Carol Brown (Tasmania, Australian Labor Party, Assistant Minister for Infrastructure and Transport) Share this | Link to this | Hansard source

I move:

That these bills be now read a second time.

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted.

The spee ches read as follows—

EXPORT CONTROL AMENDMENT (STREAMLINING ADMINISTRATIVE PROCESSES) BILL 2022

Streamlining regulation and cutting red tape is essential for growing Australia's agriculture industries, exports and market access.

Our agricultural industries produce more than our country needs. They export the bulk of their product and rely on an effective regulatory system to assist them in doing so.

It is vital that export control legislation remain current and fit-for-purpose, keeping step with developments in importing country requirements, changing regulatory objectives and industry practice advancements.

This Bill will achieve this by making information sharing provisions within the export control legislation more flexible. It will allow relevant information to be efficiently shared with regulatory partners, exporters and other key stakeholders, while maintaining appropriate control on the sharing of certain kinds of information that may cause harm.

It will support the Department of Agriculture, Fisheries and Forestry to streamline complex administrative and authorisation processes to access and utilise the export control information that it already holds, such as trade statistics, industry information and market intelligence.

Currently, all information collected under the Act is classified as 'protected' information, irrespective of whether or not it is commercially or trade sensitive, or sensitive within the meaning of the Privacy Act 1988.

Consequently, the department's ability to share non-harmful information is limited and comes with administrative complexity, time and resource costs which impact the efficient regulation of trade activities.

Streamlined information sharing requirements can assist with rapid delivery of information that can be essential in trade situations—for instance, where an importing country may hold and request further information about a consignment of fresh produce at its port.

This Bill will benefit our exporters and trade partners by satisfying the growing demand for intelligence to sustain and grow our export markets.

It will more efficiently allow for the provision of relevant information to other Australian Government departments or agencies in appropriate circumstances, while ensuring appropriate safeguards for information which could cause harm.

Being able to efficiently use and re-purpose export control information will increase our ability to innovate and to make gains from those innovations to retain Australia's competitive edge in the international agricultural export market.

The September quarter ABARES Agricultural Commodities Report, brought welcome news of a record forecast exceeding 70 billion dollars in value of Australian agricultural exports.

By cutting red tape and continuing to streamline regulation and administrative arrangements as we are here, the Government is supporting the agriculture sector's ambition to grow and becoming a $100 billion dollar industry by 2030.

The amendments in this Bill are also consistent with the broader information sharing reform work occurring across government. The government takes the protection of private information seriously, and this Bill will not affect the department's commitment to continue to protect personal or sensitive information as identified in the Privacy Act 1988.

Greater flexibility in being able to analyse and explore the export data we hold opens opportunities to support key priorities such as Busting Congestion for Agricultural Exporters and other agricultural policy initiatives.

The improved information sharing arrangements ensure greater flexibility and tailoring for export control purposes and will make the export control legislative framework more effective, efficient and future-focussed.

The Bill will also make some minor amendments to the Act to simplify processes and improve effective administration of the Act.

This Bill will support a modern export system, providing streamlined processes for exporters and improved delivery of services that will benefit our agricultural export industry.

THERAPEUTIC GOODS AMENDMENT (2022 MEASURES NO. 1) BILL 2022

I am pleased to introduce the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022.

This Bill amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest quality healthcare for the Australian public by ensuring the continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance.

In particular, the Bill supports the implementation of a scheme for the mandatory reporting by hospitals of adverse events associated with medical devices. Following the 2017 Senate Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters, the Inquiry made a number of recommendations designed to improve patient safety and better ensure the early detection of safety signals. Recommendation 1 from the Inquiry noted the vital role of adverse event reporting in post market surveillance. The Bill introduces the legislative framework for a scheme involving the mandatory reporting of adverse events associated with medical devices by hospitals, reflecting that for many patients the hospital setting is where adverse events involving medical devices occur or are recognised. This measure supports the improved monitoring of safety concerns associated with medical devices through access to information held by hospitals that identifies serious adverse events, and facilitates the earlier detection of safety signals that may raise concerns about particular devices.

The Bill encourages innovation and investment in biologicals in Australia by introducing a new dedicated pathway for marketing approval of biologicals that are for export only. This measure is designed to provide incentives for investment in the export of biologicals from Australia, and encourages development of this industry, by reducing regulatory burden and supporting sponsors of such products to obtain marketing approval. It would also ensure consistency across the regulatory schemes for medicines, medical devices, and biologicals.

The Bill addresses and alleviates the effects of medicine shortages, by amending the Act to allow the Secretary of the Department of Health and Aged Care to approve the importation or supply of an unapproved medicine that could act as a substitute for medicine that was previously approved in Australia. This measure provides an important additional mechanism to help deal with critical medicine shortages, by allowing the importation or supply of an available overseas medicine that could act as a substitute for a medicine that was approved in Australia, but has since been cancelled or suspended. In some cases, this may be the only option to deal with a medicine shortage. Before exercising such a power, the Secretary would consider the suitability of granting such an approval, including whether it is in the interest of public health.

The Bill supports the safe use of therapeutic goods by strengthening monitoring and compliance activities through a number of measures. The Bill removes review rights for decisions to require the production of information/documents which are critical in identifying and investigating potential contraventions of the Act, detecting safety concerns, and potentially preventing adverse events, associated with therapeutic goods. This measure is designed to prevent avenues of review for such decisions being misused to impede and delay timely regulatory action to protect Australians.

The Bill introduces a general information gathering power to enable the Secretary to request information from any person who may hold information relevant to a potential contravention of the Act. This may include, for example, a financial institution which may hold records of transactions, contractors involved in the supply chain or persons who are involved with the supply of illegal therapeutic goods. This general information gathering power is designed to support the comprehensive and timely investigation of possible contraventions of the Act and enhance the protection of Australian consumers from poor quality, and potentially unsafe, therapeutic goods through access to relevant documentation about potential contraventions of the Act. The Bill also extends the timeframe for holding seized goods to 120 days, to provide a more appropriate timeframe for seized goods to be laboratory tested, analytically assessed and carefully examined, and for regulatory or compliance action to be instituted where appropriate.

The Bill makes a couple of changes to the regulation of advertising of therapeutic goods. First, the Bill provides that the advertising requirements do not apply to an updated list of persons, including certain health professionals (such as oral health therapists), persons purchasing therapeutic goods on behalf of registered charities or governments, or to purchasing officers or practice managers of healthcare practices. Second, the Bill provides a mechanism for an approval of a restricted representation to be withdrawn where additional information about the efficacy of therapeutic goods becomes available. This ensures that therapeutic goods advertising only contains correct and accurate information, taking into account all relevant information known about the goods, and therefore reducing the risk of unsafe use by consumers.

The Bill contains a measure to support compliance by enabling the Secretary, on the Secretary's own initiative, to extend the due date for payment of an infringement notice, supporting the early resolution of a contravention of the Act where a person intends to pay the infringement notice, but does not do so before the expiry date. In so doing, this measure will support the early resolution of contraventions of the Act by infringement notice rather than criminal or civil court proceedings.

The Bill also makes a number of other amendments to improve the clarity and consistency of regulatory requirements, codify current practices, and make other more minor changes to remove redundant provisions and correct typographical errors. In particular, this includes amendments to:

Debate adjourned.

Ordered that the bills be listed on the Notice Paper as separate orders of the day.