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Thursday, 13 October 2005
Page: 112


Mr SOMLYAY (10:10 AM) —The purpose of the Therapeutic Goods Amendment Bill (No. 2) 2005 is to restrict the patent certification requirements under subsection 26B(1) of the Therapeutic Goods Act 1989. The amendments contained in this bill do not change any aspect of existing health, safety or quality controls for therapeutic goods under the act; they simply address the unintended breadth of an amendment relating to patents that came into force on 1 January this year. The Howard government acknowledges and supports the rights of consumers to make informed choices on matters of health. It also believes that people are entitled to expect that medicines available in Australia are both of high quality and safe when used appropriately.

Whatever form medication takes, whether it be prescription drugs, over-the-counter remedies such as analgesics or cough mixture, or complementary medicines such as vitamins or homeopathy products, we want to be confident of the safety and quality of that medication. However, in our enthusiasm for ensuring safety and quality, we must be careful not to impose unnecessary bureaucracy or restrictions on manufacturers and suppliers of such goods. We need care and we need balance, because sometimes perfectly good legislation can, in practice, have unintended consequences, as is the case here.

In Australia, all therapeutic goods must be entered in the Australian Register of Therapeutic Goods, the ARTG, before they can be supplied in or exported from Australia. The ARTG is the responsibility of the Therapeutic Goods Administration in the Commonwealth Department of Health and Ageing. To understand the meaning of this bill, we need to have a basic understanding of how therapeutic goods are assessed and either registered or listed in the ARTG. Within the registration process, there is a risk based system where the level of evaluation and regulatory control of a particular medicine is based on the relative risk of that product and on the seriousness of the condition for which it is intended to be used.

Medicines assessed as having a higher level of risk must be registered, as opposed to listed, in the ARTG. The degree of assessment and regulation these registered medicines undergo is rigorous and detailed, with sponsors required to provide comprehensive safety, quality and efficacy data. For example, prescription drugs are classed as high-risk registered medicines. They must be assessed and registered as such. However, while over-the-counter medicines such as analgesics and cough remedies must still be registered, they are evaluated under a low-risk classification.

Down the scale from the registered medicines under the act are listed medicines, which are usually considered to be relatively benign. The majority of the listed medicines are self-selected by consumers and used for self-treatment. Examples include vitamin and mineral supplements and products such as sunscreens. Listed medicines are assessed by the TGA for quality and safety but not efficacy. This does not mean that the products do not work; it simply means that the TGA has not evaluated them individually to see if they work. However, under the act, sponsors must hold information to substantiate all of their products’ claims and must make such evidence available to the TGA upon request. Sunscreens, for example, can be a listed product, but they must also have complied with testing under the Australian standard for sunscreens, and the company must be able to produce evidence of doing so.

This bill does not change any of the safeguards or quality controls currently contained in the act. It simply reduces the unintended scope of the patent amendments which came into force at the beginning of the year. The purpose of the earlier amendment was to prevent manufacturers of a generic version of a patented product from entering the market before the expiry of the patent covering that product. To this end, all applicants seeking to register or to list any product on the register are now required to provide section 26B(1) certificates declaring that they will not infringe a patent or, if they intend to enter the market before the expiry of any applicable patent, that they have notified the patent owner of their intention.

Unfortunately, the result of that earlier legislation is that all applicants for the Australian Register of Therapeutic Goods, not just those who want to market a generic product, are now required to have the section 26B(1) certificate. This can entail expensive global patent searches and legal advice. This bill responds to concerns raised by representatives from the complementary medicines industry, the over-the-counter medicines sector and the Australian biotechnology industry that the current patent certification requirements are onerous and broader than they need to be. This bill quite sensibly narrows the circumstances in which a patent certificate is required and restricts the requirement to those who under the act are required to submit safety and efficacy data and to those whose application relies on data previously submitted by another person in relation to an approved product.

The practical effect of this amendment is that the majority of complementary medicine and over-the-counter products, such as sunscreens and throat lozenges, will no longer be subject to the current certification requirements because they are low-risk therapeutic goods and safety and efficacy data is not required under the act. This bill simply means that patent certification under the act will apply only to relevant applications. There will not be a blanket requirement under the act for all applications to register or to list therapeutic goods. I therefore commend the bill to the House.