What’s Next: Maturing the Compliance Process

11.16.15 | By Geert van Gansewinkel

On Tuesday, November 10, Polaris hosted another Round Table in the series “What’s Next” in its office in Paris – this time with the topic: “What’s Next: Maturing the Compliance Process.”

The round table session was well attended by Senior Executives from pharmaceutical, bio-tech and medical device companies from across Europe. The objective of the event – enabling discussions and knowledge exchange between industry professional on current and future topics in the area of Life Sciences compliance – was well met.

An extract of the key topics and insights from the event is included here. Are you interested in joining our “What’s Next?” series? Please reach out to Polaris. Our next event is currently being planned.

In this session, the discussion focused on five key topics:

  • What to expect in 2016: learnings from countries with transparency experience
  • Harmonizing and maturing the compliance process across Europe: learnings from the industry
  • Managing external risk: Third party due diligence, risk management and fair market value
  • Data analytics, opportunities and challenges
  • Discussion: “What to expect going forward?”

During the first session, Alexandre Regniault, Partner at Law Firm Simmons and Simmons, shared his views on the latest in transparency, drawing from his expertise with transparency laws and regulations in France and other European countries. Regarding France, one of the biggest questions is around “what will happen with payments, and what will be the temporal scope?” More broadly speaking, with this many versions of the EFPIA report alone, and then additionally individual country rules and regulations, a question that is being asked is how to stay on top? For all people present, implementing their process and system to meet current and upcoming requirements has the highest priority, and within that a lot of attention for the topic of data privacy and consent.

The next discussion focused on maturing of the compliance process. During this session, Geert van Gansewinkel, Partner and Managing Director Europe of Polaris, made the case that even though for a lot of companies the current focus is – understandably so – on aggregating spend and preparing for reporting, best practice is to use transparency as a means to bring compliance as a whole to the next level. When companies focus on harmonizing and automating their spend capture process, building in checks and balances and structured ways to manage underlying elements such as business planning, fair market value, (electronic) contracting and activity validation, they will be able to improve their decision making, realize efficiencies, free up capacity for more strategic activities and generate insights leveraging data analytics. Many companies are starting to see this, and are moving in this direction.

In their session on managing external risk, Andy Bender (CEO and President of Polaris) and Darren Jones (Partner of Polaris), zoomed in on two aspects of managing third parties: due diligence and fair market value. Andy Bender explained that while companies are increasingly relying on third parties, control over these activities is not yet fully established. Independent research has shown that only 29% of compliance programs include right-to-audit clauses, and of these only 41% actually exercised this right. To manage the external risk, it is important to have a transparent, simple yet structured methodology that allows to quickly identify third parties with the highest risk profile and define adequate follow up actions. Darren Jones explained that with global transparency and anti-bribery enforcement, it will become more and more important to have an established fair market value methodology also for Third Parties. While many challenges exist in defining FMV (for example, how to compare rates for specialized activities), there definitely are ways to address these, for example leveraging benchmark data on historic activities.

In her session on data analytics, Veronique Monjardet, Country Manager France of Polaris, presented some of the opportunities that spend data are generating. Based on publicly available US transparency data (CMS), she presented what type of insights can be generated. Even though the situation in the US is not fully comparable to what we will see in Europe (for example, data is not always that easily searchable and obtainable), it is clear that transparency data provides a source of information that companies should consider. For the first time, many companies will have a full overview of what is being spent on what type of activity in what region with what frequency. Analyzing this data and generate insights (internally, but potentially also externally) will generate an opportunity for companies to start improving their strategic decision making, and it is therefore highly recommended to actively start building a capability in this area.

During the closing session, the group discussed around expected key topics for 2016. The following key areas were addressed:

  • Anti kick-back: contractual relationships with third parties, analyzing trends and total payments
  • Marketing practices: speaker programs, conference attendance, patient programs
  • Pricing and health care economics: collecting and reporting on payments
  • Individual accountability: facilitating compliance as a shared responsibility
  • Use of healthcare data to identify trends and outliers: data analytics
  • Growing attention in R&D: IIS and IIT processes, third party risks

As with the previous Round Table sessions, there was lively and active discussion among the participants. Discussions made clear that there is a lot going on in this area, now and in the future.

If you are interested in becoming part of our “What’s Next?” e-mailing group, or would like to exchange information on any of the mentioned topics, please do not hesitate to contact Polaris.