Dr. Danial Arkwell, Head of Global Key Accounts, Pharma, at Envirotainer, highlights the vital role of efficient logistics in getting orphan drugs to patients in desperate need.
There are approximately 8,000 rare diseases in the world, and many are life-threatening. To fight these illnesses, the medical community develops specialised medications known as orphan drugs. Originating from the United States Orphan Drug Act (ODA) in 1983, the term reflects the lack of attention and the investment necessary for their development.
This, and similar legislations aim to progress the development of drugs for rare diseases by offering various incentives to manufacturers. Despite government support, orphan drugs have been priced significantly higher than non-orphan drugs, owing to the inherent complexities and high production costs.
Yet, there are other barriers to patients receiving life-saving treatments. One that’s frequently overlooked is the complexity of transporting these highly sensitive drugs from the lab to the end patient. If manufacturers cannot ensure safe, cost-effective delivery, access to these rare treatments will remain out of reach for many patients. Efficient logistics must take centre stage.
Logistical barriers stand tall
Companies developing orphan drugs and other rare treatments often do so at a net financial loss. This cost is not solely placed on the research and production; the safe transport and distribution of these specialised treatments is also a consideration.
One of the biggest challenges in shipping orphan drugs is their temperature sensitivity. Many of these products require strict temperature control to protect their efficacy. Even a small temperature deviation during shipment can compromise the product and render the drug ineffective or even harmful to patients.
To further complicate the process, orphan drugs often need to be delivered to different, sometimes hard to reach, locations around the world. Import and export regulations and differing international standards can create bottlenecks and delays, increasing the risk of temperature deviations if a shipment is stuck in customs.
Unlike many medications, orphan drugs often require direct delivery to patients’ homes or specialised medical facilities, introducing additional requirements to consider. Geographical remoteness, limitations in infrastructure and the need for personalised handling add further to the complexities of last mile delivery.
All these costs and logistical challenges only push the cost of treatment up higher and potentially price-out patients who need the treatment most.
Finding the right balance
For the pharmaceutical industry, efficient logistics isn’t just about cost savings; it’s about ensuring life-saving medications reach their patients safely and efficiently. Finding the optimal shipping solution involves balancing performance, environmental impact, service level and cost.
It’s crucial to choose packaging that’s designed to maintain a consistent temperature range throughout the shipping process, mitigating the risk of temperature deviations and preventing potential product loss and rise in costs.
Strategies such as ‘smart’ secondary packing solutions with real-time temperature and location monitoring can mitigate these risks, as it can send alerts in real time if an unexpected event occurs during transit, enabling swift corrective action.
Both active and passive containers have their role to play, but the best choice depends on varying factors including product temperature requirements, tradeline complexity, Total Landed Cost (TLC) and ultimately the level of risk you are willing to take with your medicine.
Because orphan drugs are manufactured in smaller quantities, these drugs have often been seen sharing cargo space with other pharmaceutical products, potentially increasing the risk of exposure to unsuitable conditions.
By collaborating with logistics partners to optimise transportation and implementing Just-In-Time inventory strategies, manufacturers can streamline distribution processes while minimising costs.
The bottom line of efficient logistics
The journey of an orphan drug, from lab to patient, is often complex and expensive. However, the cost of rare disease drugs isn’t just in development, it’s in delivery. Inefficient logistics can eat up resources and can even lead to patients not getting the treatment they so desperately need. These barriers can be overcome, meaning more patients have access to the drugs they need, regardless of how rare their condition is.
