For patients and families living with rare diseases, orphan drugs can provide an opportunity to imagine a better quality of life. However, the perceived complexity of launching drugs into a new market can mean that patients are missing out on potential life-changing treatments developed by international firms.
Unlike in the US where it is possible to reach patients anywhere in the country with one license, one language, and one supply chain, in Europe it is necessary to think about meeting the requirements of 27 different countries. The high value/low volume nature of orphan drug supply can mean it is difficult to make the costs and efforts of navigating European complexities add up.
What is orphan drug supply chain management?
Good supply chain management can help firms to ensure the safe and timely delivery of products to pharmacies, clinics, and patients, minimize waste, and meet the regulatory requirements of the receiving countries. It covers the shipping, storage, packaging, distribution, and cash collection processes involved in supplying medications, both domestically and internationally.
To be successful, supply chain management requires multiple teams to work in synchronization to ensure that medicines are delivered safely and efficiently to those who need them.
Managing your supply chain project in Europe
Launching and distributing a new orphan drug across Europe presents a range of challenges to overcome. Understanding the entire logistical process of importing drugs, storing them in a central location, and ensuring safe and rapid delivery is crucial.
There are many ways that drugs can be transported, including by road, air, or even sea, depending on how quickly they need to reach their destination. The transport of any drug should also be tailored to its specific needs when it comes to temperature control.
There are several third-party logistics companies that can offer cold chain transportation services, but the low volume nature of orphan drug supply can make it difficult to negotiate bespoke storage and delivery conditions. Therefore, it may not always possible to guarantee the safe and on-schedule delivery of stock. For drugs, delays can cause huge problems, resulting in ruined stock and patients unable to receive the treatment they so desperately need.
Also, for international firms without access to a centralized European hub or warehouse, it can be difficult to meet the often-urgent orders for orphan medications, such as those that need to be administered within days of birth.
For these reasons, many firms choose to collaborate with an expert partner who can manage and coordinate the entire European supply chain. Over and above physical, some providers can offer a fully managed end-to-end service, designed to meet the specific challenges of launching and supplying orphan drugs in Europe. This could include support with regulatory compliance, import licenses, cash collection, customer service, order management, and the storage and delivery of products.
Sciensus’ bespoke supply chain solution
Sciensus makes the typically complex process of rare disease medicine supply and distribution simple. We offer:
A proven service model designed for supplying orphan drugs in Europe and beyond.
Over the past 30 years we’ve built a strong, flexible, and reliable international cold chain delivery network that provides validated lanes for both European and international distribution.
An established infrastructure
We operate a GDP-certified medical warehouse hub in the Netherlands, equipped for all temperature regimes, facilitating delivery to most European sites within 24 to 48 hours
GMP late-stage customization and serialization
We offer a late-stage customization service which enables us to prepare and ship precise amounts of stock directly to the receiving country with all the correct, local information and serial numbers included.
We have regulatory licensing including wholesale distribution authorisation (WDA), that allows us for the movement of pre-licensed and licensed drug products via GDP solutions.
A full order to cash service
Once our dedicated team has taken an order, we can proactively manage stock movements and take control of the complete supply process across warehousing, customer communications, delivery and cash collection.
A multilingual customer service
We have an international customer liaison team who are based in Germany. The team are multilingual, and they cover the majority of European languages (often as a first language). This additional level of expertise is highly valued by our customers. Our multilingual customer liaison team offers a range of support services and is the main contact for hospitals and pharmacies.
Schedule a meeting with our expert
To discuss your challenges and create a strategy for accessing Europe tailored to your business needs, including bespoke supply chain management, please complete the form below. Our team will contact you to schedule a meeting and provide a complimentary consultation.