Compliance – It’s an Insurance Policy

compliance programI’m not one to procrastinate. I’m pretty good about getting things done proactively. But there are a few things that I will put on the back burner for months or years, and I’m sure you can relate. I’m talking about estate planning. Doing that periodic check of how my retirement funds are doing, or how adequate my life insurance and disability insurance policies are.

Why do I do this to myself?  Why can’t I just get it done?  Because there is no immediate benefit to me. I’m safeguarding myself against problems that I may or may not have down the road.

This is why companies struggle with compliance. There is no return on investment. There is no immediate benefit.  It’s an insurance policy against problems that they may or may not have down the road.

Thus, when I finally decide to devote some time to estate planning, what do I do?  I want someone to tell me what to do. I want someone I trust to advise me. Someone to do the dirty work because I don’t have the confidence that I can do it properly myself.

If you are a pharmaceutical company, what should you do? You need to devote money and resources to a compliance program. You need an internal experienced staff, scaled appropriately for the size of the organization and number of products. Because the business case is based on an unspecified cost avoidance and not ROI, it is difficult to secure enough money and resources to do this correctly. You get what you get and you need to make the best use of the resources that you have.

Because you will have limited staff to monitor and enforce compliance, your program better be effective. The larger the organization, the more difficult it will be to train and enforce. How do you expect a Regulatory Affairs Specialist in Dubai or a Business Development Lead in Bangkok to understand the importance of compliance and put it into practice? They are under a lot of pressure to generate revenue and compliance is often an afterthought.  How do you reach these people?

Key Ingredients for an Effective Compliance Program

An effective compliance program that reaches these folks has at least six ingredients:

  1. The head of your Compliance organization needs a prominent seat on the leadership team. You cannot bury this person in the organization. This person needs a voice and they need influence so that others outside of their organization will serve as advocates.
  2. A heat map to evaluate the level of risk across the organization so you can allocate resources appropriately.
  3. Clear policies and process.
  4. Effective training for those folks in Dubai and Bangkok.
  5. A means of monitoring compliance. This may involve metrics and reporting as well as human intervention from strong champions or compliance officers in the field.
  6. Incentives for employees that drive compliance in their areas.

Just as I seek out expertise for my estate planning, if the expertise does not exist in your organization, go out and find it. If you are a small organization, you probably struggle with how to establish the program and infrastructure.  If you are a large organization, your challenges are probably more focused on monitoring and enforcing the program. Find an expert who can tailor to your needs.

Most important, don’t procrastinate! Just as I need to worry about what happens to my family if I get hit by a bus tomorrow, you need to worry about your liability when it comes to patient safety and the quality of your products.

Leave a Reply