The 2017 “Global Transparency & Reporting Congress” in London highlighted the opportunities and challenges for Life Sciences companies as they navigate the dynamic global transparency reporting environment. Regarding challenges, keeping track of changes in regulation, respecting HCPs privacy and the overall goal of transparency reporting were among those discussed. On the other hand, speakers also discussed the opportunities arising from transparency reporting – from opportunities to streamline the transparency process to enhancements in anti-corruption and compliance programs.
The conference opened with discussions regarding the varied global transparency requirements and their rapid evolution. Attendees and speakers shared their experiences and strategies to proactively keep abreast of and track the dynamic global reporting regimes. These discussions highlighted a trend we have been observing for months, namely the delegation of transparency regulatory monitoring to external consultants. Companies that have outsourced their regulatory monitoring explained that they find it quite advantageous to have a single location and format for various regulations that span the globe. This also has been a focus area for Polaris over the past 18 months as we have transferred our internal research and reporting into a client-facing resource, the Regulatory Monitoring Portal.
Privacy and HCP consent led to lively discussions dividing the attendees between those who perceive HCP consent as a responsibility of the HCPs on the one hand, and those who believe consent to be an obligation of manufacturers. The latter group views transparency as a shared responsibility between pharmaceutical/medical device companies, while the former perceives this the responsibility of HCPs to provide consent. However, there was a consensus that higher rates of consent are needed to improve overall transparency in the Life Sciences industry, particularly where there are relatively high transfers of value from companies to HCPs.
Véronique Monjardet, Polaris France Country Manager and Head of European Business Development, led an interesting panel discussion that compared the U.S. and EFPIA transparency initiatives. Panelists provided an overview of the chief differences between the two initiatives including consent, product related spends, R&D disclosure, among others. Additionally, the panel analyzed the outcomes of the U.S. and EFPIA requirements, by considering which had more effectively achieved its stated objective of better transparency and consumer/patient protections. The discussion concluded that, both regimes do provide limited insights into the transfers of values between manufacturers and HCP/Os. The discussion also highlighted the fact that the public still has little understanding of these transfers of value, and concluded with a call to action to create educational materials geared towards public education.
In contrast, the conference also highlighted the opportunities and positive externalities that global transparency reporting requirements have created. Two break-out sessions were dedicated to the potential use of transparency data. One session focused on how this data can be used to strengthen anti-corruption monitoring and oversight. This first session, “The impact of Transparency on Anti-Corruption Efforts” provided a thorough overview of the similarities among anti-corruption laws and regulations, concluding that transparency reporting obligations are a tool to prevent and mitigate corruption risks. Conversely, transparency disclosure is also a helpful tool for enforcement authorities and the public to expose and investigate potential improper transfers of value by reviewing amounts transferred on an individual basis, payments to HCP/Os, tax filings of the HCPs and Life Sciences companies, etc. The second break-out session focused on how transparency data can be leveraged internally for risk assessments and auditing and monitoring purposes. There was a widespread agreement on the enterprise-wide benefits of transparency data, as it helps (1) the business to better understand its spends, (2) compliance to know their risks and (3) audit to develop audit plans and corrective actions.
Geert van Gansewinkel, Polaris’ Managing Partner EMEA and Asia Pacific, also discussed the rise of transparency data during his comprehensive presentation about the future of transparency as an integrated business function. Historically companies concentrated on getting the data out of transaction management processes and systems such as Concur or accounts payable, and into an aggregate spend solution. Geert described Polaris’ vision of the transparency process of tomorrow by highlighting that companies should start to focus on business and process related topics, and demonstrating the potential longer term benefits resulting from transparency. Companies that are conversant in their own transparency data can make better decisions regarding their interactions with HCPs, reduce inherent risks and reduce internal spending by being planning and budgeting at a more granular level.
More generally, speakers and attendees alike agreed that as transparency reporting regimes continue to evolve globally we will continue to face significant challenges related to transparency compliance – from capturing new regulations and respecting HCPs’ privacy to creating a more transparent and informative milieu that enables broader public understanding. Despite these challenges, we as compliance professionals must also transition from thinking of transparency requirements as a burden to viewing them as an opportunity. The more we leverage the data to partner with our business colleagues, the better our interactions with the healthcare community and the lower our companies’ risk profile become.