Circular No. 15/2019/TT-BTNMT stipulates on the organization and operation of the Appraisal Board for the application to access genetic resources for commercial research and product development.

                MINISTRY OF NATURAL RESOURCES AND ENVIRONMENT                                     SOCIALIST REPUBLIC OF VIET NAM
                                                                                                                                          INDEPENDENCE - FREEDOM - HAPPINESS

                         No.: 15/2019/TT-BTNMT                                                                  Hanoi, September 11, 2019

CIRCULAR

REGULATIONS ON THE ORGANIZATION AND OPERATIONS OF THE BOARD FOR REVIEWING APPLICATIONS FOR GENETIC RESOURCE ACCESS PERMITS FOR COMMERCIAL RESEARCH AND DEVELOPMENT OF COMMERCIAL PRODUCTS
issue a Permit to access genetic resources for research purposes with a view to commercial utilization,
develop commercial products

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Pursuant to the Law on Biological Diversity No. 20/2008/QH12 dated November 13, 2008;

Pursuant to the Government Decree No. 59/2017/NĐ-CP dated May 12, 2017 on management of access to genetic resources and sharing benefits arising from the utilization of genetic resources;

Pursuant to Decree No. 36/2017/NĐ-CP dated April 4, 2017 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Natural Resources and Environment;

At the proposal of the General Director of the Environment Administration and the Director of the Legal Department;

The Minister of Natural Resources and Environment promulgates this Circular detailing the organization and operations of the Board for reviewing applications for Genetic Resource Access Permits for commercial research and development of commercial products,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular details Clause 5, Article 13 of the Government Decree No. 59/2017/NĐ-CP dated May 12, 2017 on management of access to genetic resources and sharing benefits arising from the utilization of genetic resources within the licensing authority of the Ministry of Natural Resources and Environment.

Article 2. Applicability

This Circular applies to state management agencies for the environment and biodiversity, and organizations and individuals involved in the review of applications for Genetic Resource Access Permits for commercial research and development of commercial products.

Article 3. Functions, tasks, and powers of the Board for reviewing applications for Genetic Resource Access Permits for commercial research and development of commercial products

1. The Board for reviewing applications for Genetic Resource Access Permits for commercial research and development of commercial products (hereinafter referred to as the Board) shall be established by the Minister of Natural Resources and Environment for each application for a Genetic Resource Access Permit for commercial research and development of commercial products according to the model prescribed in Appendix No. 01 issued together with this Circular.

2. The Board shall have the function of advising the Minister of Natural Resources and Environment on the examination of applications for Genetic Resource Access Permits for commercial research and development of commercial products (hereinafter referred to as the Application).

3. Activities of the Board shall be carried out through the Permanent Review Agency for Applications for Genetic Resource Access Permits for commercial research and development of commercial products (hereinafter referred to as the Permanent Review Agency). Responsibilities of the Permanent Review Agency are stipulated in Article 9 of this Circular.

4. The Board has the right to request the Permanent Review Agency to provide information, documents, and issues related to the Application for study and review.

5. Members of the Board work on a part-time basis and are entitled to remuneration in accordance with current laws.

6. The Board shall dissolve itself upon completion of its tasks.

Article 4. Principles of Operation of the Council

1. The board operates based on the principles of collective discussion, transparency, voting, and decision-making by majority.

2. Opinions of each member of the Board and the Board's review opinion shall be recorded in the minutes of the Board meeting according to the model prescribed in Appendix No. 02 issued together with this Circular.

3. The Board concludes at one of three levels:

a) Agree to approve: when at least two-thirds of the members of the Board have agreed to approve, including at least one Member of the Counterpart Committee;

b) Agree to approve with conditions for revision and supplementation: when at least two-thirds of the members of the Board have agreed to approve or agree to approve with conditions for revision and supplementation, including at least one Member of the Counterpart Committee;

c) Disagree to approve: when more than one-third of the members of the Board have disagreed to approve or both Members of the Counterpart Committee have disagreed to approve.

Chapter II

ORGANIZATION AND OPERATIONS OF THE BOARD

Article 5. Organizational Structure of the Council

The Board consists of seven to nine members, the total number of members must be odd, including:

1. The Chairman of the Board is a leader of the Ministry of Natural Resources and Environment or a leader of the Permanent Review Agency.

2. The Vice-Chairman and Secretary of the Board are civil servants of the Permanent Review Agency.

3. Members include representatives of the Ministry of Agriculture and Rural Development; relevant Ministries; People's Committees of provinces where the activities of accessing genetic resources take place; and experts and scientific staff with appropriate expertise.

Article 6. Responsibilities and Authorities of Council Members

1. Council Member:

a) Review, study, evaluate the contents of the dossier and related documents provided by the Standing Office for examination;

b) Participate in Council meetings; in case of absence from the Council meeting, it is responsible for submitting comments on the dossier to the Standing Office for examination at least one working day before the meeting takes place;

c) Write comments and fill out the evaluation form according to the model prescribed in Appendix No. 03 and Appendix No. 04 issued together with this Circular; present the comments at the Council meeting;

d) Express opinions during the Council meeting; reserve opinions in cases where there are differing views from the Council's conclusion;

đ) Write comments on the dossier that has been revised and supplemented following the Council meeting upon request in writing from the Standing Office for examination;

e) Participate in activities related to the Council's operations when requested by the Chairman of the Council or the Standing Office for examination;

g) Be responsible before the Standing Office for examination and before the law for comments and evaluations on the dossier and the assigned work content during the examination process; ensure confidentiality of information contained in the dossier and the examination process as stipulated by law, and return the documents when requested by the Standing Office for examination after completing the task;

2. Chairman of the Council:

In addition to the responsibilities and authorities of Council Members as stipulated in Clause 1 of this Article, the Chairman of the Council also has the following responsibilities and authorities:

a) Decide to convene Council meetings;

b) Chair Council meetings in accordance with Article 8 of this Circular;

c) Handle opinions raised during Council meetings; conclude the Council meeting and be responsible for the conclusions of the Council;

d) Sign the minutes of Council meetings and be responsible for the completeness and truthfulness of the contents recorded in the minutes of Council meetings;

3. Deputy Chairman of the Council:

In addition to the responsibilities and authorities of Council Members as stipulated in Clause 1 of this Article, the Deputy Chairman of the Council also has the responsibilities and authorities of the Chairman of the Council when authorized by the Chairman of the Council;

4. Council Member representing the People's Committee of the province where the access to genetic resources activity takes place:

In addition to the responsibilities and authorities of Council Members as stipulated in Clause 1 of this Article, the Council Member representing the People's Committee of the province where the access to genetic resources activity takes place also has the responsibility to provide the Council with relevant information and documents about the genetic resources proposed to be accessed locally; be responsible for the information and documents provided to the Council;

5. Council Secretary:

In addition to the responsibilities and authorities of Council Members as stipulated in Clause 1 of this Article, the Council Secretary also has the following responsibilities and authorities:

a) Provide comment models and evaluation forms for the Council members;

b) Before the Council meeting, report to the Chairman of the Council on the main contents of the dossier based on self-study and synthesis of opinions from Council members;

c) Inform the Council of the comments from absent Council members;

d) Record and sign the minutes of the Council meeting, be responsible for the completeness and truthfulness of the contents recorded in the minutes of Council meetings;

đ) Prepare supporting documents for settlement of expenses for Council activities;

e) Perform other tasks serving the Council's operations as required by the Chairman of the Council and the Standing Office for examination;

Article 7. Conditions for convening a meeting of the Council

The Council meeting shall be held when the following requirements are met simultaneously:

1. The presence of the Chairman of the Council or the Deputy Chairman of the Council authorized by the Chairman of the Council to chair the meeting in the absence of the Chairman of the Council;

In case the Council Secretary is absent for a valid reason, the meeting chairperson designates one Council member to perform the duties of the Council Secretary during the meeting and hand over the results to the Council Secretary;

2. Participation of at least two-thirds of the total number of Council Members as decided upon establishment and at least one opposing member;

3. Participation of representatives with authority of organizations or individuals requesting the issuance of a Genetic Resources Access Permit or persons authorized in writing.

Article 8. Procedure for convening the Council meeting

1. The Secretary member reads the decision to establish the Council, introduces the participants, and presents a summary of the file processing process.

2. The Chairman of the Council manages the meeting according to the authority prescribed in Clause 2, Article 6 of this Circular.

3. The authorized representative of the organization or individual requesting the Permit to access genetic resources or the person appointed in writing presents the main contents of the file.

4. Members of the Council may request clarification on the presented contents or ask questions; the authorized representative of the organization or individual requesting the Permit to access genetic resources or the person appointed in writing responds and provides additional information.

5. Council members present their comments and evaluations of the file; the Secretary member reads the comments of absent Council members (if any).

6. Delegates attending the meeting may make statements (if any).

7. The Council may meet separately (at the Chairman's discretion) to unify the content of the Council's conclusion.

8. The Chairman of the Council announces the Council's conclusion.

9. Council members may speak if they have opinions differing from the Chairman's conclusion.

10. The authorized representative of the organization or individual requesting the Permit to access genetic resources or the person appointed in writing may make statements (if any).

11. The Chairman of the Council declares the end of the meeting.

Article 9. Responsibilities of the Permanent Office for Appraisal

1. The Environmental Protection Agency is assigned as the Permanent Office for Appraisal.

2. The Permanent Office for Appraisal has the following tasks:

a) Drafts and submits to the Minister of Natural Resources and Environment for issuance of the decision to establish the Council;

b) Requests organizations or individuals requesting the Permit to access genetic resources to provide additional related documents when necessary and sends them to Council members within five working days from the date of the decision to establish the Council;

c) In cases where necessary, selects domestic and international organizations or individuals with relevant expertise to provide written opinions on the file;

d) Reports the results of file processing and proposes to the Chairman of the Council to convene a Council meeting;

đ) Organizes Council meetings according to the procedures stipulated in Article 8 of this Circular; notifies and invites Council members and representatives of organizations or individuals requesting the Permit to access genetic resources to attend the Council meeting;

e) Notify in writing the Council's conclusions to the organization or individual requesting the issuance of a Permit to Access Genetic Resources;

g) Reviews and checks the file that has been revised and supplemented according to the Council's conclusions; if necessary, sends a document requesting some Council members to comment on the file after revision;

h) Drafts a report on the appraisal results of the file to submit to the Minister of Natural Resources and Environment for consideration and decision on issuing the Permit to access genetic resources;

i) Settles accounts for expenses serving the activities of the Council in accordance with the provisions of the law;

k) Manages and retains files and documents related to Council meetings;

l) Performs other tasks assigned by the Ministry of Natural Resources and Environment related to the process of appraising and issuing the Permit to access genetic resources.

Chapter III

IMPLEMENTING PROVISIONS

Article 10. Effective Date

This Circular takes effect from October 28, 2019.

Article 11. Responsibility for Implementation

1. The Environmental Protection Agency is responsible for guiding, inspecting, and monitoring the implementation of this Circular.

2. Ministries, agencies at the ministerial level, provincial People's Committees, provincial Departments of Natural Resources and Environment under central cities, and related organizations and individuals are responsible for implementing this Circular./.