Why PPD’s global clinical supply functional service is the right choice to navigate your trials through Brexit
In this post, Levon Maselli, director of clinical supplies, PPD, explains the implications Brexit can have on the global clinical supply chain and the steps taken to ensure it does not impact patient safety and study startup timelines.
As of 31 January 2020, the United Kingdom (U.K.) is no longer a member of the European Union (EU) and entered a transition period remaining bound by the EU conventions and laws until a final trade agreement could be reached. Ultimately, a deadline of 31 December 2020 was agreed upon by the governing bodies.
While negotiations continue, a changing trade landscape will bring challenges for investigational medicinal product (IMP) and ancillary supply movement between countries as drug release and trade import/export regulations change. Trade laws based on World Trade Organization (WTO) terms likely will lead to increased cost and time as import- and export-related costs will need to be understood and budgeted.
Additionally, supply of IMPs will still rely on EU-GMP Annex 16 of “Certification by a Qualified Person and Batch Release” where an EU-based qualified person (QP) will be required to release medicinal product for use in clinical trials. This means U.K.-based QPs may no longer be acceptable for release of medicinal product within the EU.
Having an adaptable and robust clinical supply chain with the appropriate trade compliance and QP capabilities will be paramount to ensure continuity of supply and reduce risk to patients enrolled in trials.
PPD’s global clinical supply (GCS) functional service partnership (FSP) provides supply chain continuity through suitably located PPD-owned depots, specifically our EU-based Ireland facility, which is home to our QP regulatory compliance and quality teams. In conjunction with strategic partnerships across the U.K. and EU, our GCS business unit has the infrastructure and global footprint required to navigate the changing trade climate as Brexit negotiations progress.
PPD’s GCS project management team has conducted a thorough, bespoke, “Brexit Risk Assessment” for all active trials that focus on the U.K.-EU element to the clinical supply chain. Risk mitigation steps have been taken according to the complexity, scope and trial design to ensure supply chain continuity does not impact patient safety and study startup timelines.
Budget considerations have been monitored accordingly with all indirect costs including tariffs, customs fees and taxes for region-specific trade compliance.