{"id":"F2006L02853","name":"Pharmaceuticals Partnerships Program Directions No. 1 of 2006","slug":"pharmaceuticals-partnerships-program-directions-no-1-of-2006","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":60090,"registerId":"commonwealth-F2006L02853-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Pharmaceuticals Partnerships Program Directions No. 1 of 2006","content":"Commonwealth of Australia\n\nIndustry Research and Development Act 1986\n\nPharmaceuticals Partnerships Program Directions No 1 of 2006\n\nI, 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.\n\nDated 8/8/2006\n\nIan Macfarlane\n\nMinister for Industry, Tourism and Resources\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nPART 1 \\- PRELIMINARY\n\nName of directions\n\n1. These directions are the Pharmaceuticals Partnerships Program Directions No 1 of 2006.\n\nCommencement\n\n2. These Directions will come into effect on and from the day on which both of the following steps have been completed:\n\n(a) the Directions have been registered on the Federal Register of Legislative Instruments; and\n\n(b) the Directions have been published in the Gazette.\n\nObject of these directions\n\n3. The object of this instrument is to give directions to the Board in relation to:\n\n(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;\n\n(b) the policies and practices to be followed by the Board in the performance of the function.\n\nInterpretation\n\n4. (1) In these directions, unless the contrary intention applies:\n\n> agreed portfolio of activities means the portfolio of activities that is specified in an agreement.\n\n> 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.\n\n> applicant means an entity that makes an application for grant funding under the Program.\n\n> 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.\n\n> Department means the Department of Industry, Tourism and Resources.\n\n> 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.\n\n> eligible Australian pharmaceutical research and development (R&D) activities means pharmaceuticals research and development (R&D) activities that are carried out in Australia.\n\n> 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.\n\n> Minister means the Minister for Industry, Tourism and Resources.\n\n> 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\n\npharmaceutical 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.\n\npharmaceutical research and development (R&D) activities means:\n\n1. Systematic, investigative and experimental activities:\n\n(a) that involve innovation or technical risk;\n\n(b) the object of which is new knowledge, or new or improved materials, products, processes, services, or devices for the delivery of pharmaceuticals; and\n\n(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.\n\n2. Activities that directly contribute to systematic, investigative and experimental activities of the kind described above.\n\nSubject to the application of the definition of pharmaceutical research and development (R&D) activities, the following broad types of activity may be eligible:\n\n(a) basic pharmaceutical research;\n\n(b) drug discovery, including biological screening;\n\n(c) the synthesis and/or extraction of therapeutic substances;\n\n(d) drug formulation;\n\n(e) bioequivalence studies\n\n(f) stability testing on a pharmaceutical;\n\n(g) pre-clinical (including animal toxicology) work and phase I, II and III trials;\n\n(h) clinical trials of a registered drug in a new indication, formulation, route of administration or dosage;\n\n(i) pharmaceutical development activities relating to the building and testing of prototypes;\n\n(j) laboratory evaluation to determine likely commercial production processes;\n\n(k) scale-up from laboratory to pilot plant;\n\n(l) significant process improvements;\n\n(m) obtaining industrial rights, including patents (but note expenditure limits);\n\n(n) computer software activities integral to the R&D; and\n\n(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.\n\nThe following activities are, for the purposes of these directions, deemed not to be pharmaceutical R&D activities:\n\n(a) market research, market testing, market development or sales promotion (including consumer surveys, post-registration studies and product familiarisation programs);\n\n(b) quality control related to the manufacture of finished product intended for sale;\n\n(c) the making of cosmetic modifications or stylistic changes to products, processes or production methods;\n\n(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;\n\n(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;\n\n(f) epidemiology studies;\n\n(g) management studies or efficiency surveys;\n\n(h) research in social sciences, arts or humanities;\n\n(i) the making of donations;\n\n(j) routine collection of information, except as part of the R&D process;\n\n(k) preparation for teaching;\n\n(l) activities associated with complying with statutory requirements or standards other than those needed for drug or device registration; and\n\n(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.\n\n> 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.\n\nproposed portfolio of activities means all eligible Australian pharmaceutical R&D activities that are proposed to be undertaken by or on behalf of the applicant.\n\n> recipient means an entity that is entitled to receive funding under the program pursuant to an agreement between the entity and the Commonwealth.\n\n> 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.\n\n> revoked directions mean the directions revoked by clause 17.\n\n> 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.\n\n(2) In these directions,\n\n(a) may is permissive and not mandatory.\n\n(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.\n\nPART 2 – CONSIDERATION OF APPLICATIONS TO PARTICIPATE IN THE PROGRAM\n\nProcedure\n\n5. (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.\n\n(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.\n\nBoard may decline to provide merit ranking\n\n6. The Board may decide to refuse to provide a merit ranking in respect of a particular eligible application if it is not satisfied:\n\n(a) with the level of merit of an eligible application in relation to one or more of the merit criteria; or  \n\n(b) that the applicant is part of the pharmaceuticals industry;  \n\n(c) that the activities described in the eligible application are eligible Australian pharmaceutical R&D activities; or\n\n(d) that the applicant has a three year history of pharmaceutical R&D activities.\n\nPART 3 – ASSESSMENT AND MERIT RANKING OF APPLICATIONS\n\nAssessment of applications\n\n7. 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.\n\nMerit criteria\n\n8. The merit of eligible applications must be assessed against the following criteria:\n\nCriterion 1: The Track Record and Capabilities of the Applicant\n\nThe 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.\n\nIn respect of this merit criterion, applicants could address the following factors:\n\n(a) their record in successfully managing pharmaceutical R&D projects in the proposed fields/therapeutic areas;\n\n(b) their record in achieving commercial outcomes from their pharmaceutical R&D; and\n\n(c) their record in meeting commitments in Government programs they have participated in.\n\nIn respect of capabilities, applicants could address the following factors:\n\n(d) whether they have access to financial resources to fund the proposed program of projects;\n\n(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);\n\n(f) the existence of clearly focused business plans, including R&D plans, intellectual property management and creditable commercialisation strategies; and\n\n(g) the facilities, capabilities and expertise brought about through partnerships and collaborations.\n\nThese 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.\n\nCriterion 2: Scope and Nature of Partnerships and Collaborations\n\nThe 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.\n\nThe 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.\n\nIn 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.\n\nIn respect of this merit criterion, applicants could address the following factors:\n\n(a) the number, value and form of existing R&D partnerships and collaborations (including contractual arrangements and joint venture partnerships);\n\n(b) the quality of R&D partners – their capabilities and track record;\n\n(c) the extent to which the applicant proposes to extend existing, or forge new, R&D partnerships and linkages;\n\n(d) how the existing and proposed partnerships and collaborations contribute to the applicant’s business strategy;\n\n(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\n\n(f) how the applicant proposes to utilise and add value to the Australian Government’s investment in health and medical research.\n\nThese 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.\n\nCriterion 3: Technical Merit of the Proposed Activities\n\nThe Board/Committee will assess whether the eligible Australian pharmaceutical R&D activities proposed by each applicant are of high technical merit.\n\nIn respect of this merit criterion, applicants could address the following factors:\n\n(a) the extent to which the proposed activities involve leading edge technologies, techniques or skills;\n\n(b) the degree of innovation evident in the proposed activities;\n\n(c) whether the proposed activities include activity that is new and different for the applicant in Australia;\n\n(d) the extent to which the proposed activities are world class in nature;\n\n(e) the level of technical risk associated with the proposed activities, and the robustness of strategies to manage that risk; and\n\n(f) whether the research is conducted to global good laboratory, clinical and manufacturing practice standards.\n\nThese 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.\n\nCriterion 4: Level of Benefit to the Australian Economy\n\nThe 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.\n\nIn respect of this merit criterion, applicants could address the following factors:\n\n(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);\n\n(b) the extent that the applicant’s proposed R&D activities will bring benefits to Australia through existing and new partnerships and collaborations;\n\n(c) the utilisation and development of Australian competitive strengths and capabilities, resources and inputs, including Australian-developed intellectual property in undertaking the proposed projects;\n\n(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;\n\n(e) the extent to which there is likely to be future licensing and other revenues from the proposed portfolio of activities;\n\n(f) the extent to which the applicant, in undertaking its proposed R&D, will contribute to improved health outcomes for Australians;\n\n(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;\n\n(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\n\n(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.\n\nThese 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.\n\nPART 4 – ASSESSMENT OF PROPOSALS FOR CHANGES TO THE AGREED PORTFOLIO OF ACTIVITIES\n\n9. 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.\n\n10. 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.\n\n11. In undertaking an assessment of a proposal to change the agreed portfolio of activities the Board will determine:\n\n(a) whether any new activities that are proposed to be added to the agreed portfolio of activities are eligible Australian pharmaceutical R&D activities;\n\n(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.\n\nPART 5 – TECHNICAL ASSESSMENTS\n\n12. 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.\n\n13\\. 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.\n\n14. 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.\n\n15. 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.\n\nPART 6 - EVALUATION OF THE PROGRAM\n\n16. 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.\n\nPART 7 – REVOCATION OF EARLIER DIRECTIONS\n\n17. The Pharmaceuticals Partnerships Program Directions No 1 of 2003 and the Pharmaceuticals Partnerships Program Directions No 1 of 2004 are revoked.\n\nPART 8 – TRANSITIONAL PROVISIONS\n\n18. 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.\n\n19. (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.\n\n(2) The Board must consider, in relation to applications that were made under subclause 19(1):\n\n(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\n\n(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\n\n(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;\n\nas if the revoked directions under which the application was made continued to apply.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"The Directions appear consistent with the original intent of the Pharmaceuticals Partnerships Program as established under the Industry Research and Development Act 1986. The instrument maintains the program's core purpose of increasing pharmaceutical R&D in Australia through merit-based grants and industry partnerships. The 2006 version updates and consolidates earlier Directions (2003 and 2004) without apparent expansion beyond the original scope of directing the Board's functions in assessing applications, managing agreements, and evaluating program performance."},"complexity_factors":["Extensive defined terms section with 14 defined terms, including complex nested definitions for 'pharmaceutical research and development (R&D) activities' that include both an inclusive list (15 sub-paragraphs) and exclusive list (13 deemed exclusions)","Multiple cross-references between clauses (e.g., clause 6 exceptions to clause 5, clause 7 subject to clause 6, clause 19 transitional provisions referencing revoked instruments)","Conditional commencement provision requiring two separate administrative steps (Federal Register registration AND Gazette publication)","Detailed merit criteria in Part 3 with four main criteria and approximately 25 sub-factors, using permissive language ('could address', 'should not be considered exhaustive') creating interpretive flexibility","Transitional provisions preserving operation of revoked directions for existing applications (clauses 17-19)","Multiple delegated functions requiring coordination between Minister, Department delegate, and Board"],"plain_english_summary":"These Directions set how the Industry Research and Development Board runs the Pharmaceuticals Partnerships Program (P³), a government grants scheme funding pharmaceutical R&D in Australia. It frames merit-based assessment, eligibility (three years’ pharma R&D history; activities must be Australian-based, bona fide pharmaceutical R&D), and ongoing Board oversight of funded projects.\n\nThey affect pharma companies seeking grants, the Board that assesses applications, and ministers/officials who decide funding — shaping distribution of substantial public investment to grow Australia’s drug R&D capability."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument replaces and updates earlier Pharmaceuticals Partnerships Program directions (revoking the 2003 and 2004 directions — clause 17) and adds or clarifies a set of specific assessment and advisory functions for the Board: structured merit ranking rules, explicit merit criteria, requests for technical assessments of three‑year history and milestone progress, and cooperation with independent evaluations (clauses 5–16). Mechanically, it formalises and expands the Board’s advisory role compared with a generic or less-detailed set of directions by giving the Board named responsibilities and detailed assessment factors. The directions therefore broaden and make more prescriptive the operational scope of how P³ applications and changes are to be assessed, relative to an earlier, less detailed approach."},"complexity_factors":["Approximately 20 distinct defined terms in the interpretation section (clause 4) that determine who and what is in scope.","A long, detailed definition of \"pharmaceutical R&D activities\" with an explicit list of eligible activities and a separate list of activities that are deemed not to be R&D activities (clause 4).","Four multi-part merit criteria (clause 8) each with multiple illustrative factors (many sub-points a–i), producing layered, qualitative assessment standards.","Two-stage decision process: departmental delegate determines eligibility; the Board ranks eligible applications but may refuse to rank (clauses 5–7), introducing conditional flows.","Delegated technical-assessment powers where the delegate can request targeted reviews (three-year history, milestone progress, specific-activity eligibility) (clauses 12–15), creating parallel advisory functions.","Revocation of prior directions with transitional provisions that preserve prior assessments for in-flight applications (clauses 17–19), adding temporal complexity.","Substantial use of permissive language (e.g. \"may\") and qualitative judgments (e.g. \"world class\", \"benefit to the Australian economy\"), increasing interpretive discretion.","Cross-references within the instrument (e.g. clause 5 subject to clause 6) that require reading multiple clauses to trace decision paths."],"plain_english_summary":"**What this instrument does (mechanically)\n\n- It directs the Industry Research and Development Board (the Board) to perform specific, additional functions for the Pharmaceuticals Partnerships Program (P³). Those functions are mainly: assessing grant applications for merit, providing technical assessments on eligibility and progress, assessing proposed changes to approved R&D work programs, and cooperating with program evaluations (clauses 3, 5, 9–16).\n\n- It sets detailed definitions of who and what counts for the Program (for example, what is a \"pharmaceutical\", what counts as \"pharmaceutical R&D activities\", who is an \"applicant\" or \"recipient\") and lists activities that are eligible and activities that are explicitly excluded (clause 4).\n\n- It prescribes the procedure for how applications are handled: the departmental delegate first determines which applications are \"eligible\" for merit assessment, the Board assesses those eligible applications and provides a merit ranking to the delegate, and the Board can refuse to rank an application if certain conditions are not met (clauses 5–7).\n\n- It sets out the four merit criteria the Board must use when ranking eligible applications: the applicant's track record and capabilities; the scope and nature of proposed partnerships and collaborations; the technical merit of the proposed activities; and the expected level of benefit to the Australian economy. Each criterion is broken down into illustrative factors applicants can address (clause 8).\n\n- It allows the Minister's delegate to ask the Board for technical assessments about an applicant's three-year R&D history, progress against technical milestones, or whether a particular activity is eligible R&D (clauses 12–15).\n\n- It revokes earlier P³ directions from 2003 and 2004, and contains transitional provisions to deal with applications and assessments that started under those earlier directions (clauses 17–19).\n\n**Who this affects\n\n- Applicants (companies or entities) that apply for Pharmaceuticals Partnerships Program grant funding. They must meet the Program definitions and provide evidence that their proposed activities are eligible and merit funding (clauses 4, 5–8).\n\n- Recipients (entities that enter into funding agreements) who may propose changes to their agreed portfolios of activities; such proposals can be assessed by the Board at the request of the delegate (clauses 9–11).\n\n- The Industry Research and Development Board, which receives the new, specified responsibilities to assess, rank and provide technical advice (clauses 3, 5–7, 9–16).\n\n- The Department of Industry, Tourism and Resources and the Minister’s delegate, who gatekeep eligibility, request assessments, and receive the Board’s merit rankings and technical advice (clauses 4, 5, 9, 12–15).\n\n**Why it matters (purpose claimed, and mechanical effects tested against trade-offs and incentives)\n\n- Purpose claimed: The instrument says it exists to increase high-quality pharmaceutical R&D in Australia and to promote partnerships in the industry (clause 3).\n\n- How the instrument channels public funding toward that purpose: it does this by (a) narrowly defining eligible pharmaceutical R&D activities (clause 4), (b) requiring evidence of prior R&D activity (a three-year history) for some assessments (clauses 4, 6(d), 12), and (c) prioritising applications that demonstrate technical merit, partnerships, and economic benefit to Australia via the merit criteria (clause 8).\n\n- Incentives and likely behavioural effects:\n  - Applicants are incentivised to demonstrate an established R&D track record, to form or document partnerships, and to emphasise activities that are explicitly eligible (clause 8 and clause 4 definitions). That favours applicants who can document past pharmaceutical R&D and formal collaborations (clause 8(a)–(g)).\n  - The requirement that R&D be carried out in Australia (\"eligible Australian pharmaceutical R&D activities\") and that the pharmaceutical be a drug registered or intended to be registered under the Therapeutic Goods Act or equivalent (clause 4) favours on‑shore activity and projects linked to regulated drug registration pathways.\n  - The Board and the delegate have gatekeeping roles at different stages: the delegate first decides which applications are \"eligible\" for merit assessment, and the Board provides the merit ranking; the Board can also decline to rank applications that fail certain tests (clauses 5–7). This creates concentrated decision-making power in a small set of officials and committees.\n\n- Costs, compliance burden and implementation risks:\n  - Applicants face an evidentiary/compliance burden: the merit criteria call for records of past R&D success, letters of intent or draft partnership agreements for proposed collaborations, technical risk management strategies, commercialisation plans, and projected economic benefits (clause 8). That increases preparation cost for applications and advantages applicants with administrative capacity.\n  - Discretion and subjectivity: many merit factors are qualitative (e.g. \"world class\", \"quality of R&D partners\", \"level of benefit to the Australian economy\") (clause 8). That creates room for subjective assessment and inconsistent outcomes unless the delegate/Board applies tight internal guidance.\n  - The Board’s role in technical assessments (clauses 12–15) centralises technical judgment in an advisory body. The directions do not describe appeal paths or quantitative scoring methodology, so decisions could be opaque to applicants.\n\n- Effects on private enterprise and competition:\n  - The directions prioritise firms that can show prior pharmaceutical R&D and established partnerships; smaller or earlier-stage firms without a three-year R&D history may be disadvantaged (clause 6(d), 8(a)–(g)).\n  - By excluding routine manufacturing, market research, and quality control from eligible R&D (clause 4), the instrument restricts grant support to innovative, registration-focused R&D activities; that narrows the range of activities government funding can subsidise.\n\n**Concrete mechanisms that create concentrated benefits or potential skewing of outcomes**\n\n- Concentrated benefits: awarded grants and program support accrue to successful applicants/recipients (implicit through the structure of the Program and agreements — clauses 4, 9). The merit criteria and the three-year history requirement concentrate advantage toward established players able to document capability and partnerships (clauses 6(d), 8).\n\n- Administrative and opportunity costs: applicants must prepare substantive documentation and may need to structure R&D and partnership agreements to meet the criteria; the Department and Board must run merit assessments, technical reviews and evaluations, which imposes administrative cost on government (clauses 5, 9–16).\n\n**Implementation mechanics to watch (operational risk points)**\n\n- Who decides eligibility: the delegate of the Minister determines which applications are \"eligible\" for the Board to assess (clause 4 definition; clause 5). That gatekeeping step is critical to whether an application ever reaches merit ranking.\n\n- Board discretion to refuse ranking: the Board may refuse to rank an \"eligible\" application if it is not satisfied on merit, on industry membership, activity eligibility, or the applicant’s three‑year R&D history (clause 6). That creates a two-tier filter: delegate eligibility screening and Board merit filtering.\n\n- Lack of numeric scoring rules: the directions set qualitative criteria and illustrative factors but do not prescribe a scoring method or thresholds; outcome consistency depends on internal Board procedures not specified here (clause 8).\n\n**Relevant clause citations used above:** definitions and eligible activities (clause 4), Board assessment and ranking procedure (clauses 5–7), merit criteria (clause 8), assessment of changes to agreed portfolios (clauses 9–11), technical assessments (clauses 12–15), evaluation cooperation (clause 16), revocation and transition (clauses 17–19).\n"}},"importantCases":[],"_links":{"self":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006","history":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006/history","analysis":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006/analysis","conflicts":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006/conflicts","importantCases":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006/important-cases","documents":"/api/acts/pharmaceuticals-partnerships-program-directions-no-1-of-2006/documents"}}