As we step into 2024, life sciences companies continue to introduce innovative treatments to the market that improve patient health while adhering to the rules and regulations enacted by the regulatory authorities and identifying and mitigating compliance risks.

While data-driven compliance platforms are enabling compliance professionals to ensure compliance with the evolving rules and regulations, it is still important for compliance teams to gain insights into emerging trends, key updates, and changes to stay relevant, reduce risks, and build resilience to have a positive impact.

Join us as we go through the chapters of the regulatory narrative that will shape the industry’s journey in the years ahead and beyond. Here are the topics that we will be exploring today:

• Digitalization of Compliance

• Compliance Monitoring Challenges

• Whistleblower Reporting Programs

• Collaborating for Internal Investigations

• Third-Party Risk Due Diligence

1. Digitalization of Compliance

Compliance teams face increased pressure as regulatory demands in the life sciences industry evolve. Embracing technology as a tool to enhance compliance efficiency and effectiveness is becoming the clear path forward.

Beyond augmenting compliance programs capabilities, technology also provides organizations with a means to deliver tangible value and insights from data.

The combined potential of value and data analytics empowers compliance professionals to proactively identify the root causes of risks, address them promptly, and prevent them from reaching critical stages.

Artificial intelligence and automation are already reshaping and augmenting compliance monitoring procedures throughout the life sciences industry.

These digital solutions streamline compliance processes and improve the accuracy and scope of risk identification and mitigation. By tapping into digital advancements, life sciences companies can proactively adapt to changing regulations and ensure ongoing compliance that aligns with the evolving regulatory landscape.

2. Compliance Monitoring Challenges

Life sciences companies are being closely watched when it comes to how they work or interact with healthcare professionals (HCPs).

To stay compliant, life sciences organizations need to consider recent regulatory changes and the business environment as they monitor compliance risks associated with engaging HCPs or conducting speaker programs in 2024.

This helps them track and ensure compliance while engaging HCPs or conducting speaker programs. Here are a few recommendations for life sciences companies use to mitigate risk in this specific area.

1.   Use Monitoring Results to Generate Data-Driven Insights

Compliance leaders should establish a holistic data collection, analysis, and reporting process, to ensure that monitoring data can be used to derive analytical information to improve compliance program effectiveness, and become more proactive with risk monitoring and management.

2. Complying with PhRMA Code Requirements Related to Alcohol at Speaker Programs

The updated PhRMA Code states that life sciences companies should not pay for or provide alcohol in connection with speaker programs. It also clarifies that high-end restaurants and other such venues are not appropriate locations for speaker programs.

To comply with this voluntary code of ethics, comprehensive guidance and training should be provided to sales representatives, speakers, and other company personnel who are interacting with healthcare professionals to ensure compliance with the PhRMA Code.

3. Tracking Attendance & Topics Covered at Speaker Programs

The OIG’s Special Fraud Alert raises a red flag about individuals attending speaker programs too often and or on the same or substantially the same topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic).

The regulators advise life sciences companies to ensure that such attendance is genuinely driven by educational purposes, not potentially improper motives. This helps maintain the credibility and ethical standards of these programs.

Life sciences companies should create a data-driven process to identify, track, and prevent people from attending multiple speaker programs on the same topic. This would ensure that speaker programs adhere to current OIG guidance and hence minimizing the potential risk of violating the anti-kickback statute.

4. Providing Meals to HCPs Who Have No Legitimate Reason to Attend

OIG (Office of Inspector General) is skeptical about the educational value of speaker programs in which people who have no legitimate reason to attend the event.

Research conducted by the OIG revealed that HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.

Such cases strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.

For this reason, activities at a speaker program should be monitored in real-time to see what’s happening during these meals or events as they unfold. The purpose is to identify any potential instances of non-compliance so that corrective actions can be taken promptly.

In addition to that, companies need to put in place for all speaker programs processes that can be monitored before, during and after the event to ensure compliance with the guidelines.

3. Whistleblower Reporting Programs

Amid the increased attention on employee whistleblowing cases, regulatory authorities are urging companies to reevaluate their whistleblower reporting programs to see whether the program is designed to tackle the problem or just punting on responsibilities.

Here are a few suggestions for companies to improve their existing whistleblower program:

1. The reporting program should involve individuals from different organization departments, such as compliance, legal, HR, etc. The resources should be devoted to taking the issue from investigation to remediation.

2. Data-driven insights should be used to identify potential issues with the current whistleblower reporting program to enhance its effectiveness.

3. Whistleblower reporting programs should be refreshed and updated with the changing company dynamics. Emerging risks, operations, and culture are some aspects that should impact a whistleblower reporting program.

4. A lack of trust in the process eventually leads to a lack of reporting. Hence, the whistleblower reporting program should be widely known and transparent and urge all employees to participate without fear of retaliation.

4. Collaborating for Internal Investigations

Compliance professionals should combine their unique perspectives and expertise with other departments to magnify internal investigations, enhance risk identification, and reduce costs. For example, compliance teams can collaborate with legal teams to improve adherence to relevant laws and regulations.

1.   Case Assessment & Investigation Plan Development

• Collaboration would enable stakeholders with diverse expertise to offer unique perspectives to conduct assessments and investigations more effectively.

• Strategizing and synchronizing strategies, resources, data analysis, and tracking of non-compliance would help reduce redundancies and improve adherence to industry regulations.

2.   Diverse Perspectives on Data Analytics

• The different focus of each department would allow for the review of information/data from multiple angles.

• Diverse backgrounds and expertise infuse fresh perspectives on compliance, data analysis, and other aspects.

• Additional resources would identify information gaps or bring up ideas such as integrating technology solutions to enhance data collection and analysis and identifying inaccuracies.

3.   Case Reporting & Remediations

• Collaboration with stakeholders and other departments would lead to more comprehensive conclusions.

• Viewpoints of leaders may provide more actionable recommendations for risk remediations and ensuring compliance.

• A coordinated response to risk mitigation would ensure operational and cultural alignment throughout the organization.

5. Third-Party Risk Due Diligence

Business Interactions with Third Parties and Regulatory Scrutiny

As businesses in the life sciences industry engage with third-party entities such as vendors, suppliers, and partners, regulatory authorities closely monitor these interactions.

This scrutiny is driven by the need to ensure transparency, fairness, and adherence to laws. It’s important to realize that any missteps in these interactions can result in serious legal and reputational consequences.

Continuous Monitoring for Third-Party Engagements

As rules and regulations evolve over time, maintaining an ongoing monitoring and assessment of third-party engagements helps to identify any shifts that might impact compliance. It’s akin to adjusting the sails of a ship to navigate changing winds, ensuring that companies stay aligned with legal requirements.

Evaluating Speaker Programs & Fair Market Value

Speaker programs, where healthcare professionals are engaged to provide expertise, can carry inherent compliance risks if not properly managed.

Companies need to ensure that these programs have a genuine educational purpose and are not influenced by financial incentives. Moreover, assessing fair market value becomes crucial in determining the appropriateness of compensation to avoid potential allegations of overpayment or improper inducement.

Conclusion

The regulatory landscape of the life sciences industry in 2024 reflects a dynamic environment where compliance plays a pivotal role in ensuring patient well-being and healthcare professional engagement.

Technology integration, particularly in the digitalization of compliance, offers unprecedented opportunities to streamline processes, enhance risk identification, and foster data-driven insights that empower proactive decision-making.

The challenges posed by compliance monitoring underscore the necessity for meticulous attention to detail, especially in interactions with healthcare professionals.

By leveraging data-driven insights and collaborating across departments, life sciences companies can navigate these challenges while aligning with evolving regulatory expectations.

In this landscape, compliance professionals are the vanguards of adherence. They are equipped with technological tools and collaborative frameworks to navigate complexities, anticipate changes, and ensure that the life sciences industry remains at the forefront of ethical and regulatory standards.

As we progress through 2024, these insights and strategies will shape a resilient industry that prioritizes patient care while adapting to an ever-evolving regulatory horizon.