Overcoming difficulties shipping a Post-Approval Named Patient Program product to Belarus
The sponsor is a biopharmaceutical company accelerating the development of new and improved medical products for various types of cancer. Its goal is to create targeted, effective therapies that make a significant impact to the lives of patients and their caregivers around the world.
The sponsor partnered with WEP Clinical to set-up a Post-Approval Named Patient Program (PA-NPP) to supply its approved product to ex-clinical trial patients living in countries where the company does not plan to commercialize. Because the product is not approved in these countries, our team must follow appropriate regulatory channels to import the drug on an unlicensed basis. This requires support and cooperation from local physicians, who are expected to act on their patient’s behalf. However, we faced particular difficulty shipping product to Belarus, as the treating physician there was largely unresponsive to our communication and was hesitant to complete the necessary paperwork.
The lead WEP Clinical Project Manager (PM) for this PA-NPP decided to enlist the help of the CRO who had managed the company’s clinical trial efforts in Belarus, as they had experience working with the physicians during the trial. The CRO team was able to encourage the physician to compete the necessary quality forms and supported the physician through the process. However, the physician refused to complete the paperwork to apply for the import permits from the the Belarusian Ministry of Health. To overcome this issue, our PM team contracted with a local logistics company, that could apply on the physician’s behalf. The negotiations, contracts, quality technical agreements and regulatory import permits took 5 months to collect and complete, but the patient did receive treatment and the sponsor company was extremely grateful to our team for their efforts in overcoming all the challenges.