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Therapeutic Goods Amendment Bill 1991
House: Senate Portfolio: Health, Housing and Community Services Purpose To give effect to certain recommendations contained in a report titled A Question of Balance: Report on the future of Drug Evaluation in Australia. The principal amendments relate to access to unregistered/unlisted therapeutic goods; the circumstances under which an application for registration on the Australian Register of Therapeutic Goods will lapse; and time limits within which evaluations of therapeutic goods are to be completed.
Background Therapeutic goods are goods that are represented in any way to be, or likely to be taken to be, for therapeutic use (this includes goods used to cure, treat or diagnose an ailment or to effect a physiological process). Therapeutic goods also includes goods for use as an ingredient or component in the manufacture of therapeutic goods, or for use as a container or part of a container for therapeutic goods.
The objects of the Therapeutic Goods Act 1989 (the Principal Act) are to provide, within constitutional limitations, a national system of controls over therapeutic goods used in, or exported from Australia. The Principal Act provides that the Minister may, by gazettal of an order, establish a standard for therapeutic goods, identified in the order. An order establishing a standard may deal with a number of matters, including the quality of the goods; procedures to be carried out in the manufacture of the goods; require that a matter be decided in accordance with a particular test; or require that the goods be labelled, or packaged in a particular way. It is an offence under the Principal Act for a person not to comply with a standard without the written consent from the Department of Health, Housing and Community Services (the Department).
Manufacturers of therapeutic goods are required to be licensed under the Principal Act. Applications for licences are required to identify the types of therapeutic goods, the method of manufacture and the premises at which the manufacture of the goods is intended. Approved therapeutic goods are assigned a number and are either entered on a register known as the Australian Register of Therapeutic Goods or on a separate list. Registered goods are required to conform to applicable standards, have an acceptable presentation and any advertising has to conform with the regulation. Goods listed separately generally tend to be of a less hazardous nature which do not require the comprehensive evaluation of registered goods. The Secretary of the Department may revoke or suspend a licence, including where a licence holder has been convicted of an offence against the Principal Act; has breached a condition of the licence; or where the annual licensing charge, or any prescribed inspection fees have not been paid within 28 days of them becoming payable.
The principal amendments proposed by this Bill will give effect to certain recommendations contained in a report titled A Question of Balance: Report on the future of Drug Evaluation in Australia, which was tabled in Parliament in July 1991. The Report identified a number of inefficiencies in the present therapeutic goods evaluation system including delays for applications and duplication of work done by other countries. The recommendations of the Report included: * that the objects of the Principal Act be amended to reflect the need for a balance between safety and availability of therapeutic goods; * harmonisation of Australian requirements and drug evaluation processes with those in the European community; * a task force be established by 1 October 1991 to plan and achieve the elimination of the backlog of evaluations within the Therapeutic Goods Administration; * a new scheme for special access to unapproved drugs should be in place from 1 January 1992; * terminally ill patients, and seriously ill patients with life- threatening conditions, should have the right under guidelines to elect to use any therapeutic drug if they see it as their last resort; and * Australia should not develop its own standards for pharmaceuticals except for uniquely Australian products or in response to unique Australian conditions or in response to a demonstrated public health need.
Main Provisions Section 4 of the Principal Act contains the objects of the Act (note: the `Background' to this Digest contains an outline of the objects of the Principal Act). A new subsection 4(2) will be inserted into the Principal Act by clause 3 that provides that the reference in the objects to a `system of controls' is to be taken to be a reference to a system that is consistent with the need to ensure the timely availability of therapeutic goods.
Section 18 of the Principal Act provides that the regulations may, subject to any prescribed conditions, exempt therapeutic goods from the requirement to be registered on the Australian Register of Therapeutic Goods or listed. A new section 18 will be substituted into the Principle Act by clause 4 that provides that regulations may, subject to any conditions, exempt: * all therapeutic goods, except those included in a prescribed class; * specified therapeutic goods; or * a specified class of therapeutic goods; from the requirement to be registered on the Australian Register of Therapeutic Goods or listed. Where the exemption relates to the first of the above categories, the exemption will only have effect in relation to the classes of people prescribed for this reason. Where regulations revoke an exemption, the revocation will have effect 28 days after the regulations are made. This amendment will allow certain classes of people, such as those who have AIDS, greater access to unapproved drugs.
Section 19 of the Principal Act allows the Secretary to the Department to grant an approval for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods which are not either exempt goods or goods included in the Australian Register of Therapeutic Goods. New subsections 19(5)- 19(9) will be inserted into the Principal Act by clause 5, the principal effect of which will be to allow the Secretary to the Department to authorise a specified medical practitioner to supply specified therapeutic goods, or classes of goods, for use in the treatment of humans that are not either exempt goods or goods included in the Australian Register of Therapeutic Goods (proposed section 19(5)). Such authorisations may only be given to a medical practitioner included in prescribed class of medical practitioners, and in relation to a class or classes of prescribed recipients and will not render the Commonwealth, the Secretary to the Department, or his/her delegate liable to suit in respect of loss, damage or injury of any kind suffered by a person as a result of the use of exempted therapeutic goods.
It will be an offence for a person in, or in connection with, an application for listing of therapeutic goods on the Australian Register of Therapeutic Goods, to knowingly or recklessly make a statement that is false or misleading. It will also be an offence for a person to whom an authority has been given under proposed section 19(5) to supply the therapeutic goods to which the authority relates except in accordance with the authority, and any prescribed circumstances (clause 8).
A new section 22A will be inserted into the Principal Act by clause 9 that will make it an offence for a person in, or in connection with, an application for registration on the Australian Register of Therapeutic Goods, to knowingly or recklessly make a statement that is false or misleading. The maximum penalty for a breach of this provision will be a fine of $40 000.
Clause 10 will amend section 24 of the Principal Act to increase the range of circumstances under which an application for registration will lapse. The new circumstances include that the application contains inaccurate or misleading information or that the applicant has failed to supply individual patient data in relation to the goods. Individual patient data is defined to be information derived from clinical trials, including demographic, biochemical or haematological information (cluse 10).
Proposed section 24C, which will be inserted into the principal Act by clause 12, provides that where a period is set for evaluation, the applicant will only be required to pay three- quarters of the evaluation fee before the completion of the evaluation. If the evaluation is not completed at the end of the period for evaluation, the fee will be taken to have been reduced to this amount. If the evaluation is completed during the period, the full fee will be payable (clause 12).
Proposed paragraph 63(2)(da), which will be inserted into the principal Act by clause 17, provides for regulations to be made specifying the periods within which evaluations are to be completed. Information Sources * Australian Health Medical Law Reporter, CCH Australia Limited. * Bills Digest Service - Parliamentary Research Service, Therapeutic Goods Bill 1989, 1989. * Department of Health, Housing and Community Services, Annual Report 1990- 91. * P. Baume, A Question of Balance: Report on the future of Drug Evaluation in Australia, July 1991. * Therapeutic Goods Act 1989.
Bills Digest Service 6 December 1991 Parliamentary Research Service
For further information, if required, contact the Education and Welfare Group on 06 2772412.
This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.
Commonwealth of Australia 1991.
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Published by the Department of the Parliamentary Library, 1991.