On 30th January, Polaris, IQVIA and Simmons & Simmons co-hosted a European Healthcare Compliance Summit in Paris. More than 70 Life Sciences professionals, industry thought leaders and legal experts attended the daylong event to discuss challenges, best practices and future trends in healthcare compliance.
Key topics discussed included the challenges of third party due diligence, how to engage with healthcare communities, banning direct sponsorships, patient support programs, Brexit and MedTech regulations for 2019. These issues were addressed in a mix of presentations, panel discussions, roundtables and three hands-on workshops.
Alexandre Regniault, Partner at Simmons & Simmons, and Diva Duong, Global Compliance Solutions Partner at IQVIA, welcomed attendees and gave an overview of the day, before diving into an agenda packed with important topics.
Dario Ghoddousi, Compliance Product Lead at IQVIA, moderated an engaging roundtable discussion that examined the impact that corporate culture plays on the effectiveness of a compliance program. Several senior industry professionals shared their insights on the topic.
The biggest concern at the Summit was GDPR. Sarah Bailey of Simmons & Simmons discussed the impact of GDPR on the healthcare industry and outlined the aims of the regulation. They are to:
- Give control of a person’s data back to the individual
- Harmonize regulations relating to data processing
- Simplify the regulatory environment
Bailey also discussed the shift of responsibility that now puts the onus for compliance on the data controller/processer, and the sanctions that may run as high as €20 million or 4% of the annual turnover. She reviewed the territoriality, transitional provisions and consent and data subjects’ rights.
Polaris Senior Principal, Mark Scallon, led the group in a discussion that examined best practices for engaging with healthcare communities. He outlined the various types of communities and the risks associated with each group, as well as key engagement components that mitigate those hazards. One particular area of concern was the risk related to the growing use of social media for engaging directly with HCPs and patients.
After lunch, the group broke out into three workshops with the following topics:
- Ban on direct sponsorship: A legal and practical challenge for MedTech… and Pharma?
- Brexit and other challenges in implementing EU legislation by 2019
- FCPA, UK Bribery Act, Sapin II: Implementing international anti-corruption legislation
Each session generated lively debate and provided actionable insights on how participants could optimize their compliance practices in light of the specific challenges. For instance, the workshop on international anti-corruption addressed several important challenges:
- How are companies addressing international ABAC legislation?
- What compliance activities are companies taking part in to mitigate ABAC risk of employee conduct as well as third parties?
- How do companies navigate the differences between company requirements (e.g. books and records, facilitation payments, etc.)
- What are the biggest obstacles in achieving an effective ABAC compliance program?
- What types of strategies has your company implemented in order to get past these obstacles?
- Will the GDPR requirements affect how you conduct ABAC due diligence on individuals? If so, how?
Key takeaways from the other sessions included the awareness that Brexit will impact all businesses and patients. Additionally, attendees were also extremely concerned about the costs associated with complying with all the various new codes and regulations that will be implemented in the coming months.
It was clear that firms need to adopt a holistic approach to compliance, and that a robust compliance program is defined according to each single item (GDPR, third party, EU transparency, FCPA, etc.) orchestrated together to balance the risk and increase the level of compliance overall.
As the Life Sciences industry continues to face an increasingly more complex global regulatory environment, compliance organizations will find themselves facing a host of new challenges on a regular basis.
By coming together at events such as this, compliance professionals can learn about best practices, take deeper dives into creating and implementing processes and procedures that help streamline and automate many tasks, and leave with actionable plans that help decrease costs, minimize risk and increase efficiencies across their organizations.
If you’d like to be kept informed about upcoming industry roundtables and summits that Polaris and IQVIA are hosting, click here.