Pharmaceuticals Partnerships Program Directions No. 1 of 2006

The Directions build on a set of definitional and procedural concepts that determine eligibility, assessment and change-management for Program participants. The first main concept is definitions. Clause 4 provides a comprehensive glossary. Key definitional points are: a pharmaceutical is a chemical or biological substance containing one or more active ingredients used or intended for use in prevention or treatment of human disease and, for the Program, includes vaccines and blood products. Pharmaceutical R&D activities are defined in two parts: systematic, investigative and experimental activities that involve innovation or technical risk and have a direct link to development of a pharmaceutical or delivery device, and activities that directly contribute to those systematic activities (clause 4). The Directions list examples of potentially eligible activities across discovery, synthesis, formulation, bioequivalence testing, pre-clinical and clinical trials, scale-up, process improvements, software integral to R&D and supporting activities such as protocol development and clinical trial management (clause 4). Equally important is the negatives list: market research, routine quality control for manufacture intended for sale, cosmetic or stylistic changes, pre-production trials unrelated to registration, replication of existing commercial products from publicly available information, epidemiology, management studies, routine data collection, teaching preparation and routine medical care (with limited SAS exception) are expressly deemed not to be eligible pharmaceutical R&D activities (clause 4).

The second main concept is the allocation of decision roles. The delegate of the Minister determines eligibility to be admitted for merit assessment (the eligible application concept referenced in clause 4). The Board then assesses eligible applications and provides a merit ranking to that delegate (clauses 5 and 7). The Board is a technical assessor not the final funding decision-maker. The delegate can also request the Board to perform technical assessments about three year histories, milestone progress and whether activities are eligible (clauses 12 to 15). The Board must cooperate with independent Program evaluations at the delegate’s request (clause 16).

The third concept is the merit framework. Clause 8 sets four explicit merit criteria: the applicant’s track record and capabilities; the scope and nature of partnerships and collaborations; the technical merit of proposed activities; and the level of benefit to the Australian economy including sustainability of an internationally competitive pharmaceuticals industry. For each criterion the Directions list indicative factors that the Board may take into account, for example financial resources, facilities and personnel, letters of intent for proposed partnerships, innovation, global good practice standards, potential for licensing revenues and commitment to long-term business in Australia (clause 8). Those factors are expressly non-exhaustive.

The fourth concept is flexibility with constraints. The Board must assess eligible applications "as soon as practicable" (clause 5(2)) and must assess proposals to change agreed portfolios of activities (clauses 9 to 11). However, the Directions expressly allow the Board to refuse to provide a merit ranking if it is not satisfied as to specific matters including the three year history requirement (clause 6). The Directions also make clear that the word "may" is permissive, not mandatory (clause 4(2)(a)), which preserves discretionary space within the outlined procedures.

The fifth concept is continuity and transition. The instrument revokes earlier directions but carries transitional provisions preserving the operation of those revoked directions for assessments made under them (clauses 17 to 19). Finally, the Directions are part of an administrative continuum: they reference agreements between recipients and the Commonwealth and rules for the Program, but do not reproduce or alter those underlying agreements or rules directly. The agreement and rules will govern funding terms and any limits on expenditure such as limitations on claiming industrial rights costs (clause 4, note on industrial rights).

The Directions allocate roles and impose evidentiary and procedural expectations on a set of identifiable actors. The primary affected parties are applicants and recipients of Program funding, the Industry Research and Development Board, the Minister and the delegate of the Minister, the Department of Industry, Tourism and Resources, and participants in the pharmaceuticals industry whose activities may be proposed for funding.

Applicants and potential applicants: An applicant is any entity that applies for grant funding under the Program (clause 4). The document affects them by defining which activities will be treated as eligible pharmaceutical R&D activities and which will not (clause 4). Applicants must prepare evidence to satisfy the merit criteria, including matters such as track record, capabilities, partnerships, technical merit, and economic benefit (clause 8). The Directions impose a practical filter: an applicant will have to demonstrate a three year history of pharmaceutical R&D activities for the Board to be satisfied, failing which the Board may refuse to provide a merit ranking (clause 6(d)). Applicants are also affected because eligibility to be admitted for merit assessment is determined by the delegate of the Minister,thus applicants must first be accepted as eligible by the delegate before the Board will assess merit (clause 4, definition of eligible application; clause 5).

Recipients: A recipient is an entity entitled to receive funding under an agreement with the Commonwealth (clause 4). Recipients are affected post-award because the Board may be asked to assess proposed changes to an agreed portfolio of activities (clauses 9 to 11), to provide technical assessments of progress against technical milestones (clause 13), and to assess whether specific activities being undertaken are eligible pharmaceutical R&D activities (clause 14). The Directions therefore govern how recipients must secure approval for changes and how their progress and compliance may be technically evaluated.

The Board: The Board gains an additional function under these Directions (clause 3). Its duties include assessing eligible applications and providing merit rankings to the delegate (clauses 5 and 7), performing technical assessments at the delegate’s request (clauses 12 to 15), assessing proposals to change an agreed portfolio (clauses 9 to 11), and cooperating with program evaluations (clause 16). The Board also has a gatekeeping discretion to refuse to provide a merit ranking in specified circumstances (clause 6). The Directions therefore prescribe the Board’s decision architecture, evidentiary expectations and interactions with the delegate and Department.

The delegate of the Minister and the Department: The delegate determines whether an application is eligible to proceed to merit assessment (clause 4 definition of eligible application). The delegate requests the Board to consider eligible applications and to conduct technical assessments and evaluations (clauses 5(2), 9, 12 to 16). The Department is defined as the Department of Industry, Tourism and Resources and acts as administrator of the Program (clause 4).

The pharmaceuticals industry more broadly: The Definitions state that the pharmaceuticals industry is taken to include companies involved in discovery, creation and supply of pharmaceuticals regulated under the Therapeutic Goods Act 1989 or equivalent overseas regimes (clause 4). The Directions therefore target commercial entities as well as research institutions and service providers engaged in pharmaceuticals R&D.

Other affected parties indirectly: partners, collaborators and service providers that applicants propose to engage will be affected by the Directions because points in the merit criteria value partnerships that transfer skills, develop infrastructure or generate IP and royalties, and applicants are required to supply evidence of such relationships for proposed or intended collaborations (clause 8, Criterion 2). Where applicants rely on contract partners’ facilities and personnel, those partners’ capabilities are part of the assessment under Criterion 1(f).

Who does not gain rights here: The Directions do not confer any private right of appeal or create statutory penalties. They do not themselves commit Commonwealth funds; they structure how the Board interacts with the delegate and the Department for the merit-based Program. The Directions also exclude specified activities from eligibility, reducing the pool of activity that can be supported under the Program (clause 4 exclusions).

The Directions allocate a set of duties, powers and procedural relationships. The Board’s primary duty is to assess eligible applications and provide a merit ranking to the delegate of the Minister, subject to limitations and the power to decline in specified circumstances (clauses 5, 6 and 7). Clause 5(1) obliges the Board to provide a merit ranking for eligible applications, subject to clause 6. Clause 5(2) requires the Board to consider eligible applications relating to a particular funding round "as soon as practicable" after the delegate provides them. Clause 7 requires merit assessment according to the merit criteria set out in clause 8.

The Board has a conditional discretion to refuse to provide a merit ranking. Clause 6 states the Board may refuse to provide a merit ranking where it is not satisfied about the applicant’s level of merit under one or more merit criteria (clause 6(a)), whether the applicant is part of the pharmaceuticals industry (clause 6(b)), whether the activities described are eligible Australian pharmaceutical R&D activities (clause 6(c)), or whether the applicant has a three year history of pharmaceutical R&D activities (clause 6(d)). The use of "may" is explicitly identified as permissive in clause 4(2)(a), which shows the instrument deliberately allows the Board discretion.

The delegate of the Minister has the role of eligibility gatekeeper and requestor. The definition of eligible application in clause 4 ties eligibility for merit assessment to the delegate’s determination. The delegate can also request the Board to assess proposals for changes to agreed portfolios (clause 9), request technical assessments about three year histories, milestone progress, and whether specific activities are eligible (clauses 12 to 15), and request the Board to cooperate with independent evaluations (clause 16). Thus the delegate controls the flow of matters to the Board.

Applicants and recipients have consequential duties in practice. While the Directions do not impose express statutory obligations on applicants beyond their role in submitting applications and evidence, the Directions require applicants to address the merit criteria and to provide evidence for proposed partnerships (clause 8). Applicants seeking to add, discontinue or substitute activities post-award must submit a proposal to the Department for approval and may be required to have the Board assess that proposal (clauses 9 to 11). Recipients can expect technical assessment of progress against technical milestones and of whether a specific activity is eligible (clauses 13 and 14).

Rights are largely implicit and administrative. Eligible applicants have the right to have their application assessed by the Board "as soon as practicable" after it is provided by the delegate (clause 5(2)). However, there is no express right of internal review or appeal from a Board decision within these Directions. The Board’s decision to withhold a merit ranking under clause 6 will be material to funding decisions made by the delegate, but the Directions do not specify any mandatory review mechanism in such cases. Likewise, recipients may have the administrative right to propose changes to agreed portfolios and to have those proposals assessed by the Board on request (clauses 9 to 11), but the Directions do not set fixed timelines for the delegate’s decision-making beyond the Board’s obligation to assess "as soon as is practicable" when requested (clauses 5(2), 10 and 15).

The Directions also allocate procedural duties around documentation and evidence. For partnerships and collaborations that are proposed or not finalised, applicants "must provide in their application evidence of the intended partnership or collaboration" and the Directions list acceptable forms such as letters of intent, draft agreements or memoranda of understanding describing nature, timing and scope (clause 8, Criterion 2). Under Criterion 1 applicants are invited to address financial resources, facilities and personnel, business plans and IP management strategies (clause 8). These built-in evidentiary expectations impose a duty on applicants to assemble technical, commercial and legal documentation in support of grant bids.

Finally, the Directions impose a duty on the Board to cooperate with independent evaluations of the Program at the delegate’s request and to provide comment on the operations of the Directions (clause 16). The Directions therefore establish feedback channels between external evaluators, the Board and the Department.

The Directions do not create criminal offences, civil fines or explicit administrative penalties. The instrument is administrative and prescriptive about assessment processes; it does not include enforcement mechanisms such as monetary penalties, debarment provisions or sanctions. The primary enforcement mechanism is discretionary decision-making that affects entitlement to funding.

Practical enforcement is effected through the follow-on steps in the grant process. The Board assesses eligible applications and provides merit rankings to the delegate (clause 5). A failure to obtain a favourable merit ranking, or the Board’s decision to refuse to provide a ranking under clause 6 where it is not satisfied about merit, industry status, activity eligibility or three year history, directly reduces or eliminates an applicant’s prospects of receiving Program funding. Thus the principal "penalty" for non-compliance or insufficient documentary support is exclusion from financial support under the Program.

For recipients, enforcement takes form in technical assessments of progress against technical milestones (clause 13) and assessments of whether specific activities are eligible (clause 14). If a delegate requests such technical assessments and the Board determines activities are not eligible or milestones are not met, the delegate may use that information in making funding decisions under the agreement between the recipient and the Commonwealth. The Directions do not specify the delegate’s remedial options, repayment obligations or breach consequences in agreements. Those details will reside in the separate agreements and rules for the Program, which the Directions reference (clause 4, definition of agreement and of rules).

The Board’s discretion to refuse to provide a merit ranking can be seen as an enforcement lever to maintain Program standards. Clause 6 gives the Board authority to refuse to provide a merit ranking if it is not satisfied about an applicant’s fit to the merit criteria or eligibility requirements. The Direction’s express note that "may" is permissive (clause 4(2)(a)) underscores that refusal is discretionary rather than mandatory in every borderline case.

Compliance monitoring and evaluation are also mechanisms that can influence behaviour. The Board is required, at the request of the delegate, to cooperate with independent evaluations and comment on the Directions’ operations (clause 16). Those evaluations can lead to operational changes in Program rules, funding priorities or the way technical milestones are set in agreements.

Administrative law remedies outside the Directions are not provided within the instrument. The Directions do not set out an internal merits review or an appeal route against decisions of the delegate or the Board. Any judicial review or statutory review rights would arise under the parent legislation or general administrative law principles, but those are not specified in the Directions themselves. Users should therefore treat the Board’s and delegate’s procedural decisions as determinative for Program participation subject to the legal context created by the enabling Act and any agreements.

The Directions are explicit about their statutory provenance. The instrument is made under subsections 19(1) and 20(1) of the Industry Research and Development Act 1986, as stated at the head of the document. That establishes a statutory chain: these Directions are subordinate instrumentary material implementing functions under the parent Act. The Directions also reference the Therapeutic Goods Act 1989 by reference when defining the pharmaceuticals industry and what counts as a pharmaceutical for the Program (clause 4). The Directions adopt the Therapeutic Goods Act’s regulatory sphere as a boundary marker for the sort of drugs and devices the Program covers. They further note comparative regulatory regimes overseas, for example the United States Food and Drug Administration and the European Medicines Agency equivalents, to indicate an international frame of reference for regulatory status under the definition of pharmaceutical (clause 4).

Administrative registration and publication requirements are incorporated into the Directions’ commencement conditions. Clause 2 requires the Directions to be registered on the Federal Register of Legislative Instruments and published in the Gazette before they take effect. That condition aligns the instrument with the formal requirements for legislative instruments under federal legislative instrument rules.

The Directions interact with grant rules and agreements even though these are not reproduced in the text. Definitions such as agreement, agreed portfolio of activities, revised portfolio and the Program itself reference separate rules and agreements by which funding is administered (clause 4). The Directions therefore operate within a framework where the precise funding terms, payment schedules, milestone definitions, repayment obligations and expenditure limits (for example, a note that there are expenditure limits on industrial rights costs) are set out in the Program rules and in bilateral agreements between recipients and the Commonwealth (clause 4 note on industrial rights). The instrument defers such specifics to those other documents.

The Directions shape the relationship between the Department and the Board. The Department is the administrative authority for the Program, and the directions define the Board’s function as being to provide assessments and merit rankings to the delegate (clauses 4 and 5). The delegate’s role in determining eligibility, directing technical assessments and seeking evaluations places the Departmented apparatus at the hub of operational decision-making (clauses 5, 9, 12 to 16). The Board’s role is technical and advisory under these Directions.

The instrument contains transitional interaction with prior subordinate instruments. It revokes earlier Pharmaceuticals Partnerships Program Directions No 1 of 2003 and No 1 of 2004 (clause 17) but preserves the application of those revoked directions to assessments made under them immediately before commencement (clause 18) and to applications made under those earlier directions prior to revocation (clause 19). This preserves continuity and avoids retroactive disapplication for matters already in train under earlier Directions.

The Directions do not themselves amend the Industry Research and Development Act 1986 nor do they purport to alter the Therapeutic Goods Act 1989. They should be read as administrative rules implementing a funding program under the statutory powers conferred by the parent Act. The Directions also do not specify any interaction with other Commonwealth financial management law or grant guidelines, although in practice grant agreements will be subject to Commonwealth financial management and procurement frameworks. Those interactions are not detailed in this instrument and are therefore left to the underlying agreements and the statutory context.

The Directions expressly record a limited amendment and transition history within the instrument itself. Clause 17 revokes two earlier subordinate instruments: Pharmaceuticals Partnerships Program Directions No 1 of 2003 and Pharmaceuticals Partnerships Program Directions No 1 of 2004. The revocation is explicit; the 2006 Directions replace those previous Directions for matters going forward.

Clauses 18 and 19 create transitional provisions to preserve the legal effect of the revoked Directions for matters already assessed or for applications made under the earlier Directions. Clause 18 provides that the revoked directions, as they were in force immediately before commencement of the 2006 Directions, continue to apply in relation to assessments made by the Board under the revoked directions. Clause 19 applies to applications to participate in the Program made under the revoked Directions before revocation and requires the Board to consider certain requests from the delegate,technical assessments of proposed changes to agreed portfolios, technical assessments of progress against technical milestones, and technical assessments as to whether a specific activity undertaken by a recipient is an eligible pharmaceutical R&D activity,as if the revoked directions continued to apply. The transitional provisions therefore protect the legal expectations of applicants and recipients whose matters were in process under the earlier Directions.

Commencement is conditional, not immediate. Clause 2 states the Directions take effect only when they have been registered on the Federal Register of Legislative Instruments and published in the Gazette. Until both steps occur, the Directions are not in force. That requirement means the effective date may be later than the date of signing in the instrument heading. The instrument itself is signed and dated 8 August 2006, but commencement depends on registration and Gazette publication.

No other amendments or later modifications are recorded within the text provided. There is no schedule of future amendment powers or delegated regulation-making authority within the instrument beyond the general reference to the minister’s powers under the Industry Research and Development Act 1986. The instrument also does not include sunset provisions; it remains effective until revoked or superseded by subsequent Directions.

Readers should note that the Directions provide for agreements between recipients and the Commonwealth as a separate legal instrument (clause 4 definition of agreement) and that the Program is administered by the Department under separate rules. Any amendments to funding conditions, expenditure limits or detailed reporting requirements are likely to appear in those Program rules or in individual agreements rather than in the Directions themselves. The Directions make one explicit editorial note that there are expenditure limits on obtaining industrial rights including patents, where the note “but note expenditure limits” appears in the definition list (clause 4). The Directions do not set those limits; they signal that the Program’s rules or agreements do.

The Directions themselves do not record any litigation or judicial decisions. The text names no cases and contains no statement of judicial interpretation. There are no provisions in the instrument that establish internal appeal rights, enforceable statutory penalties, or remedies that would otherwise generate a body of subordinate litigation directly referenced by the Directions.

That absence means the instrument is an administrative procedural document intended to govern internal assessment mechanics between the delegate, the Board and applicants or recipients. Any litigation that could arise from the operation of the Directions would most likely engage general administrative law principles or the terms of separate grant agreements rather than the Directions themselves. For example, disputes over whether the Board appropriately exercised its discretionary power under clause 6 to refuse to provide a merit ranking, or over the delegate’s determination that an application was eligible, would in practice be the kinds of administrative decisions that could attract merits review or judicial review in appropriate circumstances. The text of the Directions, however, does not create or describe a statutory appeal or review process.

Because the instrument refers to the Industry Research and Development Act 1986 as the enabling statute, any legal challenges to the Board’s exercise of functions under these Directions would be framed by the parent Act and by general public law remedies. The Directions do not specify interlocutory rights, timelines for judicial review, or privative clauses that would oust review. They do not purport to exclude legal remedies. The Directions also do not prescribe internal mechanisms for rehearing or appeal within the Department; they set operational expectations for the Board’s functions but do not provide an internal dispute resolution avenue.

Practitioners looking for litigation history should therefore expect to consult external databases for any judicial review or administrative law cases that engage the Program’s operation, grant agreements or the delegate’s conduct. The Directions themselves provide no narrative about prior disputes, settlements, or court rulings. The transitional clauses preserving the application of revoked Directions for matters already under assessment (clauses 18 and 19) could be relevant in any litigation concerned with timing and the applicable rules to a particular application, but the Directions supply no litigation examples.

The Directions contain several traps for the unwary and practical points that materially affect eligibility, assessment and post-award flexibility. These are concrete operational features, not value judgements.

1. Eligibility gatekeeping by the delegate. The Directions define eligible applications as those the delegate of the Minister has determined to be eligible for merit assessment (clause 4). The Board assesses only applications deemed eligible by the delegate. In practice this means applicants must satisfy an initial administrative filter before the Board will consider their merits. The Directions do not set standards or timelines for the delegate’s eligibility determinations.

2. Board discretion to refuse to provide a merit ranking. Clause 6 allows the Board to refuse to provide a merit ranking if it is not satisfied on merit, industry status, activity eligibility or a three year history of pharmaceutical R&D activities. The Directions do not prescribe an internal review mechanism for a refused ranking. The Board’s refusal will materially affect prospects of funding because the delegate relies on merit rankings to make funding decisions (clause 5). The use of "may" as permissive (clause 4(2)(a)) means the Board is not bound to refuse in every borderline case, but it can.

3. Narrow definitions and an explicit negatives list. The Directions explicitly exclude many activities from being treated as pharmaceutical R&D activities, including market research, routine quality control for products intended for sale, cosmetic changes, and routine clinical care except as part of an investigative program (clause 4). If an applicant’s proposed activity sits near those exclusions,for example, scale-up activities that are framed as pre-production trials not related to registration,there is risk that the Board will find the activity ineligible.

4. Three year history requirement. Clause 6(d) gives the Board power to refuse to rank an eligible application if the applicant lacks a three year history of pharmaceutical R&D activities. The Directions define that term as activities undertaken in 2004-05, 2005-06 and 2006-07 financial years (clause 4). Applicants without that historical footprint face a heightened hurdle. The provision could disadvantage newer entrants, start-ups spun out of academia or overseas firms seeking to establish an Australian presence.

5. Evidence expectations for partnerships. For proposed partnerships that are not finalised, the Directions require evidence such as letters of intent or draft agreements describing nature, timing and scope (clause 8, Criterion 2). Vague or incomplete partnership documentation will weaken an application.

6. Responsibility for technical determinations. The Board is the technical assessor for whether activities are eligible, whether milestones have been met, and whether proposed changes to portfolios would have altered merit at the time of assessment (clauses 11 to 15). A recipient that proceeds with activities that the Board later determines to be ineligible may jeopardise funding, yet the Directions do not specify retrospective remedial steps.

7. The Directions are procedural not exhaustive. Many operational details are left to the Program rules and to recipient agreements (clause 4). For example, the Directions reference expenditure limits on obtaining industrial rights like patents but do not specify those limits. Applicants and recipients need to consult the Program rules and their agreements to understand funding amounts, milestone definitions or consequences for non-performance.

8. No internal appeal channel specified. The Directions set no express internal review or appeals process against merit rankings, eligibility findings, or technical assessments. Parties unhappy with Board or delegate decisions will need to rely on whatever review rights exist in the Program rules, in grant agreements, or in the general law.

9. Timing uncertainties. The Board is required to assess applications and proposed changes "as soon as practicable" after receipt from the delegate (clauses 5(2), 10 and 15), but the Directions do not prescribe fixed deadlines. This leaves applicants and recipients with scheduling uncertainty in relation to funding rounds and approval of portfolio changes.

10. Geographic and procedural constraints on "Australian" activity. Eligible Australian pharmaceutical R&D activities must be "carried out in Australia" (definition in clause 4). Applicants proposing offshore research or significant parts of development outside Australia need to be precise about which activities are in-Australia, and satisfying the Board that the activities are Australian in substance will be necessary.

11. Transitional oddities. For applicants whose matters began under the revoked Directions, the earlier rules may continue to apply for certain assessments (clauses 18 and 19). Practitioners must check which rules apply to their particular application to avoid surprises.

12. Lack of statutory penalties in the Directions. Because the Directions do not set penalties, enforcement depends on the separate agreement and Program rules. Applicants should not assume that the Directions set the full compliance regime.

Taken together, these features mean that applicants should not rely on the Directions alone; they must coordinate the eligibility phase with the delegate, satisfy documentary standards for partnerships and capabilities, document a three year R&D history if relevant, and be cautious of activities that might fall within the exclusions.

Compliance under these Directions primarily requires administrative and documentary steps at the eligibility and application stages, and ongoing record-keeping and responsiveness post-award. The following practical checklist aligns directly with the Directions’ clauses and merit criteria.

1. Clarify eligibility with the delegate before preparing a full submission. The delegate determines which applications are eligible to be admitted for merit assessment (clause 4 definition of eligible application). Seek early engagement with the Department or delegate to confirm that the proposed applicant and activities meet the eligibility threshold, particularly the requirement that eligible Australian pharmaceutical R&D activities be carried out in Australia.

2. Assemble a three year pharmaceutical R&D history where possible. Clause 6(d) gives the Board power to refuse to provide a merit ranking if an applicant lacks a three year history of pharmaceutical R&D activities. The Directions define the three year history reference period (clause 4). Provide clear records of activities undertaken in those financial years, including dates, nature of work, and links to how the work relates to proposed activities.

3. Tailor the application precisely to the merit criteria and supply supporting evidence. Clause 8 sets four criteria and lists factors. For Criterion 1 include records of past project management, commercial outcomes, government program participation, financial resources, facilities, personnel CVs, business and R&D plans, IP management strategies and evidence of partnerships. For Criterion 2 provide letters of intent, draft agreements, memoranda of understanding and partner CVs where partnerships are proposed but not finalised. For Criterion 3 present technical evidence of innovation, risk assessment and adherence to global standards. For Criterion 4 quantify likely economic benefits, licensing potential, capability development and the applicant’s commitment to sustained Australian operations.

4. Avoid activities explicitly excluded. The Directions list activities deemed not to be pharmaceutical R&D activities (clause 4). Review proposed workstreams and segregate or exclude routine manufacturing QC, market research, cosmetic modifications and routine medical care unless those elements are clearly part of an investigational protocol. Document how each proposed activity meets the definitional tests in clause 4.

5. Demonstrate that Australian activities are substantive. The definition of eligible Australian pharmaceutical R&D activities requires the activities to be carried out in Australia. Applicants with multinational R&D pipelines should itemise which stages will be performed in Australia and provide evidence of facilities, staff and resources onshore.

6. Provide clear IP and commercialisation strategies. Clause 8 lists industrial rights and commercialisation as relevant. Explain patent strategies, licensing expectations and intended retention or sharing of IP, noting that the Program has expenditure limits on obtaining industrial rights (clause 4 note). Cross-reference these strategies to likely economic benefits.

7. Prepare for technical assessments and milestone reporting. Recipients should expect the delegate to request technical assessments of progress against technical milestones and whether activities are eligible (clauses 12 to 15). Establish internal monitoring, milestone tracking, and documentary evidence that technical work adheres to good laboratory practice, clinical practice and manufacturing standards as applicable.

8. Manage partnership documentation. For proposed partnerships, include letters of intent, draft agreements or MOUs with dates, scopes, responsibilities and anticipated timelines (clause 8, Criterion 2). Where partners provide personnel or facilities, include partner facility statements, access letters or subcontractor agreements.

9. If seeking post-award changes, prepare a robust proposal. Clause 9 allows recipients to submit proposals to the Department to change agreed portfolios of activities. The delegate may request the Board to assess such proposals, and the Board must determine whether new activities are eligible and the effect on original merit (clauses 10 and 11). Provide a comparative analysis showing why changes are necessary, how proposed new activities meet eligibility criteria, and an assessment of how the revised portfolio would rank under the merit criteria.

10. Keep clear records for evaluations. The Board must cooperate with independent evaluations on request (clause 16). Maintain project-level documentation that can be provided to evaluators, including milestones, expenditure records, partner agreements and evidence of economic impact.

11. Be mindful of timelines and discretionary elements. The Board’s obligations are framed as "as soon as practicable" (clauses 5(2), 10 and 15). Do not assume fixed processing deadlines. Also anticipate that key decisions,the delegate’s eligibility determination and the Board’s decision to provide a merit ranking,are discretionary. Prepare submissions that are straightforward to assess and reduce ambiguity.

12. Coordinate with Program rules and funding agreements. The Directions defer specifics like funding amounts and expenditure limits to the Program rules and recipient agreements (clause 4). Obtain and comply with those documents in tandem with the Directions. Confirm repayment, audit, reporting and breach clauses that will apply once an agreement is in place.

13. Seek clarification on grey areas proactively. If an activity sits close to an exclusion (for example routine data collection versus data collection as part of an established R&D protocol), obtain a technical assessment from the Department or request guidance on whether the Board will consider such activity eligible. Where useful, provide protocol documents and demonstrate the linkage to systematic, investigative or experimental work described in the definition.

14. Consider sequencing of applications and partnerships. Because the Board values established partnerships and expects letters of intent for proposed collaborations, time the finalisation of key partnerships to strengthen the application. Where partners are overseas, ensure the partnership contributes to Australian activity and be ready to explain the locus of work.

Complying with these Directions is primarily an administrative task of evidence assembly, early engagement with the delegate/Department and careful drafting of application materials to align with the four merit criteria and the statutory definitions. Because the Directions leave many operational specifics to separate Program rules and agreements, compliance requires concurrent attention to those documents.