Regulated industries are always under scrutiny and any missteps in their processes seem to be magnified. They are also at the mercy of rapidly changing regulations which can vary among jurisdictions. While the pharmaceutical and biotech sectors have their drug safety under the microscope, other factors like corruption, bribery, and not doing thorough due diligence on customers, employees, or vendors can slip through the cracks.
The pharmaceutical industry can be a target of money launderers who seek out further methods to clean their dirty money, so they exploit the transactions in pharmaceutical products, such as providing fake medication disguised as legitimate, or the use of shell pharmaceutical companies. Failure to be compliant can negatively impact your company’s reputation, finances, and customers, as well as facing a hefty fine.
A well-known example of this is the case of the French pharmaceutical company Sanofi. In 2018 they were fined $25 million by the Securities and Exchange Commission (SEC) after being charged with FCPA violations with payments linked to bribery and corruption. So, conducting risk management and seeking ways to remain regulatory compliant are crucial.
What are the common compliance challenges?
There are several challenges experienced by the pharmaceutical and healthcare industries which require compliance solutions. One is the reliance on third-party distributors, failing to fully disclose the origin or all steps in the supply chain. Transparency and full visibility are key to eliminating the risk of bribery or corruption in the chain.
Other drawbacks their solutions have include:
- Lack of AI capabilities leading to human error or wasted time
- Multiple tools which cause a fragmented and inefficient compliance program
- No clear risk assessment or categorization to help streamline your workflow
- Rigid and inflexible systems which can’t calibrate to your business.
Discover our top 5 considerations of life sciences compliance.
How to address third-party risk
There are several ways to secure the peace of mind that your compliance program is working. Looking at big data, doing your research, getting a compliance team onboard, and introducing the right technology are all ways to keep you safe.
Here are some key benefits that advanced technology can bring to the regulatory compliance process:
- A customized workflow
- Proper risk identification across third parties
- Automation to reduce manual labor and risk of human error
- Integration capabilities to synchronize systems and keep all stakeholders informed
- Artificial Intelligence to increase efficiency and reduce costs
- Robust reporting and a clear audit trail
- Alignment with the latest regulations and FCPA guidance
- Scalability should your business grow.
Your industry prides itself on the latest healthcare and using cutting-edge technology to provide the best treatment for patients. It’s time to do the same for your business. Implementing advanced technology can build resilience for your business as well as a better return on investment. Your team will get the information they need to respond and remediate any risk, while the platform gives full visibility on all aspects of your third-party compliance program.
Status is our third-party risk management platform that’s designed for automation and efficiency. All necessary information for due diligence is integrated for effective onboarding, managing, monitoring, and auditing. Level up your compliance program and explore Status today!