Early Access Programs

New or novel therapies are often made available by global manufactures that are supplied on Managed Access Mechanisms. These mechanisms are often also referred to as Early Access Programs or Named Patient Programs.

Orspec offers a comprehensive service to ethically support pharmaceutical companies, patients, and physicians to access products with a high unmet clinical need where products are not available in the respective markets.

The mechanisms can also include:

• Post trials supplies
• Charged for managed access programs
• Companionate managed access programs

Orspec currently supports with various exclusive Early Access Programs across Australia, New Zealand, Singapore, South Korea, Malaysia, Hong Kong and Macao on behalf of partners from the United States, United Kingdom, Canada, Japan and Europe.

Medicine Shortages

Medicine shortages are a growing and complex global challenge. Shortages of essential drugs are becoming increasingly frequent globally, burdening health systems with additional costs and posing risks to the health of patients who fail to receive the medicines they need. Orspec works closely with the regulators and pharmaceutical companies in our territories to reduce the impact of medicine shortages on patients.

Each country and territory have a unique management action to minimise the effect on public health.

For information about our products that are approved in Australia by the TGA under Section 19a visit the TGA website here.

Contact us to request an alternative to a registered product currently in shortage in your territory.

Named Patient Supply

Orspec offers access to products that are not commercially available to hospitals, healthcare professionals and patients in our territories. This model allows certain health practitioners to access therapeutic goods (such as medicines, medical devices, or biologicals) that are not included in the Register of Therapeutic Goods of a country for a single patient, products affected by shortages or discontinuations or products that are otherwise commercially unavailable. These schemes are highly regulated and often complex and require adherence to regulatory standards and processes. 

As is one of the leading suppliers of unlicensed medicine in the Orspec territories, we supply products to Hospitals, Pharmacists and Physicians and have a well-established global supplier network for sourcing and supplying products in need.

Orspec have all the required licenses, in market knowledge, regulatory framework and partners in place to ensure an efficient supply route.

For more information on named patient supply in Australia, under the TGA Special Access Scheme, visit the TGA website here.

Orspec also have access and hold stock of various lines listed on the TGA SAS Category C list of products with an established history of use in Australia. For more information on products on the Category C list visit the TGA website here.

For information on the access of products under named patient supply in our other territories feel free to contact us.