Unlicensed Medicines Distribution Models and End Users

It is natural to describe unlicensed medicine supply by its distribution model, such as direct shipment or specialty pharmacy, but the type of institution at the receiving end usually decides which fulfilment route is practical.

Within the unlicensed medicines and managed access programs market, four distribution models and six end users are tracked, and each combination has its own requirements for documentation, storage, handling and timing.

The receiving institution determines who can legally accept the product. A hospital pharmacy holds a licence that allows it to receive and store medicines, while a clinic without a pharmacy may be able to receive product only through a dispensing partner.

It also determines what authority is needed. A hospital may be able to approve a request through its own pharmacy and therapeutics committee, whereas a government healthcare system may need a central decision before any shipment is released.

Storage and handling capability differ. A large academic centre may have ultra-cold storage and trained staff, while a small clinic may have neither, and the product's handling needs limit which institutions can be served directly.

Timing requirements differ too. A treatment centre that schedules patients weeks ahead can use a planned delivery, whereas an emergency request may need a courier and customs clearance within a day or two.

The distribution model is chosen to fit these conditions. A manufacturer with many small hospital customers across a region may prefer a third-party provider, while one with a few large centres may choose to supply directly.

For buyers, the practical question is how simple the process is to administer. A single point of contact that handles documents, import, shipment and safety reporting reduces the workload on hospital staff, which is a large part of the value that providers offer.

This page describes how product reaches the point of care. It makes no clinical claim about any medicine and gives no prescribing or patient-eligibility guidance.

Direct-to-Hospital Supply and Specialty Pharmacy Distribution

Direct-to-hospital supply means that the manufacturer or its appointed provider ships product straight to the receiving hospital pharmacy, without an intermediate wholesaler or retail pharmacy.

It is a very common model because most unlicensed medicines are used in hospital settings, where products are administered under supervision and pharmacies are equipped to receive controlled supply.

The model suits products with specialised handling needs. Direct shipment keeps the number of handovers low, which reduces the chance of temperature excursions or documentation errors, and it allows the sender to monitor the shipment from dispatch to receipt.

It does require the sender to hold the right authorisations in the destination country, or to work with a partner that does. Import licences, wholesale dealer permits and customs documentation are all potential requirements.

Specialty pharmacy distribution works differently. A specialty pharmacy receives product from the manufacturer or provider and dispenses it to a hospital, clinic or patient, taking on storage, dispensing and sometimes patient support duties.

This model is most common where the receiving institution does not have the capacity to manage the product itself, or where the regulatory system requires a licensed pharmacy to be the dispensing party.

Documentation travels with the shipment in both models. A typical consignment carries the prescriber's request, the import permit, a quality statement for the batch, temperature records and a delivery confirmation that closes the loop for safety reporting.

Specialty pharmacies can add services around the product, including adherence support, scheduling of deliveries and collection of safety information, which some manufacturers value as part of a program.

The choice between the two depends on the regulatory system as much as on preference. In some countries only a licensed pharmacy may hold an unauthorised product, and in others a hospital may import directly under a named patient exemption.

Third-Party Access Providers and Hybrid Distribution Models

Third-party access providers are specialist companies that manage the supply of unlicensed medicines on behalf of manufacturers. They typically combine regulatory expertise, import and export capability, logistics and pharmacovigilance in one service.

The attraction for a manufacturer is reach without infrastructure. A provider with existing licences, relationships with hospitals and experience of local rules can supply a country in which the manufacturer has no presence at all.

The provider's role is shaped by the access program types it supports, since a managed access program calls for central administration of many requests while a named patient service is more transactional.

Providers handle a series of tasks. These include receiving and checking requests, confirming eligibility against the program protocol, arranging import permits, storing product, shipping to the receiving institution and reporting safety events to the sponsor.

Hybrid distribution models combine several routes. A manufacturer might use direct supply for large academic centres, a specialty pharmacy for smaller institutions and a third-party provider for countries where it has no presence.

Hybrid models are common because no single route fits every country and customer. They add coordination work, but they allow a manufacturer to match each market to the most efficient fulfilment option.

Third-party access providers are an increasingly used model, as more manufacturers, especially smaller ones, choose to outsource rather than build the capability in-house.

Choosing a provider involves several criteria, including regulatory expertise, geographic reach, pharmacovigilance capability, supply reliability and compliance infrastructure, and these are the same criteria that buyers weight when selecting a partner.

Hospitals, Academic Medical Centres and Specialty Clinics

Six end users receive unlicensed medicines, and the first three are hospitals, academic medical centres and specialty clinics. Together they raise a large share of requests.

General hospitals are a core end user. Their pharmacies are accustomed to handling controlled supply, and requests are usually raised by a consultant and processed through the hospital pharmacy and its medicines committee.

Academic medical centres are often the most experienced users. They treat complex cases, take part in clinical research and are frequently the first to learn about products becoming available elsewhere, which leads them to initiate requests earlier than other hospitals.

Their procurement is typically more formal than that of smaller hospitals. A university hospital may have dedicated staff for non-formulary and unlicensed requests, and a clear policy governing approval, documentation and safety reporting.

Specialty clinics treat narrower patient groups, such as those with a single condition or type of therapy. They may order small volumes, and some do not have a full pharmacy, which makes them more reliant on specialty pharmacy or provider support.

Procurement pathways at these institutions are relatively formal. A request may pass through a pharmacy and therapeutics committee, an ethics review where one is required and a finance check on how the product will be funded before the order is released.

These end users also differ in their internal decision makers. In a hospital the pharmacy director and a medicines committee are central, in an academic centre clinical department heads may have more influence, and in a clinic the treating physician may make the decision.

Expectations of suppliers vary as well. Hospitals and academic centres typically expect complete documentation and clear safety reporting, while specialty clinics place more weight on ease of ordering and responsive support.

Understanding these differences helps explain why the same product may be supplied through different routes within a single country, depending on which type of institution places the request.

Oncology Centres, Government Healthcare Systems and Rare Disease Treatment Centres

The last three end users are oncology centres, government healthcare systems and rare disease treatment centres, and each has a distinctive relationship with unlicensed supply.

Oncology centres are high-volume users with established processes. They see a steady flow of patients for whom new therapies may be available abroad, and their pharmacies often have experience of requesting product through named patient and early access routes.

Government healthcare systems are different in kind. They may act as the buyer for a whole country or region, negotiate with suppliers centrally, and import specific products on a case basis or under a framework agreement.

Their procurement follows public purchasing rules, which can extend the time between a request and an award but also allows larger and more stable commitments than individual hospital orders.

Rare disease treatment centres are specialist institutions that treat patients with uncommon conditions, often from a wide geographic area. A single centre can be the main route to treatment for a country or region.

Suppliers serving these end users are covered in the discussion of the companies operating these distribution models, where the focus is on how different types of provider match different buyer needs.

Because rare disease centres are few in number, the relationship between the centre and the supplier is often close and long-lasting, with regular contact between the centre's pharmacists and the program team.

Government buyers and oncology centres tend to value breadth of supply and documentation quality, while rare disease centres place particular weight on continuity and on a supplier's understanding of their patient group.

Across all three, demand is shaped by decisions about funding and by the number of patients served, and these factors influence how often requests are made and how much product is needed.