OCTOBER - 202119TECH OUTLOOKCulture Eats Controls for BreakfastBased on an Interview with John F. Crowley, Chairman & CEO and Patrik Florencio, Chief Compliance and Risk Officer, Amicus Therapeutics [NASDAQ:FOLD]Without a 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 because all versions of the submitted material and all approvals are 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 enhances our 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, technologically advanced 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. Most importantly, 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 and 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 for commercial 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 that in 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's the public's perception of how we carry out that mission. Their perception, in other words, of our industry's lack of business ethics.What is needed is a solution whose innovation and depth match the risks and size of the problem, a solution with culture Patrik FlorencioCXO INSIGHTS
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