More than 60 percent of respondents of a survey coming out of CBI’s 16th Annual Pharmaceutical Compliance Congress (PCC), the world's largest event for compliance and legal professionals in the bio/pharma industry, say they are satisfied with their current need for compliance solutions but are open to hearing about other options. Nearly 20 percent of those who responded to the PCC 2019 Benchmarking survey are actively looking for solutions.
In fact, the survey provides insight about what is keeping compliance professionals in the life sciences awake at night. Patient interactions and support services are top of mind with respondents. Using a scale from 1 (high priority) to 5 (low priority), more than 39 percent of respondents cited patient interactions and support as a “1.”
Topping the List of Priorities
Promotional activities, followed by speaker programs and HCP engagements, were listed as a high priority by more than 23 percent and 21 percent of respondents respectively. Third-party oversight, FCPA and ABAC, clinical and R&D activities, and drug pricing and rebates also received some votes for being a high priority but not to the extent of the top three.
In addition, the survey reveals more than 70 percent of participants face compliance responsibilities in the Americas. More than 20 percent reported having compliance responsibilities in the Americas, EMEA, and Asia-Pacific. Less than 10 percent have responsibilities elsewhere.
Proposal to Lower Cost of Prescription Drugs
In an effort to bring down the cost of pharmaceutical drugs, the Department of Health and Human Services (HHS) is proposing modifications to the safe harbor discounts under the federal Anti-Kickback Statute (AKS). Specifically, the plan is to eliminate protection for drug discounts paid by manufacturers to plan sponsors under Medicare Part D or Medicaid managed care organizations or pharmacy benefit managers (PBM). The purpose is to provide incentive to offer more affordable generic drugs, thus lowering prices for Part D beneficiaries, according to K&L Gates global law firm.
About 40 percent of respondents to the PCC survey reported being concerned about HHS’ proposal, whereas nearly 50 percent said they were unsure. A little more than 10 percent responded they were not concerned.
Nurse Educator Programs
One interesting fact to emerge is that the majority of respondents, more than 30 percent, said the commercial department of their organization was responsible for overseeing their nurse educator program. Medical affairs departments lead the charge at more than 20 percent of the firms represented by respondents, followed by other (nearly 20 percent) and patient access (more than 10 percent). Only 10 percent of compliance departments lead nurse educator programs.
Artificial Intelligence and the Future of Compliance
Nearly 30 percent of respondents say their organization is looking to leverage artificial intelligence (AI) to fulfill their compliance strategy in the next 2 to 3 years. A little less than 20 percent say they will not be concerning themselves with AI. The majority, with more than 50 percent of the vote, however, are unsure. This is indicative of the fact that most people simply don’t know how far the technology will come or how affordable it will be in the next few years.
What is evident from the survey results is compliance officers have a lot on their plate. The Americas, undoubtedly driven by U.S. laws, seem to be a regional focus for transparency reporting. Patients, promotional activities, and HCP engagements remain top priorities. And some changes to policy regarding the price of medication might influence plans for the future. Most importantly, there is a robust market for handy, convenient, efficient, and automated compliance solutions that can move with the changing times.