Mike Flatt
Operations Director, Therismos
Specialist innovator drug companies with novel treatments for rare diseases can benefit from partnering with expert service providers who focus on managing the regulatory and supply chain complexity of distribution operations.
Expert distribution partners provide services to their specialist drug company clients, managing the complexities and removing the overheads but enabling the client to maintain control. This eliminates the need for their clients to establish and run regulatory-compliant distribution supply chain operations themselves.
Making rare disease treatments attainable
According to healthcare operations director Mike Flatt, this means patients with rare diseases benefit from accelerated access to treatment through established robust and cost-effective channels, while niche drug development companies benefit from the outsourced services enabling them to invest in further value-adding product development and commercialisation activities.
Simplified and quicker access to rare disease treatments
Companies must have a Wholesale Distribution Licence – also known as a WDA (Wholesale Distribution Authorisation) – before they can distribute new drugs to patients. Acquiring, maintaining and operating a WDA requires systems, procedures, premises and qualified staff.
Companies often embark on this themselves as their drug nears commercialisation. Besides the cost, it can typically take up to nine months to set up, apply for a licence and be successfully audited and approved by a health authority. To avoid this, companies may enter into distribution licencing deals with organisations but in such arrangements control of the product is lost.
Besides the cost, it can typically
take up to nine months to set up,
apply for a licence and be successfully
audited and approved by a health authority.
A third, lesser-known route, is through a partnership with a specialist distribution company focused on supporting companies with a bespoke distribution service offering. This eliminates the WDA investment risk caused by potential delays in the pricing and reimbursement phase. It simplifies the work needed for a rapid launch of patient access to groundbreaking medicines for rare diseases.
Therismos is a specialist distribution company with the infrastructure in place and the experience across several health sectors and clients to professionally offer a distribution service at the optimal time.
Cost-effectiveness for rare disease treatment supply
With a bespoke distribution partnership arrangement, companies can avoid the need to set up a local UK business entity, staffed with a supply chain and quality team, and order management and finance functions. They can avoid the investment required to obtain and manage a WDA plus the setting up and management of contracts with local partners for product storage and movement.
Additionally, the specialist distribution service company offers clients benefits from economies of scale and a means by which supply can be switched on rapidly and only when required. Unlike distribution licensing deals, clients don’t lose control of their product and the whole process is simplified for them.
