Commonwealth of Australia Explanatory Memoranda

[Index] [Search] [Download] [Bill] [Help]

THERAPEUTIC GOODS AMENDMENT (2017 MEASURES NO. 1) BILL 2017

                               2016-2017-2018




    THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA




                                   SENATE




THERAPEUTIC GOODS AMENDMENT (2017 MEASURES NO. 1) BILL 2017




          SUPPLEMENTARY EXPLANATORY MEMORANDUM




            Amendments to be Moved on Behalf of the Government




   (Circulated by authority of the Minister for Health, the Hon Greg Hunt MP)
      AMENDMENTS TO THE THERAPEUTIC GOODS AMENDMENT (2017
                    MEASURES NO. 1) BILL 2017


NOTES ON CLAUSES

Clause 1
This clause amends item 6 of the table in clause 2 of the Bill so that Part 2 of Schedule 6 to
the Bill (Removal of requirement for advertisements to be approved) commences on
1 July 2020, instead of the later of 1 July 2018 and the day after the Act receives the Royal
Assent.

Financial Impact Statement
The Government will provide $20.4 million over four years from 2016-17, including
$9.5 million in capital funding, to improve the regulation of therapeutic goods in Australia in
response to the Expert Panel Review of Medicines and Medical Devices Regulation. The
funding will improve access to therapeutic goods for consumers and introduce more flexible
and timely regulatory processes for the therapeutic goods industry.

The ongoing cost of this measure from 2017-18 will be met by the Therapeutic Goods
Administration's (as part of the Department) cost recovery arrangements.




                                               1
                     Statement of Compatibility with Human Rights

The effect of the amendments is to change the commencement of the measures in Part 2 of
Schedule 6 to the Bill, which relate to removing the requirement for certain advertisements
for therapeutic goods to be pre-approved, from the later of 1 July 2018 or the day after Royal
Assent, to 1 July 2020. As such, the amendments would appear to be compatible with the
human rights and freedoms recognised or declared in the international instruments listed in
section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, as the change of
commencement would not entail the engagement of any of those recognised rights and
freedoms.

                The Honourable Greg Hunt MP, the Minister for Health




                                              2