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This determination makes it simpler for businesses to register for the R&D Tax Incentive and claim a tax benefit on certain clinical trials.
Administered by: Industry, Science and Resources
Registered 27 Jul 2022
Start Date 30 Jun 2022

Commonwealth Coat of Arms of Australia

 

Industry Research and Development (Clinical Trials) Determination 2022

 

made under the

 

Industry Research and Development Act 1986

 

Compilation No. 1

 

Compilation date:                   30 June 2022

Includes amendments up to:   F2022N00150

Registered:                            

 

 

 

 

 

 

Prepared by the Australian Government Solicitor on behalf of the Department of Industry, Science and Resources, Canberra

 

 

 

About this compilation

This compilation

This is a compilation of the Industry Research and Development (Clinical Trials) Determination 2022 that shows the text of the law as amended and in force on 30 June 2022 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 


Contents

Part 1—Preliminary                                                                                                     1

1  Name........................................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

Part 2—Determination that phase 0, I, II, III, pre-market pilot stage, and pre-market pivotal stage clinical trials are core R&D activities                                                            4

5  Determination........................................................................................................................... 4

6  Exclusions................................................................................................................................ 4

7  Part of an activity...................................................................................................................... 5

Endnotes                                                                                                                        6

Endnote 1—About the endnotes                                                                              6

Endnote 2—Abbreviation key                                                                                 7

Endnote 3—Legislation history                                                                              8

Endnote 4—Amendment history                                                                             9

 

 


Part 1—Preliminary

1  Name

                   This instrument is the Industry Research and Development (Clinical Trials) Determination 2022.

3  Authority

                   This instrument is made under subsection 31D(1) of the Industry Research and Development Act 1986.

4  Definitions

Note:          A number of expressions used in this instrument are defined in the Industry Research and Development Act 1986 by reference to definitions in Division 355 of the Income Tax Assessment Act 1997, including the following:

(a)    core R&D activities;

(b)    R&D entity.

                   In this instrument:

biological has the same meaning as in section 32A of the Therapeutic Goods Act 1989.

biosimilar medicine means a version of an already-registered biological medicine. These medicines may be referred to as similar biological medicinal products, similar biotherapeutic products, subsequent entry products, bioequivalents, or follow-on products. Both the biosimilar and its reference medicine will have the following similar characteristics (demonstrated using comprehensive comparability studies): physicochemical, biological, immunological, efficacy and safety.

generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):

                     (a)  has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and

                     (b)  has the same pharmaceutical form; and

                     (c)  is bioequivalent; and

                     (d)  has the same safety and efficacy properties.

phase 0 clinical trial (human pharmacology (micro-dosing)) means a clinical trial that involves dosing a limited number of humans with a limited range of doses of a medicine or biological for a limited period of time with the objective of:

                     (a)  assessing pharmacokinetics; and

                     (b)  gathering preliminary data on pharmacokinetics and bioavailability to determine if the drug behaves as expected from preclinical ‘micro-dosing’ studies.

phase I clinical trial (human pharmacology) means a clinical trial that involves the first administration to humans of a medicine or biological with the objective of assessing its safety and tolerance. Such trials typically include defining or describing pharmacokinetics and pharmacodynamics; determining dosing; exploring drug metabolism and drug interactions; and identifying preferred routes of administration. Trials may be phase Ia or phase Ib as follows:

                     (a)  phase Ia: a clinical trial that involves a single ascending dose;

                     (b)  phase Ib: a clinical trial that involves multiple ascending doses.

phase II clinical trial (therapeutic exploratory) means a clinical trial undertaken in a larger group of human patients with the objective of evaluating the efficacy and safety of a medicine or biological. Trials may be phase IIa or phase IIb as follows:

                     (a)  phase IIa: a clinical trial to demonstrate clinical efficacy or biological activity through pilot studies and to explore therapeutic dose range;

                     (b)  phase IIb: a clinical trial to determine optimum therapeutic dose and regimen (with efficacy as the primary endpoint); and to resolve uncertainties regarding the design and conduct of subsequent trials.

phase III clinical trial (therapeutic confirmatory) means a clinical trial that involves a large group of patients and aims to evaluate the safety, efficacy or effectiveness of a medicine or biological. Trials may be phase IIIa or phase IIIb as follows:

                     (a)  Phase IIIa: a clinical trial to determine the therapeutic effect in patient populations for which the drug is eventually intended. It provides a definitive assessment of risk-benefit balance (to support drug registration or change in clinical practice);

                     (b)  Phase IIIb: a clinical trial to increase patient exposure and support marketing claims or publication.

phase IV clinical trial (therapeutic use) means a clinical trial of a medicine or biological that includes the following:

                     (a)    post-marketing surveillance or resolution of treatment uncertainties;

                     (b)    monitoring safety in real-world populations;

                     (c)  refining knowledge of the risk-benefit balance, detecting rare or long-term adverse effects, and drug interactions;

                     (d)  pharmacoeconomics to gather data in support of the use;

                     (e)  comparative effectiveness and community-based research (sometimes described as phase V trials);

                      (f)  trial combinations with existing products.

post-market stage clinical trial means a confirmatory investigation of a medical device to establish performance and safety; or observational investigations or surveillance to gain a better understanding of device safety, long-term outcomes, and health economics.

pre-market pilot stage clinical trial means a clinical trial of a medical device that involves a small group of human patients with the objective of being an exploratory investigation to determine preliminary safety and performance information to plan design modifications or provide support for a future pivotal study. It includes first in human and feasibility studies or proof of concept.

pre-market pivotal stage clinical trial means a clinical trial of a medical device that involves a confirmatory investigation to evaluate performance and safety for a specified intended use to satisfy pre-market regulatory requirements.

Register means the Australian Register of Therapeutic Goods maintained under section 9A of the Therapeutic Goods Act 1989.

unapproved therapeutic good means a therapeutic good yet to be entered on the Register.


 

Part 2—Determination that phase 0, I, II, III, pre-market pilot stage, and pre-market pivotal stage clinical trials are core R&D activities

5  Determination

                   Subject to section 6 of this instrument, for the purpose of Industry Innovation and Science Australia (the Board) exercising its power or performing its duty to make a finding pursuant to sections 27B, 27J or 28A of the Industry Research and Development Act 1986, phase 0 clinical trials, phase I clinical trials, phase II clinical trials, phase III clinical trials, pre-market pilot stage clinical trials, and pre-market pivotal stage clinical trials for an unapproved therapeutic good that are:

                     (a)  notified pursuant to item 3 of Schedule 5A of the Therapeutic Goods Regulations 1990 or item 2.3 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002; or

                     (b)  approved pursuant to paragraphs 19(1)(b), 32CK(1)(e) or 41HB(1)(e) of the Therapeutic Goods Act 1989;

                          are core R&D activities.

6  Exclusions

                   None of the following will be core R&D activities for the purposes of section 5 of this instrument:

                     (a)  clinical trials of generic products;

                     (b)  clinical trials of biosimilar medicines;

                     (c)  pre-clinical trial activities or projects;

                     (d)  phase IV clinical trials;

                     (e)  market and post-market stage clinical trials;

                      (f)  activities that are within the scope of subsection 355-25(2) of the Income Tax Assessment Act 1997;

                     (g)  activities that are not, or will not be, conducted in accordance with all applicable approvals, regulatory requirements, and standards that are in force at the time the phase 0 clinical trials, phase I clinical trials, phase II clinical trials, phase III clinical trials, pre-market pilot stage clinical trials, and pre-market pivotal stage clinical trials are being conducted.

Note:          For the avoidance of doubt, the inclusion of activities in section 6 of this instrument does not mean these activities are not core R&D activities. Activities listed in paragraphs 6(a), (b) (c), (d) (e), (f) and (g) of this instrument may meet the definition of core R&D activities, but they do not come within the scope of section 5 of this instrument and so an R&D entity will need to demonstrate such activities meet the definition of core R&D activities independently, without the support of this instrument.

7  Part of an activity

                   Sections 5 and 6 of this instrument can apply to part of an activity for the purpose of the Board exercising its power or performing its duty to make a finding pursuant to sections 27B, 27J or 28A of the Industry Research and Development Act 1986.


 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 


 

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

exp = expires/expired or ceases/ceased to have

reloc = relocated

effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

 

commenced or to be commenced

 

 


 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Industry Research and Development (clinical trials, phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022

 

31 March 2022 (F2022N00078)

1 April 2022 (s 2)

 

Industry Research and Development (clinical trials, phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Amendment (Minor Corrections) Determination 2022

29 Jun 2022 (F2022N00150)

30 Jun 2022 (s 2(1) item 1)

 

 

 

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

Title.....................................

am F2022N00150

Part 1

 

s 1........................................

am F2022N00150

s 2........................................

rep LA, s 48D

s 4........................................

am F2022N00150

Part 2

 

s 6........................................

am F2022N00150