This content is current only at the time of printing. This document was printed on 28 May 2020. A current copy is located at https://apvma.gov.au/node/19156
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Advisory Board Communiqué – 27 August 2015
The APVMA advisory board met in Canberra on 27 August 2015.
The agenda focussed on seeking advisory board views and advice on draft documents relating to the APVMA’s regulatory science, compliance and international engagement strategies, and a possible structure for advisory arrangements.
Members also received an overview of the APVMA’s priority regulatory projects for 2015 and an update on consideration of further reform initiatives.
Regulatory Science Strategy
The APVMA is currently finalising a consultation draft Regulatory Science Strategy. Members of the advisory board supported the positive, overall direction and adopted format of the draft document. The advisory board advised clarifying some aspects of the Authority’s role and intended pathways, risks to be addressed, measurement of outcomes and terminology.
The advisory board provided comments and advice to assist the APVMA finalise a consultation draft Compliance and Enforcement Strategy including:
- overall support for the themes and strategic directions
- a suggestion to assist stakeholder understanding by further clarifying the APVMA’s compliance role, more information about the overall process and how the strategy will address community expectations
- include consistent terminology and clearer articulation of principles and concepts using examples where available; note legislative requirements for enforcement but seek to promote a culture of voluntary compliance
- consider adding performance measures to measure effectiveness and demonstrate continuous improvement
- clarify how the Authority defines regulatory risk and add the resulting focus areas and priorities to the Annual Compliance Plan.
International Engagement Strategy
The Authority is also currently finalising a consultation draft International Engagement Strategy. The advisory board indicated support for the overall direction of the draft and members’ comments and advice included:
- providing further information about the policy and benefits covering the different types of international engagement
- ensuring consistent terminology and descriptions appropriate for the intended audience.
Advisory Board arrangements
The advisory board was requested for advice on a draft Committee Structure and how the APVMA might structure advisory arrangements should the advisory board be abolished and with regard to streamlining advisory arrangements, the APVMA’s open door consultation policy, existing consultative mechanisms and development of a new stakeholder consultation framework as outlined in the 2015-16 Operational Plan.
Members noted the value of the present advisory board process as a source of independent advice to the CEO and emphasised the importance of a workable alternative that can provide knowledgeable, impartial advice across the regulatory spectrum and also bring forward a diversity of views. Members also noted the need for consultative arrangements to add value, meet the CEOs’ needs, and ensure access and equity for all stakeholders.
The advisory board noted:
- a member relayed stakeholder feedback on the Hendra vaccine labels
- another member noted stakeholder feedback suggesting the need for further guidance regarding interpretation of ‘Confidential Commercial Information’ (CCI) and ‘similar to’ products.
- an update on preparations for the October 2015 stakeholder information sessions to be held in Canberra.
The next meeting will be held in Canberra on 5 November 2015.