Pharmaceuticals Partnerships Program Directions No 1 of 2006
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 8/8/2006
Ian Macfarlane
Minister for Industry, Tourism and Resources
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PART 1 - PRELIMINARY
Name of directions
These directions are the Pharmaceuticals Partnerships Program Directions No 1 of 2006.
Commencement
These Directions will come into effect 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
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 and the development of partnerships within the pharmaceuticals industry;
(b) the policies and practices to be followed by the Board in the performance of the function.
Interpretation
(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 application for grant funding under the Program.
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.
Section 1 - Pharmaceuticals Partnerships Program Directions No. 1 of 2006 - Pharmaceuticals Partnerships Program Directions No. 1 of 2006 | Zoe
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 Australian pharmaceutical research and development (R&D) activities means pharmaceuticals research and development (R&D) activities that are carried out in Australia.
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 (such as, in the United States, through the Food and Drug Administration, and in Europe, through the European Medicines Agency
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 (such as, 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, vaccines and blood products for human use are pharmaceuticals.
pharmaceutical research and development (R&D) activities means:
Systematic, investigative and experimental activities:
(a) that involve innovation or technical risk;
(b) the object of which is new knowledge, or new or improved materials, products, processes, services, or devices for the delivery of pharmaceuticals; and
(c) 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.
Activities that directly contribute to systematic, investigative and experimental activities of the kind described above.
Subject to the application of the definition of pharmaceutical research and development (R&D) activities, the following broad types of activity may be eligible:
(a) basic pharmaceutical research;
(b) drug discovery, including biological screening;
(c) the synthesis and/or extraction of therapeutic substances;
(d) drug formulation;
(e) bioequivalence studies
(f) stability testing on a pharmaceutical;
(g) pre-clinical (including animal toxicology) work and phase I, II and III trials;
(h) clinical trials of a registered drug in a new indication, formulation, route of administration or dosage;
(i) pharmaceutical development activities relating to the building and testing of prototypes;
(j) laboratory evaluation to determine likely commercial production processes;
(k) scale-up from laboratory to pilot plant;
(l) significant process improvements;
(m) obtaining industrial rights, including patents (but note expenditure limits);
(n) computer software activities integral to the R&D; and
(o) 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, activities associated with complying with statutory requirements or standards needed for drug or device registration.
The following activities are, for the purposes of these directions, deemed not to be 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 reproduction 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.
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 eligible Australian pharmaceutical R&D activity in Australia and the development of partnerships within the pharmaceuticals industry.
proposed portfolio of activities means all eligible Australian 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.
revoked directions mean the directions revoked by clause 17.
three year history of pharmaceutical R&D activities means the pharmaceutical R&D activities undertaken by or on behalf of an applicant in each of 2004-05, 2005-06 and 2006-07 financial years.
(2) In these directions,
(a) may is permissive and not mandatory.
(b) a reference to financial year means the 12 month period beginning on 1 July in one calendar year and ending on 30 June in the following calendar year.
PART 2 – CONSIDERATION OF APPLICATIONS TO PARTICIPATE IN THE PROGRAM
Procedure
(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 by the delegate of the Minister.
Board may decline to provide merit ranking
The Board may decide to refuse to provide a merit ranking in respect of a particular eligible application 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;
(c) that the activities described in the eligible application are eligible Australian pharmaceutical R&D activities; or
(d) that the applicant has a three year history of pharmaceutical R&D activities.
PART 3 – ASSESSMENT AND MERIT RANKING OF APPLICATIONS
Assessment of applications
Subject to clause 6, the Board must assess each eligible application on its merit according to the extent to which the application meets the merit criteria.
Merit criteria
The merit of eligible applications must be assessed against the following criteria:
Criterion 1: The Track Record and Capabilities of the Applicant
The Board/Committee will assess each applicant’s track record of undertaking pharmaceutical R&D activities, and their capabilities to undertake the proposed eligible Australian pharmaceutical R&D activities.
In respect of this merit criterion, applicants could address the following factors:
(a) their record in successfully managing pharmaceutical R&D projects in the proposed fields/therapeutic areas;
(b) their record in achieving commercial outcomes from their pharmaceutical R&D; and
(c) their record in meeting commitments in Government programs they have participated in.
In respect of capabilities, applicants could address the following factors:
(d) whether they have access to financial resources to fund the proposed program of projects;
(e) the facilities and research infrastructure available to the applicant, and the capabilities of the personnel to be involved (this can include the facilities and personnel of contract partners);
(f) the existence of clearly focused business plans, including R&D plans, intellectual property management and creditable commercialisation strategies; and
(g) the facilities, capabilities and expertise brought about through partnerships and collaborations.
These factors should not be considered exhaustive nor will they all be applicable to all applicants. Applicants are also welcome to provide further relevant evidence to support their claims under this merit criterion.
Criterion 2: Scope and Nature of Partnerships and Collaborations
The Board/Committee will assess whether each applicant has established, or proposes to establish, an appropriate range of R&D partnerships and collaborations between themselves and research and medical institutions, biotechnology companies, local or global pharmaceuticals companies and pharmaceutical service providers, and the nature of those partnerships and collaborations.
The Board/Committee will consider the extent to which the applicant’s existing and proposed partnerships and collaborations contribute to the applicant’s business strategy, and benefit the Australian industry overall, such as through the transfer of skills and technology; the development of infrastructure and/or co-location of partners; and the generation and sharing of intellectual property and/or royalties.
In relation to partnerships and collaborations that are proposed or still to be finalised, applicants must provide in their application evidence of the intended partnership or collaboration. This may include letters of intent, draft agreements or memoranda of understanding from potential partners or collaborators describing the nature, timing and scope of the arrangements.
In respect of this merit criterion, applicants could address the following factors:
(a) the number, value and form of existing R&D partnerships and collaborations (including contractual arrangements and joint venture partnerships);
(b) the quality of R&D partners – their capabilities and track record;
(c) the extent to which the applicant proposes to extend existing, or forge new, R&D partnerships and linkages;
(d) how the existing and proposed partnerships and collaborations contribute to the applicant’s business strategy;
(e) the extent that partnerships will result in the development of infrastructure and/or co-location of partners in Australia, the sharing of intellectual property and/or royalties, and the sharing and/or transfer of skills and technology in Australia; and
(f) how the applicant proposes to utilise and add value to the Australian Government’s investment in health and medical research.
These factors should not be considered exhaustive nor will they all be applicable to all applicants. Applicants are also welcome to provide further relevant evidence to support their claims under this merit criterion.
Criterion 3: Technical Merit of the Proposed Activities
The Board/Committee will assess whether the eligible Australian pharmaceutical R&D activities proposed by each applicant are of high technical merit.
In respect of this merit criterion, applicants could address the following factors:
(a) the extent to which the proposed activities involve leading edge technologies, techniques or skills;
(b) the degree of innovation evident in the proposed activities;
(c) whether the proposed activities include activity that is new and different for the applicant in Australia;
(d) the extent to which the proposed activities are world class in nature;
(e) the level of technical risk associated with the proposed activities, and the robustness of strategies to manage that risk; and
(f) whether the research is conducted to global good laboratory, clinical and manufacturing practice standards.
These factors should not be considered exhaustive nor will they all be applicable to all applicants. Applicants are also welcome to provide further relevant evidence to support their claims under this merit criterion.
Criterion 4: Level of Benefit to the Australian Economy
The Board/Committee will assess the level of benefit to the Australian economy from the eligible Australian pharmaceutical R&D activities proposed by each applicant, including the contribution to the sustainability of an internationally competitive pharmaceuticals industry in Australia.
In respect of this merit criterion, applicants could address the following factors:
(a) how the applicant’s proposed R&D activities will enhance or strengthen the Australian 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 that the applicant’s proposed R&D activities will bring benefits to Australia through existing and new partnerships and collaborations;
(c) the utilisation and development of Australian competitive strengths and capabilities, resources and inputs, including Australian-developed intellectual property in undertaking the proposed projects;
(d) 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;
(e) the extent to which there is likely to be future licensing and other revenues from the proposed portfolio of activities;
(f) the extent to which the applicant, in undertaking its proposed R&D, will contribute to improved health outcomes for Australians;
(g) the extent to which the applicant is committed to doing business in Australia in the longer-term, including by reference to the applicant’s long-term R&D and business strategy in Australia;
(h) how participation in P³ secures Australia’s position as a provider of world-class pharmaceutical R&D, through, for example, the establishment of an R&D hub in Australia; and
(i) whether the applicant’s R&D facilities in Australia will be responsible for a higher proportion of its global R&D as a result of participation in the Program.
These factors should not be considered exhaustive nor will they all be applicable to all applicants. Applicants are also welcome to provide further relevant evidence to support their claims under this merit criterion.
PART 4 – ASSESSMENT OF PROPOSALS FOR CHANGES TO THE AGREED PORTFOLIO OF ACTIVITIES
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.
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.
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 Australian 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
A delegate of the Minister may request the Board to provide a technical assessment as to whether an applicant’s three year history of pharmaceutical R&D activities comprises pharmaceutical R&D activities.
13. 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.
A delegate of the Minister may request the Board to provide a technical assessment as to whether a specific activity undertaken or proposed to be undertaken by an applicant or a recipient is an eligible Australian pharmaceutical R&D activity.
If the Board receives a request under clause 12, clause 13 or clause 14, 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
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.
PART 7 – REVOCATION OF EARLIER DIRECTIONS
The Pharmaceuticals Partnerships Program Directions No 1 of 2003 and the Pharmaceuticals Partnerships Program Directions No 1 of 2004 are revoked.
PART 8 – TRANSITIONAL PROVISIONS
The revoked directions, as in force immediately before the commencement of these Directions, continue to apply in relation to assessments made by the Board under the revoked directions.
(1) This clause applies to an application to participate in the Program made under either the Pharmaceuticals Partnerships Program Directions No 1 of 2003 or the Pharmaceuticals Partnerships Program Directions No 1 of 2004 before those directions were revoked.
(2) The Board must consider, in relation to applications that were made under subclause 19(1):
(i) a request by the Delegate to provide a technical assessment of a proposal for approval of changes to the agreed portfolio of activities by a recipient; or
(ii) a request by the Delegate to provide a technical assessment of the progress reported by a recipient against a technical milestone for the agreed portfolio of activities; or
(iii) a request by the Delegate to provide a technical assessment as to whether a specific activity undertaken by a recipient is an eligible pharmaceutical R&D activity;
as if the revoked directions under which the application was made continued to apply.