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Governance

Under the Public Governance, Performance and Accountability Act 2013 (PGPA Act), the APVMA is a Commonwealth corporate entity. The APVMA is a body corporate with a separate legal identity from the Commonwealth of Australia. The CEO of the APVMA is responsible for the governance and management of the APVMA, with the support of the executive team (see Chapter 2) and the Audit Committee (see below).

The APVMA governance structure aligns accountabilities to ensure decision making delivers best-practice scientific assessment and operational effectiveness. The APVMA CEO is the accountable authority for the purposes of the PGPA Act and is appointed as a statutory officer by the minister. The CEO, who is responsible for the management and governance of the authority together with the APVMA’s executive team, is also responsible for delivering against the performance measures within the Regulator Performance Framework.

The APVMA governance committees (APVMA governance committees) adhere to the principles of public sector governance to provide accountability, transparency, integrity, stewardship, efficiency and leadership.

APVMA governance committees

Group

Description

APVMA Relocation Advisory Committee

This committee provided strategic advice to the executive on major aspects of the relocation and the transition of operations from Canberra to Armidale, including the business model, digital strategy, strategic risk and mitigation, stakeholder issues and engagement. The committee was disestablished on 31 July 2019 following completion of the physical relocation to Armidale.

Executive Leadership Team

The Executive Leadership Team comprises the Senior Executive and is chaired by the CEO. The team provides strategic, whole-of-organisation advice and direction relevant to decision making, management and oversight of the APVMA’s operations and performance.

Senior Leadership Team

The Senior Leadership Team provides a forum for the senior operational managers in the agency to identify opportunities for cross-agency collaboration, innovation and performance improvement, and to develop leadership.

Audit Committee

This subcommittee reports to the CEO. It assists the agency in discharging its responsibilities under the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Public Governance, Performance and Accountability Act 2013 regarding financial reporting, performance reporting, risk oversight and management, internal control and compliance with relevant laws and policies. The committee is not responsible for the executive management of these functions.

Science Quality Committee

This subcommittee reports to the executive team. It advises and provides recommendations on matters of science and science quality relevant to the functions of the APVMA.

Enforcement Committee

This subcommittee reports to the executive team. It oversees the potential and actual use of coercive powers.

Change Management Committee

The board oversees the progress of projects that are significant to the operational direction of the agency, including project deliverables, resourcing requirements, timeframes and management of risks. It also ensures that cross-project opportunities and issues are identified and addressed. This committee took over the responsibilities of, and replaces, the former Major Projects Board, and the Relocation Program Board.

Business Systems and Technology Committee

The forum provides oversight of ICT work identified through the Business System Change Request process for new systems and system enhancements. The committee took over the responsibilities of, and replaces, the former Executive Leadership Team Prioritisation Forum.

The governance structure, senior management support and guidance material support operational effectiveness and help APVMA staff to adhere to the public sector values to be impartial, committed to service, respectful, accountable and ethical.

APVMA guidance material for employees includes policies relating to security, appropriate management of confidential information, financial and procurement practices, use of social media, conflicts of interest, travel, performance management and workplace safety. These policies operate in line with, and in addition to, requirements under the APS Code of Conduct and legislative framework governing the conduct of APS employees. The APVMA undertakes corporate risk management with regular review by executive staff.

The APVMA has a Work Health and Safety Committee and a Staff Consultative Committee to handle employee matters.

APVMA Audit Committee

Consistent with s. 45 of the PGPA Act, the CEO maintains an Audit Committee. The committee met four times in 2018–19. The APVMA Audit Committee is part of the APVMA governance and risk framework. Its terms of reference are to provide independent assurance and advice to the CEO concerning the risk control and compliance framework, the APVMA’s financial and management responsibilities, and performance reporting and external accountability responsibilities.

The committee members include an external independent chair, a representative from an external organisation, and a member of the APVMA executive team. Committee observers and advisers can include representatives from the Australian National Audit Office, the internal auditor, the APVMA CEO, Chief Financial Officer and other management representatives.

Manufacturers’ Licensing Scheme Industry Liaison Committee

The Manufacturers’ Licensing Scheme Industry Liaison Committee (MLSILC) is a forum for the APVMA to discuss with industry representatives and auditors strategic and operational issues relating to the Manufacturers’ Licensing Scheme and the Overseas Good Manufacturing Practice Scheme.

The terms of reference of the MLSILC are to:

  • obtain the views of industry members and auditors on issues of an operational, technical or strategic nature
  • advance the development and review of operating procedures, manufacturing standards and guidelines relevant to the Australian Manufacturers’ Licensing Scheme and the Overseas Good Manufacturing Practice Scheme
  • ​provide industry input into APVMA operational planning processes relating to manufacturing issues
  • identify opportunities for regulatory reform within the existing framework
  • consider the effect of proposed policy changes on APVMA operations, and implications for industry
  • facilitate communication with industry and other stakeholders.

Meetings and attendance

The committee met twice in 2018–19: in September 2018 and March 2019. Figures for membership and attendance at MLSILC meetings are shown in Attendance at Manufacturers’ Licensing Scheme Industry Liaison Committee meetings, 2018–19.

Attendance at Manufacturers’ Licensing Scheme Industry Liaison Committee meetings, 2018–19

Representative

Member organisation

Meetings eligible to attend

Meetings attended

Michelle Wooster (Chair)

APVMA

2

2

Garry Hartridge (Secretary)

APVMA

2

2

Maggie Hardy, Chief Regulatory Scientist

APVMA

1

1

Martin Snowball

Animal Medicines Australia Ltd

2

2

Noelene Davis

Feed Ingredients and Additives Association of Australia

2

1

Ian Wheatley

Auditors’ representative

1

1

Tony Rowland

Auditors’ representative

1

0

Jim Adams

Veterinary Manufacturers and Distributors Association

2

2

Issues considered

Issues considered in 2018–19 included:

  • consultation for the proposed revision of the Australian Code of Good Manufacturing Practice
  • update on the changes to audit scheduling based on risk rating
  • successful recruitment of new auditors
  • the possibility of adopting a first-party audit model for European Community—Australia Mutual Recognition Agreement certificates
  • update on implementation of the memorandum of understanding (MOU) between the APVMA and the Therapeutic Goods Administration, and information on service-level agreements included in the MOU
  • the APVMA’s cost-recovery model for manufacturing licences
  • use of ‘Objective Connect’ by auditors and its possible extension to industry as a replacement for secure email
  • update on the Manufacturing Quality and Licensing team structure and staff transition
  • accreditation of audits conducted to FAMI-QS (Feed Additive and Pre-Mixture System) standards and their recognition by the APVMA.

Declarations of conflicts of interest

There were no matters declared by any member of the MLSILC that would give rise to any personal material conflict of interest. The APVMA maintains records of declarations.

Science Quality Committee

The Science Quality Committee is a subcommittee reporting to the APVMA CEO and executive team. The committee provides advice and makes recommendations related to matters of science and science quality relevant to the functions of the APVMA.

The objectives of the committee are to:

  • provide a forum for open debate of scientific issues relevant to the function of the APVMA
  • foster and encourage regulatory scientific excellence in the APVMA
  • approve and prioritise proposals for development and adoption of scientific methodologies
  • test guidelines and guidance documents by the APVMA and partner advising agencies.

Related entity transactions

The APVMA contracted the Department of Environment to provide environmental scientific assessment advice during 2018–19. During 2018–19, there were 11 individual transactions totalling $114 000.