Planning in the Unknown – Supply Chain Operations in the Age of Brexit

By SUZANNE KENNEDY

Since the referendum in 2016, AstraZeneca has prioritised the continuity of supply of medicines to patients in the UK and worldwide. The early and consistent clarity of strategy, continuity of supply, planning for the worst and advocating for the best, have been critical factors in delivering the Company’s Brexit readiness strategy.

In order to assure end-to-end supply of commercial & clinical medicines to patients worldwide, Global Operations immediately started Brexit Planning. This enabled AstraZeneca to better:

• Accommodate the long lead times associated with supply chain changes for small molecule medicines, biologics & vaccines.
• Uncover and adjust the very detailed and complex regulatory and trade activities in AstraZeneca that were predicated on the UK’s membership of the European Union (EU), and which would become immediately invalid upon the UK’s exit

The Brexit impact for AstraZeneca’s Global Operations has been examined by brand and SKU for registration and supply chain impact of Brexit, by

• Quality arrangements for Quality Control (QC)
• Quality Assurance (QA) & Certification (QP)
• by route for freight and logistics arrangements,
• market for licensing arrangements, by export / import pairing for its trade, GMP licensing & customs arrangements.

The resulting company-wide programme mobilized leading experts in their fields including regulatory arrangements, programme management, IT (SAP) change management, , trade & customs arrangements, freight & logistics management, communications, and risk management.

Regulatory

Once the UKs exits from the EU, UK legal entities will no longer be EU Marketing Authorization Holders (MAH) for any EU centralized license. This means licenses with UK MAH will be invalid in the EU and all central licenses will require a separate UK license.

The Company has completed the transfer of the 216 licenses held by AstraZeneca UK for other EU affiliates to AZAB, its Swedish entity, with the associated label changes requiring switch management at supply sites.

Trade and AstraZeneca Supply

For goods to marketed, the EU regulatory framework requires all EU medicines to have a registered EU test site for QA & QC unless there is a negotiated Mutual Recognition Arrangement. Each batch of medicines for EU patients must also be certified by an EU Qualified Person (QP) once the product has arrived in the EU.

Product manufactured outside the EU must also be owned by an EU established entity, and procured from a manufacturer or importer. As an Anglo-Swedish company, AstraZeneca UK, under the freedoms associated with EU membership, had an extensive ownership, import/export & license footprint in the EU. To remove reliance on AstraZeneca UK, changes included removing reliance on AstraZeneca UK Wholesale Dealers Authorization for direct sales, establishing an EU site for QC, QA & QP activities, establishing stock control locations upon entry from the UK to the EU, changing intra-company trading arrangements. This has required extensive updates to IT systems within AstraZeneca and across its outsourced services providers. Impacts on arrangements with markets beyond the EU, whether through EU trade arrangements, or regulatory follower arrangements, have also been addressed.

AstraZeneca’s Suppliers
For AstraZeneca to secure its outbound supply it must also assure its supply of input materials for its 30 manufacturing sites worldwide. A detailed programme of risk assessment & action monitoring will continue until at least the first post-Brexit replenishment of materials & services has been received by the Company.

Congestion at Borders
In the event of a Hard Brexit, we anticipate significant congestion at EU/UK borders. To mitigate this, AstraZeneca continues to hold a four-week commercial finished pack stock build in the EU, six weeks in the UK, as well as significant stock in clinical trials depots both in the UK and EU.

Additional resources remain in place to manage the impact of any additional customs clearances post Brexit. New trade routes are already in operation using long straits crossings, commissioning additional warehousing space and having risk-assessed air routes as stand-by options.

Advocacy
AstraZeneca has continued to advocate for a Withdrawal Agreement with its associated transition period between the UK and EU and an optimal post Brexit EU UK relationship that protects patients and maintains as close alignment as possible on medicines regulation. We have worked at senior levels in the UK and Brussels as well as with Sweden and other key EU member state governments.

In the UK, we have worked with the Government and industry’s life science Brexit planning group and with our trade associations. We worked particularly closely with the Departments of Health and Social Care and Transport on contingency measures for any “no deal” exit, helping identify and improve the measures for the later October exit date once the original March date was deferred. We continue to stress to the UK Government, the EU institutions and Member States, the need to avoid a “no deal” exit and to prioritize continued close regulatory, research and trade agreements in the future relationship.

AstraZeneca is a global, science-led biopharmaceutical company headquartered in the UK with R&D centers located in the UK, Sweden, and the U.S. AstraZeneca has been a partner of the MIT LGO Program since 2017.