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August 6, 2020

A guide to medical affairs compliance

Compliance is crucial in the life science industry. Here’s how a virtual engagement strategy can help medical affairs teams adhere to important requirements.
medical affairs compliance

As government agencies have increased scrutiny of drug promotion, pharmaceutical companies have turned away from the traditional sales rep model and moved toward the medical affairs model. In fact, within the last decade, medical affairs has grown by more than 300% – making it one of the fastest-growing roles in the industry. 

This isn’t limited to pharmaceutical organizations, either, as medical device, diagnostics, and biotech companies have followed suit and established their own medical affairs and MSL teams. Within these life science organizations, medical affairs teams serve as a firewall between R&D and commercial divisions. 

What is medical affairs?  It is a department of a pharmaceutical or medical company that is in charge of communicating accurate information to healthcare providers or professionals. So, what are the medical affairs skills needed to work within a medical affairs team?  

Professionals within medical affairs have significant scientific and clinical experience and carry out various duties, including managing KOL relationships, disseminating educational content, and publishing clinical trial data, among others. People working in medical affairs understand the complex research behind life science products and play an important role in the scientific exchange between companies and healthcare providers or professionals. More recently, the medical affairs role has expanded to include health economics and outcomes research, and pharmacovigilance.

Because of the importance of providing credible medical information and the growing scrutiny on medical affairs, one of the most important responsibilities of medical affairs is facilitating effective and legally compliant interactions between life science organizations and HCPs. 

What is compliance in the context of medical affairs?

Medical affairs teams are charged with gathering expert insights through the KOL relationships they manage, and they must balance this need for information with regulatory compliance risk. Compliance risk can occur when there is a breach in the firewall mentioned above – and medical affairs must ensure that scientific exchange is separate from marketing activities.

As regulatory requirements become more strict and patients and HCPs demand more diverse clinical data and health outcomes information that demonstrates the efficacy of new products, it’s essential that life science companies balance the value to their clinical and commercial goals with the need for compliance to relevant codes and laws.

A variety of laws and regulations apply to medical affairs compliance, including OIG Compliance Program Guidance, PhRMA Code on Interactions with HCPs, and the Sunshine Act.

What are common compliance issues in medical affairs?

Medical affairs personnel do not have sales goals, and their education and training emphasize medical and scientific knowledge. But as laws, regulatory guidance, industry standards, and provider restrictions have limited interactions of sales reps with HCPs, life science companies increasingly look to medical affairs professionals to fill this role.

The problem is that customer-facing and proactive information-gathering efforts can seem to be commercial in nature. And as medical affairs teams work more and more closely with commercial teams, these relationships could be seen to compromise medical affairs’ role as a source of independent perspective and judgment.

As laws and regulations evolve, it can sometimes be difficult for companies to judge what activities may be viewed as noncompliant when governing bodies evaluate past conduct. But a lack of awareness about what may be considered problematic can result in significant fines – sometimes adding up to billions of dollars – and negative publicity. These issues can include:

  • Sponsoring articles on off-label uses without disclosing the company’s role
  • Failure to separate sales and medical affairs activities
  • Touting positive study results without disclosing negative results
  • Use of misleading or unbalanced educational materials

In light of ever-changing rules, medical affairs teams should collaborate closely with compliance departments. In some companies, people in compliance roles are even positioned within medical affairs to ensure the two functions are on the same page. Other steps that can reduce regulatory compliance risk include:

  • Establishing standard operating procedures to reduce the risk of unlawful interactions between medical affairs and commercial colleagues 
  • Ensure that employees are thoroughly trained
  • Set clear policies on how to respond and document off-label questions from HCPs
  • Leverage technology to make compliance as easy as possible

How can a virtual engagement strategy help medical affairs teams?

Advisory boards are an important part of the strategy for obtaining non-binding but informed guidance on a host of topics. And as companies continue to expand their medical affairs team footprint across the globe, they need more consistency and uniformity in the process for these activities. 

One way to bring about innovation in medical affairs organizations and achieve this consistency in their medical affairs KPIs is to use virtual engagement technology across the enterprise, regardless of what is being discussed or who is being engaged. This allows companies to standardize advisory board interactions in a central virtual platform, with reliable and repeatable processes and outputs, for a strategy that enables medical affairs teams to get better insights while remaining compliant. 

Using a single platform to conduct engagements like a virtual advisory board provides visibility into medical affairs activities, streamlines sharing and disseminating information to internal stakeholders, and establishes an audit trail should any issues come to light. It also makes it easier for employees to adhere to established standard operating procedures and policies. Medical affairs teams can set guardrails to reduce their risk when interacting with HCPs and patients while still having the means to collect the insights that inform strategic decisions.

To understand more about how virtual engagement reduces the risk for medical affairs teams, read an article about the value of ROI-positive digital interactions.

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