How would the new Authority and proposed joint regulatory scheme affect Māori?
Fact sheet
July 2007
Why does New Zealand need a joint scheme with Australia?
New Zealand's current regulatory framework around therapeutic products is outdated and out of line with international best practice. In addition New Zealand's current regulatory capacity is not sustainable even in the short-to mid-term.
Establishing a new Authority with Australia has advantages for both countries in terms of efficiency, making the most of scarce technical expertise, sharing resources and reducing overall costs. A significant amount of consultation on the proposal is ongoing with industry, other stakeholders and the public.
Would one country take over the other country's therapeutic products regulation?
No. This is a joint trans-Tasman proposal that aims to establish a new trans-Tasman regulator in which both countries have equal say.
New Zealand will have equal say in the setting up and running of the new Authority which will be equally accountable to the Health Ministers and Parliaments of both countries. It is important to be clear that the new Authority would be a single entity with offices in both New Zealand and Australia.
Once established, the offices would administer the Rules of the new regulatory scheme as agreed by both the New Zealand and Australian Ministers of Health. These Rules would be put to the New Zealand and Australian parliaments in the same way as regulations are put to Parliament now.
The governance and accountability arrangements have been agreed under an international agreement signed by both countries, which means that they can't be changed by just one country.
Could someone in Australia change the Rules without the agreement of New Zealand (or vice versa)?
No one person will have the power to make changes to the regulatory framework that will be set out in Rules.
As set out under the international Agreement, the Board of the new Authority and its Managing Director will be appointed by the two-person Ministerial Council which will comprise the New Zealand and Australian Ministers of Health.
The Managing Director and the Board are accountable to the Ministerial Council and the Parliaments of both countries.
Both New Zealand and Australian consumers and industry would be able to influence the operation of the Authority in a number of ways, including through public consultation processes.
Because the Authority would be accountable to the New Zealand Minister of Health, the Australian Minister for Health and Ageing and to the New Zealand and Australian Parliaments, companies and consumers would be able to raise any issues of concern with their Minister or with their Member of Parliament.
What commitments have both countries given to establishing the proposed joint regulatory scheme?
The new Authority is being established under an international Agreement signed between New Zealand and Australia in December 2003.
The Agreement contains a commitment by both countries to establish a joint Authority and a joint regulatory scheme.
It sets out the mechanisms under which each country will have an equal voice in the Authority.
The Agreement does not set up or establish the detail of the proposed regulatory scheme, which is still in development and the subject of public consultation.
The Agreement would need to be ratified after the passing of legislation in both countries.
Would the relationship between the New Zealand Crown and Māori under the Treaty of Waitangi be damaged?
No - this would not happen.
The new Authority is being established under an international Agreement signed between New Zealand and Australia in December 2003.
This Agreement sets out the mechanisms under which each country will have an equal voice in the new Authority.
Any obligations that the New Zealand Minister of Health has in respect of the Treaty of Waitangi will remain under the new arrangement.
Will the proposals impact on the Wai 262 Claim?
The Wai 262 claim is about the creation of intellectual property rights over New Zealand native fauna and flora. If there are changes to intellectual property policy or law as a result of the Wai 262 claim these would be taken into account by the new Authority.
It is important to note that New Zealand and Australia will retain separate intellectual property law.
Some claimants have expressed concern about the impacts of the proposals. The Ministry of Health has been consulting with claimants on the regulatory detail to ensure that exemptions from the requirements to obtain product and manufacturing licences are appropriate to allow the continued practice of Rongoa Māori.
Will Rongoa be restricted or made illegal?
The traditional practice of Rongoa Māori will not be regulated by the new Authority and will not be subject to the requirements of the proposed joint regulatory scheme for therapeutic products.
Traditional healers and the products they prepare for individual patients will not be regulated by the Authority.
There will be no barrier under the new Authority to the collection of plant material. Maori will be able to continue to use these plants in rākau rongoa just as they do now.
Will consumers still be able to access natural health products?
Consumers will continue to have access to a wide range of complementary medicines, with the sort of products currently sold through retail outlets continuing to be available in this way. When purchasing these products, consumers have a right to expect they will be safe and of high quality.
The main aim of the proposed joint regulatory scheme for therapeutic products is to safeguard public health and safety by providing assurance about the safety, quality and efficacy or performance of therapeutic products.
URL: http://www.anztpa.org/cm/fs-maori.htm