Business Continuity in Pharma: the Role of Risk Management


Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains.

One example that is very present in our memories is related to the COVID-19 vaccine production. As you surely remember, many well-known pharmaceutical companies reported equipment, materials, and staff shortages, as well as a limited number of suppliers. Which, naturally, ended up slowing the scaling-up of vaccine production and delaying vaccine supply. Learning from this experience and strengthen pharma’s BCP is an opportunity to avoid future drug shortages.

In this blog post, we’ll talk about having a business continuity plan for pharma, with a focus on how to assess and mitigate risks for flexibility and effectiveness.

Interested? Keep reading!


What are the 4 Stages of Business Continuity Planning to Avoid Drug Shortages?


First, it’s important to understand what a business continuity plan is. BCP consists of an advanced plan prepared by companies to ensure the performance of critical business functions during emergency events.

Therefore, it’s essential that pharma companies have a structured and comprehensive BCP to ensure the ongoing supply of important medicines. In order to achieve that, a BCP should include these 4 stages:

  • Product prioritization
  • Risk assessment
  • Mitigation options
  • Implementation and execution of response plans

For the purpose of this post, let’s focus on the risk assessment and mitigation stages!


How to Assess Risks to Prevent Drug Shortages?


Once the product priority is established, you should consider the areas of potential drug shortage risk. Generally, these areas are the following:

  • Product
  • Supply
  • Logistics
  • Patients
  • Environment

Next, to clearly assess the risk of each of these areas, you should address the 3 fundamental questions described in ICH Q9:

  • What might go wrong?
  • What is the likelihood it will go wrong?
  • And what are the consequences (severity)?

During this risk assessment, it’s important to keep in mind the product priority defined earlier, since products with low priority and minimal patient impact might not need an extensive risk assessment.

With the key risks identified and evaluated, it’s time to mitigate them!


How to Mitigate the Identified Risks?


First, you should consider the different kinds of mitigation options: traditional mitigation options and agility strategy.

When it comes to traditional mitigation options, such as inventory stockpile, you’ll benefit of using well defined and applied strategies. However, these options can be expensive and complex due to operational costs and creation of additional facilities, sources of supply, or inventory. Because of that, you shouldn’t use these strategies in low priority products.

On the other hand, agility is applied in the absence of additional facilities or inventory stockpile. Although it requires specific processes to detect uncertainty and a structured approach to be successful, an agility strategy will allow quick operational reactions to disruptive events, such as choosing alternative materials or operations to ensure product supply.

Therefore, the best strategy to ensure a continuous supply is, generally, a mix of both. Once you decided in which risks will you implement traditional mitigation options, agility should be developed to mitigate remaining risks.


We can Help Your Business Continuity Process


Improving your response to threats doesn’t have to be complex! With our risk management platform and ValGenesis experts, we can help you identify, quantify, and prioritize risks for a robust business continuity plan!

If you want to know more about our services, check out our page and don’t hesitate to reach out!

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.