Questions & answers about the joint therapeutic products agency project
June 2003
- What is the Joint Agency and what will it do?
- What are the implications of establishing a joint agency?
- What will be the institutional arrangements for the joint agency?
- What might be the implications for Australian and New Zealand industry?
- What might be the implications for Australian and New Zealand consumers?
1. What is the Joint Agency and what will it do?
Why are we establishing a trans Tasman therapeutic products agency?
The key objectives in establishing the agency are to:
- Maintain an effective and sustainable regulatory capacity to manage risks to public health and safety arising from the use of therapeutic products; and
- Resolve the special exemption for therapeutic goods 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.
Forming a joint agency will help both countries with the regulatory capacity issues that confront therapeutic product regulators around the world. It is also likely to lead to closer co-operation between countries and regulators in Asia-Pacific region.
What will form the basis of the new joint 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 joint agency be responsible for?
The role of the joint agency will be to safeguard public health and safety through regulation of the quality, safety and efficacy of therapeutic products in both Australia and New Zealand. Products will be regulated in a timely manner according to the level of risk posed to consumers.
The regulatory activities of the agency will include:
- pre-market evaluation and assessment;
- product licensing;
- post-market monitoring and surveillance;
- licensing of manufacturers; and
- setting of standards.
When will the joint agency begin operation?
The agency is due to commence operations in mid 2006.
2. What are the implications of establishing a joint agency?
What are the advantages of having a trans Tasman therapeutic products agency?
The joint agency has a number of benefits for both countries. The joint agency will:
- create a single market for therapeutic products;
- facilitate trade and reduce compliance costs by replacing dual regulatory processes with single product approval 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.
What changes can we expect to the regulation of medicines and medical devices under a joint agency?
New legislation and a new rule book will be developed for the joint agency. The regulatory scheme will apply international best practice in the regulation of therapeutic products. There will be no lowering of existing standards for therapeutic products.
- Australia and New Zealand already regulate prescription and OTC medicines in a similar manner. The joint regulatory scheme will not bring about significant changes in the approach to the regulation of these medicines.
- There are currently no pre-market requirements for medical devices in New Zealand. Australia has a well-developed regulatory scheme based on the Global Harmonisation Task Force (GHTF) framework. Under the joint agency, the regulatory scheme for medical devices would be substantially the same as that currently operating in Australia.
- Most complementary medicines are sold as dietary supplements in New Zealand, under food legislation. There are no pre-market registration requirements and few standards for dietary supplements. It is not permissible to make a therapeutic claim relating a dietary supplement. If they are regulated under the joint agency, therapeutic-type dietary supplements will be regulated as complementary medicines, as currently occurs in Australia. Therapeutic claims will be permitted. The level of regulatory control applied to complementary medicines will be proportional to the risk associated with the ingredients and claims.
- There will be no lowering of standards. There will, however, be some differences in the way the joint agency operates compared with the way the TGA or Medsafe currently operate. These will enhance the agency’s responsiveness and transparency and its ability to function effectively as a joint regulator.
Will industry and consumers be consulted during the transition to the new agency?
Yes. Since 1998 there has been extensive consultation with industry and consumer groups on the proposal to establish a joint therapeutic products agency. There is no intention to change this approach during the agency’s implementation phase. Close consultation will continue with key stakeholders, especially on the final proposals for the establishment and implementation of a joint regulatory scheme.
3. What will be the institutional arrangements for the joint agency?
How will this joint agency be established?
A treaty will establish the two-member Ministerial Council (comprising the Australian and New Zealand Ministers of Health) and the Board of the agency.
The agency will derive its legal personality from an Australian Act. This Act will provide that the members of the Board are constituted as a body corporate - the Joint Agency. The Agency will be recognised in a New Zealand Act.
There will be a common set of Rules, which will be made by the Ministerial Council. The framework for the regulatory scheme administered by the Agency will be set up under the Treaty and implemented through the Acts, the Rules and, in the case of technical matters, in Orders made by the Managing Director.
The Managing Director, who is a member of the Board, will be the statutory decision-maker.
How will the joint agency be funded?
Consistent with previous government decisions, ongoing funding of the agency will be by full cost recovery from the Australian and New Zealand therapeutic products industry.
Who will the joint agency be accountable to?
The Agency would be accountable to Australian and New Zealand stakeholders as well as key Australian and New Zealand institutions including:
- The Australian and New Zealand Parliaments.
- The Australian and New Zealand Courts.
- The Australian and New Zealand Governments (through the Ministers of Health).
4. What might be the implications for Australian and New Zealand industry?
What effect might the establishment of the joint agency have on costs for industry?
The overall cost of regulating medicines and medical devices in the two countries is not expected to increase under a joint agency. In fact, there is potential for cost savings as a result of reduced duplication of effort (e.g. in both countries separately evaluating new products, as occurs at present) and the move to a single market. It will be some time before fees and charges to apply under the joint agency can be determined.
For the medical device industry in New Zealand there will be new compliance costs because these products are largely unregulated at present. The same would apply to the New Zealand complementary medicines industry if these products are to be regulated under new legislation.
For the therapeutic products industry as a whole, the joint agency will mean making one application, meeting a single set of requirements and paying one set of fees and charges in order to obtain an approval to supply the product in both countries.
Will parallel importation be an issue with a trans Tasman agency?
The joint agency scheme will not increase or decrease existing controls on parallel importation.
5. What might be the implications for Australian and New Zealand consumers?
Will Australian consumers still be able to be confident that their medicines and other therapeutic products are regulated to world’s best practice standards?
Yes. There will be no lowering of standards as a result of the joint agency being established. The new agency will have an enhanced ability to effectively and efficiently regulate therapeutic products into the future.
What advantages would there be for New Zealand consumers in having their medicines and other therapeutic products regulated by a joint agency?
For prescription and OTC medicines, which are already regulated in a similar way in both countries, New Zealand consumers will continue to be able to have confidence in their medicines and in the ability of the agency to regulate medicines efficiently and effectively into the future.
For complementary medicines and medical devices, which are largely unregulated in New Zealand at present, consumers would benefit by being able to have confidence in the safety and quality of the products they use. In addition, health providers purchasing medical devices (e.g. for use in hospitals) would gain access to the information they need to make sound purchasing decisions and protect the public from the risks of poor quality products.