Pharmaceuticals Partnerships Program Directions No. 1 of 2006

Administered by Department of Industry, Science and Resources

Legislation au F2006L02853 In force Legislative Instrument

Legislation content

Explanatory Statement

 

Issued by the authority of the Minister for Industry, Tourism and Resources

 

Industry Research and Development Act 1986

 

Pharmaceuticals Partnerships Program Directions No 1 of 2006

 

General Outline

 

The Pharmaceuticals Partnerships Program (the Program) is a competitive, merit based, grants program aimed at increasing the amount of high quality eligible Australian pharmaceutical R&D activity in Australia and the development of partnerships within the pharmaceuticals industry.  

 

The Pharmaceutical Partnerships Program Directions No 1 of 2006 (the Directions) reflect the emphasis on partnerships within the program and include new merit criteria, and definitions for pharmaceuticals R&D activities and eligible Australian pharmaceuticals R&D activities.

 

The Directions provide the Industry Research and Development Board (the Board) with an additional function in respect of the Program and the policies and practices to be followed by the Board in the performance of the function. In accordance with the Directions, the Board assesses applications against merit criteria outlined in the Directions and provides a ranking of those applications to the delegate of the Minister (Program Delegate).  The Program Delegate decides which eligible applications to fund taking into account the merit ranking provided by the Board, the available Program funding, and the policy objectives of the Program.

 

The Directions do not affect the rights of a person (other than the Commonwealth) as at the date of registration so as to disadvantage that person or impose liabilities on that person (other than the Commonwealth) in respect of anything done or omitted to be done before the date of registration on the Federal Register of Legislative Instruments.

 

Legislative authority

The Directions are issued to the Board by the Minister for Industry, Tourism and Resources acting under clause 18A and sub-clauses 19 (1) and 20 (1) of the Industry Research and Development Act 1986.

 

Consultation

The Minister for Industry, Tourism and Resources consulted the Board during the development of the Directions, as required under sub-clause 20 (2) of the Industry Research and Development Act 1986. 

 

In June 2003, public consultation was conducted including workshops on the Program's design (and resultant Guidelines) in a number of capital cities, and acceptance of submissions in response to the discussion paper issued in relation to the Program. In the latter half of 2005, consultation with the Pharmaceuticals Industry Action Agenda Implementation Group on program design informed Government consideration of the Round Three Guidelines.
Financial Implications

The Directions have no financial impact.  The Directions provide a framework by which the Board provides assessments and merit ranking of eligible applications to the Program Delegate.  The Program Delegate makes the final decision in determining the quantum, terms and conditions of grants under the Program.

 

Date of effect

The Directions commence on and from the day on which both of the following steps have been completed:

 

(a) the Directions have been registered on the Federal Register of Legislative Instruments; and

 

 (b) the Directions have been published in the Gazette.

 

Notes on Provisions of the Directions

 

PART 1 – PRELIMINARY

 

Name of Directions

 

Clause 1

 

These Directions constitute the Pharmaceuticals Partnerships Program Directions No 1 of 2006.

 

Commencement

 

Clause 2

 

The Directions commence on and from the day on which both of the following steps have been completed:

 

(a) the Directions have been registered on the Federal Register of Legislative Instruments; and

 

 (b) the Directions have been published in the Gazette.

 

Object of these Directions

 

Clause 3

 

The object of the Directions provides the Board instructions in relation to an additional function of the Board – namely the provision of assessments and merit rankings of eligible applications under the Program - and the policies and practices that the Board must follow in the performance of this additional function.


Interpretation

 

Clause 4

 

This clause explains key terms used in the Directions and definitions of R&D activities. It includes a new definition to explain an additional eligibility criterion allowing applications from companies that have a three year track record in undertaking pharmaceutical R&D activities either in Australia or overseas, or a combination of both.

 

PART 2 – CONSIDERATION OF APPLICATIONS TO PARTICIPATE IN THE PROGRAM

 

Procedure

 

Clause 5

 

This clause provides a guide to the Board on the assessment and merit ranking of eligible applications.  The Board must consider eligible applications in relation to a particular funding round as soon as practicable after the Program Delegate has provided those applications to it. 

 

Board may decline to provide merit ranking

 

Clause 6

 

The Board may refuse to provide a merit ranking of a particular applicant if it is not satisfied that its application shows sufficient merit, is part of the pharmaceuticals industry or that the activities of the applicant are eligible. 

 

PART 3 – ASSESSMENT AND MERIT RANKING OF APPLICATIONS

 

Assessment of eligible applications

 

Clause 7

 

The Board assesses the merit of each applicant's activities against the merit criteria contained within the Directions.

 

Merit Criteria

 

Clause 8

 

The Board will assess applicants against the merit criteria in the Directions.  These criteria are:

–       the track record and capabilities of the applicant;

–       scope and nature of partnerships and collaborations;

–       technical merit of the proposed activities; and

–       the level of benefit to the Australian economy.

 

PART 4 – ASSESSMENT OF PROPOSALS FOR CHANGES TO THE AGREED PORTFOLIO OF ACTIVITIES

 

Clauses 9-11

 

If a grant recipient submits a proposal to the Department to vary its activities, the Program Delegate may refer the request to the Board for assessment (clause 9).  The Board must assess the proposal as soon as practicable (clause 10) and determine the effect of the proposed changes (clause 11).   

 

PART 5 –TECHNICAL ASSESSMENTS

 

Clause 12

 

The Directions advise that the Program Delegate may request the Board to assess an applicant's three-year history of pharmaceutical R&D activities and allows the Program Delegate to draw on the Committee's expertise in determining the eligibility of those activities.

 

Clauses 13-15

 

The Program Delegate may request the Board to assess progress against technical milestones and eligibility of activities.  The Board must provide an assessment to the Program Delegate as soon as practicable after receiving the request. 

 

PART 6 – EVALUATION OF THE PROGRAM

 

Clause 16

 

At the request of the Program Delegate, the Board must cooperate with any independent evaluation of the Program and provide comment on the operations of these Directions.

 

PART 7 – REVOCATION OF EARLIER DIRECTIONS

 

Clause 17

 

These Directions revoke any prior Directions.

 

PART 8 – TRANSISTIONAL PROVISIONS

 

Clauses 18 – 19

 

The revoked Directions continue to apply in relation to assessments made by the Board under the revoked Directions.

 

 

 

Overview

The Pharmaceuticals Partnerships Program Directions No 1 of 2006 were introduced to enhance the Pharmaceuticals Partnerships Program, which is a competitive grants program established under the Industry Research and Development Act 1986. The primary objective of the Directions is to bolster the quality and quantity of eligible Australian pharmaceutical research and development (R&D) activities, as well as to foster partnerships within the pharmaceutical industry. The Directions are issued by the Minister for Industry, Tourism and Resources, and they provide the Industry Research and Development Board with an additional function in assessing and merit ranking eligible applications for the Program. The Board assesses applications against merit criteria and provides a ranking to the delegate of the Minister, who then decides which eligible applications to fund based on the merit ranking, available funding, and the policy objectives of the Program. These Directions were developed in consultation with the Industry Research and Development Board and with public consultation in June 2003 and the latter half of 2005. They establish the framework by which the Board provides assessments and merit rankings of eligible applications, while the Program Delegate makes the final decision on the quantum, terms, and conditions of grants under the Program. The Directions revoke any prior Directions, but the revoked Directions continue to apply in relation to assessments made by the Board under the revoked Directions.

Scope and Application

The Pharmaceuticals Partnerships Program Directions No 1 of 2006 (the Directions) are issued under the Industry Research and Development Act 1986 and pertain specifically to the Pharmaceuticals Partnerships Program, a grants program intended to enhance the quality of eligible Australian pharmaceutical research and development (R&D) activities and foster partnerships within the pharmaceutical industry. These Directions provide the Industry Research and Development Board (the Board) with an additional function, which involves the assessment and merit ranking of eligible applications for funding under the Program. The Board, acting on behalf of the Minister for Industry, Tourism and Resources, assesses applications against merit criteria outlined in the Directions, including the applicant's track record, the scope and nature of partnerships, the technical merit of the proposed activities, and the level of benefit to the Australian economy. The final decision on which eligible applications to fund is made by the Program Delegate, who considers the merit ranking provided by the Board, the available Program funding, and the policy objectives of the Program. The Directions do not affect any rights of a person (other than the Commonwealth) as at the date of registration, and they provide a framework for the Board to conduct assessments and merit rankings of eligible applications to the Program Delegate.

Key Provisions

The Pharmaceuticals Partnerships Program Directions No 1 of 2006 (the Directions) provide a comprehensive framework for the assessment and merit ranking of applications for the Pharmaceuticals Partnerships Program, which aims to increase high-quality pharmaceutical research and development (R&D) activities in Australia. Under Clause 3, the object of the Directions is to instruct the Industry Research and Development Board (the Board) on its additional function, which includes assessing and merit ranking eligible applications for the Program. Clause 4 interprets key terms used in the Directions and provides definitions for R&D activities, including a new criterion for eligibility that allows applications from companies with a three-year track record in pharmaceutical R&D either in Australia or overseas. The Directions impose specific obligations on the Board and the Program Delegate, the delegate of the Minister. Under Clause 5, the Board is required to assess eligible applications for a particular funding round as soon as practicable after they are provided by the Program Delegate. The Board may decline to provide a merit ranking of a particular applicant if it is not satisfied that the application shows sufficient merit, is part of the pharmaceuticals industry, or that the activities of the applicant are eligible (Clause 6). The Board must assess the merit of each applicant's activities against the merit criteria set out in the Directions, which include the track record and capabilities of the applicant, the scope and nature of partnerships and collaborations, the technical merit of the proposed activities, and the level of benefit to the Australian economy (Clauses 7 and 8). Failure to comply with the Directions may lead to the Board declining to provide a merit ranking of an application (Clause 6), which could potentially affect the applicant's eligibility for funding under the Program. If a grant recipient submits a proposal to vary its activities, the Program Delegate may refer the request to the Board for assessment, and the Board must assess the proposal as soon as practicable and determine the effect of the proposed changes (Clauses 9-11). The Directions also require the Board to cooperate with any independent evaluation of the Program and provide comment on the operations of these Directions at the request of the Program Delegate (Clause 16). There are no explicit offences, penalties, or civil/criminal consequences for breach stated within the text of the Directions. However, the failure to comply with the Directions may result in the Board declining to provide a merit ranking of an application, which could potentially affect the applicant's eligibility for funding under the Program. Additionally, the Directions revoke any prior Directions (Clause 17), which means that any previous provisions or requirements will no longer be in effect once the Directions come into force.

Legal classification tags

Area of Law
Technology Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Assessment & Evaluation
Merit Criteria
Catchwords
Pharmaceuticals Partnerships Program
Industry Research and Development Act 1986

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.