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Establishing and maintaining an in-house team, leading life sciences organizations periodically fill compliance gap assessments and enhance monitoring programs.
FREMONT, CA: The life sciences industry faces several existing and emerging challenges from a regulatory and compliance perspective, posing a constant threat to sustainability processes. Companies that can effectively handle these concerns can take a more proactive stance on risk, stick to evolving regulatory standards and ultimately create a competitive advantage. The following are key takeaways that life sciences organizations should consider to deploy controls that promote compliance and deter fraud and corruption.
Regulatory enforcement in the life sciences industry continues to increase, forcing firms to continually evaluate their risk and assess their present compliance programs' adequacy. Due to the present regulatory environment, life sciences firms must take steps to know new and emerging risks to rapidly respond and adapt. This latest scrutiny has resulted in a dramatic rise in defendants charged in health-care-related fraud cases. Given the increased regulatory enforcement activities, life sciences firms should be mindful of risks and create controls that limit malicious activities.
Life sciences firms are particularly susceptible in a few specific areas.
The European Union’s General Data Protection Regulation (GDPR) needs all firms that hold, transmit or process EU data to comply with the law, regardless of whether firms or contracted third parties function in the EU. GDPR raises the bar for securing consumer information and needs speciﬁc tracking from collection to disposal. To address these and data security concerns, firms should periodically audit security and privacy strategies, amend controls and planning as required, align governance appropriately and have an incident response plan in place.
Due to the nature of their business, life sciences firms encounter more bribery and corruption than other industry segments. These firms often must interact with foreign and domestic governmental entities and officials, inherently generating higher public corruption risks. Also, many firms continue to assess their compliance and internal audit functions to decide whether their resources have adequate knowledge and experience. Regulatory authorities look favorably upon firms who have actively taken steps to follow guidance and deploy effective programs.