Joe Ludwig (Queensland, Australian Labor Party, Manager of Government Business in the Senate) Share this | Hansard source

I table a revised explanatory memorandum relating to the Therapeutic Goods Amendment (Poisons Standard) Bill 2008 and 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 speeches read as follows—

THERAPEUTIC GOODS AMENDMENT (POISONS STANDARD) BILL 2008

This Bill makes a number of amendments to the Therapeutic Goods Act 1989 to address the legal consequences arising from a recent decision of the Federal Court in Roche Products v National Drugs and Poisons Schedule Committee on 30 August 2007. In that case the Federal Court held that decisions made by the National Drugs and Poisons Schedule Committee under subsection 52D(2) of the Therapeutic Goods Act 1989, which include decisions to amend the Poisons Standard, are legislative in character.

On the basis of that decision, it is likely that the Poisons Standard and its amendments are legislative instruments for the purpose of the Legislative Instruments Act 2003. As such, they are required to be registered in the Federal Register of Legislative Instruments, known as FRLI, to be enforceable. However, as they were treated as non-legislative instruments prior to the Federal Court decision in Roche, the Poisons Standard and amendments made to it up to the time of the Roche decision have not been registered in FRLI. Furthermore, as certain amendments made to the Poisons Standard were not registered within the periods specified by the Legislative Instruments Act, that Act operates to repeal the amendments. It is therefore necessary to reinstate those amendments, and provide for the integrity and enforceability of the Poisons Standard up until the Roche decision.

The Poisons Standard consists of decisions made by the National Drugs and Poisons Schedule Committee, established under the Therapeutic Goods Act 1989, regarding the classification of drugs and poisons into different schedules, from schedule one to nine, signifying the degree of risk. The Poisons Standard also contains a number of appendices which supplement the schedules by setting out additional controls, qualifications and exemptions affecting substances contained in the schedules. The higher the schedule, the higher the risk attributed to a relevant substance.  Substances are then regulated under relevant State and Territories legislation depending upon in which schedule the substances are included.

The Poisons Standard is also relied upon by the Commonwealth under the Therapeutic Goods Act for regulatory and enforcement purposes, such as for regulating advertising and labelling in connection with certain medicines.

Scheduling and rescheduling decisions by the Committee are made based upon considerations of public health and safety, balanced with the need for public access to a substance. The Committee may, for example, reschedule a “prescription only” medicine to a “pharmacist only” medicine on this basis, or vice-versa; or prohibit a substance from general access by the public to reduce the risk of abuse or dependence. It is therefore necessary in the interest of public health and safety to ensure that regulatory actions taken in reliance upon scheduling decisions made by the Committee continue to operate.

To this end, the Bill reinstates any scheduling decisions that may have been repealed, and puts beyond doubt that scheduling decisions made before the Roche decision are enforceable because they are deemed to have complied with the requirements of the Legislative Instruments Act.

The retrospective effect of the amendments will not add any new regulatory requirement. Rather, the retrospective effect of the amendments is necessary to preserve the status quo of the Poisons Standard, and amendments made to it, before the Roche decision. Decisions and actions taken by both the regulator and business relied upon the enforceability and integrity of the Poisons Standard and its amendments, and the retrospective effect of the Bill is necessary to provide certainty for those decisions and actions.

The Bill also makes it clear that the Poisons Standard and amendments made to it are exempt from the Parliamentary disallowance process. This exemption recognises that it is inappropriate for Commonwealth instruments forming part of an intergovernmental scheme to be unilaterally disallowed, and the exemption is consistent with the operation of subsection 44(1) of the Legislative Instruments Act 2003. The exemption is also appropriate because of the need to ensure certainty in the continuing application of State and Territory laws which refer to the Poisons Standard. The exemption does not affect the consultative processes required to be followed by the National Drugs and Poisons Schedule Committee when it makes decisions to amend the Poisons Standard.

The Bill also provides for a compensation regime in the event that the operation of the amendments to the Act should result in an acquisition of property from a person other than on just terms.

TRADE PRACTICES AMENDMENT (ACCESS DECLARATIONS) BILL 2008

The Trade Practices Amendment (Access Declarations) Bill 2008 amends the Trade Practices Act 1974 to clarify that access declarations, and extension notices which extend the period of access declarations, are not legislative instruments for the purposes of the Legislative Instruments Act 2003.

Access declarations are made by the Australian Competition and Consumer Commission under subsection 152AL(3) of the Trade Practices Act, to identify telecommunications services that should be subject to access obligations.

A service can only be declared following a thorough inquiry process in accordance with Part 25 of the Telecommunications Act 1997. The ACCC must be satisfied that the making of the declaration will promote the long term interests of end-users. Once a service has been declared, telecommunications providers wishing to make use of the service may seek access to the service from other telecommunications providers. Access obligations in Part XIC of the Trade Practices Act require access providers to supply access to declared services to access seekers, and provisions in that Part detail the terms and conditions on which access must be given.

In considering the long term interests of end-users, the ACCC must take into account whether declaration of the service would promote competition, any-to-any connectivity, and the efficient use of, and investment in, infrastructure. Any-to-any connectivity is the ability of each end-user to communicate with all other end-users.

The primary objective of the Bill is to provide certainty to the telecommunications sector by clarifying that access declarations that have been made by the ACCC are not, and never have been, legislative instruments for the purposes of the Legislative Instruments Act.

Eleven access declarations are currently in force, covering key services that are fundamental to telecommunications competition and the ability of end-users to communicate with all other end-users. They include services such as the unconditioned local loop, local call resale, call origination and termination, wholesale line rental and trunk transmission.

On the understanding that access declarations are not legislative instruments for the purposes of the Legislative Instruments Act, the ACCC has not registered any access declarations on the Federal Register of Legislative Instruments, nor tabled them in both Houses of Parliament. These are requirements that the Legislative Instruments Act imposes for legislative instruments. Unregistered legislative instruments are unenforceable.

A recent Federal Court decision, Roche Products Pty Limited v National Drugs and Poisons Schedule Committee, may have implications for access declarations. As a consequence of that decision, it is possible that access declarations may be open to legal challenge on the basis that they are legislative instruments and are invalid as they have not been registered or tabled.

In the absence of these amendments, it is possible that a court could decide that all access declarations made by the ACCC up to this point are invalid due to their not having been registered and tabled in accordance with the Legislative Instruments Act. If this were to happen, this could cause serious disruption to the operation of the Part XIC access regime.

In the interests of providing the telecommunications industry with certainty in relation to access to key services, this Bill will remove doubt about the validity of access declarations.

The ACCC may also issue extensions of time for access declarations. The Bill will also clarify for the avoidance of doubt that these extensions of time, are not, and never have been, legislative instruments.

Furthermore, the Bill will have the effect that revocations and variations of access declarations are not and have never been legislative instruments.

The Bill contains a clause that will protect the validity of the Bill in the event that it was found to result in an acquisition of property other than on just terms and in that event, requires the Commonwealth to pay a reasonable amount of compensation. If the Commonwealth and the person do not agree on the amount of compensation, the person may institute proceedings in the Federal Court and the Federal Court will determine the amount of compensation. This provision mirrors similar provisions found elsewhere in the Trade Practices Act and in the Telecommunications Act.

While Part XIC of the Trade Practices Act deals with the telecommunications-specific access regime, Part IIIA of that Act deals with access to services more broadly. This Bill does not deal with Part IIIA of the Act. No inferences should be drawn about the status of access declarations made under that Part of the Trade Practices Act as a result of this Bill.

Debate (on motion by Senator Ludwig) adjourned.

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