Commercial interactions in the Life Sciences industry have been subjected to increasing levels of scrutiny in recent times as the regulatory landscape continues to evolve.
One of the cornerstones for commercial compliance in the industry is transparency reporting – the public disclosure of financial support given to patient organisations and transfers of value (ToV) to healthcare professionals (HCP) and healthcare organisations (HCO) through commercial interactions.
Transparency reporting helps Life Sciences organisations build reputation and trust with their key stakeholders, including HCPs, HCOs, patients, regulatory bodies, and investors. It has now become a global mandate as regulatory bodies, legal authorities and member associations across continents have adopted it as standard. We’ve worked with a number of these organisations when supporting clients with reporting solutions, including: EFPIA, ABPI UK, US Sunshine Act, Transparence France, BeTransparent Belgium, Farmaindustria Spain & Italy, CGR Netherlands, and FSA Germany.
An essential but complex process
Accuracy of reports and adherence to reporting timelines is paramount, but the complexity of the process can present challenges. As well as direct payments made to HCPs, HCOs, and patient organisations through in-country or cross-border mechanisms, companies must also account for indirect payments which go through third parties like CROs and Meeting Agencies.
The other consideration is inclusion of incidental expenses without HCP contracts (e.g. meals, travel, and accommodation etc.) which are usually governed by organisational policies and dependent on the local regulation in terms of public disclosure. The disclosure requirements are country- and region-specific and periodically undergo changes based on regulatory authority updates.
Interactions with healthcare professionals and healthcare organisations remain one of the most critical processes in commercial compliance. These interactions generate all the data points required for several compliance reporting activities, from initial calls and meetings, to contracting, and eventually through to payments.
Beneficiary information (i.e., HCP, HCO, patient organisation details), nature of payment, and payment details must be captured correctly at the source, then standardised and compiled into an accurate report. For many Life Sciences organisations, a lack of standardisation measures means they run a high risk of error in reporting transfer of value (ToV) within disclosure reports. And errors in reporting not only risk damaging the business’ reputation but may also come with legal repercussions.
Reducing risk with standardisation
A joined-up HCP/HCO engagement process with seamless recording of ToV in each applicable step improves efficiency in transparency reporting. Standardisation of processes can help in key areas such as:
- customer onboarding
- procure-to-pay
- customer interactions (events, meetings) leading to ToV
- monetary transactions towards beneficiaries through third-party vendors
Creating a clear, set process for each of these areas can help in defining control points and business rules for every interaction – thereby ensuring capture of near-complete data at source with better quality. This approach not only offers standardisation across markets but also addresses the need for local regulation and processes. Life Sciences organisations can then integrate their existing enterprise systems in a more meaningful way that enables joined-up data collection and reporting.
Laying a foundation for efficiency and innovation
When reporting processes are standardised, it becomes much easier to incorporate automation into the workflow, leading to greater operational efficiency. And when manual data collation and reporting tasks are automated—and augmented by AI—compliance personnel can spend their time engaging in more strategic work.
Additionally, by stitching together better-quality data from several business functions, such as finance, procurement, commercial, and compliance, and implementing compliance analytics, Life Sciences organisations can benefit from business-wide insights. This enables improved risk monitoring, better identification of potential risk areas and faster deployment of resources to mitigate emerging risks.
Designing the right solution
Before jumping into the development of a standardised transparency reporting solution, it’s important for Life Sciences organisations to review their current ways of working, processes and incumbent systems. This helps in conceptualising a tailored transparency solution for the business aimed at improving reporting accuracy and efficiency.
Cognizant’s consulting team have frequently partnered with Life Sciences organisations in the early phases of their implementation programs to assess the current landscape and recommend the best-fit transparency solution. In many cases, this involves product assessment exercises, evaluating off-the-shelf transparency reporting platforms in line with the organisations’ technological landscape and process maturity.
But not all transparency reporting solutions need to be off-the-shelf; they can often be developed in-house with low total cost of ownership. For one client, the consulting team created a transparency reporting capability from the ground up, integrating with incumbent systems and leveraging the existing reporting platform. This included defining control points and tuning business processes, as well as blueprinting and building the end-to-end solution.
Taking a process-first approach to transparency reporting
Transparency reporting has evolved into a critical compliance capability within Life Sciences organisations. But this capability must be built through collaborative efforts, ensuring stakeholders are aligned from the onset and that all supporting business functions have the visibility and flexibility they need—across people, processes and systems.
Designing the transparency reporting capability with a process-first approach ensures the final solution is tailored to the organisation’s size, ways of working and unique business requirements. It also means that standardisation is embedded in the end-to-end process—ensuring accuracy, efficiency and compliance.
