After 7 Elements has established your risk profile, we will diligently work with your company to plan for items such as ethical interactions with healthcare professionals, consumers, and payers; transparency requirements; medical-commercial interactions; market access activities; state regulations; government price reporting; credentialing; and product promotion development. Manufacturers will have the option of selecting and customizing standard operating procedures, policies, and manuals—all of which will ensure your company meets all pertinent compliance standards.

7 Elements is uniquely acquainted with the complexities of anti-kickback statutes, preapproval information exchange, corporate compliance, and ethics. And because each pharmaceutical company’s business is exclusive—and healthcare regulations are constantly changing and subject to interpretation—your company’s decision to invest in corporate compliance training is a priority. When all stated objectives have been met, your company will be well positioned to protect your patients, providers, employees, investors, and shareholders.

The integration of sustainability objectives into a company’s core business strategy might be challenging, but the end product will be very rewarding and provide a structure that is indestructible. It’s also the right thing to do. Companies that integrate sustainability objectives will win the trust of regulatory agencies and other stakeholders, including advocacy groups. That means they become your partners, and then you are on the path to long-term success. 7 Elements is committed to helping manufacturers outline their sustainability goals and establishing programs to ensures success.

The Office of Inspector General states that a compliance program must begin with a formal commitment by the pharmaceutical manufacturer’s board of directors or other governing body, and developing a code of business conduct and ethics solidifies that commitment. The manufacturer’s compliance team maintains and implements relevant policies and procedures based on periodic assessments of risks rooted in the specific business and the ever-evolving compliance, regulatory, and legal environments. From time to time, manufacturers might need assistance ensuring that an audit of risks is conducted and provided to the board of directors for its review. 7 Elements is here to not only guide you through developing your code of conduct, but also to perform the enterprise risk audit required by the board.

ESG includes ethical, sustainable, and corporate governance issues, e.g., climate impact, diversity, equity, and inclusion accountability and governance, and it drives shared values. It’s a vital subset of nonfinancial performance indicators.

In 2021, the Securities and Exchange Commission (SEC) formed the Climate and ESG Task Force within the Division of Enforcement to proactively identify ESG-related misconduct. The task force had two cases in ’21 and six cases in ’22. 7 Elements expects enforcement actions to rise in ’23. To adhere to ESG practices and principles and accurately portray public disclosures, do what you say and say what you do. The SEC cracks down on misstatements. Companies and advisers take care to not make ESG-related statements that cannot be proven, whether in SEC-required filings or voluntary statements made, for example, in corporate sustainability reports, on websites, or in marketing materials. As with the governance of disclosures, ESG statements should be accurate, consistent, and verifiable . 7 Elements can assist with this process.