WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
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.
- To give the Department of Health and Family Services the power
to recall batches of drugs which do not meet Australian
standards;
- to cut down the time Australian patients must wait before newly
developed therapeutic devices manufactured in the EC may be
imported into Australia. The Bill does this by implementing the
Agreement on Mutual Recognition in Relation to Conformity
Assessment Certificates and Markings between Australian and the
European Community. This allows certain overseas bodies, approved
by Australian authorities, to certify that a therapeutic device
imported from the EC meets Australian standards. Once this
certificate has been supplied to Australian authorities, the device
may be marketed here, provided the Secretary of the Department of
Health considers it does not threaten the health or safety of
users.
Speeding up the system
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:
- to cancel the goods from the Register of Therapeutic Goods, and
then recall them; or
- prosecute the manufacturer or other relevant body for supplying
goods which do not meet the required standards.
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:
- force the recall of batches of therapeutic goods which, in the
Secretary's opinion, do not meet the applicable standard;
and/or
- require those responsible to inform the public, or segments of
the public, that the goods do not meet the applicable
standard.
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
Information and Research Services
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.
IRS staff are available to discuss the paper's contents
with Senators and Members and their staff but not with members of
the public.
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
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