In April 2013, senior-level executives from bio/pharmaceutical and medical device companies across the globe gathered in Brussels to discuss the latest regulations and processes for transparency reporting of HCP spend. Compliance and business professionals shared experiences, strategies and knowledge on how the landscape has evolved and in turn, how the industry is reacting. As information spreads and the industry becomes more informed about the regulations, focus turns to process implementation and business leverage. While the compliance function has been the driver behind these conversations, teams are becoming increasingly cross-functional as entire organizations begin to see the necessity for and the value of transparent financial industry relationships. Here are some of the key takeaways from the 3rd Global Transparency Reporting Congress:
1. Demonstrate value of HCP/industry relationships
The assumption exists that relationships between pharmaceutical companies and healthcare providers are unhealthy. In the public eye, money transferred from the manufacturer to the physician could bias prescribing practices. Disclosing these payments could help the public to understand why and how this money is being spent. In fact, these relationships drive innovation and clinical research. This transparency could help to drive the message that these transactions are necessary and important to ensure that new treatments are discovered and more patients are treated. In organizing standards and reporting systems, manufacturers are making an effort to display the information in a way that will distinguish clinical and promotional spend in order to demonstrate how money is being spent in a meaningful way.
2. Leverage reported data for better business practice
Reporting of financial data leads not only to critical conversations about the transparency of industry/HCP relationships, but presents the opportunity for manufacturers to use the information constructively to better business processes and control spend. For example, Boehringer-Ingelheim has created a Corporate Clearing House, a global system to collect and aggregate all necessary data for the company. This strategy enables the business to look closely at where money is allocated for payments to HCPs and rethink certain practices to strengthen the business.
3. Create a strong internal structure
Internal organization of projects is critical. All stakeholders must be involved in the process so the burden does not rest solely on Finance and IT and the data can be used for the company in a beneficial way. It is helpful to determine an “owner” for the process, to drive the message to the business for full involvement, buy-in and integration in disclosure efforts. Biogen Idec and Takeda discussed strategies for this structuring in each of their organizations, stressing the important of assigning accountability and working cross-functionally to ensure the success of these projects.
4. Institute collaborative responsibility between stakeholders
Ultimately, it is the patients who benefit from collaboration. While the onus has been placed on industry to generate this transparency and disclose payment information, these efforts will not have the desired outcome of driving more innovative research and patient access without the strength of these partnerships. Key stakeholders must work together to find solutions and share accountability. ABPI together with the Royal College of Physicians has put out a survey and created a set of initiatives to understand the public perception of industry/HCP relationships and determine how the groups can work together to share responsibility and ensure full transparency.
5. Understand the boundaries of privacy law
With the disclosure of financial information, privacy law is an important concern. Manufacturers must collect consent from physicians in many cases and physicians may at times be uncomfortable with these disclosures. It is critical to understand how these laws may vary in different regions around the world and make sure that these laws are upheld. A key piece of these considerations is that if information is important and necessary for public interest, physician consent to disclose cannot be withdrawn.
6. Examine potential risks and discrepancies in the disclosed data
Looking towards the U.S., the federal government says that potential conflicts of interest of suspicious activity that arises within the data can be used in an investigation against the manufacturer. Porzio, PwC and Dendreon cautioned participants to understand what information is released with the published data to eliminate risk of bolstering an investigation. Examining the data in an organized way can not only improve business process but will drive more compliant practices.
7. Prepare to comply with EU standards
Europe-wide EFPIA reporting standards will require reporting in 2016 of aggregate clinical and R&D data collected in 2015. Discussion of EFPIA standards brings key conversations forward – what should come first, national or EU-wide dialogues? Where should transparency directives originate? What collaboration is needed to spur these initiatives? Members of the EFPIA Compliance Committee shed light on how these conversations have taken place internally, highlighting the need for increased dialogue within industry. EFPIA keeps a finger on the pulse of industry practices and evolving regulations to ensure that the new set of standards will align as closely as possible with efforts already in motion.
8. Implement a system for master data management
When it comes to implementing a system to track, collect and report data, master data management is one of the biggest challenges. Boehringer-Ingelheim, for example, uses a cross-functional approach to give marketing, finance, R&D, medical, information services, legal and compliance each a seat at the table. Legal and compliance owns this process but the cross-functional team collaborates to find solutions with the ultimate goal of creating one global tool that will collect global master data. Other companies may be using similar tactics or exploring new avenues, but all are asking similar questions – how many people are needed in a department for these efforts? What is the turnaround time for this kind of project? Who authorizes HCP engagements? How does the personnel reporting structure work for internal organization? What is the cost? Who is building these systems? How is management and country buy-in obtained? Each organization must ask these questions to build an effective system.
9. Assess the needs of the business prior to data collection
For any system, financial data tracking and reporting is an evolutionary process. As many companies lament, bigger budgets and more manpower would of course make these initiatives easier. However, with cost pressures in place, collaboration both internally and externally to organize data and analysis is crucial to ease these challenges. Gathering requirements for business data up front, before setting up a system, can be the key to a successful, funded project. By having internal conversations early, teams can make sure that the system in place will meet both compliance and business needs.
10. Facilitate change management through effective messaging
Developing key messages and orchestrating change management is an important part of transparency reporting. Companies must determine how information will be communicated both to internal partners and external sources, ensuring consistency from all stakeholders. Messaging should be fair, balanced and accurate. In order to facilitate effective change management, the who, what, when, where, why and how must be identified to create a tool kit for the company to move forward. Roche has developed a number of templates to guide this process and ensure consistency across the organization.
While participants at this meeting were able to have a focused conversation around these issues, financial transparency is a critical topic that should continue to drive discussion across the industry. Ensuring compliance with global regulations, implementing and adapting systems for meaningful business use and promoting appropriate messages around industry/HCP relationships can ultimately increase innovation and patient access. Join us for the 4th Global Transparency Reporting Congress in April 2014! In the meantime, continue the conversation and see how other companies are creating systems at the 7th Annual Forum on Sunshine and Aggregate Spend!