Structure, governance and accountability arrangements for the new Authority
Australia and New Zealand – working together to safeguard public health and safety both now and into the future
Fact sheet
January 2007
What are the key governance and accountability arrangements?
Two key goals have guided the design of the governance framework of the new Authority and the joint regulatory scheme that it would administer:
- Ensuring that the New Zealand and Australian Ministers have an equal say in the oversight of the Authority and in the content and operation of the proposed regulatory framework; and
- Ensuring that that the new Authority is equally accountable to the Ministers, the Australian and New Zealand Parliaments, and the public in both countries.
The Authority will be
- Required to provide an annual report, a statement of intent and other accountability documents equivalent to those that apply to a New Zealand Crown entity and a Commonwealth authority in Australia, which will be tabled in each Parliament;
- Required to appear before Select Committee in New Zealand; for example, for financial reviews or inquiries;
- Subject to scrutiny of its regulatory decisions by the courts, through a merits review process and judicial review; and
- Subject to other legislative requirements in both countries; e.g. Official Information/Freedom of Information Acts, Privacy Acts, Ombudsmen Acts, and scrutiny by Auditors-General.
How will the Authority be established?
The Authority is to be established under an international agreement, a Treaty signed between New Zealand and Australia in December 2003. 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 (pdf,79kb) has the effect of an agreement to work to towards the establishment of the new Authority and the proposed joint regulatory scheme. The Treaty also sets out the governance and accountability arrangements and ensures an equal voice for each country in the setting up and running of the new Authority.
There will be two separate but aligned Bills introduced into the New Zealand and Australian Parliaments to implement the scheme. Once the legislation is passed in both countries, the Treaty will be ratified and come into force. As it does so, it will establish the Ministerial Council and the Board of the Authority. It will also allow the regulatory details, or the Rules and Orders, to be formally made.
What are the Rules and Orders?
Much of the detail of the joint regulatory scheme will be contained in the Rules and Orders. The Rules will be similar to regulations and the Orders will contain the more technical detail of the regulatory scheme. Public consultation is underway on the Rules.
Rules will be made by the Ministerial Council and the Orders will be made by the Managing Director and tabled in both the New Zealand and Australian Parliaments where they will be subject to scrutiny and disallowance. If Rules or Orders are disallowed by either country’s Parliament, they will cease to have effect for both countries.
What governance framework will be in place for the new Authority and Scheme?
The key measures, as agreed under the Treaty, that will oversee the running of the proposed joint regulatory scheme will be:
- A new trans-Tasman agency – the Australia New Zealand Therapeutic Products Authority (ANZTPA)
- A 2-member Ministerial Council made up of the Australian and New Zealand Ministers of Health; and
- A 5-member Board of the Authority which will include the Managing Director of the Authority.
What is the role of the Ministerial Council?
A Ministerial Council, comprising the New Zealand Health Minister and the Australian Health Minister, will oversee the running of the Authority and the joint scheme. This arrangement ensures that each country has an equal voice and oversight in the joint regulatory scheme.
The Ministerial Council will be responsible for:
- Ensuring the Authority is equally accountable to the governments of New Zealand and Australia;
- Making the Rules of the joint regulatory scheme;
- Appointing the members of the Authority's Board;
- Establishing and appointing members to the Authority’s expert advisory committees; and
- Appointing members of the Merits Review Panel.
How will the Board be appointed?
There will be five members on the Board appointed by agreement of the Ministerial Council. The Board will comprise:
- The Chair and the Managing Director of the Authority;
- A member with broad commercial expertise;
- A member with broad experience in public health and regulatory matters in New Zealand; and
- A member with broad experience in public health and regulatory matters in Australia.
The Board will be responsible to the Ministerial Council for the governance of the Authority. The Board won’t be responsible for the Authority's regulatory functions.
The Authority will be headed by a Managing Director, who will be responsible to the Board for the management of the Authority. The Managing Director will perform the regulatory functions on behalf of the Authority. The Managing Director will be appointed by consensus agreement of the Ministerial Council.
What are the Authority's accountability arrangements?
In New Zealand the new Authority’s accountability framework will be similar to any other Crown owned entity. For Australia, the new Authority's accountability framework will be similar to that applying to any other Commonwealth statutory authority.
The Authority will be:
- Required to provide an annual report and statement of intent and other accountability documents equivalent to those of a Crown entity or Commonwealth authority, which will be tabled in Parliament in New Zealand and in Australia;
- Required to appear before Select Committee in New Zealand; for example, for financial reviews or inquiries;
- Subject to scrutiny of its regulatory decisions by tribunals and courts in each country, through a merits review process and judicial review; and
- Subject to other legislative requirements in both countries; e.g. Official Information/Freedom of Information Acts, Privacy Acts, Ombudsmen Acts, and scrutiny by Auditors-General.
Can regulatory decisions made by the Authority be subject to a review?
Yes. Decisions made by the Authority for approvals to manufacture, supply, import, export or promote a therapeutic product could be subject to a two-stage merits review process.
The Authority can be asked to undertake an internal review of a decision and if a person were dissatisfied with the outcome of that review, they could request to have the matter referred to an independent Trans-Tasman Merits Review Tribunal in either country.
Tribunal members will be drawn from a Merits Review Panel to be appointed by the Ministerial Council. In Australia, the Australian Administrative Appeals Tribunal will act as the Tribunal. New Zealand will set up its own body to act as the New Zealand Tribunal.
There will be a right of appeal from a Tribunal decision on questions of law to the requisite Court in the country where the review was conducted. Decisions of a Merits Review Tribunal or a Court in one country will have effect in the other country.
Would the proposed joint regulatory scheme be subject to judicial review?
Yes. Existing Australian and New Zealand judicial review processes will be adapted to accommodate the proposed joint regulatory scheme. For the purposes of the joint regulatory scheme, decisions made by the High Court of New Zealand or the Federal Court of Australia would be effective in both countries.
Will Australian and New Zealand consumers and industry be able to influence the operation of the Authority?
Yes. Australian and New Zealand consumers, industry and other stakeholders will be able to provide input into aspects of the Authority’s operation because the Authority will be accountable to the Australian Minister for Health and Ageing, the New Zealand Minister of Health and to the Australian and New Zealand Parliaments; companies and consumers would be able to raise any issues with their Minister or with their Member of Parliament.
Is the model for the ANZTPA different from the trans-Tasman food standards model?
Yes. The model for the therapeutic products Authority is different from the Food Standards model. The governance structures of Food Standards Australia New Zealand do not provide for an equal voice for New Zealand.
By contrast, Australia and New Zealand will be equal partners in the governance and control of the Australia New Zealand Therapeutic Products Authority (ANZTPA). The new Authority will be subject to similar (and no lesser) accountability requirements than is currently the case for New Zealand's Medicines and Medical Devices Safety Authority, Medsafe, and the Australian Therapeutic Goods Administration (TGA). These arrangements have been agreed under the international agreement or Treaty.
URL: http://www.anztpa.org/about/fs-structure.htm