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No. 1 of 2003 Directions/Other as made
These Directions provide the Industry Research and Development Board an additional function of the Board in respect of the Pharmaceuticals Partnerships Program, a program to increase the level of high quality pharmaceuticals research and development activity in Australia by companies at all stages of the pharmaceuticals development process and the policies and practices to be followed by the Board in the performance of the function.
Administered by: Innovation, Industry, Science and Research
Registered 29 May 2009
Gazetted 09 Sep 2003
Date of repeal 28 Aug 2006
Repealed by Pharmaceuticals Partnerships Program Directions No. 1 of 2006

Commonwealth of Australia

 

Industry Research and Development Act 1986

Pharmaceuticals Partnerships Program Directions No 1 of 2003

 

I, Ian Elgin Macfarlane, Minister for Industry, Tourism and Resources, acting under subsections 19(1) and 20(1) of the Industry Research and Development Act 1986, give the following directions to the Industry Research and Development Board.

 

Dated 3 September 2003

 

Ian Macfarlane

Minister for Industry, Tourism and Resources

 

________________

 

PART 1 – PRELIMINARY

 

Name of directions

 

1.                  These directions are the Pharmaceuticals Partnerships Program Directions No 1 of 2003.

 

Commencement

 

2.         These directions commence on the day on which the directions are published in the Gazette.

 

Object of these directions

 

3.         The object of this instrument is to give directions to the Board in relation to:

 

(a)    an additional function of the Board in respect of the Pharmaceuticals Partnerships Program, a program to increase the level of high quality pharmaceuticals research and development activity in Australia by companies at all stages of the pharmaceuticals development process.

 

(b)    the policies and practices to be followed by the Board in the performance of the function.

 

Interpretation

 

4.         (1)  In these directions, unless the contrary intention applies:

 

agreed portfolio of activities means the portfolio of activities that is specified in an agreement.

 

agreement means an agreement between a recipient and the Commonwealth for grant funding under the program, as amended from time to time in accordance with the rules for the program.

 

applicant means an entity that makes an eligible application.

 

delegate of the Minister means an employee of the Department who has been empowered by the Minister, or otherwise duly authorised, to carry out the relevant function in respect of the program.

 

                  Department means the Department of Industry, Tourism and Resources.

 

eligible application means an application for grant funding under the Program, that the delegate of the Minister has determined to be eligible to be admitted for merit assessment by the Board.

                 

                  eligible pharmaceutical research and development (R&D) activities

                  means:

 

1.       Systematic, investigative and experimental activities:

(a)        that involve innovation or technical risk;

(b)        that are carried out in Australia;

(c)        the object of which is new knowledge, or new or improved materials, products, processes, services or devices for the delivery of pharmaceuticals; and

(d)        which have a direct link to, or are of direct relevance to, the development of a pharmaceutical or a device for the delivery of a pharmaceutical.

2.       Activities carried out in Australia that directly contribute to systematic, investigative and experimental activities of the kind described above.

 

Subject to the application of the definition of eligible pharmaceutical research and development (R&D) activities, the following broad types of activity may be eligible pharmaceutical R&D activities:

a.           basic pharmaceutical research;

b.           drug discovery, including biological screening;

c.           the synthesis and/or extraction of therapeutic substances;

d.           drug formulation;

e.           stability testing on a pharmaceutical;

f.            pre-clinical (including animal toxicology) work and phase I, II

        and III trials;

g.           clinical trials of a registered drug in a new indication, formulation, route of administration or dosage;

h.           pharmaceutical development activities relating to the building and testing of prototypes;

i.       laboratory evaluation to determine likely commercial production processes;

j.       scale-up from laboratory to pilot plant;

k.           significant process improvements;

l.       obtaining industrial rights, including patents (but note expenditure limits);

m.         computer software activities integral to the R&D; and

n.           supporting activities that are directly related to the carrying on of the R&D activities referred to above, including pharmaceutical services such as protocol development; the development, preparation and supply of active ingredients for use in non-clinical testing and clinical trials; clinical trial management; bioinformatics; and biostatistical analysis.

 

 

The following activities are, for the purposes of these Directions, deemed not to be eligible pharmaceutical R&D activities:

 

a.           market research, market testing, market development or sales promotion (including consumer surveys, post-registration studies and product familiarisation programs);

b.           quality control related to the manufacture of finished product intended for sale;

c.           the making of cosmetic modifications or stylistic changes to products, processes or production methods;

d.           pre-production activities, such as demonstration of commercial viability, tooling-up or trial runs, which are not related to the product registration process such as with the Therapeutic Goods Administration;

e.           any activity related to the production of a commercial product or process by a physical examination of an existing system or from plans, blueprints, detailed specifications or publicly available information;

f.            epidemiology studies;

g.           management studies or efficiency surveys;

h.           research in social sciences, arts or humanities;

i.       the making of donations;

j.       routine collection of information, except as part of the R&D process;

k.           preparation for teaching;

l.             activities associated with complying with statutory requirements or standards other than those needed for drug or device registration; and

m.         specialised routine medical care or the provision of drugs under the Special Access Scheme (SAS), except when they are a component of an investigative program with an established protocol.

 

funding round means a period of time in which applications received by the delegate of the Minister will be assessed for eligibility and technical merit under the rules of the Program.

 

                        Minister means the Minister for Industry, Tourism and Resources.

 

pharmaceuticals industry means companies that participate in the discovery, creation and supply of pharmaceuticals that are, or are intended to be, regulated under the Therapeutic Goods Act 1989 as registered drugs or under equivalent provisions in comparable countries (that is, in the United States, through the Food and Drug Administration, and in Europe, through the European Agency for the Evaluation of Medicinal Products).

 

Pharmaceutical means a chemical or biological substance containing one or more active ingredients used, or intended for use, in the treatment or prevention of disease in humans. For the purposes of this program, a pharmaceutical is a drug registered or intended to be registered under the Therapeutic Goods Act 1989 or under equivalent provisions in comparable countries (that is, in the United States, through the Food and Drug Administration, and in Europe, through the European Agency for the Evaluation of Medicinal Products). For the purposes of this program blood products and vaccines are a pharmaceutical.

Program means the Pharmaceuticals Partnerships Program, a merit-based program that is administered by the Department and is designed to increase the level of high quality pharmaceutical R&D activity in Australia.

 

proposed portfolio of activities means all eligible pharmaceutical R&D activities that are proposed to be undertaken by or on behalf of the applicant.

 

recipient means an entity that is entitled to receive funding under the program pursuant to an agreement between the entity and the Commonwealth.

 

revised portfolio of activities means a portfolio of activities that is proposed to replace the agreed portfolio of activities pursuant to a proposal of the kind contemplated in clause 9.

 

            (2)  In these directions, may is permissive and not mandatory.

 

PART 2 – CONSIDERATION OF APPLICATIONS TO PARTICIPATE IN THE PROGRAM

 

Procedure

 

5.         (1)  Subject to clause 6, the Board will assess eligible applications and provide a merit ranking of those applications to the delegate of the Minister.

 

      (2)  The Board must consider eligible applications made in relation to a particular funding round as soon as practicable after those applications have been provided to the Board.

 

Board may decline to provide merit ranking

 

6.         The Board may decide to refuse to provide a merit ranking in respect of a particular applicant if it is not satisfied:

           

(a)    with the level of merit of an eligible application in relation to one or more of the merit criteria; or

 

(b)    that the applicant is part of the pharmaceuticals industry; or

 

(c)    that the activities described in the eligible application are eligible pharmaceutical R&D activities.

 

PART 3 – ASSESSMENT AND MERIT RANKING OF APPLICATIONS

 

Assessment of applications

 

7.         Subject to clause 6, the Board must assess each eligible application by comparing the merit of the eligible application with the merit of other eligible applications considered by the Board in that funding round.

 

Merit Criteria

 

8.         The merit of eligible applications must be assessed against the following criteria:

            (1)  Criterion 1: The Track Record and Capabilities of the Applicant

 

            The Board will consider:

 

(a)    the facilities and research infrastructure available to the company, and the capabilities of the personnel to be involved (this can include the facilities and personnel of contract partners);

 

(b)    the company’s track record in managing R&D and achieving outcomes in the proposed fields/therapeutic areas;

 

(c)    the company’s track record in meeting its commitments in any other Government program it has participated in;

 

(d)    the existence of a clear and detailed R&D plan including intellectual property management and commercialisation strategies;

 

(e)    the level of technical risk associated with key R&D activities, and the robustness of strategies to manage that risk, where technical risk is taken to be the uncertainty of a scientific or technical outcome which is resolved by following the scientific method; and

 

(f)     whether the company has access to financial resources to fund the proposed portfolio of activities.

 

(2)    Criterion 2: Scope and Nature of Partnerships and Linkages

 

            The Board will consider:

 

                  (a)  the number, size and form of R&D partnerships and linkages (including contractual arrangements) between the applicant and research and medical institutions, biotechnology companies, local pharmaceuticals and companies and pharmaceutical service providers;

 

                  (b)  the quality of R&D partners – their capabilities and track record;

           

                  (c)  the extent to which the application creates new or improved linkages along the value chain with suppliers and customers;

 

                  (d)  the extent to which the application utilises and promotes the public investment in health and medical research; and

 

                  (e)  the extent to which the applicant will extend existing, or forge new, links with research and medical institutions and biotechnology companies, local or global pharmaceuticals companies, and pharmaceuticals service providers.

 

(3)    Criterion 3: Technical Merit of the Proposed Activities

 

            The Board will consider:

 

                  (a)  the extent to which the proposed portfolio of activities suggests scope for future growth beyond the time frame of the application;

 

                  (b)  the extent to which the proposed portfolio of activities involves leading edge technologies, techniques or skills;

                  (c)  the extent to which the proposed portfolio of activities includes activity that is new for the company in Australia;

           

                  (d)  the extent to which the proposed portfolio of activities are of global importance in the specific therapeutic area(s);

 

                  (e)  the extent to which the proposed portfolio of activities is world class in nature;

 

(f)     the degree of innovation evident in the proposed portfolio of activities; and

 

(g)    whether the research is conducted to global good laboratory, clinical and manufacturing practice standards.

 

(4)    Criterion 4: Level of Benefit to the Australian Economy

 

            The Board will consider:

 

                  (a)  the extent to which the proposed portfolio of activities enhances or strengthens industry’s capabilities (for example, by filling a gap in the value

                        chain, developing expertise, or introducing new skills, knowledge, technologies or techniques);

 

                  (b)  the extent to which there is potential for benefit to other industries as a result of the company’s introduction of new transferable skills, knowledge, technologies or techniques;

 

                  (c)  the extent to which the proposed portfolio of activities utilises Australian capabilities, resources and inputs including Australian-developed intellectual property;

                 

                  (d)  the extent to which there is likely to be future licensing and other revenues from the proposed portfolio of activities;

 

                  (e)  the extent to which the company, in undertaking R&D, will contribute to improved health outcomes for Australians; and

 

(f)     the extent to which any of the R&D activities would fail to happen or proceed significantly more slowly in Australia if the company was not granted entry to the program.

 

(5)    Criterion 5: Sustainability of an internationally competitive pharmaceuticals industry in Australia

 

            The Board will consider:

 

(a)    the extent to which the proposed portfolio of activities represent a commitment to doing business in Australia in the longer term, including by reference to the company’s long-term R&D and business strategy in Australia.

 

(b)    the extent to which participation secures Australia’s position as a provider of world-class pharmaceutical R&D, through, for example, the establishment of a R&D hub in Australia;

 

(c)    the extent to which the proposed portfolio of activities utilises and builds upon Australia’s competitive strengths;

 

(d)    the extent to which the proposed portfolio of activities is an integral part of the company’s global R&D strategy; and

 

(e)    the extent to which R&D facilities in Australia will be responsible for a higher proportion of the company’s global R&D as a result of participation in the program.

 

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

 

9.          If a recipient has submitted a proposal to the Department for approval of changes to the

        agreed portfolio of activities, including the addition of new activities, the discontinuance of activities, or the substitution of new activities in the place of discontinued activities, the delegate of the Minister may request the Board to assess the proposal.

 

10.   If the Board receives a request under clause 9, it must assess the proposal as soon as is practicable and provide the assessment to a delegate of the Minister.

 

11.   In undertaking an assessment of a proposal to change the agreed portfolio of activities the Board will determine:

 

(a)        whether any new activities that are proposed to be added to the agreed portfolio of activities are eligible pharmaceutical R&D activities;

 

(b)        the effect that the proposed changes would have had on the relative merit of the application under the merit criteria in clause 8 if the revised portfolio of activities had been admitted for assessment instead of the proposed portfolio of activities in the funding round in which the application was assessed by the Board.

 

PART 5 - TECHNICAL ASSESSMENTS

 

12.   A delegate of the Minister may request the Board to provide a technical assessment of the progress reported by a recipient against the technical milestones for the agreed portfolio of activities.

 

13.   A delegate of the Minister may request the Board to provide a technical assessment as to whether a specific activity being undertaken by a recipient is an eligible pharmaceutical R&D activity.

 

14.   If the Board receives a request under clause 12 or clause 13, it must assess the proposal as soon as is practicable and provide the assessment to a delegate of the Minister.

 

PART 6 – EVALUATION OF THE PROGRAM

 

15.   The Board must, at the request of a delegate of the Minister, cooperate with any independent evaluation of the program, and provide comment on the operations of these Directions.