How To Create A Culture Of Substantial Compliance In Your Company

How To Create A Culture Of Substantial Compliance In Your Company


The journey from ‘good enough’ to ‘good’ is a fluid one in the pharmaceutical industry. As a result of high-innovation, ruthless– and now cross-border—competition, evolution in every area of the global pharmaceutical space is the one variable that can safely be factored in.

As a result of developments across each function of the global medical drug and device space, compliance needs to keep itself ahead. It must foresee changes before they occur; before they have an impact; and often even before the respective function can foresee the consequences of its action.

Pharmaceutical compliance, therefore, needs to move from the role of corporate watchman to a fully-embedded responsibility in each function of the organization. This evolution will take place as it moves from its position as a “Traditional Compliance” function to one of “Substantial Compliance.”

  1. Understanding The Difference Between Traditional And Substantial Compliance

Substantial compliance easily travels out of the stereotype traditional compliance has been suffering from for too long.

Traditional compliance is often borne out of a response to regulation, best industry practices and internal housekeeping. It is the new addition to the legal/audit family to keep pace with the evolutionary practices above. It is also the recipient of the same guarded, arms-length response from areas whose reservations—or simply lack of resources—make compliance mandated documentation a challenge.

Is Substantial Compliance an add-on over traditional compliance activities? Is it a glamorous re-wrap of existing tasks and processes?

It is not.

While it is true that substantial compliance will absorb many of the activities that fall in the traditional realm, it will differ in its outreach and approach.

2. Does Your Pharmaceutical Company Need Substantial Compliance?

Compliance in its formal (traditional) form is demanding as is. It is a cumbersome exercise that consumes time and resources to yield an historical diagnosis. It is the basis for justifying spend behavior, and by itself, is a lot of work.

Why then, would anyone want to adapt an even more rigorous form of compliance, i.e. Substantial Compliance?

Here are three strong reasons to consider introducing substantial compliance in your company:

  1. Preventive Rather Than Curative: Whereas traditional compliance is an annual exercise that tells you what went wrong in physician/HCO engagement in conclusion, substantial compliance helps identify and plug it on the spot. I.e. Because of its holistic nature, substantial compliance is able to make timely identification of process detours; and thus; is able to make timely, long-term recommendations to changes in the system.
  2. Beyond Planning, Towards Management: Compliance is no longer about developing systems for other departments’ execution. Compliance is everyone’s job, and involves end-to-end, internalized application of compliance concepts. Thus, instead of being in adversarial roles, departments work with the compliance function to devise, develop and maintain compliance-friendly policies.
  3. Not Cost, But Result Multiplier: One of the most revolutionary aspects of Substantial Compliance is that it shifts compliance’s perception as an all-round cost-center to one of potential revenue. How does it do that? When compliance (i.e. substantial compliance) becomes everyone’s job, hidden cost centers are proactively identified. Similarly, fund leakages in HCP/HCO relationships are identified and plugged. This helps add measurable value to the organization’s bottom line. Hence, robust substantial compliance techniques lead to profit multiplication. Conversely, poor substantial compliance will multiply these concealed costs.

The Substantial Compliance Checklist

Your pharmaceutical company needs substantial compliance, if it:

  • Has a culture driven by proactive rather than reactive market response
  • Invests heavily in minimizing reputational risk, and eliminating associated risks.
  • Cannot afford to have R&D projects and clinical trials be halted due to regulatory action
  • Is interested in growing and leveraging HCP/HCO relationships, instead of short term stakeholder engagement

3. Identifying Internal Gaps

Once your organization has decided to embark on its substantial compliance program, it needs to complete a gap analysis.

The following areas need to be approached:

Once the gap analysis has been completed, it is time for the compliance function to roll out responsibilities in accordance with the new structure. This will be a consultative process.




Download Substantial Compliance Culture Guide here.