As the industry faces the year ahead, it’s important to keep in mind that, in the eyes of public, perception can often equal reality, even if that perception is flawed. Dragged down by the acrimony in the broader debate about the state — and costs — of the American healthcare market, drug manufacturers are subject to judgement in the court of public opinion.
While companies continue to invest in remarkably innovative therapeutics and specialty drugs, increasing competitive pressures has caused spending on marketing and advertising to rise, as well. This visibility can be a double-edged sword: A Kaiser Health Tracking Poll finds that eight in 10 respondents think medicine costs are “unreasonable,” and more than three quarters say pharmaceutical company profits are a major reason for rising healthcare costs.
Gallup Poll results find that more than half of the American public has a negative view of the pharmaceutical industry, and fewer than one third have a positive view. (The remaining 16% expressed “neutral” sentiment.)
The existence of an effective compliance program satisfying the requirements of the OIG has become an assumption and is no longer a milestone achievement. However, today compliance managers face a growing array of regulatory risks and complexities for which limited guidance exists. This necessitates the need to apply consistent principal-based judgement, which becomes more difficult as the marketing and medical platforms also become more complex.
Today much of compliance complexities and risks, for which clear and consistent guidance is lacking, stem from direct patient interactions and third-party engagement with customers. These require high-bandwidth protocols including adherence to complex global privacy laws, full transparency in reporting, and rigorous due diligence. It seems like stating the obvious, but specialty and rare disease markets inherently have hard-to-find patients and often patients that require more comprehensive care. While trying to do the right thing for patients, many identification and support programs have become aggressive commercial strategies, which can be inconsistent with manufacturers’ stated mission, vision and values.
New healthcare delivery paradigms will require continued vigilance and adherence to these expectations. They also will demand the ability to work across corporate and industrial silos and develop new channels of communication and information management. We have already seen compliance departments tasked with collecting, securing and analyzing data pertaining to HCP contracting, field engagement and aggregate spend reporting — and these kinds of responsibilities will only grow in the future. They will need to stay ahead of the curve in order to proactively identify risk, target remediation and support fast-response training wherever and whenever the situation demands it.
This is not a small to-do list, and to accomplish it successfully requires a fundamental rethinking of the building blocks to good compliance: Responsibility and accountability.
Whereas the traditional role of compliance might have been seen more as that of a gatekeeper, these new market forces shaping every aspect of the field demand compliance-centered thought leadership. Developing decision support frameworks and maintaining their relevance and integrity are the key. With this, senior management can unlock the tools to excel in their missions while operating within a truly compliant enterprise ecosystem.
In this way, compliance officers become more proactive rather than reactive, and partners instead of participants. The sharing of responsibility and accountability across management tiers and silos creates a nimble, adaptable role in which compliance can be baked into a corporation’s operational D.N.A.
Darren Jones, Senior Principal, Global Compliance Consulting Practice Leader, IQVIA Commercial Compliance
Darren is the Senior Principal of IQVIA Commercial Compliance, where he leads a global consulting practice of over 20 professionals dedicated to supporting clients’ compliance risk management needs. He has over 18 years of global experience supporting the broad business and compliance needs of large global pharmaceutical manufacturers, as well as emerging biotech companies and medical technology. Darren has led global compliance consulting engagements across all healthcare interaction risk areas, and has developed deep expertise in commercial and medical affairs operations.