TRADE COMPLIANCE
not until companies scale up their operations and apply resources to trade compliance that these opportunities become realised.
Can you share insights on your key strategies for developing US and international tax/ customs duty processes? It starts with awareness, an understanding of the risks involved. I like to bring others into the process early: a scientist on chemical classifications, finance team on valuations, and technical operations on the flow/origin of materials. Once the supply chain is mapped in full, the opportunities present themselves, and it’s a matter of understanding the requirements and working with the government agencies involved to ensure your processes are in compliance.
What do you think are the biggest trade compliance mistakes that clinical trial supply professionals make? It’s my opinion, but I often see a disconnect between clinical and commercial supply, where the logistics and trade compliance function is more often associated with the latter. As a result, the clinical side is more reliant on the clinical research organisation (CRO) or courier for trade compliance, even though the risk and responsibility is with the sponsor. At a minimum, the documentation accompanying the depot and site shipments should be reviewed by a trade compliance professional to ensure the data and statements being reported are accurate and truthful.
How does trade compliance affect contracts with CROs when it comes to shipping? Know your Incoterms – they play the greatest role in determining the relationship with your CROs around shipping and customs. If the responsibility is yours, own the process. Also, as the one responsible for logistics and
trade compliance for your company, ensure you’re involved in the drafting and approval of both the master and quality agreement language specific to shipping and delivery of materials.
What should clinical supply professionals be aware of when dealing with import and export activities?
I recommend clinical supply professionals research and understand the import/export requirements for animal content in the capsules and/or tablets
56 | Clinical Trial Supply Handbook
they’re moving across borders. The US and other countries have specific guidance on lactose and gelatine, so it’s important to understand the requirements and/or licensing involved well before the initial shipment.
What are the key factors to create an effective global compliance awareness campaign? Creativity, you need to reach a wide audience within your organisation, one that includes executive leadership and reaches across all departments. Take it a step further than read and understand – work with your marketing team to create an image/brand for global trade compliance. Create an animated short on trade specific to your supply. Think outside the box, but ensure you’re using care to educate and train those persons responsible for cross-border transactions.
How has the pandemic affected your work, and is there still a knock-on effect on international tax/customs activities? Yes, in being 100% remote, I believe that we’ve retreated back into a silo mentality somewhat when it comes to performing our individual tasks, so there is a risk of isolating the customs knowledge within the organisation. For me, those minutes around the water cooler or in passing a colleague are opportune times to promote the trade compliance brand. Externally, we’ve experienced some delays in the processing of trade schemes globally, but overall US entry process has been smooth and effective for expediting shipments. I believe US Customs personnel have done an exceptional job of keeping supply moving during the pandemic.
If you could advise someone navigating the global supply and customs compliance arena, what would your main tips be for smooth compliance activity? I hark back to the awareness question. Educate yourself, educate your team, and educate your organisation on the basic tenets of trade compliance. Develop a governing policy with supporting procedures specific to the day-to-day activities performed around trade – and don’t be shy, pull in other departments by highlighting the opportunities out there. Also, do your homework, know what import/
export schemes are available and the effect they have on your bottom line.
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