Senator CAROL BROWN (2:46 PM) —I rise to speak briefly on the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]. By way of context, the Therapeutic Goods Act 1989 requires that therapeutic goods be registered, listed or included in the Australian Register of Therapeutic Goods before they can be lawfully imported into, manufactured in, supplied in or exported from Australia. The act also requires a person to obtain a manufacturing licence in order to manufacture therapeutic goods in Australia. The Therapeutic Goods Administration, the TGA, is responsible for administering the provisions of the legislation as the TGA’s objective is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety, and performance of medical devices.

The bill before us proposes a range of amendments to the Therapeutic Goods Act. The majority of these proposals were to be implemented with the proposed joint regulatory scheme in New Zealand, which was postponed in July 2007 due to the New Zealand government’s decision to not proceed with enabling legislation due to insufficient parliamentary support. The Rudd government has decided to pursue these long-overdue regulatory reforms in an Australia-only context while negotiations on the Australia New Zealand Therapeutic Products Authority remain postponed. These reforms will strengthen the existing regulatory framework for therapeutic goods and improve protections for consumers. Public consultation outlining the government’s plans for reforms to the therapeutic goods regulatory framework was undertaken in late July and early August last year.

The industry strongly supported progress in these areas, especially as changes were delayed for several years in anticipation of the Australia-New Zealand therapeutic goods authority legislation. Therefore, this bill amends the Therapeutic Goods Act 1989 in a number of ways. First, as has already been pointed out, it incorporates into the act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations without the requirement for such devices to comply with the act. These provisions are based on similar provisions added to the act in 2002 allowing medicines to be stockpiled and supplied in emergency situations. These emergencies could include an act of bioterrorism or the emergence of a new highly contagious disease in Australia. In 2002 the then parliamentary secretary, in introducing the bill, explained that the amendments were necessary to strengthen the ability of the Commonwealth to plan for and respond to national emergencies in which there was the potential for large numbers of people to require emergency treatment. She gave us examples of such acts of bioterrorism or the emergence of a new highly contagious disease in Australia. Exactly the same rationale applies to the amendments contained in this bill.

The act presently operates very effectively to ensure that medical devices supplied in Australia to meet our daily healthcare needs meet very high standards of manufacture and quality control in general. It is an offence to supply devices that have not been approved by the Therapeutic Goods Administration. However, in the event of a national emergency there may be a need for the government to supply large volumes of goods and, as such, it may need to source these volumes from manufacturers who do not regularly supply goods to the Australian market and who have not sought to have their products approved by the TGA. The amendments in schedule 1 to the bill allow the minister to exempt devices from the requirements of the act so they can lawfully be stockpiled and made available in an emergency. The minister can only make such an exemption if she or he is satisfied that it is in the national interest to do so. The minister’s power may only be delegated to the Secretary of the Department of Health and Ageing. The minister may impose conditions on the exemption, including limiting the people allowed to import, manufacture or supply devices, and must notify those people of any other conditions on the exemption. Breaching a condition of exemption is a criminal offence.

Second, the bill gives effect to a range of amendments which have been in contemplation for a number of years and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority. It replaces an unduly subjective and harsh test of who is a fit and proper person to hold a manufacturing licence with a much narrower and more objective test requiring the secretary to have regard to breaches of the act or offences against it together with offences involving fraud or dishonesty over the previous 10 years. Again, just by way of background, the act was amended in 2003 to introduce a ‘fit and proper persons’ test. The aim of the test was to mitigate the risk posed by those who have already breached or may be coerced or tempted to breach manufacturing standards. However, the test has proven difficult to administer and has been criticised by some in industry as elaborate, complex and intrusive.

The main problems identified with the existing legislation are that it requires the fitness and propriety of a very broad range of people—the applicant, a senior manager or any other person who controls the applicant—to be assessed. It requires a very broad range of conduct to be considered, including the conduct of additional third parties and irrelevant conduct, such as convictions for minor traffic offences. It requires a decision maker to exercise a significant amount of discretion and to determine what matters are relevant.

The legislation does not set out an exclusive list of factors that can be considered, nor balance all relevant factors to determine whether a particular person is a fit and proper person. It does not contain sufficient powers to enable the TGA to monitor the ongoing suitability of a person to hold a manufacturing licence or a conformity assessment certificate. The new test, requisite amendments of which are contained in this bill, will require the secretary to have regard to past breaches of manufacturing licences or conformity assessment certificates, offences against the act or corresponding state law, and offences involving fraud or dishonesty over the previous 10 years. The persons covered by the test are the applicant, senior managers of the applicant’s affairs, and shareholders with more than one-fifth of the shares or votes.

The bill also establishes the United States Pharmacopoeia and the European Pharmacopoeia as alternative default standards to the British Pharmacopoeia—I really want Senator Back here to help me with the pronunciation—which standard goods must comply with if the minister has not determined other standards. As I have noted, this will give manufacturers greater flexibility in choosing what standard to comply with when providing goods to the Australian market.

The provisions will allow the TGA to release a wider range of information to inform members of the public about the therapeutic goods and devices that are available in Australia and to further assist them to make better informed choices and decisions about their use of therapeutic products. They will also allow the TGA to publish the minutes and deliberation of expert advisory committees as well as the summaries of the evaluation of applicants for the registration of prescription medicines.

The existing provisions governing release of information to other regulators has also proven to be unduly restrictive and operationally difficult, and the amendments also address these issues. In this regard the bill also seeks to widen the provisions of the Therapeutic Goods Act, allowing the secretary to release information obtained under the act to other regulatory agencies or to the public.

Finally, the bill makes technical amendments to clarify the operation of the provisions limiting the claims that can be made in advertisements for therapeutic goods and to bring the criminal offences provisions in line with the latest criminal law policy. Therefore, the amendments to the Therapeutic Goods Act contained in this bill represent logical, good public policy. As I noted earlier, the majority of these proposals were to be implemented in a joint regulatory scheme with New Zealand, which was postponed in July 2007. However, the government has decided to pursue these long-overdue regulatory reforms in Australia.

These reforms will strengthen the existing regulatory framework for therapeutic goods and improve protection of consumers. Public consultation outlining the government’s plan for reforms to the therapeutic goods regulatory framework was undertaken in late July and early August last year, and the industry strongly supported progress in these areas. I commend the bill to the chamber.