Upon the start of the new year, many of our colleagues will be turning their attention to the preparation of the annual disclosure submissions across the pharmaceutical industry. It is often a considerable challenge to prepare these submissions, but it doesn't need to be that way. In working with some of the best performing companies when it comes to disclosure, we have discovered a set of critical activities that they all perform and have detailed these key ingredients below for you to adopt. Enabling you to achieve a more confident and enjoyable disclosure submission.
What are the top 5 critical activities that you can put in place for a successful disclosure submission in 2022?
Pre-Disclosure is the single most important activity that any company can do to best prepare for a successful submission / publication. When executed well (individual companies providing HCPs with a convenient way to review a detailed breakdown of their ToV and principle place of practice information), pre-disclosure represents significant benefits whilst ironing out many of the issues that companies face in the preparation of the annual disclosure report. Including: significantly reducing the number of queries post publication/submission; prevention of breaches of the code and incorrect data being disclosed against the wrong induvial; ensures data such as the HCPs principle place of practise is correct; enhances the relationships with HCPs; and re-emphasises the basis for disclosure. Click here to read our article on what is pre-disclosure and what are the benefits
Business reviews of the data - The best performing companies conduct early reviews of the data directly with business teams that are responsible and have an intimate understanding of the activities / engagements. This is particularly important when validating the assignation of indirect transfers of values such as registration fees, travel expenses, medical education goods and services (MEGS); other joint working initiatives to HCPs and HCOs and ToVs from other affiliates. Much of this data is often prepared by either 3rd parties or maintained on huge spreadsheets, the business reviews act as a form of critical assessment to validate that the data represents, the benefit, consumption or usage for the individual / organisation. This is where we have seen considerable errors identified - such as invited individuals that haven't attended events but have a ToV assigned to them or where a simple division of the cost is being allocated across all delegates despite some individuals benefiting at considerably different rates etc.
Comparisons - An early review and analysis of the headline data, comparing categories of spend vs. previous years provides considerable comfort and helps to detect any inconsistencies in approach and where there may be missing data. Comparisons include: total value per category; number of individuals / organisations in each category; year on year comparison of spend per individual / organisation; assessment of the detail making up aggregated spend vs. previous years. The aim is not to create a similar number but to understand, to spot major deviations and with curiosity seek to understand what is causing such differences.
Deep and broad assessment of all commercial relationships - Coupled with the business reviews, best performing companies also take a very broad assessment of all commercial relationship to determine whether expenditure should be disclosed. The term of an HCO is open to varied interpretation (download our best practice guide to see what constitutes an HCO and the tests that you can apply to practically assess this) and many companies fail to review broader commercial engagements to determine if these meet the tests of being classified as an HCO. Whilst the generation of a company's disclosure data is often sourced from accounting ledgers, it's accuracy is often impacted upon the (in)consistency of coding and narrow focus of how the ledgers are queried. The very best companies include the tests outlined within our guide to determine if the vendor should be classified as an HCO during their vendor onboarding so that they are prospectively manging their disclosures.
Well planned and consistent approaches - Its always surprising to see how many company's fail to have clear project plans of how they will approach the annual disclosure process from the preparation of data, validation phase to submission. The very best companies have a project plan, with timelines and clear outcomes for every stage with clear accountabilities and robust documentation. Inconsistency in approach is often in our experience the key cause of errors and re-work.
Other resources available to you
Best Practice Guide To Disclosure - Get first-hand insights and guidance on best practices to disclosure across the pharma industry. PLUS, helpful tips on how you can improve your disclosure reporting for 2022
To find out more about how PAYCE can help you with your pre-disclosure practices, visit www.payceportal.com/pre-disclosure