4 Tips for Life Sciences To Comply With the DOJ’s Updated ECCP

Sep 25, 2023 | Prath Krishnamoorthy

Today’s HCPs are coming to expect a higher level of customer service from the life sciences industry—which often means engagement over digital channels. However, the regulatory guidance surrounding these channels continues to be a developing area, leading to hesitancy for compliance teams to embrace these channels due to perceived compliance risks.

Recently, regulators have also crafted new frameworks to define the proper usage of these channels and reduce the gray area. In March of 2023, for instance, the United States Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs (ECCP) that tightened its scrutiny of messaging apps across all industries.

The updates govern the use of personal devices, communications platforms, and messaging applications.

How the DOJ uses the ECCP

The ECCP is a document DOJ prosecutors reference when investigating a company’s compliance programs. It defines the criteria prosecutors use to determine if a company’s compliance program is sufficient.

The standards defined in the ECCP can also be used by the DOJ when deciding on remedial actions during settlement negotiations.

New evaluation criteria in the ECCP

The new evaluation criteria for digital communications in the ECCP can be summarized into three main areas:

• Company policy: A company’s policies should ensure that business-related electronic data and communications are accessible and able to be preserved by the company.
• Communications channels: A company should provide clear guidance on what communication channels its employees can use for conducting business, with expectations set regarding data retention and monitoring practices and consequences for noncompliance.
• Policy enforcement: The company should evaluate and reinforce the mechanisms in place to manage and preserve the information in each electronic communication channel.

How to prepare for the ECCP regulations

With the right solutions and processes in place, adapting to these new standards doesn’t have to hinder your promotional activities. They can also allow your commercial teams to re-evaluate strategy and discover new opportunities.

To help your company meet the new ECCP guidelines, consider the following recommendations:

1. Evaluate your business process for compliant communication on your communications platforms: email, text, and instant messaging.

This includes the internal regulations within your company about proper channel usage and the consequences for violating these internal regulations. Another critical aspect to examine is the processes you’ve established to store and access electronic communication records.

2. Reinforce guidelines with customer-facing teams when conducting business.

Sufficient training is needed to ensure that your customer-facing teams understand the business rules around digital communications and the severity of violating these rules. In addition to training, it’s also worth looking at tools within the communication platforms available to your teams, such as help text or special settings, that help prevent noncompliance.

3. Enable compliance monitoring for electronic communications

Comprehensive tracking of communications across all digital platforms, along with alert mechanisms when potential violations are detected, helps your compliance teams protect the company against violations.

If a compliance violation occurs, your company should also put together a detailed plan to address the violation and prevent similar violations from happening in the future.

4. Consider compliant solutions for electronic communications

An increasing number of engagement solutions for life sciences are now designed with compliance in mind. Veeva CRM Approved Email and Veeva CRM Engage come with full traceability by default, so you have an end-to-end view of every conversation with a customer over these platforms.

These four areas of consideration don’t just represent areas that need to be remedied for regulators; they are also opportunities to enhance your commercial strategy.

For example, compliant solutions often contain tools better tailored to HCPs’ engagement preferences, while retraining customer-facing teams can help the field gain the skills for operating in new, HCP-preferred channels. If this change is navigated with the right mindset, your biopharma could begin this project for compliance and end up with a more effective field force ready to provide more HCP-centric support.

Want more details about the specific regulations outlined in the ECCP? Get the guide now.