Planning your EU orphan drug stock management with Sciensus
Launching an orphan drug across multiple European Union (EU) countries is a complex task that requires careful planning and execution. Sciensus, with extensive expertise in taking stock ownership and guiding clients through the European regulatory landscape, can make the whole process smoother and more effective. Here, we look at how Sciensus can streamline stock management and ensure a successful product launch across the EU.
Managing stock across multiple European countries can be challenging. Each of the 27 member states has its own demand patterns, regulatory requirements, and distribution channels. For orphan drugs, the challenge is made even bigger thanks to small patient populations and a frequently urgent need for access. Understanding these variations can be crucial in effective stock management, with demand for orphan drugs being much less predictable and more sensitive to delays.
Thorough market research is key to understanding these variations from market to market. By looking at a range of factors, such as population size, healthcare infrastructure, and disease prevalence, Sciensus successfully segments the entire EU market into distinct clusters. This can support the development of carefully tailored strategies, designed to address the specific needs and operating conditions of each country.
Critical considerations for a successful European stock management strategy
Regulatory requirements
When it comes to regulatory compliance, it’s important to note that each EU country has specific regulations around stock storage, labeling, and expiry dates.
With extensive expertise in supporting clients to widen access to orphan medications, we can help you ensure compliance with both the European Medicines Agency (EMA) and national regulatory bodies. This includes following guidelines on proper storage conditions, tailored packaging and information, and managing stock with appropriate expiry dates to prevent wastage, which is particularly crucial for high-cost orphan drugs.
Our fully flexible approach and bespoke facilities have been created especially for the low volume associated with orphan drugs. From our centrally located medical warehouse, we offer full inventory management options, including late-stage customization which enables us to prepare and ship precise amounts of stock with all the correct local information included in the product packaging and information.
Logistics and distribution
Smooth and reliable logistics and distribution practices are, of course, essential for maintaining a steady supply chain. With the low volume nature of orphan drug supply, however, it’s not always easy to negotiate bespoke storage and delivery conditions with third-party logistics suppliers, making it difficult to guarantee the safe and on-schedule delivery of stock. For orphan drugs, delays can cause huge problems, with stock ruined and patients unable to receive the treatment they so desperately need.
With a well-established distribution network across the whole of Europe and beyond, Sciensus can coordinate transport, warehousing, and customs clearance for each country, ensuring that stock moves smoothly from our warehouse in the Netherlands to your customers. We’re experts in finding the most suitable routes, providing bespoke storage solutions, and navigating the complexities of customs regulations to minimize delays and disruptions.
Applying this knowledge to your stock management approach
It can be extremely challenging to decide how to balance the risks of having too much stock with not having enough. While it can be tempting to keep stock levels to an absolute minimum, this risks being unable to meet demand should there be a surge in orders or an unexpected stock loss. Conversely, keeping too much stock risks wastage of these high-value medications which directly hits your bottom line.
While there is no way to predict demand with 100% accuracy, we support our clients with advanced forecasting techniques to help them predict demand patterns as closely as possible and set appropriate stock levels. Clients also benefit from holding unpackaged stock at our European warehouse which means it can be used to fulfill orders in any European country within 24-48 hours further reducing wastage.
With more than 30 years of experience, we can also help you develop risk mitigation strategies for stock shortages and currency fluctuations, while monitoring the regulatory landscape for any upcoming changes that could impact your European operation.
How Sciensus can make it easier
Effective stock management for a multi-country launch of orphan drugs in the EU requires a deep understanding of market dynamics, regulatory compliance, and logistical coordination.
Sciensus is a trusted partner and we guide our clients through the complexities of this process. By emphasizing thorough planning, leveraging local expertise, and implementing robust risk mitigation strategies, we ensure that stock is managed efficiently and effectively. With our expertise, you can confidently navigate the intricacies of stock management and ensure that patients with rare diseases receive the treatments they need.