Health, Medical & Pharmaceutical Governance – Governance Five™ Guide

Governance Five™ © is applied as a repeatable, evidence-aligned decision-to-delivery flow for non-clinical topics where clarity, participation, traceability or public accountability are required and where decisions intersect multiple teams, organisations, jurisdictions or public-value outcomes.

In health, medical and pharmaceutical contexts, this typically covers access, affordability, equity, program design, partnerships, supply, social-value claims, sovereign capability and public communication – never clinical judgement or scientific evidence.

• Govern: Define the non-clinical intent, fairness principles, decision boundaries and evidence rules and who is responsible for them – separate from clinical or regulatory authority. For example, how equity, regional access, affordability, workforce stability, public value or local capability will be considered.
• Engage: Identify and schedule the required voices – such as clinical leaders, program managers, patients and carers, communities, funders, privacy/cyber, First Nations representatives, workforce, regulators, delivery partners and vendors – and record how and when they contribute to non-clinical decisions.
• Aggregate: Bring together evidence, modelling, constraints, risks, ethics considerations, public-value inputs and stakeholder feedback into one clear, documented basis for a non-clinical decision. This may include demand and capacity data, funding options, equity analysis, social-value impacts and implementation risks.
• Deliver: Align contracts, funding models, partnerships, procurement, digital enablement, operating procedures and public communication with what was authorised at the governance stage – so there is a visible line from decision to delivery for non-clinical aspects of a program or initiative.
• Evolve: Use reviews, incidents, complaints, inquiries, evaluations, new evidence and regulatory changes to update governance settings, not just operations. This makes learning part of the method origin, rather than an afterthought.

This flow does not alter or replace clinical, scientific or regulatory decision-making. Those remain governed by the appropriate authorities, committees, laws and evidence bodies in each jurisdiction. Governance Five™ focuses on how non-clinical decisions are structured, evidenced, delivered and improved around those obligations.

Governance Five™ © is concerned with how decisions affecting people, resources, access, equity and public value are structured and traced – particularly when work involves:

• Multiple organisations – e.g. hospitals, PHNs, ministries, insurers, NGOs, community partners, universities, industry sponsors.
• Multiple geographies or jurisdictions – cross-state, cross-border, or multi-country collaborations and supply chains.
• Blended objectives – clinical outcomes plus access, affordability, workforce stability, social value, or sovereign capability.
• Complex funding or procurement – value-based care models, innovative access agreements, group contracting, shared infrastructure, research partnerships.
• Public narrative and trust – where communities, patients or media need to understand “why this decision and who decided?”.

In these settings, Governance Five™ can provide a single, authored flow that makes non-clinical governance visible, auditable and explainable without changing clinical standards or regulatory requirements.

Health and pharmaceutical organisations already work within established specialist frameworks, for example:

• Clinical-governance models in hospitals and health services.
• Medicines and devices regulation (e.g. TGA, EMA, FDA or comparable authorities).
• Good practice standards – GxP (such as GMP, GCP, GLP) and quality systems in manufacturing and research.
• Ethics review, human-research governance and privacy/data-protection requirements.
• Public-health, safety and infection-control frameworks.

Governance Five™ © does not attempt to replace, certify, approve or interpret any of these sector-specific requirements. Instead, it can be used to:

• Provide a single non-clinical governance flow for programs that cut across multiple frameworks.
• Clarify who is engaged, when and under what rules when decisions affect patients, clinicians, communities or markets.
• Align procurement, contracting, funding and delivery pathways with declared values and public commitments.
• Document how evidence, risks and stakeholder input are aggregated before decisions are made.
• Ensure reviews, incidents and lessons (Evolve) feed back into governance, not only operations.

In simple terms, existing frameworks say “what must be done clinically and legally”. Governance Five™ helps show “how non-clinical governance and participation were structured around those obligations”.

Without changing clinical or regulatory standards, organisations sometimes experience governance friction in areas such as:

• Fragmented decision paths – clinical, commercial, funding and community considerations move through separate, unaligned processes.
• Unclear ownership – no single, visible flow shows who is accountable at each step when multiple partners are involved.
• Participation “fatigue” – patients, clinicians or community groups are consulted repeatedly without a clear, traceable line from input to decision.
• Public-value blind spots – access, affordability, equity, workforce stability or sovereign capability are discussed but not tied to a structured governance method.
• Evidence scatter – data sits across systems, vendors and jurisdictions with no consistent way to aggregate it for non-clinical governance decisions.
• Review learning loss – post-incident or post-program learnings are documented but do not reliably feed back into upstream governance.

Applying the Governance Five™ Flow — Govern → Engage → Aggregate → Deliver → Evolve™ © — can help organisations:

• Make non-clinical decision structure explicit and repeatable across sites and partners.
• Connect stakeholder engagement to traceable criteria and commitments.
• Show how evidence and perspectives were aggregated before a funding, contracting or program decision.
• Demonstrate that delivery aligns with what was authorised and promised to patients, communities or funders.
• Convert reviews and lessons into governance adjustments, not just operational workarounds.

These are non-clinical governance benefits. They sit alongside, and must never override, clinical, scientific or regulatory judgement.

Scenario A – Multi-hospital access & affordability program

A health network launches a program to improve access to high-cost therapies across multiple hospitals and regions. Clinical protocols remain governed by existing clinical and regulatory frameworks. Governance Five™ is used to structure:

• Govern: Non-clinical objectives (equity, affordability, regional consistency), decision rights and safeguards.
• Engage: Structured participation of clinicians, health economists, consumers, payers and community representatives.
• Aggregate: Combined view of demand, funding pathways, capacity, and social/public value considerations.
• Deliver: Transparent contracting, implementation roles and communication to affected communities.
• Evolve: Feedback from outcomes, complaints, access issues and evaluations into governance revisions.

Scenario B – Public–private research & innovation partnership

A university, hospital and industry partner collaborate under a research and innovation agreement. Ethics, safety and scientific standards are managed by existing committees and regulators. Governance Five™ is applied to:

• Clarify non-clinical governance for topics like data access, community benefit, local capability and intellectual ownership.
• Make engagement with patients, communities and professional bodies structured and traceable.
• Aggregate evidence and perspectives before decisions about roll-out, scaling or commercialisation.
• Ensure that any social-value or public-benefit claims are backed by a documented governance path.

Scenario C – Pharmaceutical patient-support and community programs

A pharmaceutical company funds non-clinical patient-support or adherence programs, working with third-party providers or charities. Governance Five™ may be used to:

• Define governance boundaries between clinical care, sponsor responsibilities and partner delivery.
• Ensure community, patient and clinician input is structured and documented before program design is finalised.
• Make non-clinical outcomes (e.g. access, navigation, financial stress reduction) traceable to explicit decisions.
• Provide an auditable basis for ESG, social-value or public-value narratives linked to the program.

Scenario D – Health infrastructure, equipment & digital procurement

A system invests in hospitals, diagnostic equipment or digital platforms. Clinical-safety and technical standards are managed by existing frameworks. Governance Five™ supports:

• Transparent, traceable engagement with clinicians, IT, procurement, finance, cyber, consumers and vendors.
• Clear aggregation of clinical requirements, user needs, sovereign capability and public-value objectives.
• Defensible delivery and contract management aligned to what was agreed at the decision stage.
• Systematic learning from implementation and incidents back into future governance.

These examples are illustrative only. They do not endorse or describe any particular program, product, therapy, sponsor or jurisdiction.

The following example statements are designed to be neutral and non-clinical. Organisations should still adapt wording to their own legal and regulatory advice.

These examples are informational only. They should be reviewed by your own legal, clinical-governance and regulatory teams before being used externally.

Leaders may wish to consider these non-clinical governance questions when exploring Governance Five™:

• Can we clearly describe the governance flow behind our major non-clinical decisions that affect patients, access, affordability or public value across our network?
• Do our current frameworks make it easy to show who was engaged, what was considered, and how trade-offs were decided in non-clinical matters?
• Are community, patient, workforce and partner voices included consistently and transparently, or only in ad hoc ways?
• When we make ESG, social-value or public-benefit claims about our health programs, can we show a structured governance basis for those statements?
• Across jurisdictions and partners, are we implicitly relying on a single staged method without having named it or checked its authorship and licensing status?
• Would a single licensed governance flow make it easier for clinical leaders, executives, boards and regulators to understand how non-clinical decisions are made?

These prompts do not judge current practice. They simply help identify whether method origin, provenance and licensing should be part of your governance conversations.

Governance Five™ © / Power Group Purchasing™ © is a documented, authored system whose five-stage flow Govern → Engage → Aggregate → Deliver → Evolve™ © has been on public record since 2010.

Health, medical and pharmaceutical organisations may wish to consider licensing or alignment discussions where their non-clinical frameworks:

• Use a similar five-stage governance flow to justify access, value, social impact, affordability or sovereign capability.
• Are promoted as a single, proprietary system for cross-organisation public-value decision-making.
• Underpin tenders, reimbursement submissions, ESG reports, public-value cases or multi-year agreements in ways that resemble Governance Five™ public examples.

In such cases, organisations may decide – with their own legal, IP and regulatory advisors – to:

• Confirm that their method is independently founded with dated pre-2010 provenance, or
• Explore licensing or attribution where there is substantive structural overlap with Governance Five™ ©.

Nothing in this section is a legal finding or allegation. It is a governance-awareness prompt only. Any decision about licensing, alignment or attribution remains the responsibility of each organisation and its professional advisors.