By Sinead McGlone, Director, Quality, IQVIA
Business continuity planning (BCP) ahead of the next pandemic or natural disaster is essential to ensure the success of any enterprise, but it's particularly crucial for companies in the life science industry. A sound BCP gives companies a roadmap and processes to follow in times of crisis. The plans outline what the company must do to react quickly and efficiently, and the measures to put in place so critical operations can continue.
In life science, and pharmacovigilance (PV), a continuity strategy is vital to ensure critical patient safety activities and global regulatory compliance continues. That’s because regulatory compliance activities that are mandated by global agencies including FDA, EMA and PMDA can be impacted by multiple factors ranging from cybercrime to natural disasters. Rethinking BCPs regularly is crucial to preparing for future disaster events.
The Prevalence of Disastrous Events
While it’s impossible to foresee and plan for every type of event, life science companies should consider the possible scenarios that could cause business disruption. These include disastrous weather events, cyberattacks, disease, civil disturbance, arson, crime or war. Some events allow for forewarning, while others occur without notice.
In 2022, the world experienced $29 billion weather disasters, 15 of which occurred in the United States. These include droughts, flooding, severe storms, tropical cyclones, wildfires and windstorm events. Ongoing geopolitical conflicts have resulted in supply chain disruptions, and various challenges faced by workers have impacted the export of raw materials and products from certain regions.
How COVID-19 Impacted BCPs
Most life science organizations’ BCPs were severely tested when COVID-19 struck. Outside of cyberattacks, very few events to date required this level of response. Most BCPs focus on adjusting operations in specific geographical regions, so shutting the entire globe down caused unprecedented challenges. Employees’ individual needs required a lot of micro-adjustment, such as enabling them to work from home. Demand for common and chronic drugs remained at pre-pandemic levels, while production and delivery became more challenging due to staffing shortages and supply chain disruptions.
The pandemic also caused an increase in inquiries related to COVID-19 vaccines. As regulators approved vaccines, there was an unprecedented surge in reporting adverse reactions. Demand for pharmacovigilance and expertise in vaccines quickly rose. These events forced companies to pivot swiftly to new operating models that were, at the time, largely untested.
Organizations should apply the learnings from COVID-19 to rethink their future plans and make sure they can set their BCP protocols in motion at a moment’s notice.
Rethinking BCPs in Life Science
Creating or updating a business continuity plan based on recent events can be a relatively simple task for smaller firms. However, this becomes a far more complicated process for larger international entities, with countless variables that must be considered. Most BCPs focus on business influencers such as drug recalls and weather incidents, not geopolitical events. This viewpoint could be counterproductive. For example, recent geopolitical conflicts show the importance of monitoring such events and giving thought to how unexpected occurrences could impact operations.
Multiple business divisions, several locations, broader scope, and a more extensive employee base often create the need for separate BCP plans for each. In addition, regulatory requirements, the need for qualified people for pharmacovigilance (QPPV) in each country, local support, and so much more must be taken into account. Here’s what companies can do to develop a viable plan to get them through future challenges.
- Implement the four-part Ready program in tandem with FEMA, which includes conducting a business impact analysis, envisioning recovery strategies, developing an action plan and testing to be ready for deployment.
- Develop basic principles that can be applied to multiple scenarios and standards to help prepare for impacts such as loss of workforce, loss of facilities, etc. Flexibility and contingency plans must ensure connectivity and remote working options for all staff.
- Deploy technology to automate and enable virtual operations, including collaboration platforms, conferencing tools and cloud services for data storage and remote, multitenant access.
- Install systems that can deliver suitable bandwidth and increased security under pressure. Invest in an uninterruptible energy supply to keep all onsite systems operational.
- Automate and streamline business processes, increase response speed and introduce consistent communication methods supported by alternative infrastructure.
- Create a human resources reserve to tap when extra resources are needed to handle emergency tasks. For example: Pharmacovigilance specialists to process and assess adverse events and submit to Competent Authorities. Mass hiring and shifting of human resources can introduce risk into the workflow, so BCPs must include staff training, compliance, and monitoring methods to ensure flawless PV.
Life science companies with multiple locations must cooperate with local stakeholders to provide support in the event of a catastrophe. These could include establishing central hubs vs. individual offices as well as updating and consolidating plans at an above-country level.
Preparing for Business Interruption
Organizations can best prepare for the next workplace upset by focusing on people, processes, technologies, and communication. For example, if technology is impaired, then remote work will be off the table. If energy sources are compromised, communication with employees will be impossible. BCPs with a regional focus must be reviewed through an international lens because events on the other side of the globe could impact the enterprise.
Now that COVID-19 is under control in most countries, what’s the next layer of potential risk? This is a question for life science business continuity experts, information technology, business security and human resources personnel to solve collaboratively as they develop new and improved BCP strategies.