Australia, NZ propose scheduling and product vigilance provisions

In late 2003 the Australian and New Zealand governments signed an agreement for the joint regulation of therapeutic products, including complementary medicines, over-the-counter and prescription medicines, medical devices, blood and blood products and tissues and cellular therapies.

The agreement involves setting up the bi-national Australia New Zealand Therapeutic Products Authority (ANZTPA), which will be accountable to both governments and replace Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe.

The plan has proved controversial since, although complementary therapies and supplements were previously bundled together with prescription drugs under the TGA's bailiwick, historically New Zealand has had a more lenient regulatory structure than its neighbour, meaning that many more products have been available on the market.

Detractors of the plan have argued that consumer choice will some products will cease to be available, with consequences for consumer choice, and manufacturers may be lumbered with hefty submission costs.

Philip Davies of the Joint Agency Establishment Group, which is overseeing the transition said that the Australia New Zealand Therapeutic Products Authority (ANZTPA) aims to protect public health "by regulating the quality, safety and effectiveness or performance of therapeutic products both before and after they enter the marketplace".

Other world markets, such as the United States with the 1994 Dietary Supplements Health and Education Act and the EU with the 2002 Food Supplements Directive, have drawn a bolder line between supplements and pharmaceuticals.

Last September the two countries' respective consumer self-medication industry associations the mirrored the regulatory approach to establish the joint Australia New Zealand Self-Medication Industry Alliance (ANZSMI).

The executive director of ASMI, Juliet Seifert, and the executive director of NZSMI, Tony Miller said: "It will enable us to speak with one voice on issues of importance and will optimise our effectiveness in dealing with the unified regulatory regime that will shortly operate across the Tasman.

One of the key priorities will be to work closely with the Joint Agency Establishment Group.

"It is essential that the new framework deliver, for the benefit of both consumers and industry, a true single market," said the alliance. "Labelling requirements will be key to this."

The papers released this week include proposals for scheduling of ingredients in Australia and New Zealand, for which the authority plans to establish a Medicines Scheduling Committee (MSC). This is a key issue for the industry, and follows the recommendations of the Galbally Review - the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation.

It is envisaged that the MSC will be made up of 12 to 16 experts drawn from the fields of pharmacy, medical practice, medical regulation in Australia and New Zealand, toxicology and clinical pharmacology. In a nod to manufacturers' interests, one member should have expertise in industry issues and one in consumer issues.

The authority expects to issue scheduling decisions on all submissions prior to the issue of a product license, and it also may schedule new substances under its own initiative. All submissions are to be made public and subject to comments. There are also provisions for urgent scheduling and re-scheduling.

A consultation paper has also been published this week on product vigilance, which covers the import, export, supply, manufacture, promotion of medicinal products.

The plan is to move from a reactive approach presently taken by Medsafe and the TGA, to a more proactive approach "within all parts of a product's lifecycle". This means that restrictions may be imposed at any time.

Comments on the paper are sought up to December 6.

A third consultation paper published this week covers the proposed regulation of blood under ANZTPA