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.