Three EU Pharma Logistics Trends to Watch

The European pharmaceutical landscape is unlike any other, with unique concerns and regulations impacting therapeutic development and distribution across numerous member states and Britain. Yourway supports clinical trials through elements such as primary/secondary clinical packaging and transportation; the interconnectedness of the industry makes it important to pay attention across the spectrum of current events in pharmaceutical logistics. Here are three noteworthy trends in Europe — and related regulations — that Yourway is keeping an eye on. 

Supply chain concerns

The European Union (EU) has long been struggling with drug shortages, with rising demand and low production capacity at the center of the challenge. Manufacturing disruptions, such as those caused by the European energy crisis; geopolitical events, such as the Russia-Ukraine war; shortages of raw materials; and distribution issues have all contributed to the problem, along with other factors. Some blame fixed pricing for exacerbating shortages, with companies unable to make enough profit to justify the manufacture of large quantities of generics when prices don’t adjust with the market. 

To address shortages of critical medicines, the European Commission (EC) has recently adopted a set of actions. Among other measures, these actions will allow a member state to flag a needed medicine to be redistributed from other states’ supplies, and allow regulatory flexibilities to help medicines reach patients in a timely manner. Additionally, a pharmaceutical legislation revision in April of 2023 will ensure the security of medicine supply and availability — regardless of location in the EU — as a key priority.

Coordinating the transport and logistics of medicines across EU member states represents only one piece of the larger medicinal supply chain. Other key components include manufacturing and access to raw materials. Nevertheless, the safe transport of these critical medicines is more important now than ever, with 95% of EU hospital pharmacists experiencing shortages, and pediatric treatments (such as those for RSV) particularly impacted by the shortages. Regardless of how difficult it is to access an area — whether due to a remote location or adverse events — ensuring reliable delivery, with urgency at the time of need, is paramount, especially when many locations do not have large stockpiles of medications on which to fall back. 

Temperature controlled shipping

The COVID-19 pandemic dramatically increased the need to ship vaccines at much lower-than-standard temperatures, catapulting temperature-controlled shipping to the forefront of logistical concerns in biopharma. The global call for these capabilities appears likely to continue for the foreseeable future. While growth has slowed slightly, reports as recent as 2020 saw temperature sensitive products—those that must adhere to strict rules and procedures to ensure proper storage and distribution—growing at roughly twice the rate of those that do not rely on cold chain. 

One of the main drivers of growth in temperature-controlled shipping is the increased European adoption and medicinal spending for biologics and cell and gene therapy. Known in Europe as advanced therapeutic medicinal products (ATMPs), these innovative therapies require carefully maintained conditions for their viability. Currently, EU agencies have turned their attention to promoting the development and approval of ATMPs. While recent reform from the EC is primed to provide improved regulatory support for ATMPs to the European Medicines Agency (EMA), the EMA’s PRIME initiative will provide enhanced support for developing priority medicines — including ATMPs — for unmet medical needs.

Such organized support for the development of ATMPs means that logistics organizations can expect further demand for temperature-controlled transport. Whether from clinical trials for ATMPs in development, or supply for biologics and ATMPs entering the market, the number of relevant therapeutics needing transport is poised to rise. As more ATMPs are adopted, or enter clinical trials, their reach across the EU will continue to spread into varied locations and regions. This necessitates providing the infrastructure to ensure uninterrupted stability during temperature-controlled storage and distribution to accommodate that reach. 

Prefilled drug delivery

Another trend that has gained momentum in the European market is prefilled drug delivery. Specifically, preloading syringes with a single dose before shipping out has been beneficial for multiple stakeholders. Economic models have shown that for health systems in the EU, using prefilled syringes can lead to cost savings across multiple drugs. This method also helps to improve accuracy of dosing and easier administration, with less risk of injury. 

This ease of delivery also adds a patient-centric component to prefilled syringes, allowing greater accessibility of self-administration for patients that must routinely use injectable medications — for example, GLP-1 restrictor agonists that are used in the treatment of diabetes or obesity, and which are rising in popularity. Autoinjectors with loadable, prefilled cartridges further improve patient centricity, easing the use of injectables to an even greater extent.

Particularly in light of the new EU GMP Annex 1 regulations on aseptic packaging, which took effect in August of 2023, those logistics providers responsible for packaging prefilled syringes will need to focus on sterility and product safety. While sterility is always important when considering drug packaging, it is a particular priority for therapeutics — and associated devices — meant to be introduced parenterally. And, because integrating GMP packaging services with the full logistics chain enhances efficiency and facilitates shorter lead times, it is in the interest of all stakeholders for companies that offer integrated services to be prepared to offer GMP compliant packaging for a variety of drug delivery methods — including prefilled syringes. 

Pharma logistics in the EU

Current events are affecting the full spectrum of logistics for the biopharma industry, from packaging to storage to transport, all across Europe. GMP-certified and integrated logistical value-chains have an important role to play in accommodating the trends explored here, as well as others yet to develop. Regional coverage across the EU, Britain, and other neighboring non-EU countries will be critical to supporting these value chains with agility, reliability, and efficiency. Through strategic positioning and connectivity, such as through a GMP depot in Dublin, organizations such as Yourway can provide the necessary logistical support to clinical trials across Europe.