What is a Managed Access Program (MAP) and How Does HL Pharma Support Them?
For patients with a serious or life-limiting condition, treatment options do not always wait for a medicine to be registered in Australia. A Managed Access Program (MAP) can help bridge that gap, giving eligible patients structured, compliant access to a medicine before or outside standard commercial availability.
What is a Managed Access Program?
A Managed Access Program (MAP) is a sponsor-led arrangement that provides eligible patients with access to a medicine that is unapproved, not yet commercially available or not routinely reimbursed, where there is an identified clinical need and appropriate regulatory, clinical and institutional oversight.
MAPs operate within applicable Therapeutic Goods Administration (TGA) pathways and hospital governance requirements, most often to support early access ahead of registration or continuity of treatment after a clinical trial ends.
A well-run MAP gives a sponsor visibility and control over how their medicine reaches patients, and gives hospitals a documented, auditable process to follow. Gaps in sourcing, storage, documentation or distribution are usually where programs stall, particularly for sponsors coordinating access across Australia, New Zealand and the wider Asia-Pacific region from overseas.
How HL Pharma supports Managed Access Programs
We manage the operational and regulatory backbone of a MAP end to end, giving sponsors, CROs and hospitals one partner across:
- Global medicine sourcing from a vetted network of licensed suppliers
- Regulatory and TGA pathway support, including ODC licensing and permit requirements
- Importer of Record services across Australia and New Zealand
- Validated temperature-controlled storage, including Schedule 8 and 9 vault storage under continuous surveillance
- National and international distribution, with chain-of-custody controls and audit-ready records
- Reverse logistics, including reconciliation and approved destruction of unused or expired stock
All of this is delivered under our ISO 9001:2015-certified quality system and aligned with GDP and GWP standards, so sponsors retain governance and audit readiness throughout.
One partner across the full pathway
HL Pharma acts as a single point of accountability across global sourcing, Australian sponsorship where appropriate, importation, temperature-controlled storage, national distribution and, where requested, coordinated pharmacovigilance support through specialist partners. Our Melbourne facility operates as a regional depot for Australia, New Zealand and key Asia-Pacific markets. We work alongside your CROs, regulatory consultants and safety partners to support continuity of treatment where the appropriate access pathway is available.
Where we can support you:
• Post-trial supply management: importation, storage, distribution and pharmacy dispensing for extension studies and continued access
• Permit support: biological import permits, controlled drug licences and regulatory paperwork
• TGA pathway advice: SAS, Authorised Prescriber and post-trial access routes
• Reverse logistics: return, reconciliation and destruction of unused trial materials
• Post-trial drug retention: secure, temperature-controlled storage after study completion
• Global medicine sourcing across Europe, the UK, India, the USA and beyond
• Temperature-controlled storage across CRT, refrigerated, frozen and ultra-low environments
• Schedule 8 and 9 vault storage with full ODC compliance
• Pharmacovigilance and TGA reporting support throughout the programme lifecycle
All delivered under our ISO 9001:2015-certified quality management system, aligned with GDP and GWP standards.
Frequently asked questions
How is a Managed Access Program different from the Special Access Scheme?
The Special Access Scheme provides access on a case-by-case basis for an individual patient. A MAP is a broader, sponsor-led program that can support multiple eligible patients, typically operating through the same underlying TGA pathways.
Who applies for access under a Managed Access Program?
Patients don’t apply directly. A sponsor establishes the program, and the treating hospital or prescriber applies on behalf of an eligible patient.
How long does it take to set up a Managed Access Program in Australia?
Timelines vary depending on the medicine, regulatory pathway, sourcing country, scheduling status and documentation available. Where the pathway is clear and the required product and import information is available, HL Pharma can often move quickly to coordinate sourcing, importation, storage and distribution arrangements.
Early engagement helps identify regulatory, licensing, temperature-control and site-delivery requirements upfront, reducing avoidable delays and supporting faster program activation.
Does HL Pharma supply the medicine directly to patients?
No. HL Pharma supports sponsors with sourcing, importation, regulatory coordination, storage and distribution. Supply to patients occurs through the treating hospital or prescriber under the applicable access pathway.
Planning or scaling a Managed Access Program?
Most MAP supply chains rely on separate providers for sourcing, regulatory support and logistics, adding handoffs and risk at every join. As a Managed Access Program provider in Australia and New Zealand, HL Pharma removes those joins, extending the same support into post-clinical trial supply and continuity of treatment, so sponsors have a single partner across the full patient access journey.
Speak with HL Pharma’s Managed Access team about planning, launching or scaling your program in the region. Contact us at hlpharma.com.au/contact/ or call +61 3 7036 0141. Learn more about our Managed Access Programs service.
This article is directed at pharmacists, prescribers, hospital procurement teams and accredited healthcare facilities. It does not constitute advice to individual patients or consumers.