Getting Started
Meeting planners that meet basic code guidelines at the beginning will be able to breathe easier long term. Companies need
to first appoint a compliance officer and committee to develop the best policies and procedures; at minimum, companies have
to develop a compliance program that involves the different departments. A compliance program ensures that internal regulations
and policies will be met. Other practices include:
• Make sure key stakeholders coordinate with internal and external resources involved in the compliance initiative
• Review PhRMA and OIG codes, as well as individual laws applicable in each state where the company is holding a meeting
• Locate relevant data within the company or with its suppliers and make sure all information is easily accessible
• Ensure software is up-to-date and can consolidate all the data on meeting spend. If necessary, use a system that can track
spend by individual meeting and individual physician
• Take careful notes of every procedure and communication required to implement the compliance program; this may include changes
to IT systems and any written requirements related to expenses for medical meeting spend
• Identify whether the current system needs to be changed or new applications need to be developed
Pharma companies often use an internal system to manage compliance programs, but it may be more advantageous to partner with
an outside contractor to augment the company's system.
Creating an Audit Trail
Companies need a system that keeps track of all physician-related data. As regulations and laws multiply, companies need to
calculate exact spend per physician per meeting, rather than average spend across all physicians or all meetings. In order
to achieve this, the system should:
• Capture an individual identification number for each medical meeting and for each individual physician tracked across all
systems and suppliers
• Provide a central mechanism to keep track of every medical meeting expenditure, including travel, lodging, meals, honoraria,
expense checks, and gifts
• Create a paper trail of all payments, cancellations, and changes to the program arrangements
• Monitor all the changing regulations of different compliance requirements. If a doctor practices in Pennsylvania, the state
expects pharmaceutical companies to report to the state every time the doctor is paid to speak at a meeting—even if the meeting
is arranged and takes place in another state
• Provide compliant options when selecting a venue or choosing appropriate experts
• Provide contracts to trained speakers based on company guidelines
• Track speaker and attendee information and remunerations
With a central program like this in place, compliance officers and meeting planners will have a database to refer to if they
need to locate information related to any meeting activity.
Partnering and Communicating with the Experts
Pharma companies need to use all their resources to ensure their meetings stay compliant. An experienced meeting planning
company can be a tremendous resource for implementing a successful compliance program. They can design and implement the program
using systems to protect against non-compliance, as well as provide comprehensive data to stakeholders eyeing pharma's every
move.
In the past, companies often allowed sales reps to make decisions before meetings about venues, menu selections, open-bar
options, and even speaker selection. Clearly this move created serious risks of compliance problems. Policies need to be enforced
uniformly. The success of the initiative should be the result of a joint development effort between an experienced planning
company and pharma.
Educating and Training Employees and Suppliers
Compliance rules change, so pharma companies must develop educational materials and conduct seminars on company policies and
regulations. Vendors also need to be trained on company guidelines since they are an extension of the program, supplying goods
and services for meetings. In turn, a valuable supplier will help companies develop informational literature and provide training
assistance. Managing change in a systematic way is critical to ensure compliance occurs.
In today's pharma climate, companies with the most effective compliance programs and effective partnerships will come out
winners by demonstrating to customers, lawmakers, and the public that ethical conduct is a basic tenet of how they do business.
|