15 July 2005
Key Points:
Harmonising Australian/New Zealand standards
As part of the preparation for the new trans-Tasman agency, the respective Governments have appointed an expert advisory committee to oversee the establishment of standards for therapeutic products under the proposed agency.
Headed by Australian Emeritus Professor Stella O'Donnell, the Joint Interim Advisory Committee on Standards has eight members with expertise in chemistry; pharmaceutical sciences; biomedical engineering; blood; tissues and cellular therapies; microbiology and virology; and good manufacturing practices and quality systems. Sixteen associate members will provide additional help on specific standards.
Work has already started, with the committee considering what the default standard should be for the new agency.
Legislation planned for the life sciences industry
The Government has indicated it has three bills it intends to introduce into Parliament of particular interest to the life sciences industry.
The Therapeutic Goods Amendment (Regulatory Issues) Bill is intended to:
The Therapeutic Products Bill and the Therapeutic Products (Consequential Provisions) Bill are the long-awaited bills to establish the common regulatory scheme for therapeutic products in Australia and New Zealand. This has been expected for some time, and needs to be passed before the start date for the new trans-Tasman agency, which iscurrentlyset to be 1 July 2006.
No more details were available at the time of publication. The earliest we could expect to see copies of these Bills will be August, when the Federal Parliament sits again.
Regulation of gene technology under review
Five years after it came into effect, the Gene Technology Act 2000 is under review.
The Gene Technology Ministerial Council (made up of State and Territory Ministers for health, agriculture or industry development) is required under the Act toreviewthe Act's operations and the Office of the Gene Technology Regulator. The resulting report must be tabled in Federal Parliament by 21 June 2006.
Chaired by lawyer Ms Susan Timbs, the review panel's members are Mr Murray Rogers, who chairs the Quarantine and Exports Advisory Council, and the microbiologist and lawyer Ms Kathryn Adams. Under the terms of reference, they will be required to examine:
At the same time, the Council has authorised the Regulator to proceed with public consultation on proposed changes to the Gene Technology Regulations 2001. These changes are mainly to the definitions and classifications.
Concerns over rising costs of FTA compliance
It has been reported that the recently implemented Australia/US Free Trade Agreement (FTA) legislation is "trapping listed OTC and complementary medicines in a cost spiral" and it is feared that this has led to some listed medicines being marketed illegally.
Under the FTA, sponsors of new therapeutic products are required to certify that the marketing of the product does not infringe any existing patent. Failure to comply with these regulations may result in substantial penalties. It has been suggested that complying with these regulations is costing sponsors thousands of dollars per application on patent searches and legal advice.
In a number of statements the Government has claimed that the FTA will not initiate an increase in the price of OTC and complementary medicines, however this has been questioned. For example, the vitamin industry recently released a statement claiming that compliance with the FTA rules is expected to add five to eight percent to the cost of vitamins. The Parliamentary Secretary for Health, Christopher Pyne, and the TGA have reported that it is unlikely that the laws will be changed however they are optimistic that they can work towards a solution.
Distinguishing cosmetics from therapeutic goods
In Australia, sunscreen containing moisturisers are currently classified as therapeutic goods and therefore must be listed. However, a TGA review has made a recommendation that these moisturisers, among other things, should no longer be regulated as therapeutic goods under the joint trans-Tasman agency. The review calls for guidelines on cosmetic claims to be established by the joint agency with the aim of clarifying the distinction between cosmetics and therapeutic goods.
Under current guidelines, products are determined to be either "cosmetics" or "therapeutic goods" based on two factors: the composition of the product and the proposed use of the product. The context in which the product is marketed is also of importance. For example, a product marketed as a cosmetic must not be promoted in such a way that indicates the product has a therapeutic consequence. The TGA oversees the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations. Products subject to this legislation are "therapeutic goods". Products intended to be therapeutic goods include products which claim to modify a physiological process; or prevent, diagnose, cure or alleviate a disease or defect. Normally, cosmetic products do not come within the ambit of this legislation.
Alternatively, cosmetic substances or preparations are products intended for topical application to an external part of the body, mouth and/or the teeth with a view to altering the odours of the body, cleanse, alter appearance, promote attractiveness and maintain good condition. It is sometimes difficult to determine the difference between a cosmetic and a therapeutic product. Nevertheless, where a product claims to modify a physiological process (or treat or prevent disease) then it falls within the bounds of the legislation, thus requiring inclusion in the Australian Register of Therapeutic Goods prior to consumer supply.
The motivations underlying the development of the Joint Agency relate to both consumer welfare and trade. The primary objectives of the Agency are to: safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of the quality, safety and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export and promotion.
Under the proposal, the classification of a number of products will change (subject to certain conditions). For example, under the joint agency arrangements, antiperspirants that derive their antiperspirant properties from inorganic salts of aluminium, zinc, or zirconium only, should not be classified as therapeutic products. Primary sunscreens where SPF isgreater than or equal to4 should be classed as therapeutic products and described as Class 1 medicines. Primary sunscreen products where the SPF isless than or equal to4 should not be classified as therapeutic products. Similarly moisturisers that contain a sunscreen as and for a secondary purpose where the SPFgreater than or equal to4 should not be classified as therapeutic products provided they meet a number of conditions.
