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Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future

16 July 2012

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The benefits for consumers, health professionals, industry and government

The outcome The benefit
Transparency Clearly communicates TGA's role as a regulator in the health system, and ensures TGA decisions are evidence-based and better understood.
Empowerment Improves access to information that assists consumers in their healthcare decision making.
Confidence Increases consumer and health professionals' confidence in the effective regulation of therapeutic products.
Visibility Increases awareness of the TGA's proactive role as the therapeutic goods regulator—creating 'active transparency'.
Integrity Increases compliance with industry requirements, and the active participation of consumers and health professionals in the safety monitoring system.
Consistency Creates a more consistent approach to regulation across different classes of therapeutic goods.
Efficiency Assists the TGA to realise better productivity in delivering its functions.
Influence Increases recognition of the TGA's scientific expertise and its role in informing scientific debate.
Reputation The TGA's reputation as a trusted and effective regulator is reinforced and enhanced.

A phased approach

The phasing of the Blueprint reforms over four years will:

  • allow the TGA to plan for and deliver early outcomes that will build confidence in the implementation plan and the TGA as it implements the Blueprint reforms;
  • allow effective outcomes of the Blueprint reforms to occur in harmony, or as part of, the TGA's daily business activities, and take advantage of opportunities to embed positive change in its business as usual processes as it occurs;
  • provide milestones for internal and external stakeholders to use to evaluate progress; and
  • provide opportunities to evaluate lessons learned throughout the implementation of the Blueprint reforms, including early achievements or challenges, and make necessary changes to the implementation plan.

The three implementation phases (January-June 2012; July 2012-June 2013 and July 2013-December 2015) are outlined in the figure below.

Three implementation phases: Jan-Jun 2012; Jul 2012-Jun 2013; Jul 2013-Dec 2015

Attachment A provides more detail about the TGA's plan to implement the Blueprint reforms. Attachment B provides an implementation schedule for the plan.

Managing implementation

Implementing the Blueprint reforms will involve six streams of activity:

  1. communication and stakeholder engagement
  2. advertising of therapeutic products
  3. complementary medicines
  4. medical devices
  5. governance and management
  6. organisational change

Streams 1 to 4 correspond to the themes set out in the Blueprint. Streams 5 and 6 are intended to underpin the delivery of the reforms and provide the TGA with capability to deliver, future reforms. All Blueprint reform work streams will be delivered through discreet and definable implementation projects.

Governance

The Government has announced that it will establish an Australian Therapeutic Goods Advisory Council (the Council) to encourage wider community input into the future direction of the TGA, including the implementation of the Blueprint reforms.

The Council will provide advice to the TGA National Manager, including on whether the TGA's Blueprint reform activities are meeting the needs and expectations of consumers, health professionals and the therapeutic goods industry.

Additional governance will be provided by the Blueprint Steering Committee established by the Department of Health and Ageing, which will monitor progress and ensure the implementation plan is delivering the required benefits.

Internally, the TGA Executive Committee will monitor and evaluate the delivery of the implementation plan and ensure the Blueprint reform recommendations, for which the TGA is responsible, are integrated effectively into the TGA's business operations. Separate steering committees have also been established within the TGA management structure to support the delivery of implementation plan streams and projects.

Monitoring implementation

The Office of Program Management has been established within the TGA to support the management of this implementation plan and monitor its progress. The Office will help ensure resources are used optimally and the Blueprint reform projects deliver their intended benefits in a reasonable timeframe. Progress will be reviewed and findings reported and published annually, with incremental results used to progressively inform improvements or refinements to the implementation plan as required.

Funding implementation

The full cost of regulating therapeutic goods is met through cost recovery from the regulated therapeutic goods industry.

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