Published September 2011
A medicines amendment bill provides an opportunity to amend some specific provisions of the Medicines Act to streamline the legislation.
A more comprehensive overhaul of the Medicines Act will be required in the future to modernise and recast the medicines legislation and to address issues such as the regulation of medical devices and cellular therapies, and controls on advertising.
This assessment considers options to amend the provisions of the Medicines Act to improve the efficiency and flexibility of approval processes for new medicines and related products, streamline the prescribing framework and make it more responsive to innovative practice and a number of other technical or minor amendments to the legislation. The proposed changes are consistent with the Government’s commitment to review existing regulation in order to identify and remove requirements that are unnecessary, ineffective or excessively costly.
The Ministry consulted with key stakeholders on specific proposals and their feedback has been incorporated in the final proposals. A number of the options contained in this assessment, including most of the technical or minor amendments, were developed as part of the Therapeutic Product and Medicines (TPM) Bill. These proposals were developed, consulted on and supported in 2007. Due to the previous work undertaken on these issues and the limited timeframes available to develop a medicines amendment bill, the Ministry has not developed multiple options for implementing these proposals. The proposal for delegated prescribing was publicly consulted on in 2007. There was strong support for the general proposal.
In 2003, Australia and New Zealand signed an Agreement to establish a joint agency to regulate therapeutic products. This treaty remains in place today. The TPM Bill proposed the establishment of a joint Australia New Zealand Therapeutic Products Authority but was put on hold in 2007 due to a lack of Parliamentary support. The proposals relating to the prescribing frameworks and the technical or minor amendments would not preclude or be inconsistent with the establishment of a joint Australia New Zealand regulatory scheme. These proposals are ones which would either sit within domestic medicines legislation or are compatible with the expected regulatory approach under a joint regulatory scheme should such a proposal be progressed in the future. The proposals in relation to the approval process for medicines will be of interest to industry and to Australian officials given the New Zealand and Australian Governments’ agreement to restart work to progressively implement the Australia New Zealand Therapeutic Products Agency.
None of the proposals outlined in the assessment will impair private property rights, market competition, reduce incentives on health care providers to innovate and invest or override fundamental common law principles. None of the options covered in this assessment impose additional costs on the health sector. The proposals aim to improve efficiency and enhance innovation by reducing regulation where possible and making the legislation more enabling and responsive.
David Wood, Deputy Director General, Strategy and System Performance Directorate