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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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 1—Amendments
Part 1—Main amendments
Therapeutic Goods Act 1989
1 Chapter 5 (heading)
Repeal the heading, substitute:
Chapter 5—Advertising, inducements, counterfeit therapeutic goods and product tampering
2 After Part 5‑1
Insert:
Part 5‑1A—Inducements
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 2—Application 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.