Five trends shaping EHS compliance in biopharma companies

As a fast-growing, highly technical industry, the field of biopharma has been experiencing a unique set of business challenges and opportunities that are shaping companies’ approaches to EHS compliance management. To name a few:

• Lean EHS teams that need to “do more with less”
• A rapidly expanding global footprint introducing new regulatory requirements
• Highly skilled teams with different risk profiles.

If these sound familiar to you, it’s because other industries are seeking to follow in the footsteps of biopharma’s recent success by accelerating research and development (R&D), leveraging highly skilled teams, digitizing operations, and expanding globally.

In this article, Enhesa expert Taylor Murphy will lead us through an exploration of five major trends and their impact on EHS compliance, to see what the biopharma industry can teach us.

Trend 1: Lean EHS teams with a lot of responsibilities

Often, biopharma companies — or biopharma business units within larger companies — are made up of smaller teams that have very technical work environments and specific risk profiles to manage. This presents a challenge whether you have a lean EHS team or a larger EHS team with limited experience in the biopharma space. This is because, like in many industries, EHS teams serving biopharma often have to do more with less.

Because regulatory requirements and risks can be different from lab to lab, state to state, or country to country, companies need to empower their EHS teams with a clear and complete view of EHS requirements to help ensure they have the means to understand what they’re required to do on a site-by-site basis. Furthermore, in pharma or biopharma spaces, EHS teams often have to be experts in their EHS responsibilities and in the technical aspects of the labs or facilities they manage. Doing “double duty” in this way can sometimes mean that, on top of their normal responsibilities, EHS professionals must learn the (often highly specialized) language of the teams they work with.

An EHS compliance program that provides high-level and jurisdictional-specific EHS regulations and requirements lets EHS teams more easily track a facility’s progress against those requirements, even if they can’t visit every site regularly. Tools that empower teams to understand regulatory landscapes and track actionable EHS requirements can allow leaner EHS teams to efficiently manage biopharma labs and facilities across the globe.

At the same time, what can really cement a culture of safety in labs — and really in any workplace — is aligning the EHS team with a local champion at the worksite. This can allow a leaner EHS team to have more interaction and understanding of facilities they manage without having to be on the floor every day. Having a direct supervisor or fellow team member be an EHS champion outside of the traditional EHS team can help others understand the importance of safety in the labs and in the workplace, allowing the EHS teams to focus on other tasks.

Trend 2: A mix of risk profiles — R&D labs, warehouse operations, and office and remote workers

EHS teams in biopharma often have to deal with different operations and different risk profiles. Managing the risks in an R&D lab, a warehouse storing products and equipment, and an office environment can all require different approaches from the same EHS team. Some biopharma companies even have manufacturing operations to manage as well. Managing all these different risk profiles can present a challenge to EHS teams working in biopharma, but it’s not necessarily unique to this industry.

One major challenge is that the primary health and safety risks present in an R&D lab (e.g., biological and chemical hazards, potentially explosive atmospheres, poisonous fumes, and flammable materials) do not always match the primary health and safety risks of a warehouse (e.g., industrial powered trucks, materials handling, lockout/tagout) or an office environment (e.g., indoor air quality, visual display screens, lighting). If you take even just one of these topics as an example — ergonomics — we can see that there are many ways EHS teams in biopharma may have to deal with this across their facilities due to all the different environments workers will be operating in.

In an R&D facility, common ergonomic risks can include, for example, prolonged standing at a workstation, use of equipment like microscopes, flow cytometers, or pipettes, and performing work in awkward body postures, such as when using a fume hood or safety cabinet. In a warehouse, common ergonomic risks can include repetitive motions (like bending or twisting), lifting without proper equipment or techniques, or prolonged standing or walking. In an office, common ergonomic risks can include sitting for long periods of time, improper lighting, and improper set up of the computer station (including the keyboard and height of the desk and chair).

With so many different risk profiles to manage, an EHS team may want to develop and implement corporate standards based on their risks and on the company’s values. In the pharma space, companies usually prioritize health and wellness: in other words, setting standards that not only protect employees from being injured on the job but also reflect company values. When we look at the ergonomics example, corporate standards will need to address the areas that impact all risk areas — such as visual display screens and proper workstations — while maintaining flexibility for the work that is unique to only one type of facility. When EHS teams are equipped with knowledge about the regulatory requirements in the jurisdictions where they operate, they’ll be better able to develop corporate standards that not only meet regulatory minimums but also advance worker health and company values.

Trend 3: Managing highly skilled and fast-growing teams

EHS teams in the pharma industry, especially in the area of R&D, have a unique challenge when it comes to the personnel they work with. Typically, the professionals in this industry are made up of highly trained, highly educated scientists. R&D labs can have a culture of exploration and thinking outside the box to solve issues. This could make communicating the importance of health and safety measures and even implementing them more of a challenge. EHS teams need to make sure they’re speaking the same language as their R&D labs and other teams to ensure safety is high on everyone’s priority list. This is where enlisting an EHS champion on the R&D team can help.

When managing a highly skilled and/or highly educated team, sometimes EHS managers need to adjust the way they present health and safety initiatives. It can help to focus on the why — why do we have to wear safety goggles even if it might make the job a little more difficult, why do we have to wear protective clothing if it isn’t the most comfortable option? What’s more, in the pharma and R&D space, EHS professionals are often managing scientists who are used to working with dangerous substances — so their personal tolerance for risk may also be higher. That’s why real-world examples and clear reasons as to why personal protective equipment, or engineering controls to mitigate worker exposure to harm, can help motivate workers to follow health and safety programs more so than, ‘we don’t want to get fined if the health and safety authority comes through.’

Another challenge in the biopharma industry is the fast pace of growth of these companies, especially with startups. While high growth is a goal for many firms, formalizing and transferring knowledge of risk and safety to new employees who don’t have the innate skills their tenured counterparts do is an important consideration for EHS teams. As the workforce ages and turns over across many industries, maintaining institutional knowledge is something a lot of companies are dealing with. But when it comes to expanding companies and growing startups, the challenge can be seen through a different lens: how can companies, especially those with lean EHS teams, streamline and capture institutional knowledge so new employees can get up to speed even faster? And how can they ensure labs stay safe after employee training if the EHS team cannot be onsite every day?

Efficiently and effectively managing fast-growing teams requires EHS managers to capitalize on institutional knowledge and on-the-ground health and safety champions outside the core EHS team. Ensuring that health and safety procedures are accessible for everyone, training done often and in a digestible format, and leveraging those employees who can be health and safety champions in the lab every day will allow EHS teams to do more with less for these growing — and highly skilled — teams.

Trend 4: Globalization

Closely related to expanding teams, the globalization of biopharma firms can impact EHS compliance — especially as they experience growth into new locations worldwide while still depending on those lean teams. The EHS team of a growing company needs to know what regulations apply in the countries they’re expanding into, whether that’s through M&A activities, offshoring manufacturing or other operations, or market expansion. For example, if regulations in those new sites grow stricter, companies will need to adjust. A centralized system to understand and track these requirements anywhere in the world they operate is key.

Often, the new global locations will have different risk profiles as well. For example, if a company has R&D facilities in Europe, office buildings in Europe and the United States, and manufacturing in Asia, the EHS team will have to learn and adjust to the regulations that apply to operations in all those locations. Centralized systems can be an extremely efficient way to prepare for and understand requirements across the globe. If the EHS team has less experience with the requirements related to office buildings in the United States or machine safety requirements in China, a centralized system can provide a standardized view of regulations worldwide, so you don’t have to necessarily be an expert in each jurisdiction to find the information you’re looking for. This type of standardized, centralized system will help lean teams efficiently find information and understand their obligations, no matter where they work.

Trend 5: Digitization

As companies globalize and regulatory responsibilities increase, systems are coalescing. No organization wants to manage obligations and processes in a series of spreadsheets, multiple, disconnected tools, or unique, site-by-site datasets and procedures — and EHS compliance is no exception. A similar trend has been seen in recent years across quality management — a top concern for biopharma companies — wherein the digitization and centralization of data helps to ensure that issues can be tracked, corrected, and improved, with that improvement scaled to other teams to avoid an issue in the future.

In a similar way, centrally managing compliance data can help scale visibility and best practices to other teams. For example, if your company has a robust waste management program or a comprehensive emergency response plan, it won’t mean much if your teams cannot access those programs in the individual labs across other sites.

Digitizing your EHS compliance can:

• Harmonize and categorize various EHS regulations from around the world
• Deliver guidance in the local language no matter where you are
• Provide one view into compliance standards, processes, and status for anyone at the company

Digitizing compliance and therefore having transparency from the individual R&D labs to the corporate level can also help with public perception. Increasingly, customers and investors believe that corporate values matter, and they are choosing which companies to support based on their environmental impact and how they treat their employees. Furthermore, a company’s ability to hire and retain talented employees can also be impacted by these same concerns. For example, as of 1 January 2024, companies in the US with 100 or more employees in certain high-hazard industries must electronically submit injury and illness information to OSHA, which will then be posted on OSHA’s public website. Making this information more easily accessible to the public could impact a company’s reputation because published information will provide overall greater transparency and access to safety and injury information and data.

Conclusion

These trends highlight the unique EHS compliance challenges in the biopharma industry due to lean EHS teams who must manage highly technical work environments with varying risk profiles in a fast-growing, globalizing, and digitalizing sector of the economy. While these are significant challenges, each one is not necessarily a biopharma-only challenge.

The trends we identified in the biopharma space are closely related to each other — as lean EHS teams need global tools to make understanding and acting on compliance easier and more efficient. But if EHS teams recruit local champions to promote a culture of safety, gaining buy-in from highly skilled teams may be easier. And to equip everyone who needs it with knowledge of the regulatory landscape and compliance status of the organization, digital tools are key. They are a shared space to track risks, understand compliance progress, enhance transparency among teams, and promote internal EHS knowledge