Without doubt, technology critically enhances the effectiveness of the controls we rely on to govern our business. In the world of corporate compliance, an electronic approval system is vastly superior to a paper-based one becauseallversions of the submitted material and all approvalsare documented in a single place.The same is true in the world of good practices (GxPs), where validated computer systems are not only superior to paper-based ones, they are required by regulation to ensure data integrity. In the world of finance, scandals like Enron and WorldCom led to SOX and other international regulations that also require strong automated controls.Beyond electronic systems, technology also enhancesour compliance monitoring capabilities, provides data analytics to identify patterns of behavior, and enables faster detection of areas of risk.
But controls and computer systems can only go so far. There is always a way to circumvent controls if the intent is bad.For example, a validated GxP system is hardwired with an electronic audit trail showing all changes to data in the system, but that doesn’t prevent false lab, clinical, and manufacturing data from being input into the system right from the get-go. As the saying goes: garbage-in, garbage-out. Likewise, in compliance, the strongest controls and computer systems can’t prevent unlawful activities from occurring out in the field.
In the end, we’re talking about human behavior and culture has a far greater impact on behavior than do controls, however technologicallyadvanced those controls may be.Culture reflects the very ‘intent’ of an organization. It underlies and shapes the organization’s collective behavior and is a manifestation of its level of integrity and business ethics. Mostimportantly, it reflects the organization’s attitude toward compliance which, from an enterprise risk management perspective, is the greatest indicator of whether an organization is likely to engage in significant or systemic compliance violations.Thus, while it’s often been said that culture eats strategy for breakfast, it eats controls for breakfast too.
Has Pharma Done Enough to Build & Sustain a Culture of Business Ethics?
Looking back over the last twenty years, one might say that our industry has under-emphasized the importance of visibly and consistently fostering a culture of business ethics. Indeed, during these past twenty years our industry has paid over twenty-five billion dollars in fines forcommercial compliance violations alone, which doesn’t include the hundreds of millions of dollars paid in attorney’s fees or the major productivity loss which occurs during the prolonged investigation period.The public has become so used to hearing about yearly pharma industry violations and ‘pharma greed’ in the media that it’s no wonder thatin the most recent Gallup Poll of industry reputations, pharma ranked last. According to the Poll, the public had a more negative perception of pharma than it had of oil and gas, the federal government, and of all other assessed industries. That terrible ranking is not a reflection of our medical mission, it’sthe public’s perception of how we carry out that mission. Their perception, in other words, of our industry’slack of business ethics.
What is needed is a solution whose innovation and depth matches the risks and size of the problem. A solution with culture at its core. A “performance culture” that attracts and retains the best people, provides the drive to win, and increases productivity is vital to the success of business, but so too is a “compliant culture” that fosters the respect, trust, and goodwill of employees, avoids fines and penalties, and ensures a company’s long-term sustainability. Both of these essential goals can be achieved through a balanced culture. But thecurrent culture at many companies continues to inadequately balance the time, energy, and rewards placed on performance versus compliance.
The New Commitment to Patients and the Public
In January 2020, two hundred and fifteen biopharma CEOs and industry leaders signed a New Commitment to Patients and the Public in which they proactively re-affirmed their personalcommitment, and that of their companies,to act with the highest level of integrity and social responsibility.This was an excellent first step toward rebuilding pharma’s reputation in the community. But,for this commitment to lead to meaningful change in the real world, it is now incumbent on each of these leaders, along with the rest of pharma, to take the concrete steps neededtofully embed and operationalize that commitment into the daily activities of their companies.
The concrete steps we’ve taken at Amicusto foster a global culture of business ethics are centered around the following seven building blocks (figure 1).
1. Select a Small Number of Prioritized Values: Integrity Leadership is one of only four key values so that our focus on it is meaningful.
2. Connect Values to Bonus:Our four values are together worth fifty percent of the bonus.
3.Deeply Define Integrity Leadership:We have not just added the word integrity to a list of values. We have deeply defined the specific Integrity Leadership behaviors we want to visibly and consistently see.
4. Embed Integrity Leadership Into All Aspects of Management: Including, for example, talent decisions, onboarding, leadership and other management courses, awards programs, etc.
5. Continuously Coach the Leadership Team: Leaders set the tone and are a company’s most important group of role models. Quarterly coaching sessions with leaders are vital to continuously teach and reinforce how they can be great Integrity Leaders themselves, and how they can assess the Integrity Leadership of their teams.
6. Continuously Measure Integrity Leadership: Managers are better able to assess the Integrity Leadership of their teams if they get multiple sources of data, like skip-level data from the employees who work for their direct reports and cross-functional data from employees in other departments working with their direct reports.
7. Audit Bonus Rationales:When Integrity Leadership is part of the bonus, auditing a cross-section of the bonus ratings and rationales is critical to ensuringthis concept is well understood by management, or whether more training is needed to properly assess Integrity Leadership.
In the end, the raison d’être of our entire industry is to serve patients. We believe this to be one of the most important guiding lights when it comes to compliance and business ethics. When you authentically put patients, rather than profits, at the center of everything you do, you will not only fulfill your mission, but also have a strong and sustainable business.