The Global Compliance Congress for Life Sciences, which took place in London on November 15th and 16th, offered a fascinating glimpse into the ongoing impact of the increasingly global and interconnected nature of our industry on Compliance.
In this context, the evolving role of the compliance function and its progressively more symbiotic relationship with other stakeholders, such as Medical Affairs, Sales & Marketing, R&D, Procurement & Operations etc. permeated many of the conference sessions.
The emergence of Compliance as a true partner to the commercial organization was frequently identified as a key global trend for the past couple of years. Moreover, there was general consensus among attendees that compliance teams need to continue to adapt and become more focused on practical fostering partnerships with commercial stakeholders. The emergence of transparency reporting and data that could be used to empower the ethical decision-making of the business at the local level is now seen as only the initial catalyst for such a partnership. Increasingly, compliance functions are going beyond transparency and working closely with the business to embed compliance controls and tools related to, for example, HCP engagement and vendor due diligence as an integral part of business operations on the local level. As this trend continues, the role of Compliance will continue to shift away from one focused on directly enforcing compliance regulations to one where Compliance will provide oversight of processes directly embedded in the business.
The changing role of Medical Affairs, and by extension of Compliance’s relationship with that function, was also identified as an important trend by numerous speakers and attendees. At the same time, while there was consensus that the role of Medical Affairs is changing and expanding at many global companies, some speakers also noted that the boundaries between Medical Affairs and other parts of the organization are becoming increasingly more nebulous. For example, about 50% of attendees indicated that Medical Affairs is involved in promotional activities like speaker programs at their companies. In this context, local compliance organizations should work closely with Medical Affairs to define clearly compliant Key Performance Indicators (KPIs) for that function. A session focused on this topic generated lively debate around KPIs such as addressing scientific knowledge gaps, scientific coaching of speakers, effecting HCP tiering etc.
The increased interaction of Compliance with other internal stakeholders such as procurement and the supply chain organization was also noted as an evolving trend. This is particularly true in the context of mitigating risk related to interactions with third party vendors. Polaris’ Managing Partner for Europe and APAC Geert van Gansewinkel led a discussion on this topic, and more specifically on the need for establishing an effective risk management and due diligence process for such interactions. When effectively implemented, due diligence at the local level should not be seen as an impediment to the execution of procurement and operational processes. On the contrary, much like in the case of interactions with commercial stakeholders, effective vendor due diligence can allow Compliance to step in the role of providing general oversight over processes that are simply good business practices.
As the Life Sciences industry continues to pursue scientific and commercial success in an increasingly more complex global regulatory environment, compliance organizations will find themselves interacting in different ways with other internal stakeholders. The discussions at the Global Compliance Congress for Life Sciences reinforced the need for those organizations to be more effective business partners that are constantly seeking to provide innovative and easy to implement solutions and processes that help to make compliance good business practice. For more information about how Polaris works with clients to help them achieve this practical objective, please visit our website or contact us.