About the trans Tasman therapeutic products agency project

What is the project about?

The trans Tasman therapeutic products agency project has involved New Zealand and Australia giving consideration to establishing a joint agency to regulate therapeutic products (medicines, medical devices and complementary medicines/dietary supplements that have therapeutic uses) in both countries.

The decisions of the Australian and New Zealand Governments to establish a trans Tasman agency to regulate therapeutic products have moved the project into a new phase. This phase of the project sees the development of the final details of the regulatory framework and the legislation underpinning the joint agency, the treaty between Australia and New Zealand, and the transitional arrangements to create a new agency.

Text of the treaty: Agreement between the Government of Australia and the Government of New Zealand for the establishment of a joint scheme for the regulation of therapeutic products (pdf, 79kb)

Other documents relating to the treaty

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Why are we establishing a trans Tasman therapeutic products agency?

The key objectives in establishing the Agency are to:

Establish a trans Tasman regulatory scheme for therapeutic products that will safeguard public health and safety in Australia and New Zealand by regulating therapeutic products and maintain an effective and sustainable regulatory capacity in both countries; and

Resolve the special exemption for therapeutic products under the Trans Tasman Mutual Recognition Arrangement (TTMRA) in a manner that facilitates trans Tasman trade and enhances Closer Economic Relations between Australia and New Zealand.

The establishment of a trans Tasman agency is also likely to lead to closer cooperation between countries and regulators in the Asia-Pacific region.

Trans Tasman Mutual Recognition Arrangement

The TTMRA is an arrangement between the Australian Commonwealth, State and Territory governments and the government of New Zealand. The TTMRA seeks to remove regulatory barriers and facilitate trade between Australia and New Zealand.

The differences between the New Zealand and Australian systems for regulating therapeutic products were sufficient to necessitate a special exemption to the TTMRA that allowed officials time to assess options to resolve the need for a special exemption.

The options identified for resolving the special exemption were mutual recognition, permanent exemption and harmonisation of regulatory systems.

Australian and New Zealand Health Ministers agreed that harmonisation of regulatory systems was likely to be the best option. The establishment of a trans Tasman therapeutic products agency will deliver a harmonised approach with the flow on benefits of lowering trade barriers between Australia and New Zealand and enhancing CER.

Regulatory capacity

Regulatory Impact Assessments undertaken by the New Zealand Institute of Economic Research (NZIER) in 2000 and 2002 confirmed that New Zealand's current system for regulating therapeutic products is not sustainable. New Zealand does not have sufficient capacity in terms of technical expertise to continue to evaluate the risks and benefits of increasingly complex high risk products (such as medicines of biological origin). Such expertise is in demand internationally and is scarce in some disciplines. Australia may face a similar challenge to its regulatory capacity in the longer term.

National Interest Analysis on the Agreement Between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products (March 2004)

New Zealand Regulatory Impact Statement (September 2003)

New Zealand Regulatory Impact Statement on a proposal for a trans Tasman agency to regulate therapeutic products (November 2002)

Assessment of regulatory options for therapeutic products - report to the trans-Tasman working group (October 2002)

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What will form the basis of the new agency?

The new Agency will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and be accountable to the Australian and New Zealand Governments. It will be recognised in law in both Australia and New Zealand and assume responsibility for the regulatory functions currently undertaken in both countries.

What will the agency do?

The role of the Agency will be to safeguard public health and safety through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand.

The regulatory activities of the agency will include:

pre-market evaluation and assessment;

product licensing;

controls on manufacture;

post-market monitoring and surveillance; and

setting standards.

A risk-based approach will be taken so that the level of regulation is commensurate with the level of risk associated with the products.

What are the advantages of having a trans Tasman therapeutic products agency?

The Agency has a number of benefits for both countries. The Agency will:

assist in creation of a single market for therapeutic products;

facilitate trade and reduce compliance costs by replacing dual regulatory processes with harmonised regulatory requirements;

strengthen each country's regulatory capacity to meet a new wave of innovative therapeutic products which are being driven by emerging technologies and globalisation; and

ensure consumers have early access to new products entering the market, while maintaining confidence in public health and safety.

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How will the agency be set up?

The Agency will:

have a distinct legal identity and be recognised in the legislation of both countries;

be established, and operate, in accordance with key principles set out in a Treaty between the two countries;

be directly accountable to both Ministers and to both Parliaments;

deliver common regulatory outcomes and have the authority to implement and enforce laws in both countries;

operate subject to the ability of either country to depart from the joint regulatory scheme. This will apply in extraordinary circumstances, under agreed criteria and within agreed timeframes and will include a process for the future resolution of issues that have led to a separate decision; and

be subject to common regulatory review and appeal mechanisms that are suitable for therapeutic products and provide access for industry in both countries.

The Agency will be overseen by a two-member Ministerial Council comprising the New Zealand Minister of Health and the Australian Health Minister. The Agency will also have a five member Board. A Treaty will establish the Ministerial Council and the Board of the agency. The Board will be responsible for the strategic direction and financial management of the Agency. One of the Board members, the Managing Director, will be responsible for regulatory decisions about therapeutic products and for the day to day management of the Agency. The Board and the Managing Director will be appointed by the Ministerial Council.

The framework for the regulatory scheme administered by the Agency will be set up under the Treaty and implemented through Acts of Parliament in both countries, a single set of Rules made by the Ministerial Council, and technical Orders made by the Managing Director.

Accountability arrangements

It has been agreed that a fundamental requirement for the joint agency must be that the Agency has no lesser accountability to Ministers, Parliaments, industry and the public than is currently the case for Medsafe and the TGA. Work continues on further defining accountability requirements for the Agency, such as:

procedures for appropriate stakeholder input into, and parliamentary scrutiny of, initial and subsequent legislation, including Rules and Orders;

review of regulatory decisions;

annual, corporate and financial planning;

access to official information;

privacy requirements; and

human rights/anti-discrimination regimes.

Stakeholder consultation

Since 1998 there has been extensive consultation with industry, health professionals and consumer groups on the proposal to establish a joint therapeutic products agency. Consultation will continue with key stakeholders, especially on the final proposals for the establishment and implementation of a joint regulatory scheme.

Discussion documents and other reports and documents designed to keep stakeholders informed on developments towards the establishment of a joint agency can be found on this website. Stakeholders should regularly check the website for new information and updates on progress towards establishing the trans Tasman agency.