Registrar shall communicate the final decision made under sub-regulation (3) to the applicant and the person who lodged the objection within 14 days of receipt of the decision.

7. Registration of traditional knowledge or expressions of folklore

The Registrar shall, within 30 days of the determination of an objection or within 30 days of the expiry of the period within which to lodge an objection—

(a) approve the application for registration of traditional knowledge or expressions of folklore, if the application meets the requirements of the Act; or

(b) reject the application, if the application does not meet the requirements of the Act and notify the applicant in writing stating the reasons for the rejection.

8. Certificate of registration

(1) The Registrar shall, where the Registrar approves an application for the registration of traditional knowledge or expressions of folklore, issue a certificate of registration in Form VI set out in the First Schedule.

(2) The Registrar shall cause to be entered in the Register the particulars of the registered traditional knowledge or expressions of folklore as provided in the Act.

9. Access to registered traditional knowledge or expressions of folklore

(1) A person who intends to access a registered traditional knowledge or expressions of folklore shall apply to the holder for prior informed consent on terms and conditions that the holder may determine.

(2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule.

(3) The Registrar may on receipt of an application under sub-regulation (2)—

(a) grant prior informed consent if the application meets the requirements under the Act; or

(b) reject the application and notify the applicants in writing stating the reasons for the rejection.

(4) The holder or Registrar may grant prior informed consent in Form VIII set out in the First Schedule.

(5) Where prior informed consent is obtained from the holder, a user shall, on payment of the fee set out in the Second Schedule, submit the prior informed consent to the Registrar for approval in Form IX set out in the First Schedule.

(6) The Registrar shall within 30 days of the receipt of an application under sub-regulation (4)—

(a) approve the prior informed consent if it meets the requirements of the Act; or

(b) reject the prior informed consent if it does not meet the requirements of the Act.

(7) The Registrar shall, in considering whether the holder has given prior informed consent, take the following into consideration—

(a) whether the holder had adequate knowledge of the value of the traditional knowledge or expressions folklore;

(b) whether the holder had sufficient time to consider the application and make necessary consultations; and

10. Application for approval of licensing agreement

(1) A holder who intends to authorise or licence the expressions of folklore may conclude a licensing agreement.

(2) The holder shall, on conclusion of the licensing agreement, apply to the Registrar for approval of the licensing agreement in Form IX set out in the First Schedule on payment of the fee set out in the Second Schedule.

(3) The Registrar shall within 30 days of receipt of the application for approval, approve or reject the licensing agreement.

(4) Where the Registrar rejects the application under sub-regulation (3), the Registrar shall inform the applicant in writing, stating the reasons for the rejection.

PART III
ACCESS TO GENETIC RESOURCES

11. Application for prior informed consent

(1) A person who intends to access genetic resources shall apply to the holder, for prior informed consent on terms and conditions that the holder may determine.

(2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule.

(3) The Registrar shall, within 30 days of receipt of an application under sub-regulation (2)—

(a) grant prior informed consent if the application meets the requirements under the Act; or

(b) reject the application and notify the applicant in writing stating the reasons for the rejection.

(4) The holder or the Registrar, may grant prior informed consent in Form VIII set out in the First Schedule.

(6) The Registrar shall in considering whether the holder has given prior informed consent take the following into consideration—

(a) whether the holder had adequate knowledge of the value of the resources being accessed;

(b) whether the holder had sufficient time to consider the application and make necessary consultations;

(d) where the genetic resource is communally owned, whether the views of the community were taken into account.

(7) On approval of the prior informed consent, the Registrar shall cause the particulars of the prior informed consent contract to be entered in the Register.

12. Access permit or exploration permit

(1) A person who intends to access genetic resources shall apply to the Registrar for an access permit in Form XIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(2) A person who intends to explore genetic resources shall apply to the Registrar for an exploration permit in Form XIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(3) Where the application for an access permit or exploration permit meets the requirements of the Act, the Registrar shall within 14 days of receipt of the application, submit a copy of the application to the appropriate institution for recommendation.

(4) The appropriate institution shall, within 60 days of receipt of the application for an access permit or exploration permit, communicate its recommendations, in writing, to the Registrar.

(5) The Registrar shall, on receipt of the recommendation from the appropriate institution, approve or reject the application for an access permit or exploration permit.

(6) Where the Registrar rejects the application under sub-regulation (5), the Registrar shall inform the applicant, in writing, stating the reasons for the rejection.

(7) Where the Registrar approves an application for an access permit or exploration permit, the Registrar shall issue an access permit or exploration permit in Form XIV and Form XV set out in the First Schedule, respectively.

(8) The Registrar shall cause to be entered in the Register the particulars of the access permit or exploration permit as provided in the Act.

(9) An access permit or exploration permit issued under this regulation shall be valid for a period of two years and may thereafter be renewed annually on the payment of the fee set out in the Second Schedule.

(10) An application for renewal of an access permit or exploration permit shall be in Form XVI set out in the First Schedule and shall be made at least three months before the expiry of the permit.

(11) The Registrar may, in consultation with the appropriate institution and the holder, renew an access permit or exploration permit in Form XVII set out in the First Schedule.

PART IV
GENERAL PROVISIONS

13. Access agreement

(1) A person who intends to access traditional knowledge or genetic resources shall sign an access agreement with the holder.

(2) The holder and user may adopt the model access agreement set out in Form X in the First Schedule.

(3) A user shall apply to the Registrar for approval of the access agreement in Form IX in the First Schedule on payment of the fee set out in the Second Schedule.

(4) The Registrar shall, within 14 days of receipt of the application under sub-regulation (3), cause the access agreement to be published in a newspaper of daily circulation in the Republic or other media.

14. Objection to access agreement

(1) A person may, within 30 days from the date of the publication of the access agreement, lodge an objection with the Registrar in Form III set out in the First Schedule.

(2) Regulations 4, 5 and 6 shall apply to an objection lodged under this regulation, with the necessary modifications.

15. Approval or rejection of access agreement

(1) The Registrar shall, within 30 days of the final determination of the objection to an access agreement—

(a) approve the access agreement if it meets the requirements of the Act; or

(b) reject the access agreement if it does not meet the requirements of the Act.

(2) On approval of the access agreement, the Registrar shall cause the particulars of the access agreement to be entered in the Register.

(3) Where the Registrar rejects the access agreement, the Registrar shall notify the holder and the user of the rejection in writing stating the reasons for the rejection.

16. Alteration, suspension or termination of access agreement

Where the Registrar alters, suspends or terminates an access agreement, the Registrar shall notify the holder and the user in writing.

17. Compulsory licence

(1) Where traditional knowledge or genetic resource that is protected in accordance with the Act, is not being sufficiently exploited by the holder or where the holder refuses to grant access, a person may, on payment of the fees set out in the Second Schedule, apply to the Minister for a compulsory licence in Form XI set out in the First Schedule.

(2) Subject to sub-regulation (1), the Minister may grant a compulsory licence in Form XII set out in the First Schedule.

18. Appointment of agent

(1) A person who intends to engage an agent for purposes of lodging any document under these Regulations with the Agency shall apply to the Registrar for appointment of an agent in Form XVIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(2) Despite sub-regulation (1), a person that ordinarily does not reside in the Republic, shall lodge documents under sub-regulation (1) with the Agency through an agent.

19. Request for information from Register

A person may, on the payment of the fee set out in the Second Schedule, request the Registrar in Form XIX for a copy of a document recorded in the Register or any other particulars from the Register.

20. Notification of change of particulars

(1) A person whose details are registered in the Register or any other register maintained by the Agency shall notify the Registrar of any change in that person's registered particulars.

(2) A notification under sub-regulation (1) shall be in Form XX set out in the First Schedule.

(3) The Registrar on receipt of the notification under sub-regulation (2), enter the changes in the Register.

21. Application for duplicate certificate

A holder may apply to the Agency for a duplicate certificate of registration in Form XXI set out in the First Schedule on the payment of the fee set out in the Second Schedule.

22. Application for amendment or correction of document

A person may apply to the Agency for the amendment or correction of a document lodged with the Registrar in Form XXII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

23. Competent National Authority and National Focal Point

For purposes of the Nagoya Protocol—

(a) the Agency shall be the Competent National Authority responsible for—

(i) grant of access permit under the Act;

(ii) issuance of written evidence that access requirements have been met; and

(iii) giving advice on applicable procedures and requirements for obtaining prior informed consent; and

(b) the Ministry responsible for natural resources shall be the National Focal Point for purposes of providing information on—

(i) procedures for obtaining prior informed consent and establishing mutually agreed terms for applicants seeking to access genetic resources or traditional knowledge associated with genetic resources; and

(ii) appropriate institutions and relevant indigenous and local communities.

24. Fees

The fees set out in the Second Schedule are payable for the matters specified therein.

FIRST SCHEDULE

[Regulations 3, 4, 5, 7, 8, 9, 10, 13, 14, 15, 16, 19, 20 and 21]

FORM I

[Regulation 3(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE
TRADITIONAL KNOWLEDGE EXPRESSIONS OF FOLKLORE (Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO THE REGISTRAR:
Details of applicant
(a) Full names
(b) Nationality
(c) Residential address
(d) Identity number
(e) Mobile number
(f) Email address
Details of holder
(a) Full names
(b) Nationality
(c) Identity number
(d) Email address
(e) Mobile number
(f) Physical address
1. Description of the traditional knowledge expressions of folklore and its associated economic, social scientific, technical, environmental or any other benefit that is likely to accrue to the traditional community or a holder.
...........................................................................................................................................
...........................................................................................................................................
2. Use of the traditional knowledge expressions of folklore (in the traditional context)
...........................................................................................................................................
...........................................................................................................................................
3. I/We function a2(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} expressions of folklore
3. Date ........................
...................................................... Signature of holder/representative
FOR OFFICIAL USE
Application received by: ....................
Date received: .................................

FORM II

[Regulation 3(2)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

NOTICE OF APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

Traditional knowledge Expressions of folklore

NOTICE is given that an application for registration of the traditional knowledge/expressions of folklore

DETAILS OF APPLICATION

1. Type and economic value of traditional knowledge/expressions of folklore

.........................................................................................................................................

2. Registration No. .................................................................................................................

3. Name of applicant ..............................................................................................................

4. Name of holder ..................................................................................................................

5. Location ............................................................................................................................

A person who has an objection to this registration shall lodge the objection, in writing, with the Registrar within sixty days of the date of publication of this notice.

Dated this ............. day of ...................... 20......

...................................
Registrar

FORM III

[Regulations 4(1) and 14(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

NOTICE OF OBJECTION
	TO THE REGISTRAR:
	I/We function a6(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);}
	(a) the registration of traditional knowledge/expressions of folklore
	(b) licensing/assignment
	(c) licensing/assignment
	(d) access agreement
Here insert the reference No. of registration/ licensing/ assignment/ access agreement	which appeared in the ...................................................... of the ......... day of ........................... 20..........., on page number ...................... under the ..... number .....
The grounds of objection are as follows:
(a) .................................
(b) .................................
(c) .................................
	Dated this .... day of .......... 20....

	......................................................... Signature of the person objecting
FOR OFFICIAL USE ONLY
Received by: ................................
Date received: ...............................

FORM IV

[Regulation 4(3)]

(To be completed in duplicate)

Counter-Statement No.: .................

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

COUNTER-STATEMENT TO AN OBJECTION
TO: THE REGISTRAR
Details of application or agreement number
(1) Here insert application or agreement number	IN THE MATTER of application for registration of traditional knowledge/expressions of folklore/access agreement/licensing agreement
Grounds in support of application
(2) Here insert grounds relied on to support application (in case of additional information attach extra sheets)	I/We function a12(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);}...................................................................................................., give notice that the following are the grounds on which I/we function a14(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);}
..................................................................................................................
..................................................................................................................
..................................................................................................................
..................................................................................................................
..................................................................................................................
Allegations admitted
(3) Here insert allegations admitted if any	I/We
..................................................................................................................
..................................................................................................................
..................................................................................................................
(4) Here insert signature of holder/ representative	Dated this .... day of ....... 20..
(4) ............................................ Holder/representative

FORM V

[Regulation 5(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

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