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Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

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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.



 

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