Compliance in the Life Sciences Sector

It will benefit the life science compliance team if they collaborate with trusted partners to reduce risk. 

FREMONT, CA: There are several issues specific to the field because any compliance professional employed in life sciences recognizes them. It is a highly regulated industry, and compliance programs in the life sciences often become complicated, involving multiple jurisdictions addressing extended supply chains and numerous third parties. Life sciences compliance has been put under scrutiny to look at challenges presently the industry is dealing with, how to solve them, and what is there in the future.

Unavoidable Compliance Risks

When it comes to bribery and corruption, the life sciences industry does not have a decent reputation. It is estimated that more than US$7 trillion is spent on health care worldwide, according to The Lancet, but at least 10-25 percent of this global investment is wasted directly through corruption.

The stakeholders' structure is a primary explanation for this, with many companies directly partnering with hospitals or other government-owned entities. Strong dependency on sales teams and third-party agents or finders to attract government customers reveals an apparent vulnerability to public corruption. As a result, businesses, powered by local customs and regulations, are subject to many enforcement problems, which may include:

• Management of gifts and entertainment

• Exposure to government interference

• A common use of kickbacks in the sales process

• Engagement with politically exposed persons

• Complex supply chains

See Also: Top Pharma and Life Sciences Analytics Consulting Companies

Many compliance programs for life sciences are costly and unwieldy. Some work in silos or are isolated, missing an enterprise-wide view of the problems they face in compliance. In addition to this tension between the management of regulatory risk and the achievement of business objectives, it is obvious why issues occur.

Rising to the Challenge: Next-Gen Compliance

To prevent a regulatory fall-out, it is essential for life sciences companies build a comprehensive enforcement strategy enterprise-wide. In enabling this to happen, the enhancement of enforcement and risk management systems through the implementation of technology frameworks would play a key role. Compliance anomalies would be easier to detect and fix as compliance procedures become more automated.

For example, using a compliance platform for third-party management that continuously reviews each third-party relationship's status would detect problems before they trigger concern. By integrating upfront and annual enforcement training for both workers and third parties, such a platform could serve a dual purpose. In a post-merger situation, introducing AI-based technologies to support high volume diligence remediation services may also help define FCPA's successor responsibility in inherited transactions.

Compliance teams in the life sciences will benefit from partnering to support successful risk reduction initiatives with a trusted partner. They have extensive experience at IntegrityRisk, helping clients manage a broad range of risks to produce positive results.