The Australia New Zealand Therapeutic Products Authority Newsletter 1

The Australia New Zealand Therapeutic Products Authority Project

Newsletter No 1, July 2006

This is the first in a series of newsletters that aim to provide regular information and updates to New Zealand industry and other stakeholders about the proposal to establish a trans-Tasman regulator for therapeutic products. The overall aim of this proposal is to protect the health and safety of both New Zealanders and Australians, now and into the future, by establishing a world class regulatory scheme for therapeutic products which meets international best practice, in the most cost-effective way. While this first newsletter focuses mainly on issues relating to complementary medicines, future newsletters will cover different aspects of the proposals to establish the Australia New Zealand Therapeutic Products Authority.

Stakeholder meetings

Meetings about the establishment of the Australia New Zealand Therapeutic Products Authority and the proposed joint regulatory scheme were held in New Zealand and Australia last month and were attended by over a thousand people. The meetings provided an opportunity for audiences to hear further details about the proposed regulatory scheme for prescription and over-the-counter medicines, complementary medicines, and medical devices, along with information on the fees and charges proposals, the progress of the project to date and details about what happens next.

The slides from these meetings are now available from the Australia New Zealand Therapeutic Products Authority website and can be downloaded at: http://www.anztpa.org/consult/0606pres.htm

The proposed joint regulatory scheme

When buying therapeutic products consumers expect they will be safe and of high quality. To ensure that this is the case products are to be regulated. The proposed joint regulatory scheme is based on categories or scales of risk as not all products have the same safety concerns.

As we recognise that most complementary medicines are low risk products, they will require the lowest level of regulation. In most cases complementary medicines suppliers will be able to obtain a licence to sell their products by entering details into an on-line form. Details will need to be included such as the product’s ingredients and that the supplier holds evidence to support claims on the label. We expect that consumers will continue to have access to a wide range of complementary medicines, with the sort of products currently sold through retail outlets such as health food stores and supermarkets continuing to be available in this way.

It is important to note that the proposals for regulation and licensing apply only to pre-prepared and manufactured complementary medicine products which are sold off the shelf to consumers.

They do not apply to:

practitioners such as naturopaths, traditional Chinese or Maori healers, and the products they make and supply to individual patients;
the cultivation of herbs, for example feverfew, for personal use in preventing or treating ailments;
personal imports by consumers for their own or immediate family use.

Tighter controls are being proposed for prescription medicines, non-prescription medicines and medical devices, such as pace makers and heart valves, as they are higher risk products.

In addition, specialist expertise will be required to properly assess the potential risks posed by complementary medicines, medical devices or prescription and non-prescription medicines, and so there will be separate offices for complementary medicines, medical devices and prescription and non-prescription medicines within the offices of the joint Authority in Wellington and in Canberra.

Further details about the proposed joint regulatory scheme are available at: http://www.anztpa.org/consult/consdocs1.htm

The proposed ANZTPA Management structure

The Authority will be equally accountable to the Health Ministers and Parliaments of New Zealand and Australia and it will have head offices based in both Wellington and Canberra. There will be a two-member Ministerial Council comprising the New Zealand and Australian Ministers of Health who will oversee the Authority. These and other accountability arrangements were agreed under an international agreement, or Treaty, signed by both countries in December 2003.

New Zealand will have an equal say in the setting up and running of the joint Authority. The Board of the joint Authority and its Managing Director will be appointed by the agreement of the Ministerial Council. The Managing Director and the Board are accountable to the Ministerial Council. It is important to emphasise that no one person would have the power to make unilateral changes to the Authority’s regulatory framework (the Rules and Orders) as the Authority is required to consult on all changes to the regulatory framework and both the Rules and Orders can be disallowed by the Parliament of either country.

New Zealanders would be able to influence the operation of the Authority in a number of ways, including through public consultation processes. In addition, 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 Members of Parliament. Select Committees will also be able to ask questions of the Authority in the same way that they can ask questions about New Zealand Crown Entities.

Proposed fees and charges for complementary medicines

The discussion paper on the proposed fees and charges for the joint regulatory scheme was released for consultation on 23 May 2006 and sets out cost recovery proposals along with indicative fees and charges. It is important to emphasise that these are proposals and we are genuinely seeking constructive comments and suggestions that will be considered as part of the development of the scheme.

The indicative fees for complementary medicines have, in many cases, been based on estimates and assumptions about the New Zealand market. This is because there is currently no requirement in this country for most complementary medicine products or their distributors to be registered and therefore, there is limited information about how many products are sold in New Zealand or the extent to which the same products are being marketed in Australia and in New Zealand.

It’s proposed that once the joint Authority is established, all Class 1 complementary medicine products that are lawfully on sale in New Zealand and are listed in Medsafe's transitional COMET database, would automatically be issued free of charge with an interim product licence.

The interim product licence would then allow the product to continue being sold on the New Zealand domestic market during a proposed 3-year transition period. At any time during that transition period the product sponsor could apply to the joint Authority for an ANZTPA product licence, which would also be issued free of charge.

To obtain an ANZTPA product licence, the sponsor would need to show that the product met all the safety and quality requirements and standards of the joint scheme and was also made by a manufacturer who met Good Manufacturing Practice (GMP) requirements. An ANZTPA product licence would allow the distributor to sell their product in both the New Zealand and Australian markets if they wished to do so.

Your views on the proposed fees and charges and on the assumptions used in deriving the figures are important in enabling the cost recovery model to be refined prior to the development of the fees and charges draft Rule. Submissions on the discussion document close on 15 August 2006.

Copies of the discussion paper on the proposed fees and charges are available at: www.anztpa.org/consult/consdocs1.htm

Further information about COMET can be found at: www.medsafe.govt.nz/CompMedPage.htm

Upcoming events and meetings

On 10 July 2006 a consultation Hui is being held in Rotorua to discuss with Maori traditional healers and community members with an interest in Rongoa the proposed joint regulatory scheme for therapeutic products.

On 11 July 2006 a meeting is being held for the New Zealand anthroposophic and homeopathic medicines industry in Auckland to provide further information about the proposed joint regulatory scheme and what it will mean for their industry.

The Interim Joint Expert Advisory Committee on Complementary Medicines has been appointed to provide advice to the Authority’s Interim Ministerial Council. It will consider the safety of a range of additional ingredients found only in New Zealand complementary medicines. The Committee next meets on 20 and 21 July and we expect to begin publishing the preliminary outcomes of the Committee’s work around August.

For further information about these meetings please contact Donna Fong at Medsafe: 04 819 6860 or donna_fong@moh.govt.nz

Ongoing consultation

The latest version of the draft Labelling Order was released on 13 June 2006, along with an accompanying report about the consultation to inform stakeholders of the outcomes of the process.

The draft Labelling Order has been in development since 2003 and has been subject to a series of public consultations. The aim is to develop a single, harmonised set of labelling requirements for medicines that would apply in both New Zealand and Australia under the joint Authority.

The updated draft Labelling Order will help stakeholders to assess the final proposed labelling requirements in relation to their existing products, particularly for those with small label space. New comments are being welcomed around any perceived difficulties with the application of the proposed labelling requirements to particular products.

There is also still plenty of time to make submissions on the current set of consultation documents on the draft Rules for medicines, medical devices and administrative matters, along
with the discussion paper outlining the proposed arrangements for setting fees and charges to be levied by the Authority. Submissions on these consultation documents close 15 August 2006.

Two further phases of consultation on the proposed joint regulatory scheme will begin in mid-September 2006 and March 2007.

In addition, separate but closely aligned Bills are expected to begin their formal Parliamentary processes soon in both New Zealand and Australia. In New Zealand the New Zealand Bill will be available for public consultation as part of the select committee process.

Copies of these consultation documents, along with further information about the project, is available on the Australia New Zealand Therapeutic Products Authority website: www.anztpa.org