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A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes
For authoritative information on the progress of bills and on amendments proposed to them, please see the House of Representatives Votes and Proceedings, and the Journals of the Senate as available on the Parliament House website.
Registered 05 Mar 2013
Introduced Senate 28 Feb 2013
Table of contents.

 

2010‑2011‑2012‑2013

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

Presented and read a first time

 

 

 

 

 

 

Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

 

No.      , 2013

 

(Senator Di Natale)

 

 

 

A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

  

  


Contents

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 1

3............ Schedule(s)......................................................................................... 2

Schedule 1—Amendments                                                                                                3

Part 1—Main amendments                                                                                         3

Therapeutic Goods Act 1989                                                                                     3

Part 2—Application provisions                                                                                8

 


A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes

The Parliament of Australia enacts:

1  Short title

                   This Act may be cited as the Therapeutic Goods Amendment (Pharmaceutical Transparency) Act 2013.

2  Commencement

                   This Act commences on the day this Act receives the Royal Assent.

3  Schedule(s)

                   Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.


 

Schedule 1Amendments

Part 1Main amendments

Therapeutic Goods Act 1989

1  Chapter 5 (heading)

Repeal the heading, substitute:

Chapter 5Advertising, inducements, counterfeit therapeutic goods and product tampering

2  After Part 5‑1

Insert:

Part 5‑1AInducements

  

42DQ  Definitions

                   In this Part:

arrangement means a contract, agreement, understanding, scheme or other arrangement:

                     (a)  whether formal or informal, or partly formal and partly informal; and

                     (b)  whether written or oral, or partly written and partly oral; and

                     (c)  whether or not enforceable, or intended to be enforceable, by legal proceedings.

registered medical practitioner means an individual who is registered under a State or Territory law to practise in the medical profession.

regulated corporation means:

                     (a)  a corporation that imports regulated pharmaceutical products into Australia; or

                     (b)  a corporation that manufactures regulated pharmaceutical products in Australia; or

                     (c)  a corporation that supplies regulated pharmaceutical products in Australia.

regulated pharmaceutical product means a medicine that is a listed good or a registered good.

reportable payment has the meaning given by subsection 42DT(4).

42DR  Civil penalty relating to prohibited inducements

             (1)  A regulated corporation contravenes this subsection if:

                     (a)  the corporation enters into an arrangement to provide commercial sponsorship for a conference, convention, educational seminar or other event that is to be held outside Australia; and

                     (b)  at the time the arrangement is entered into, the corporation expects, or ought reasonably to expect, that a majority of the people who will attend the conference, convention, educational seminar or event are registered medical practitioners.

Maximum civil penalty:    600 penalty units.

             (2)  A regulated corporation contravenes this subsection if:

                     (a)  the corporation provides hospitality, including by paying for meals or entertainment, to registered medical practitioners while they are attending an educational seminar or event; and

                     (b)  the value of the hospitality provided is, on average for the seminar or event, more than:

                              (i)  $100 per registered medical practitioner; or

                             (ii)  if a higher amount per registered medical practitioner is prescribed by the regulations—that amount.

Maximum civil penalty:    1,200 penalty units.

42DS  Civil penalty relating to unreported inducements

             (1)  A regulated corporation contravenes this subsection if:

                     (a)  the corporation:

                              (i)  pays a registered medical practitioner to attend a conference, convention, educational seminar or other event; or

                             (ii)  pays the travel or accommodation costs, or both, of a registered medical practitioner who is attending the event; and

                     (b)  the registered medical practitioner, in attending the event, is not representing the regulated corporation or a sponsor of the event.

Maximum civil penalty:    1,200 penalty units.

             (2)  For the purposes of paragraph (1)(a), a corporation is taken to have made a payment to a registered medical practitioner to attend a conference, convention, educational seminar or other event if the corporation does one or more of the following in exchange for the practitioner attending the event:

                     (a)  pays a fee, honorarium or other amount to the practitioner or to the practitioner’s employer;

                     (b)  pays an amount that will be used, whether or not by the practitioner, for the purposes of medical research;

                     (c)  makes a donation to a charity on behalf or in relation to the registered medical practitioner;

                     (d)  gives a gift of more than $25 in value to the practitioner or to the practitioner’s employer.

42DT  Reporting requirements

             (1)  A regulated corporation must:

                     (a)  prepare a report in accordance with subsection (2) for each financial year; and

                     (b)  make the report available to the public in accordance with subsection (3).

             (2)  The report must be in writing and contain:

                     (a)  the following details in respect of each reportable payment made by the corporation during the financial year to which the report relates:

                              (i)  the amount or value of the payment;

                             (ii)  the name of the recipient of the payment;

                            (iii)  the date on which the payment was made;

                            (iv)  the nature of the payment;

                             (v)  the reasons for making the payment; or

                     (b)  if no reportable payments were made by the corporation during the financial year—a statement to that effect.

             (3)  The report must be made available to the public on the corporation’s website:

                     (a)  within 1 month after the end of the financial year to which the report relates; and

                     (b)  until the end of the period of 5 years after the day the report is first made available on the website.

             (4)  A regulated corporation makes a reportable payment if:

                     (a)  the corporation pays a fee, honorarium or other amount to a registered medical practitioner who attends a conference, convention, educational seminar or other event on behalf of the corporation;

                     (b)  the corporation pays a fee, honorarium or other amount to a registered medical practitioner or to the practitioner’s employer; or

                     (c)  the corporation provides a service to a registered medical practitioner or to the practitioner’s employer; or

                     (d)  the corporation pays the travel or accommodation costs of a registered medical practitioner, or provides travel or accommodation related services to a registered medical practitioner or to the practitioner’s employer; or

                     (e)  the corporation pays an amount that will be used for the purposes of medical research; or

                      (f)  the corporation makes a donation to a charity on behalf or in relation to the registered medical practitioner; or

                     (g)  the corporation gives a gift of more than $25 in value to a registered medical practitioner or to the practitioner’s employer.

             (5)  However, a payment, service, donation or gift mentioned in subsection (4) is not a reportable payment if the payment, service, donation or gift is made is respect of a registered medical practitioner:

                     (a)  who is a full time employee of the regulated corporation; or

                     (b)  who is an employee of the regulated corporation and provides the majority of their employment services to the regulated corporation;

                     (c)  is a consultant retained by the regulated corporation and provides the majority of their consultancy services to the regulated corporation.

42DU  Civil penalty relating to reporting requirements

                   A regulated corporation contravenes this section if:

                     (a)  the corporation is required to prepare a report under section 42DT; and

                     (b)  either or both of the following apply:

                              (i)  the corporation does not prepare the report in accordance with that section;

                             (ii)  the corporation does not make the report available to the public as required by that section.

Maximum civil penalty:    3,000 penalty units.


 

Part 2Application provisions

3  Application

(1)       The amendments to the  Therapeutic Goods Act 1989, as inserted by this Schedule, apply in relation to acts and omissions that occur on or after 1 January 2014.

(2)       For the purposes of this item, if an act or omission is alleged to have occurred between 2 dates, one before and one on or after 1 January 2014, the act or omission is taken to have occurred before 1 January 2014.