Business Continuity Planning in Pharmacovigilance: A Real-World Case from an Internet Shutdown in Uganda

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This month brought an unprecedented challenge in my provision of pharmacovigilance services to clients, due to a complete internet shutdown in Uganda, where I am based. The shutdown began on the evening of 13 January and lasted until late in the night of 17 January. For those who may not be aware, the Government of Uganda shut down the internet ahead of the presidential and parliamentary elections held on 15 January.

In this newsletter, I share my experience collaborating with clients to navigate this challenging period and highlight the importance of having a business continuity plan (BCP) in pharmacovigilance.

Anticipating the internet shutdown

Internet shutdowns in Uganda ahead of elections are not entirely new; the first of such being enforced during the preceding 2021 general elections. Like many others in Uganda, I anticipated that a shutdown would occur again even as the responsible bodies made ambiguous statements on the matter. Ten days before the elections, I wrote to clients to inform them of this potential inconvenience and proposed preparatory measures in case it occurred.

Reviewing business continuity plans

Before being onboarded by new clients, I undertake training on several Standard Operating Procedures (SOPs). Some clients have SOPs on BCP, which I reviewed as part of my preparation for the shutdown. This ensured that I was familiar with the communication and documentation requirements, including how to record the event in the BCP Activation Record. Preparation also ensured that we had all the necessary tools and information to activate the BCP if required.

Setting the BCP in motion

Once the government confirmed that there would be an internet shutdown, we activated the BCP to ensure that critical pharmacovigilance operations continued despite my temporary unavailability. The following actions were taken:

• Communication with stakeholders:
  The BCP team ensured that regulators, other operational teams, Marketing Authorisation Holders (MAHs), and clinical trial sponsors were informed of the internet shutdown and the mitigation measures in place.
• Reassigning tasks:
  A client team member based in another country temporarily assumed my role of submitting safety reports to regulators as my deputies who would typically step in during my absence were also affected by the shutdown as they’re also based in Uganda.
• Requests for waivers on local procedures:
  Waivers are required when planned deviations from local procedures are anticipated. For some regulatory submissions, responsibilities could not be reassigned. These planned deviations were documented, and the MAH informed the regulatory authorities in advance.
• Alternative means of communication:
  As part of the preparation, I tested all my project managers’ phone numbers on file with  standard calls to ensure seamless communication during the internet blackout. And when it happened, I stayed in contact with clients by phone, making myself available for any assistance they might need.
• Monitoring international media:
  Project managers monitored international media coverage of the situation in Uganda during the shutdown. This ensured that any additional developments requiring amendments to the BCP were promptly identified.

Reflections

We closed out the BCPs after internet access was restored and communicated this to the stakeholders mentioned earlier. Since then, I have reflected on the impact of the shutdown, regulatory expectations during such unfavourable circumstances, and what could have been done better.

Guidelines such as those in Zimbabwe require the MAH PV quality system to document appropriate instructions for processes to be followed in urgent situations, including business continuity. I encourage PV professionals and MAHs to review their local authority guidelines and confirm that business continuity requirements are adequately addressed within their quality systems. This must be done alongside reviewing the local Pharmacovigilance System Master File (PSMF) to ensure that business continuity arrangements are clearly described and can help avoid last-minute uncertainty during crises.

There were also personal and professional impacts:

• Lost income:
  As an independent contractor, some projects are paid exclusively based on deliverables. When deliverables are completed by another individual, invoicing is not possible. While the shutdown was brief and income loss limited, this further highlights the importance of contractors and service providers openly discussing continuity arrangements and financial implications with clients during onboarding.
• Reputational impact:
  Internet shutdowns negatively affect perceptions of a country’s suitability for remote work. Organisations that rely on distributed PV teams may wish to factor such country-level risks into their continuity planning and talent strategies, rather than addressing them reactively.

The shutdown also highlighted broader considerations that warrant proactive attention:

• Operational resilience:
  Events such as internet shutdowns, political unrest, or natural disasters can significantly disrupt PV activities. MAHs may benefit from assessing whether their current reliance on single-country resources introduces avoidable risk, and whether cross-border backup arrangements are clearly defined and tested.
• Regulatory preparedness:
  Early and transparent communication with regulators proved essential. Establishing predefined communication pathways and escalation criteria within BCPs can help organisations respond more confidently when standard procedures cannot be followed.
• Individual readiness:
  From a personal perspective, one area for improvement was the lack of an “out of office” auto-reply on all my email accounts. For PV professionals working remotely, simple measures such as predefined OOO messages, updated contact lists, and alternative communication plans can significantly reduce confusion during outages.

Situations like this serve as a reminder that business continuity planning should not be a theoretical exercise, but one that is routinely reviewed, tested, and adapted to local realities. Ultimately, this experience reinforced that business continuity in pharmacovigilance is a shared responsibility—one that requires coordination between individuals, service providers, MAHs, and regulators. Proactively reviewing plans, testing assumptions, and acknowledging real-world constraints can make the difference between disruption and resilience when the unexpected occurs.

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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