Senator Tambling addresses MIAA on global harmonisation for medical devices

Work continues on preparations to make important reforms to Australia's system for regulating medical devices by harmonising regulatory standards to international best practice.

Senator Tambling speaking at the conference

The Parliamentary Secretary to the Minister for Health and Aged Care, Senator Grant Tambling, outlined the reforms when he addressed the annual conference of the Medical Industry Association of Australia in Sydney on 2nd August.

Senator Tambling said the harmonisation of Australia's regulatory standards represented one of the important challenges facing the Federal Government and the medical devices industry.

He said the proposed reforms would cut 'red tape' and costs for manufacturers, lead to improved public health and safety as well as timely availability of therapeutic goods on the market.

Some of the key elements of the Australian harmonised regulatory model include:

• a risk-based device classification system;
• four classes of devices in ascending order of risk;
• device classification based on manufacturer's intended purpose;
• minimum safety and performance requirements that all devices must meet - the essential principles;
• devices must be safe for their intended purpose;
• standards may be used to demonstrate conformance with essential principles for safety and performance;
• manufacturers have a choice in the way they demonstrate conformance with the essential principles; and
• increased emphasis on post-market controls.

Senator Tambling said that as with all new systems there can be some disadvantages.

"Some disadvantages of the new regulatory system may include that all medical devices will require technical documentation that may be inspected by government authorities," he said.

"Non-exporting Australian manufacturers may incur increased costs if they do not have the appropriate manufacturing quality assurance systems."

He told the MIAA conference there were many advantages in the new regulatory system.

"All medical devices must comply with the essential principles for quality, safety and performance.

"Devices will be classified using rules that take into account the level of risk and the manufacturers' intended use.

"The proposed system reduces Australia's unique regulatory requirements thereby facilitating exports and it has the capacity to accommodate new technology."

Senator Tambling said a harmonised Quality Assurance system for manufacturing may reduce administrative burdens on manufacturers and maximise the benefits from existing and future international agreements.

"I think that the outlined reforms provide an exciting opportunity for manufacturers and Government to work together to achieve a cooperative approach to health care and medical devices regulation in Australia."

The Government is proposing the reforms to medical devices regulation in response to the Industries Commission report on Medical and Scientific Equipment Industries.

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Controls on medicines and poisons to be reviewed

Senator Tambling recently announced the start of The Review of Drugs, Poisons and Controlled Substances Legislation and the appointment of Ms Rhonda Galbally as independent Chair of the Review. She will be assisted by a Steering Committee with membership drawn from all jurisdictions. Secretariat support will be provided by the Therapeutic Goods Administration.

The Review will address the controls that apply to drugs, poisons and controlled substances. It will address such issues as differences in the controls between the States and Territories, the costs of these controls to business and their benefits to the community generally.

Evidence from stakeholders will be critical to the outcome of the Review. However the better the quality of evidence the better the analysis will be to underpin the recommendations. It will also be important to quantify the costs and benefits involved. The Review is being undertaken under the Competition Principles Agreement by all Australian Governments and must examine issues in terms of their costs and benefits. For this Review, costs means the financial / economic impact on your activities or on the community at large; benefits means the extent and quality of public health standards in the community.

Input from stakeholders is important and critical to the success of the Review. The Chair especially wants maximum opportunities for stakeholders to have their say. Initially the Chair will consult with key stakeholders across Australia and visit all States and Territories in August 1999. Meetings with the Chair can be arranged by the Secretariat.

A regular newsletter will be circulated by the Secretariat to keep stakeholders abreast of developments with the Review. A copy of the newsletter can be obtained from the Secretariat at the address below and will also be available on the TGA homepage.

Address:

The Secretary
Review of Drugs, Poisons and Controlled Substances Legislation
TGA
PO Box 100
WODEN ACT 2606

Establishment of an Interim Office of the Gene Technology Regulator

In the context of 1999 Federal Budget, the Government announced it would establish an Office of the Gene Technology Regulator (OGTR) to regulate all Genetically Modified Organisms (GMOs) not currently covered by existing legislation. The objective of the OGTR will be to ensure human safety and environmental protection and realise the benefits of gene technology for the Australian community, industry and environment, through regulation that is timely, science based, consistent with international obligations and takes account of ethical concerns.

An Interim OGTR has now been established in the TGA to oversee the development of the new regulatory framework and the establishment of the OGTR. In addition, the Interim OGTR will continue to support the Genetic Manipulation Advisory Committee (GMAC). GMAC is a non-statutory expert advisory committee that currently oversees the development and use of novel genetic manipulation techniques in Australia. The Interim Office, operating as a Branch within TGA, is headed by Liz Cain and staffed by a small team including experienced officers transferred across from the Department of Industry, Science and Resources.

The Interim OGTR is working closely with other Commonwealth agencies and the States and Territories to develop a nationally consistent regulatory scheme. Funding of $7.5 million over two years has been made available as the Commonwealth's contribution to developing the OGTR and associated regulatory system. The OGTR is expected to be established and fully operational by 1 July 2001. The functions of the OGTR will be to:

• Regulate all aspects of the development, production and use of genetically modified organisms and their products, where no other existing regulatory body has responsibility, in accordance with principles agreed and enacted by all jurisdictions;
• Work with regulatory bodies to ensure the consistent application of standards and harmonise assessments across all systems of regulation; and
• Undertake or commission research in the area of risk assessment.

The OGTR will deliver increased assurances to the public about the maintenance of high standards of health and environmental protection, and streamlined approval processes with a clear pathway to market for industry.