When shipping clinical products and supplies to the US, companies can experience numerous obstacles in customs once their shipment arrives. While the hold-up at the border can be down to various reasons, it could have far-reaching implications on your clinical trial, delaying its start (or halting it altogether), incurring large costs.
So what can you do as the sponsor?
CTA recently sat down with Anthony Orosz of US Customs and Border Protection (CBP) who heads up the newly formed Centres of Excellence & Expertise (CEE). CTA picked his brain on what the CEE does and how it can help pharmaceutical companies transport clinical products efficiently.
Clinical Trials Arena: Explain the significance of the CEE for pharma companies
Anthony Orosz: I think it’s very important the pharmaceutical industry understands just what the CEE can do for them. There’s not any obligation for them to reach out to us, but if companies are experiencing holds at customs, paperwork issues, other government agency issues, things where you would never have direct contact with the government before, now the CEE offers companies that central point of contact with the government.
CTA: Elaborate more on what the CEE does and what it can do for pharma companies
AO: We essentially change the way customs does post-entry business. Cargo release is still up to the ports. If officers on site feel there’s a security check that needs to be done, they still carry that out at the port, we don’t have anything to do with that. We are involved with the entry summary part of the process. So if you import under our tariff range – which is broken down for pharmaceutical, health and chemical products – it will be routed directly to our centre.
CTA: What factors do companies need to consider when transporting clinical products in and out of the country?
AO: From an operational standpoint, nothing changes for pharma companies who import or export products, they can still use the ports they normally use, and fill out all the necessary paperwork and use the same brokers. But if an issue arises, or you need a point of contact with customs and border protection, or even another government agency for that matter, we can help you.
CTA: What should companies now do in the event a product is held up on the port of entry?
AO: Hopefully they will have all their paperwork in order. A lot of times it’s not CBP’s issue, it could be another government agency’s issue or there was an oversight on the part of a broker. The key thing is, before you would have to call the port and ask around to find out what the issue was. Now if you call the centre, we can directly contact the port to resolve the issue, and answer questions on how to expedite the shipment through to customs, why it’s being held, what the problem is and so forth. We’re here to improve the relationship between the US government and the private industry.
CTA: How can pharma companies import and export products efficiently so their clinical trials can start without delays?
AO: I would encourage companies to contact CEE beforehand to give us plenty of time and warning of when you’re going to import a new product. Then we can work with you directly and the other government agencies to find out what’s required, what the commodity is so we can do the research on the classifications and what paperwork is needed well before you import your product to make sure your trial goes ahead smoothly.