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Therapeutic Goods Amendment Bill 1997
Date Introduced: March 26 1997
House: The Senate
Portfolio: Health and Family Services
Commencement: The part of the Bill relating to recalling batches
of drugs commences on Royal Assent; the part relating to the Agreement
on Mutual Recognition with the European Community commences on a day to
be fixed by proclamation, or if no date is fixed, six months after the
agreement comes into force.
This Bill is just one of a number of changes spawned by the push in the 1980s and early 1990s to speed up access for Australian patients to new drugs and other medical technology, developed overseas. The initial push came from AIDS groups tired of seeing AIDS sufferers die without being allowed to try controversial new drugs available elsewhere in the world. They criticised Australia's approval procedures as being too cumbersome and time consuming.
The pressure lead to more streamlined approval processes and a consequent cut in waiting periods.
This Bill aims to reduce the time taken to get therapeutic goods developed in European Community countries onto the Australian market.
It is underpinned by an international agreement - the Agreement on Mutual Recognition with the European Community in relation to Conformity Assessment Certificates and Markings between Australia and the European Community.
The agreement is being negotiated by the Department of Science and Technology, and covers seven industry sectors, not just therapeutic goods.
The Department of Health and Family Services hopes it will be signed at a Ministerial Conference in Brussels in November.
If it is finalised then, Australia would be the first country outside Europe to sign such an agreement with the EC.
In general terms, 'therapeutic goods' break down into two categories - drugs, herbal remedies and similar products; and 'therapeutic devices' which range from bandages, dressings, condoms, needles and imaging equipment like ultrasound, to heart valves, implantable pacemakers and intra-ocular lenses.
Under the Bill, if a therapeutic device is manufactured in the EC, and a certificate provided by a European assessment body recognised by Australia, stating that the item meets Australian standards, then the Secretary of the Department of Health and Family Services must include the device on the Australian Register of Therapeutic Goods (ie to register or list it depending on how the device is classified). The device is then allowed onto the Australian market. A therapeutic good must be on the register before it may be legally sold in Australia.
In the jargon of the Bill, if a conformity assessment certificate is issued by an approved conformity assessment body, then the Secretary must list or register the device.
The Secretary may only refuse to do so if s/he believes it may compromise the health or safety of users.
The Secretary must also notify the importer of his/her decision within 28 days of making a decision. If the device is to be refused entry into the market, written reasons must be provided.
However, according to the Department of Health and Family Services, this new regime will not start immediately in the case of higher risk therapeutic devices. First, there is to be 18 months of confidence building. During that time, the European body making the assessment will be required to provide Australian authorities with copies of relevant reports so they can verify the reports' quality for themselves.
In the case of drugs and herbal remedies, the Bill simply continues procedures put in place under an earlier Pharmaceutical Inspection Convention between Australia and a number of individual European countries. Under this arrangement, the Secretary is obliged to take into account a certificate from a relevant body stating that the product's manufacture meets Australian requirements. However, s/he is not obliged to allow their importation simply because such a certificate is produced.
Recalling drugs
The Bill also gives the Secretary of the Department of Health and Family Services the power to compulsorily recall batches of therapeutic goods which do not meet Australian standards.
The current compulsory recall procedures are cumbersome. They are contained in the Trade Practices Act 1974 and require consultation and co-ordination between the Australian Competition and Consumer Commission and the department. The department may only request a recall, not compel one. Instead it has two, more draconian, choices:
Under the Bill, the Secretary may only take the softer option of recalling the batch if there have been no similar lapses in the previous six months.
In practice, recalls will be handled by the Therapeutic Drugs Administration.
The department expects that most recalls will continue to be voluntary.
Item 1 of Schedule 1 adds a new clause 30B. This gives the Secretary the power to:
If the Secretary takes one or both of these courses of action, s/he is required to publish the details in the Gazette.
The proposed section makes it an offence to intentionally refuse or fail to comply with a requirement imposed by the Secretary, with fines of up to $6,000 for an individual or $30,000 for a corporation.
The new powers are in addition to the Secretary's existing power to either cancel the goods from the Register of Therapeutic Goods and then recall them; or to prosecute those responsible.
Items 2 - 7 contain new definitions. These include 'approved conformity assessment body', 'conformity assessment body', 'conformity assessment certificate'.
Item 8 repeals existing clause 25(2)(a) and substitutes a new one. It deals, in general terms, with registrable drugs - which include all prescription and over-the-counter drugs. It empowers the Secretary, when deciding whether to allow a product into Australia, to take into account whether a conformity assessment certificate has been issued by a recognised body in a European Community country.
Item 9 inserts a new section 25A dealing with registrable therapeutic devices. A registrable device is one considered to be of higher risk, for example, a heart valve, implantable pacemaker or intra-ocular lens. This proposed section says the Secretary must list the device on the Australian Therapeutic Goods Register providing a conformity assessment certificate is provided. The only exception: if the Secretary considers the device might compromise the health or safety of users.
The Secretary must notify the applicant within 28 days of making the decision. Written reasons must be included if the Secretary decides to refuse to list the device.
Item 11 repeals the old section 26(2)(a), and substitutes a new one. This item is similar to item 8 except that this one deals with listable medications - including herbal remedies, vitamins, minerals and sunscreens.
It empowers the Secretary, when deciding whether to allow a product into Australia, to take into account whether a conformity assessment certificate has been issued by a recognised body in a European Community country.
Item 12 inserts a new section 26AA. This is similar to item 9, except this item deals with listable therapeutic devices. A listable device is one considered to be of lower risk, for example, bandages, dressings, condoms and imaging equipment ie ultrasound. This new section says the Secretary must list the device on the Australian Therapeutic Goods Register providing a conformity assessment certificate is provided. The only exception: if the Secretary considers the device may compromise the health or safety of users.
Item 13 repeals the old section 26A(4)(a) and susbstitues a new one. This section ensures, the new procedures extend to electronic applications.
Bronwyn Young
27 June 1997
Bills Digest Service
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This Digest does not have any official legal status. Other sources should be consulted to determine whether the Bill has been enacted and, if so, whether the subsequent Act reflects further amendments.
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ISSN 1328-8091
© Commonwealth of Australia 1997
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Published by the Department of the Parliamentary Library, 1997.
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Last updated: 14 July 1997