The life sciences industry plays a crucial role in global healthcare, constantly innovating to develop new drugs, medical devices, and therapies.
However, alongside innovation comes the critical need for stringent compliance monitoring to ensure compliance with applicable regulatory standards within the U.S.
Regulatory adherence is where the challenge primarily lies as compliance officers generally must keep up with evolving rules and regulations. In addition, even the slightest issue of non-compliance can escalate to critical levels if not remediated/mitigated on time.
For instance, imagine a pharmaceutical sales representative violating a company’s spending policies on HCP meals by exceeding the limit every time he visits an HCP for lunch and learning activities. This single aspect would pose the following challenges for life sciences companies:
- Compliance Violations
- Legal Penalties
- Reputational Damage
- Financial Losses
- Increased Regulatory Scrutiny
- Loss of Trust
- Internal Audits and Investigations
Additionally, this makes it imperative for compliance officers to leverage AI solutions to conduct a 100% audit of expense data to detect suspicious transactions, anomalies, and more – thus, effectively reducing the risk of non-compliance.
Let’s explore other critical best practices and challenges associated with global compliance monitoring and see how businesses can overcome them, assuring adherence to global regulatory standards for life sciences companies.
Why Compliance Monitoring is Important for Life Sciences Companies
Compliance monitoring is essential in the life sciences industry to uphold regulatory requirements set by regulatory authorities such as the DOJ (Department of Justice), OIG (Office of Inspector General), FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and similar agencies worldwide. These regulations ensure that products are safe, effective, and manufactured under strict quality standards before they reach patients.
This makes it imperative for companies to implement compliance best practices, and leverage life sciences compliance solutions to augment the capabilities of compliance programs by leveraging data analytics, detecting issues of regulatory breaches, and more.
The 6 Best Practices in Global Compliance Monitoring
1. Establishing a Robust Compliance Monitoring Program
- Comprehensive Program Design: A compliance monitoring program should be designed to provide a clear and comprehensive outline of procedures, responsibilities, and processes that ensure marketing and sales activities meet regulatory requirements. It serves as the key driver of mitigating compliance risks in the life sciences industry.
- International Standards Implementation: Developing and implementing a compliance program based on international standards, such as the Foreign Corrupt Practices Act (FCPA), helps maintain consistency and integrity across global operations. Adhering to these standards not only ensures regulatory compliance but also reinforces the organization’s commitment to ethical practices.
2. Adherence to Applicable Commercial Compliance Guidelines
- Establishing robust commercial compliance guidelines provides a framework for conducting sales and marketing activities ethically and in accordance with legal standards. These guidelines should cover all aspects of commercial operations, from promotional practices to interactions with healthcare professionals.
- One of the best ways to enhance regulatory compliance programsis by conducting regular audits and inspections, which is crucial for verifying compliance with commercial compliance requirements. These assessments help identify potential areas of non-compliance and enable timely corrective actions, ensuring that all activities remain aligned with legal standards.
3. Document Control and Record Keeping
- Maintaining accurate and comprehensive documentation is crucial for demonstrating compliance during audits and inspections by regulatory authorities.
- Document control systems ensure that documents are up-to-date, accessible, and securely stored is imperative to ensuring that all regulatory documents are readily accessible in case there’s a need.
4. Training and Competency Development
- Continuous training programs ensure that employees understand regulatory requirements and are proficient in their roles.
- Training also promotes a culture of compliance throughout the organization as every employee learns what’s at stake in case there’s an issue of non-compliance and how they can ensure adherence to the law effectively.
5. Risk Management Strategies
- Identifying and mitigating risks associated with commercial operations in the initial phase is essential. A great way to detect emerging risks is by leveraging Data-driven compliance monitoring tool Purpose-built tools provide compliance officers with the ability to centralize all compliance data, monitor and audit all of it from a central location, and pinpoint risks as soon as they occur, assuring timely mitigation of risk.
- Implementing risk management frameworks, such as FMEA (Failure Mode and Effects Analysis), helps prioritize and address potential risks.
6. Surveillance and Vigilance in Commercial Compliance
- Proactive Monitoring of Promotional Activities: Implement advanced surveillance systems to continuously monitor marketing and promotional activities for compliance with regulatory and internal standards. This proactive approach ensures any deviations are identified and addressed promptly.
- Real-Time Response to Compliance Breaches: Develop a robust vigilance system that allows for rapid detection and response to potential compliance breaches in sales and marketing. This system should facilitate immediate corrective actions and regulatory notifications, minimizing risks and maintaining the integrity of commercial operations.
The Top Five Challenges in Global Life Sciences Compliance & Their Solutions
1. Navigating Diverse Regulatory Requirements in Life Sciences
Challenge: Adhering to complex and varied regulatory frameworks governing interactions with healthcare professionals (HCPs) globally.
Solution: Compliance officers must interpret and implement guidelines from entities like the FDA, EMA, and local health authorities.
This includes navigating regulations on promotional activities, scientific exchange, and sponsorships to ensure compliance with the Anti-Kickback Statute (AKS), Anti-Bribery and Corruption (ABAC) laws, and the Foreign Corrupt Practices Act (FCPA).
Additionally, compliance officers can leverage best practices for compliance audits to assure regulatory adherence.
2. Managing Compliance in HCP Engagements
Challenge: Ensuring transparency and legality in engagements with healthcare providers (HCPs).
Solution: Compliance officers oversee activities such as advisory boards, consulting agreements, and speaker programs, ensuring they meet regulatory requirements and internal policies.
This involves robust monitoring, documentation, and training to mitigate risks associated with improper inducements or conflicts of interest.
It is highly recommended that compliance officers start utilizing data-driven HCP Engagement solutions that are designed to streamline compliance processes, provide actionable insights into all engagements, and help compliance officers effectively mitigate risks.
3. Adapting to Evolving Legal and Regulatory Environment
Challenge: Staying updated with changing laws and guidelines enforced by regulatory bodies like the DOJ and OIG.
Solution: Officers monitor updates to AKS safe harbors, OIG guidance on compliance program effectiveness, and DOJ enforcement priorities.
They proactively adjust compliance strategies, conduct regular audits, and provide ongoing training to mitigate legal risks and uphold ethical standards in commercial practices.
This aspect also involves reevaluating your compliance monitoring strategies in a life sciences company to see if they’re effective and whether you’re monitoring the key risk areas identified by the regulatory authorities such as the OIG.
4. Ensuring Anti-Bribery and Corruption Compliance (ABAC)
Challenge: Mitigating risks related to bribery and corruption in global operations.
Solution: Compliance officers implement policies and controls to prevent improper payments, gifts, or inducements to government officials, HCPs, or third parties.
They conduct thorough due diligence on business partners, maintain accurate records, and monitor transactions to comply with ABAC laws and internal anti-corruption standards.
5. Maintaining FCPA Compliance in International Operations
Challenge: Complying with the Foreign Corrupt Practices Act (FCPA) in international markets.
Solution: Officers ensure that interactions with foreign officials, HCPs, and intermediaries adhere to FCPA requirements. This includes rigorous oversight of sales and marketing activities, due diligence in acquisitions and partnerships, and comprehensive training to prevent violations and potential legal consequences.
The insights above provide a focused view on overcoming compliance challenges in the life sciences that commercial compliance officers in the life sciences industry face.
Conclusion
Global compliance monitoring in the life sciences industry requires proactive adherence to regulatory standards, robust compliance controls, and effective risk management practices.
By implementing best practices such as establishing a robust compliance monitoring program led by AI, leveraging data to ensure adherence to the law, and prioritizing training and risk management strategies, companies can navigate the complexities of global regulatory environments more effectively.
Despite challenges like diverse regulatory requirements, proactive monitoring and adaptation ensure that the company’s commercial operations are compliant with global standards, ultimately benefiting patients worldwide. This is why one of the 5 five top priorities for CCOs happens to be leveraging data-driven global compliance monitoring.
In conclusion, continuous improvement and vigilance in compliance monitoring are essential for sustaining innovation and maintaining public trust in the life sciences industry.
