Sustainable solutions in clinical trial supply chains are an emerging trend across various industry stakeholders. Although sustainability has not been a major priority a decade ago, ongoing drug shortages and global ecological concerns are making eco-friendly businesses desirable assets for the clinical trial industry.
As sustainability becomes a key focus of agendas and technologies such as blockchain, interactive response technology (IRT), and just-in-time (JIT) emerge, many players in the industry are reinventing business practices to minimise their contribution to climate change and clinical trial supply shortages.
Although sustainable drug sourcing and technological advancements are the most discussed measures, experts believe sustainability needs to begin at the start of the supply chain when the investigational drug is being transported to clinical trial sites.
Packaging and temperature monitoring devices play a crucial role in the supply chain, yet this unglamorous topic is often overlooked. Clinical trial supply chain experts tell Clinical Trials Arena how sustainability can be improved across supply chains.
Repurposing temperature monitors
Temperature monitoring systems are used to collect temperature data inside shipments of clinical trial supply material. Even though the components that are inside of these monitors have a lifespan of 10–20 years, the usual lifecycle of a data logger is approximately 110–365 days, depending on the use case, says Jeroen van Loo, global business manager at monitoring solution provider Elpro.
Unfortunately, many of these devices are discarded at the final destination, says van Loo. “It is not nice to say, but 80% of devices are disposed,” he notes. However, due to a shortage of materials and resources caused by the Covid-19 pandemic and inflation tripling the price of monitors, repurposing became not only a sustainable solution but also a commercial one.
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Elpro has extended the lifespan of its data loggers to up to three years. As every component has a serial number, it is easy to track their location and how often they are used. The company has also started renting the devices instead of selling them to customers. “The customer pays per use, but the device remains our property and it is circled back to us for a refit or a reuse,” van Loo explains.
However, repurposing is not easy. If a sponsor sends its supply to regions where reverse logistics infrastructure is not advanced, sending back devices to the supplier is not as efficient and still contributes towards CO2 emissions.
The best way to reduce the industry’s impact on the environment is to team up with other international suppliers and use the same shipping containers, as there are many empty containers being shipped back and forth, says van Loo. “It’s all about being smart and efficient,” he adds.
Reuse the packaging or recycle?
When it comes to packaging, single-use shippers are still most of the shipping systems used today, says Stephen Corcoran, Europe, Middle East, and Africa (EMEA) regional sales manager at Cold Chain Technologies. The insulated packaging solutions provider offers shippers that are 100% curbside recyclable, meaning materials can be collected from the location and sent to recycling centres.
However, recyclable packing may lack strength. Amardeep Chahal, senior vice president of marketing and corporate development at Cold Chain Technologies, explains that in the past, single-use packaging solutions used mechanically strong insulation materials such as expanded polystyrene or polyurethane. The materials that are being used for recyclability and insulation can be paper- or starch-based, and they tend to lack mechanical strength.
Chahal notes that customers think of recyclable solutions when it comes to sustainability, but now the knowledge of reusable packaging is growing steadily. One of the main benefits of reusable shippers is that the client does not have to worry about the disposal, as the boxes are collected from the delivery points and then repurposed, says Sharon Courtney, logistics service manager at Almac.
“It minimises the impact to clinical sites to not have to destroy or discard big bulky boxes, particularly given that many countries have varying regulations related to packaging disposal,” she adds.
Still, like temperature monitors, there are complexities around reverse logistics. Corcoran explains that these complexities depend on the customer, the shipping and destination locations, and the infrastructure setup. If the product is shipped long distances and the shipments are not frequent, the cost of sending it back is going to be high, and single-use may make more sense, Chahal says.
Industry’s perception has changed
While the conversation around sustainability has been ongoing for the past decade, the industry’s attitude towards eco-friendliness has changed dramatically in the past few years, and especially in 2023, says Luiza Cervetto, senior global strategy and product manager at Cold Chain Technologies.
“We had this recycling program for five or more years now, but over the last two or four months, we have gotten more requests than we have gotten over the last five years,” she explains.
Courtney also agrees that there has been a lot more traction at the end of 2022 and the start of 2023. “We’re seeing an increased focus from our customers who are requesting more information on what our sustainability plans and projects are,” she adds.
While the outlook has changed and companies are setting out individual goals, there is no international body or agency that would measure sustainability efforts. Currently, sustainability efforts are measured regionally, and it would be challenging to measure them internationally, says Courtney.
Recent European supply chain due diligence laws, such as the Germany’s Act on Corporate Due Diligence Obligations in Supply Chains (LkSG) and EU’s Corporate Sustainability Due Diligence Directive, are now setting more perspective requirements for supply chain responsibility, says Pete Rau, vice president of solution consulting at EcoVadis, a provider of business sustainability ratings.
“We believe these new regulations are a good sign for levelling the playing field and raising everyone’s game and should apply to pharma companies as they would any other industry,” he says.
Chahal notes that there is an opportunity for a higher body to enforce sustainability efforts. He explains that with the wave of sustainability, there is incorrect terminology that leads to greenwashing.
“People can get swayed by using different terms. For example, recyclable could mean different things to different people, but curbside recyclable is different than recyclable,” he adds.
However, according to van Loo, the extra steps and requirements created by a legislation might result in a price increase. He adds that public perception and pressure are pushing companies to be more sustainable as they do not want to be seen as not eco-friendly.
Ways to become eco-friendly
While the conversation around sustainability in supply chains is ongoing, it is important to act on said actions. Corcoran advises sponsors to understand internal company goals and not follow the steps that other companies are announcing. “Don’t do it because everybody else is doing it,” he says.
Rau says it is essential to take steps that assess, benchmark, build capacity and make improvements both within the operations and in supply chain. The assessments should cover all material issues, such as environment, ethics, sustainable procurement, and labour and human rights. This will help understand the starting points and guide improvements that sponsors need to work on to reach their target.
One of the key things a supplier looks for in a partner is a department or a focus on sustainability, says Courtney. She adds that it is important to jointly work together as partners and to understand what can be done to streamline overall logistics processes.
Even though companies are hiring people into sustainability roles, Cervetto says that sponsors should invest in sustainability education because it is a complex area. These employees should not only understand what the company is trying to achieve internally, but also what are the regulatory requirements.
The industry used to see sustainability as one of the boxes to be checked on the agenda, but now it has become a core part of businesses. However, Chahal says that many people still think about the disposal aspect when they talk about sustainability. “Sustainability straddles all the way from cradle to grave,” he notes.