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Therapeutic Goods Amendment Bill 1999
Date Introduced: 25 November 1999
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: On Royal Assent
To facilitate the
implementation of a mutual recognition agreement between Australia
and three members of the European Free Trade Association (EFTA).
Under the agreement, the testing and certification of certain
products including medical devices and pharmaceuticals can be
carried out in the country of export rather than the country of
destination. The Bill will allow the Secretary of the Department of
Health and Aged Care to accept conformity assessment certificates
in relation to therapeutic goods issued by conformity assessment
bodies in Iceland, Liechtenstein and Norway.
The Therapeutic Goods Act 1989 (the
Principal Act) provides a uniform national system of controls for
therapeutic goods.(1) The legislation provides for an Australian
Register of Therapeutic Goods that are approved for import, export
In 1997 Australia entered into a mutual
recognition agreement with the European Community.(2) In order to
implement part of the agreement the Parliament passed the
Therapeutic Goods Amendment Act 1997. In brief, the
legislation allowed the Secretary of the Department of Health and
Aged Care to accept conformity assessment certificates issued by
conformity assessment bodies in the European Community (EC). These
documents state that therapeutic goods manufactured in the EC
member states to which the certificates apply meet all Australian
regulatory requirements relating to good quality, safety and
efficacy. Acceptance of these certificates precludes the need for
further evaluation or assessment of the products before they are be
included in the Australian Register of Therapeutic Goods and
approved for general marketing.(3)
The Bill seeks to extend this regime to apply to
Iceland, Liechtenstein and Norway.
Recognition Agreement (MRA) between Australia and EFTA
EFTA was established in 1960 by the Stockholm
Convention to eliminate tariffs and other restrictions on trade
between EFTA members. The Member States of EFTA are Switzerland,
Iceland, Liechtenstein and Norway.(4)
The last three nations are also members of the
European Economic Area (EEA). The EEA was instituted by an
agreement signed in 1992 by the EC and the EFTA States. Under the
terms of that agreement where the EC negotiates an MRA with a third
country, it does so on the proviso that the third country will
conclude an equivalent agreement with Iceland, Liechtenstein and
The proposed mutual recognition agreement with
Iceland, Liechtenstein and Norway was tabled in May this year and
examined by the Joint Standing Committee on Treaties (JSCT) in its
Twenty-Second Report. The Committee recommended that binding action
should be taken in relation to the Treaty.
The JSCT defined a MRA in the following
A mutual recognition agreement is a treaty
through which Australia and other Parties recognise that Conformity
Assessment Bodies (CABs) designated by each other are competent to
test and certify a specified range of products to meet their
domestic regulatory requirements.(6)
In the case of therapeutic goods, the agreement
covers medical devices and pharmaceuticals.(7)
By allowing testing, inspection and
certification to occur in the country of origin, it is hoped that
the MRA will help to reduce technical barriers to trade.
While the MRA is designed to promote Australian
exports,(8) the focus of this Bill is to make it easier for
manufacturers in Iceland, Liechtenstein and Norway to export to
Australia. It will allow the Secretary of the Department of Health
and Aged Care to accept conformity assessment certificates issued
by conformity assessment bodies in these countries.
Switzerland is a member of EFTA but is not a
member of the EEA. As a consequence, Australia is not obliged by
its MRA with the EC to conclude an agreement with Switzerland. The
JSCT reported that Switzerland is yet to indicate formally any
interest in negotiating such an agreement.
In evidence before the Committee, a
representative of the Department of Industry, Science and Resources
stated that the lack of an MRA with Switzerland would not present
exporters with any difficulties because the Swiss will accept all
goods marked CE (conformity European) regardless of their
origin.(9) The Swiss may, however, wish to negotiate a treaty with
Australia so as to obtain similar benefits.
The amendments to the principal Act are
essentially definitional changes to incorporate the new MRA within
the framework that was developed to implement the treaty with the
Items 1 to 6 amend subsection
3(1) of the Act.
Items 1 and 2 expand the
definition of conformity assessment body and conformity assessment
certificate. Whereas these terms were previously defined by
reference to the mutual recognition agreement with the EC, they now
also cover the MRA with EFTA.
Item 6 removes the definition
of 'mutual recognition agreement' which specifically referred to
the MRA between Australia and the EC. It is replaced by separate
definitions that describe an EC mutual recognition agreement and an
EFTA mutual recognition agreement (items 3 and
Item 5 defines a 'member of
EFTA' as a country declared to be so by the Minister. Item
7 inserts a new section 3A(1), which will
allow the Minister to determine, for the purposes of the Act which
countries are members of the EC and EFTA.
Section 25 of the Act deals with registrable
medicines.(10) Where goods are manufactured outside Australia, the
Secretary of the Department of Health and Aged Care must determine
whether the manufacturing and quality control procedures used in
the manufacture of the goods are acceptable. In making this
determination under subparagraph 25(2)(a)(i) the Secretary must
take into account a conformity assessment certificate if the goods
were manufactured in the EC. Item 8 amends this
subparagraph to provide that the Secretary must also take into
account certificates issued in relation to goods emanating from
The amendment proposed by item
9 is of similar effect. The item deals with section 26
2(a)(i). In determining whether procedures used in the manufacture
of listable medicines such as vitamins, suncreens and herbal
substances are acceptable the Secretary must, under the amendment,
take into account a conformity assessment certificate if a step in
the manufacture of the product took place in an EC or EFTA
Item 10 amends subparagraph
26(4)(a)(i). At present, in deciding whether to certify that
procedures used in the manufacture of certain listable
medicines(11) overseas are acceptable, the Secretary may take into
account whether the applicant has provided a conformity assessment
certificate if a step in the manufacture of the goods occurred in
the EC. The amendment allows the Secretary to take account of a
certificate if the goods were manufactured in an EFTA country.
Section 61(1) outlines circumstances in which
the Secretary can release the information on Therapeutic Goods.
Item 11 amends the section so that information
that came into the possession of the Department in connection with
the performance of the Department's functions under the EFTA MRA
can be released.
- Therapeutic Goods are defined broadly to include items such as
antibiotics, vaccines and herbal products as well as therapeutic
devices such as pacemakers, heart valves and contraceptives.
- Agreement on Mutual Recognition in Relation to Conformity
Assessment, Certificates and Markings between Australia and the
- Therapeutic Goods Amendment Bill 1997, Senator the Hon. Ian
Campbell, Second Reading Speech, Senate Hansard 26/3/1997,
- More information on EFTA can be found on the Association's
- Joint Standing Committee on Treaties (JSCT), Twenty-Second
Report, June 1999, p. 29.
- ibid, p. 25.
- The MRA also covers automotive products, electrical equipment
and telecommunications equipment.
- The JSCT highlighted an estimate that assessment regimes can
add between 2 and 10 percent to the cost of making and exporting a
product. At present three tests would probably be required to
export goods to Iceland, Liechtenstein and Norway but under the
MRA, one test in Australia would suffice. JSCT, p. 26.
- Guy Wilmington (DISR), Transcript of Evidence before the Joint
Standing Committee on Treaties, 7 June 1999, p. 33.
- This includes all prescription and over-the-counter drugs.
- This includes predominantly over-the-counter drugs, herbal
preparations and vitamins that are described in schedule 4 of the
Therapeutic Goods Regulations. Where such products are supplied for
use in Australia s26A applies. Listable drugs that are exported
from Australia must be processed under s26 along with listable
2 December 1999
Bills Digest Service
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