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How one company in particular has adjusted its internal and customer-facing strategies in compliance training amid today’s heightened business-risk climate.
The past two years placed a spotlight on the life sciences industry. This focus, along with the changing ways that people did business, forced compliance teams at biopharmaceutical companies to adjust their policies while also maintaining a high standard of training.
At biotech giant Regeneron, for instance, Beth Holly, its senior vice president and compliance officer, was challenged with this task. She and her team took the opportunity to assess the status quo and see where opportunities existed to do things differently.
“A big part of our philosophy is partnering with the business to identify and mitigate risks that can interfere with our business objectives,” says Holly. “We have roles that we call compliance risk navigators that work with the business, either by project or by business unit, to identify areas of compliance risk that could interfere with progress and goals. [They ask questions such as,] how can we develop strategies to mitigate that risk, what can we do to monitor to see how those risks are being managed?”
Holly’s team consists of 25 people working in a variety of areas, including policy development, training, communications, investigations, and monitoring.
The COVID-19 pandemic changed the way that sales reps met with clients, meaning that her team had to either adjust existing compliance strategies or develop new ones. She says her team’s approach to compliance is for it to be more than just “pretty words on a page.” The goal is for employees to retain the importance of the policies and to internalize the teachings. “We want them to be skilled at making ethical decisions in the moment,” Holly explains. For this to be successful, she sees communications and training as flip sides of the same coin.
Her team works on developing impactful ways of communicating its policies in more novel forms. For example, in the past, her team used a “read and certify” model for compliance training. Employees would be sent a policy in PDF format and they would have to certify that they read the document. The problem, according to Holly, was that many employees would certify that they read the document less than a minute after opening it.
“You know that they’re not reading it, let alone absorbing it,” she says. “So we created more interactive modules, with knowledge checks in the e-learning mode that has been common in our industry for quite some time. Now we’re looking to innovate once again. We’re not replacing those activity and learning modules, but we are moving toward having a steady stream of prompts in a number of different ways.”
For example, Holly notes the televisions sprinkled around Regeneron’s Tarrytown, NY, campus will feature ads about the company’s open-door policy and ethics-reporting hotline, or reminders to employees about making sure they file expense reports appropriately. “Things that help [keep] those compliance topics top of mind,” she says.
The team, Holly adds, is also is working on ways to reinforce the compliance training that will more easily grab employees’ attention, such as creating humorous animated shorts.
The goal is to use multiple channels to interject compliance as part of employees’ conversations. One of those channels is an application called the field book, which sales reps can use in the field. The compliance team posts content to the app so that the information is available in the same way that those reps obtain other information important to their jobs. This helps integrate compliance messaging into the way that employees regularly conduct business.
In order to determine how successful the new initiatives are, Regeneron’s compliance team launched a survey over the spring. It provided insights into how employees feel about compliance, whether they understand some of the key policies, and how comfortable people are raising compliance issues. Next year, the team will initiate a new survey, which will allow the wider company to track progress.
“It is a little hard to know how many views a screen gets by the elevator banks or how many people are internalizing that message,” says Holly. “But we’re hoping that by the survey vehicle and looking at the responses, [we’ll] get a sense of whether we are having an impact the way that we hope we are.”
As Regeneron’s compliance team adjusted its training and policies in response to the pandemic, and the company’s reps changed the ways they engaged with healthcare clients, implementing a more virtually model came with technical challenges that needed to be met. That also required attention from the compliance team.
Policies had previously not allowed reps to FaceTime or make virtual appointments with clients, so new policies had to be developed. Holly says that her team had to consider how to handle a virtual speaker program and answer questions such as whether refreshments could still be offered to attendees. She explains that many of these decisions had to be made quickly on some very tactical levels.
The team also had to develop policies directly related to the pandemic, such as how to handle a situation where a sales rep who had been out in the field tested positive for COVID. Her team, working in collaboration with the commercial operations department, had to establish policies to determine how to handle contact tracing, notification, etc.
“There were a lot of changes that had to be made to enable the business to move forward, and that’s just focusing on the commercial side,” says Holly. “In the clinical space, we had our own COVID development program. We’re running clinical trials on other pipeline products around the world, then suddenly you have patients that can’t make it into the doctor’s office or supplies that can’t get to the doctor’s office easily. How do we adapt our policies to enable the important research that’s going on to continue? [We had to be] flexible and agile in adapting to a changing environment. The pandemic brought those skills into sharp focus.”
Now that in-person engagement has resumed between reps and healthcare professionals (HCPs), along with other elements of the traditional sales model, many of the original compliance policies are applicable again. Holly notes, however, that she doesn’t believe that things are fully returning to what they were. Over the past two years, many HCPs became much more comfortable with virtual engagements. From a compliance standpoint, this means that going forward, the new methods will have to run parallel to the traditional methods.
“I don’t think the pandemic has brought an end to live sales rep engagement,” says Holly. “We’re fully back in the field now. I don’t think there’s a fundamental change to the way we educate about our products. We’ve seen the addition of new tools in the tool kit that supplement the more traditional selling model. What we’ve learned is that can change, and if our customers are more comfortable with a virtual engagement or find that to be more consistent with the way they want to learn, we now have the means, policies, and tools to enable that.”
Holly believes that going forward, her team will see a blend of the newer ways of doing things with a return of some of the old methods. Technologies emerge all the time that provide the company with new and innovative ways to educate and inform clients about their products. These advancements require Holly’s team to consider the compliance-related implications of business innovation. Last fall, Regeneron launched its first commercial organization outside of the US. For the compliance arm, that meant that the unit had to extend its program into new, foreign territories. Doing so requires Regeneron to make the proper adjustments to ensure that its policies are compliant with local laws, regulations, and industry codes, while still maintaining a global code of conduct and business ethics that remains consistent throughout the company.
As part of this process, Holly and her team can not just simply assign the US training to employees around the globe. Instead, they’ve had to customize the program to ensure that it’s focused on the issues that are most relevant to each market. That includes diving into the core areas that are important for the employees and clients in those countries.
Across the globe, the foundational principles of compliance tend to be fairly similar. The biggest differences, according to Holly, come into play when dealing with patient interactions. For example, the US is one of the few countries that allows direct-to-consumer advertising from the pharma industry.
“Doing something as seemingly harmless as an employee liking a post on news about one of our products can be deemed direct-to-consumer communications in Europe, so our social media policy must be a little bit different there,” she explains. “The local codes have different requirements of how much a meal can cost if you’re having an out-of-office meal with a healthcare practitioner or what process needs to be followed before you can invite someone to an advisory board. Those interactions are very different on a local level and are very tied to individual country codes. That’s unique country by country. It’s in the execution that you see these differences.”
Mike Hollan is Pharm Exec’s Editor. He can be reached at email@example.com.