Australia New Zealand
Therapeutic Products
Authority

Information last updated: October 2002
URL: http://www.anztpa.org/about/
   0210costbenefit.htm

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Assessment of regulatory options for therapeutic products

Report to the trans-Tasman working group

NZ Institute of Economic Research (Inc.)

October 2002

This report assesses the impacts of:

• extending the regulation for complementary healthcare products and medical devices in New Zealand; and
• establishing a single regulatory regime across New Zealand and Australia for all therapeutic products, including pharmaceuticals. ('Pharmaceuticals' covers prescription and over-the-counter medicines, including biological products.)

See below for the terms of reference of this study and for a list of the contents of the report.

Report

This report is available in pdf and rich text format.

• Assessment of regulatory options for therapeutic products - Report to the trans-Tasman working group (October 2002) (pdf, 437kb)
• Assessment of regulatory options for therapeutic products - Report to the trans-Tasman working group (October 2002) (zipped rich text format, 89kb)

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Contents of the report

• Executive summary

1. Introduction
   • 1.1 Purpose
   • 1.2 Current regulatory regime
   • 1.3 Context
   • 1.4 Previous report
   • 1.5 Caveats
2. Analytical framework
   • 2.1 Methodology
   • 2.2 Business compliance costs
3. Problem definition
   • 3.1 Risk
   • 3.2 Efficient use of scarce regulatory resources
   • 3.3 Resolving the special exemption on TTMRA
4. Objectives
   • 4.1 Health objectives
   • 4.2 Wider social and economic objectives
5. Regulatory options
   • 5.1 Options for New Zealand
6. Key Methods and Assumptions
   • 6.1 Basic approach
   • 6.2 Number of product licences
   • 6.3 Regulatory Agency Costs
   • 6.4 Business compliance costs
   • 6.5 Total administrative and compliance costs
   • 6.6 Transition costs
7. Cost Benefit Assessment
   • 7.1 Option 1: Status Quo
   • 7.2 Option 2: Enhanced Medsafe
   • 7.3 Option 3: Unilateral Recognition
   • 7.4 Option 4: Joint Therapeutic Agency
8. Conclusions

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Terms of reference of the cost benefit study of the proposed joint trans-Tasman therapeutic products agency being undertaken by the New Zealand Institute of Economic Research

August 2002

The New Zealand Institute of Economic Research (NZIER) is undertaking a cost-benefit assessment of the proposed joint Agency. The report of the study will be published on this website once completed - towards the end of 2002.

The terms of reference for the work being undertaken by NZIER (the contractor) are that:

The services to be provided under the Agreement shall take place in two phases.

Phase 1

During phase 1 the Contractor will:

• Conduct a review of the information used by the Contractor to prepare its initial impact assessment on the proposal to establish a joint therapeutic goods regulator (JTA) (dated October 2000).
• After completing this review the Contractor will identify the information it requires to perform the services under this Agreement and will:
  • Update existing data held by the Contractor where this is necessary for performing the services to the expected quality standards for phase 1 and phase 2.
  • Identify additional or new sources of data required for performing the services to the expected quality standards for phase 1 and 2, where such data exists or is capable of compilation within the timeframes available to perform the services.
• Consult with the trans-Tasman officials Working Group (which comprises staff from Medsafe and the TGA) and other government agencies nominated by the Manager, to gain further clarification of the most likely organisational model for the JTA, and any alternative scenarios for the regulation of therapeutic goods including, New Zealand adopting a unilateral recognition model for approving therapeutic goods.
• Consult with government agencies and industry groups to identify the costs and benefits and their incidence with a JTA compared to the following counterfactuals:
  • For Australia: the continuation of current Australian regulatory arrangements, with a permanent exemption from the trans-Tasman Mutual Recognition Arrangement.
  • For New Zealand:
    1. The adoption of a new regulatory framework similar to that proposed for the JTA and local evaluation of products to international standards; or
    2. The adoption of a system based on the unilateral recognition of products approved by other regulatory authorities who were themselves working to a regulatory framework similar to that proposed for the JTA; or
    3. The status quo.
• Identification of any outstanding issues, information gaps or risks relevant to Phase Two of the project and how these will be addressed.

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