Memorandum of Understanding

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​​An arrangement for the collaborative working relationship between – the Department of Health and the Department of Agriculture

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1. Introduction

1.1 This Memorandum of Understanding (Memorandum) provides a framework for the significant regulatory and policy interactions between:

  1. the Department of Health (Health);
  2. the Department of Agriculture (Agriculture); and
  3. at the time of commencement of an Annex to this Memorandum, any body who signs the Annex in accordance with clause 9 of this Memorandum;

hereinafter referred to as the Parties.

1.2 The Parties may be taken to include the departments (including in relation to Health, the Therapeutic Goods Administration) as well as any portfolio agencies that execute an Annex to the Memorandum. This may include, but is not limited to, the Office of the Gene Technology Regulator, Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority.

1.3 The Parties will work together in the management of regulatory functions that have a direct or indirect impact on human health; such as those related to the import of food and animal products, and management of disease outbreaks and emergencies.

1.4 The purpose of this Memorandum is to:

  1. establish and support the collaborative working relationship between the Parties in their joint administration of legislation;
  2. develop and strengthen practical cooperation in areas including (but not limited to);
    1. the performance of functions and exercise of powers under the Quarantine Act 1908, the Gene Technology Act 2000, the Imported Food Control Act 1992 and the Therapeutic Goods Act 1989;
    2. the prevention and control of outbreaks of pests and diseases that could present a risk to human and animal health;
    3. management of antimicrobial resistance;
    4. management of emerging and zoonotic diseases;
    5. monitoring of imported food for food safety;
    6. regulation of agricultural and veterinary chemicals and veterinary medicines;
    7. regulation of genetically modified organisms; and
    8. implementation of international agreements including (but not limited to) the International Health Regulations (2005) and the World Trade Organization Agreement on the application of Sanitary and Phytosanitary Measures (SPS Agreement).
  3. clarify roles and responsibilities; and
  4. provide flexibility to respond to specific issues that may arise.

1.5 As a principles-based document, the Memorandum sets out the overall framework within which the Parties work together to provide a high level of collaboration, support and service to each other and the Australian Government.

1.6 The cooperative and collaborative intent outlined in this Memorandum reflects the Parties’ desire to:

  1. achieve a consistent approach across Government in areas of joint responsibility; and
  2. achieve the Australian Government’s objectives efficiently and effectively.

2. Roles and Responsibilities

Department of Health

2.1 The matters Health has responsibility for under this Memorandum include:

  1. the performance of functions and the exercise of powers in relation to human biosecurity under the Quarantine Act 1908;
  2. regulation of food and development of food standards;
  3. regulatory and risk assessment advice in relation to human health effects of agricultural and veterinary chemicals;
  4. engagement through appropriate steering/working groups to jointly develop a comprehensive national strategy to respond to antimicrobial resistance;
  5. monitoring and inspections of laboratories that handle Security Sensitive Biological Agents under the National Health Security Act 2007;
  6. regulatory and risk assessment advice in relation to management of human health risks associated with imported goods including biological products;
  7. national coordination of food surveillance, response to food borne disease outbreaks, and food contamination issues;
  8. national coordination of surveillance for and response to outbreaks of communicable diseases;
  9. performing inspections of manufacturers of veterinary medicines on behalf of Agriculture/ the Australian Pesticides and Veterinary Medicines Authority; and
  10. regulation of genetically modified organisms in relation to risks to human health and the environment.

Department of Agriculture

2.2 The matters Agriculture has responsibility for under this Memorandum include:

  1. the performance of functions and the exercise of powers in relation to plant and animal and general biosecurity under the Quarantine Act 1908;
  2. delivery of human biosecurity services at the border under the Quarantine Act 1908;
  3. regulation of agricultural and veterinary chemicals;
  4. engagement through appropriate steering/working groups to jointly develop a comprehensive national strategy to respond to antimicrobial resistance;
  5. auditing and licencing of manufacturers of agricultural and veterinary chemicals and veterinary medicines;
  6. management of imported food under the Imported Food Control Act 1992;
  7. national coordination of the animal health aspects of emerging and zoonotic disease management;
  8. risk assessments of commodities (including Import Risk Analyses), and the granting of import permits for goods to be brought into Australia (including biological products); and
  9. regulation of imports of genetically modified organisms.

3. Collaboration

3.1 The Parties agree to a high level of collaboration, support and service to each other and to the Australian Government and, in a spirit of mutual cooperation, will afford reasonable assistance to each other in doing so.

3.2 The collaborative relationship is based on a commitment to cooperating in the pursuit of common goals. With designated responsibilities and functions to protect Australia from a range of existing and potential threats, the Parties:

  1. respect each other’s different but complementary functions; and
  2. enhance the effectiveness of each other’s activities.

4. Governance Arrangements

4.1 The Parties will engage in annual Senior Executive Service-level meetings to set and monitor the strategic direction and priorities for inter-departmental activity.

4.2 Meetings will be chaired alternately by the Secretary of Health and the Secretary of Agriculture (or their nominated representatives) with secretariat for the meeting being provided by the chair’s department.

4.3 Where necessary, issues may be dealt with out of session by the Secretaries of Health and Agriculture (or their nominated representatives).

5. Communication Strategy and Media

Communication Strategy

5.1 Where a matter involves issues of mutual interest, the Parties may develop agreed protocols and guidelines to provide a common and consistent approach to any communication strategy used to communicate with internal and external stakeholders. This may also include establishing arrangements to use and share resources where appropriate.

Media

5.2 The Parties agree, where practicable, to collaborate on any media releases and communication with the media and third parties which involve issues of mutual interest or issues which concern the other.

5.3 Notwithstanding this clause, the Parties acknowledge that any cooperation with respect to the media remains subject to each Party’s statutory obligations.

6. Ministerial Briefs

6.1 Where a ministerial brief involves a matter affecting both Parties, the Parties agree to (where appropriate) provide relevant information and assistance to each other.

7. Legislative and Policy Change

7.1 The Parties will consult each other on policy or legislative development where it may impact the other, before seeking ministerial approval for the proposed policy or legislation.

7.2 Any joint legislation or policy development will be led by the Party with the most significant responsibility in that area, unless otherwise agreed. Leadership will be agreed prior to the commencement of any work on joint changes.

7.3 Each Party will assist the other wherever possible in relation to the interpretation of legislation and internal policy requirements necessary for meeting obligations under this Memorandum.

8. Financial Arrangements

8.1 Except where expressly otherwise provided for in this Memorandum, an Annex to this Memorandum, or through a separate written agreement, each Party will bear their own costs in fulfilling their commitments under this Memorandum.

9. Annexes

Annexes

9.1 The Parties (which may include the Therapeutic Goods Administration, the Office of the Gene Technology Regulator, Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority) may develop Annexes to support this Memorandum. These Annexes will form part of the Memorandum, when created, in accordance with this clause.

9.2 Each Annex will:

  1. relate to an agreed issue; and
  2. set out an approach for the most effective working relationship required to manage each issue.

9.3 In accordance with this clause, an Annex:

  1. is made under this Memorandum if it is signed by the Secretary of Health, and the Secretary of Agriculture or their nominated representatives or the head(s) of any portfolio agency performing roles described in an Annex; and
  2. commences, unless otherwise specified, on:
    1. the date it is signed by all Parties to the Annex; or
    2. the date the last Party to the Annex signs, where it is not signed by the parties to the Annex on the same day.

9.4 Once an Annex has been made, it may be modified or terminated by a written agreement signed by the Secretary of Health and the Secretary of Agriculture (or their nominated representatives) or the head(s) of any portfolio agency performing roles described in an Annex.

10. Instructional Material

10.1 Each Party may develop its own instructional material to detail the working procedures required to give practical effect to the Memorandum and each Annex.

10.2 Any instructional material must be consistent with the principles outlined in this Memorandum and any relevant Annexes.

10.3 The Parties will consult each other on procedures that will be adopted to implement the Memorandum and Annexes.

10.4 Each Party will make any relevant instructional material available to the other on request.

11. Intellectual Property

11.1 Nothing in this Memorandum is intended to change or affect the ownership of intellectual property of either Party.

11.2 If, at any time, either Party seeks to enter a contractual or other agreement with a third party which could affect the intellectual property rights of either or both Parties, the Parties will consult with each other before doing so.

12. Official Disclosure and Confidentiality

12.1 The Parties agree to, as far as is practicable and within the constraints imposed by or under law:

  1. share relevant information in areas of mutual interest; and
  2. consider any requests for information and consult each other where needed.

12.2 The Parties acknowledge the need to provide appropriate protection and ensure that material is not subject to unauthorised access, interference, use, loss or disclosure at any time.

12.3 Each Party will comply with Commonwealth legislative and policy requirements in relation to official collection, use, storage and disclosure of information; and ensure their officers, employees, consultants and contractors are fully aware of their obligations.

13. Dispute Resolution

13.1 The Parties recognise the importance of communicating issues of concern to each other in a professional manner as a method of improving cooperation between them.

13.2 The resolution of disputes arising under this Memorandum or the Annexes will be based on the following principles:

  1. the Parties will continue to cooperate under this Memorandum while resolving the dispute;
  2. the Parties will initially seek to resolve a dispute within the functional areas of the Party in which the dispute arose;
  3. each Party will ensure it has appropriate mechanisms in place:
    1. for raising a dispute to higher levels of management in the event that the dispute is not resolved by the functional areas; and
    2. to disseminate information regarding resolution of disputes to other areas in the organisation who would benefit from such information.

13.3 If discussions undertaken by functional areas and higher levels of management fail to resolve the dispute, the dispute will be referred to the Secretary of Health and the Secretary of Agriculture for further direction or final resolution.

13.4 Disputes will not be referred to any third party or tribunal.

14. Delegations

14.1 The Secretary of Health may:

  1. sign this Memorandum on behalf of Health or may appoint a nominated representative to do so; and
  2. either generally or otherwise, authorise a person to exercise all or any of his or her powers and functions under this Memorandum.

14.2 The Secretary of Agriculture may:

  1. sign this Memorandum on behalf of Agriculture or may appoint a nominated representative to do so; and
  2. either generally or otherwise, authorise a person to exercise all or any of his or her powers and functions under this Memorandum.

15. Commencement, Duration and Termination

Commencement

15.1 This Memorandum commences on:

  1. the date it is signed by the Parties; or
  2. the date the last Party signs, where the Parties do not sign the Memorandum on the same day.

Duration

15.2 This Memorandum remains in force until it is terminated in accordance with this clause.

Termination

15.3 This Memorandum or any Annex may be terminated at any time, subject to clause 15.4.

15.4 Termination of this Memorandum or any Annex requires a minimum of three (3) months written notice of an intention to terminate or such other notice as agreed.

15.5 The Memorandum may only be terminated by the Secretary of Health or the Secretary of Agriculture, or both.

15.6 Where this Memorandum is terminated:

  1. all Annexes made under it will also cease to have any effect;
  2. the continuation of any joint cooperation activities already commenced prior to termination of this Memorandum will be subject to agreement by the Secretaries prior to the termination taking effect; and
  3. the provisions of this Memorandum concerning costs, security and confidentiality and the settlement of disputes will continue in effect notwithstanding the termination of this Memorandum.

16. Variation

16.1 The Parties acknowledge the importance of ensuring the Memorandum remains relevant to their needs and aspirations. As such, the Parties will consult one another with the aim of making arrangements for the continuing and effective implementation of this Memorandum considering possible variations of this Memorandum as circumstances require.

16.2 Where the Parties agree to vary this Memorandum, any variation will:

  1. be made jointly by the Secretary of Health and the Secretary of Agriculture or their nominated representatives; and
  2. be made by agreement in writing; and
  3. will take effect as specified in clause 16.3.

16.3 Unless otherwise stated, a variation to this Memorandum commences on:

  1. the date it is signed by the Parties; or
  2. the date the last Party signs, where the Parties do not sign the variation on the same day.

17. Review of Memorandum

17.1 The Parties will review this Memorandum every five (5) years from the date on which it commences, or within such other period as agreed by the Parties.

18. Status and Interpretation

Status

18.1 This Memorandum is administrative in nature and does not maintain or govern legal relations or obligations between the Parties. The obligations arising under legislation for the Parties are not affected by this Memorandum.

18.2 Any previous Memoranda of Understanding or agreements entered into by the Parties (or any organisations or entities under the control or administration of the Parties):

  1. will cease to have effect twelve (12) months following commencement of this Memorandum; or-
  2. may be redeveloped into an Annex under this Memorandum.

18.3 Where previous Memoranda of Understanding or agreements referred to in clause 18.2 are inconsistent with this Memorandum, this Memorandum will prevail.

18.4 Any previous agreements between the Parties which include other departments or agencies as parties (i.e. a multi-agency agreement) are not revoked, varied or replaced, and remain in effect.

18.5 The Parties will endeavour to finalise all Annexes within 12 months of the commencement of this Memorandum.

18.6 Each Party will ensure that its officers, employees, consultants and contractors and all other entities that act on its behalf will comply with the requirements established by this Memorandum and Annexes made in accordance with it.

Interpretation

18.7 Unless the contrary intention appears, a term used in this Memorandum has the meaning shown in the table below:

TermDefinition

Annex

means an Annex made in accordance with this Memorandum.

Biological product

means biological materials of human, animal or microbial origin of potential human or animal biosecurity concern.

Biosecurity

means the prevention of the entry, establishment or spread of unwanted pests and infectious disease agents to protect human, animal or plant health or life, and the environment. Biosecurity includes ‘quarantine’ for the purpose of the Quarantine Act 1908.

Commonwealth

means the Commonwealth of Australia.

Information

means data, whether or not processed or analysed, and documents, reports, and other communications in any format, including electronic, or certified or authenticated copies of such data.

Intellectual property

includes all rights in copyright (including rights in relation to phonograms and broadcasts), all rights in relation to inventions, plant varieties, registered and unregistered trade marks, designs and circuit layouts, and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields and any right to registration of such rights existing in Australia or elsewhere, whether created before, on or after commencement of this Memorandum.

Memorandum

means this Memorandum of Understanding on the collaborative working relationship between the Department of Health and the Department of Agriculture.

Variation

means variation and includes amendments, deletions or other changes.

Instructional Material

includes Practice Statements, Departmental Policies, Instructions and Guidelines or any reference material made in accordance with the Memorandum.

19. Signatures

[Signed] at Canberra for and on behalf of the Department of Health, by Prof Jane Halton PSM Secretary

[Signed] at Canberra for and on behalf of the Department of Agriculture, by Dr Paul Grimes PSM Secretary