Draft of New EFPIA Disclosure Template for UK Spend

By Greg Hawley

ABPI’s New Draft of its EFPIA Disclosure Code Reporting Template Suggests New Upcoming Requirements for Disclosure in the UK

abpi_logoPolaris has obtained a copy of a new draft reporting template that ABPI has recently issued to at least some of its member companies for consultation. The template is based on, and very similar to, the Standardized Model Template that EFPIA published in 2013 (the “EFPIA template”), when it released the Disclosure Code. This British version (the “ABPI Template”), however, requires more detailed collection and reporting of HCP/O demographic information, and requires itemized reporting for each HCO payment.

As mentioned, EFPIA released its Disclosure Template in 2013. Under the standard EFPIA rules, companies would complete one of these templates for each European country in which they had any spend, needing only to translate the field names for each country’s language. Click here for a more in-depth review of the EFPIA Disclosure Code.

As part of the transcription of the EFPIA Code, however, member associations like ABPI have the right to increase the minimum standard requirements for any payments made to HCP/Os in their respective countries. This new draft template indicates where ABPI will add to the base rules, and how companies can prepare their collection accordingly.

New Demographic Fields

Under the EFPIA template, disclosure of demographic (i.e., non-transactional) information on HCP/O recipients is limited and general. The fields are:

  • Full Name
  • City of Principal Practice (HCP) / City where registered (HCO)
  • Country of Principal Practice
  • Unique Country Identifier (Optional)
    • E.g. RPPS (France), BIG (Netherlands)

Under the draft ABPI template, the list of demographic fields would be expanded to:

  • Title (HCP only)
  • First Name (HCP only)
  • Initial (HCP only)
  • Last Name (HCP only)
  • Specialty (HCP only)
  • Role (HCP only)
  • City of Principal Practice (HCP) / City where registered (HCO)
  • Country of Principal Practice
  • Institution Name
  • Location
  • Address Line 1
  • Address Line 2
  • Post Code
  • Email
  • Local Register ID or Third Party Database ID

It isn’t explicitly clear which of these new fields will be mandatory, though it appears all but the last one will be. Regardless, companies should pay particular note to Title, Specialty, Role, and Email, which for many will require additional data collection. Title, Specialty and Email are relatively self-explanatory, but it isn’t quite clear whether “Role” refers to what Americans call “credential”, or refers to role within an organization or engagement.

Increased Itemization for HCO Payments

The second key development is that each HCO payment will be listed individually. Under the basic EFPIA rules/template, each HCP and HCO recipient is listed in a single line item, and payments to that recipient are aggregated by category. For example, if Dr. Smith received three consulting payments for €1000 each, and 2 transfers of value of €100 each in the form registration fees, all from the same company, the company would list all payments to Dr. Smith under the same line-item, listing total fee payments (€3000) and total registration fee payments (€200) under the relevant columns. Under the EFPIA rules, the same applies the HCO payments.

Under the ABPI template, HCP payments are listed in this same manner. Each HCO payment, however, is itemized and listed in its own row. So if Pharma A made 3 different grant payments to St Thomas’ Hospital, each for £1000, the template should be filled with 3 rows, each including the demographic information of St Thomas’s Hospital, with £1000 listed under the Donations and Grants to HCOs column. This doesn’t apply to R&D payments, which are still reported completely in the aggregate. This compares to the level of itemization found in the US CMS Open Payments (Sunshine) reporting.

Finally, the ABPI template asks whether or not each HCO payment is associated with a Joint Working Agreement. If companies answer yes, they must insert a link to the Joint Working Agreement. The ABPI Code of Practice defines a Joint Working as a situation “where, for the benefit of patients, one or more pharmaceutical companies and the [British National Health Service] pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery.”

Miscellaneous Notes

Finally, the ABPI template differs from the EFPIA template in a number of smaller ways that may or may not have an impact of collection and disclosure:

  • Where the EFPIA template asks for “Donations and Grants to HCOs”, the ABPI template adds the words “and Benefits in Kind to HCOs”.
  • Regarding fees for service or consultancy, the EFPIA template asks for “related expenses agreed in the fee for service or consultancy contract, including travel & accommodation relevant to the contract”. The ABPI template omits the italicized language, above, in its version.
  • The ABPI includes 3 new columns on the right-hand side of the template, though they are currently all marked “Blank Column.” It’s unclear what their purpose will be.
  • The ABPI template asks for certain company information at the top right of the template:
    • Company Name
    • Disclosure for the Year X
    • Date of Submission to Central Platform (click here for more information)
    • A link to the companies Methodological NoteThe ABPI template makes numerous references to “Clause X” as a source reference, presumably as a placeholder for new ABPI materials that have not been released yet. A much better understanding can be expected when that comes out.
      • This would be akin to the assumptions documents that companies have written in relation to US Sunshine reporting. Methodological Notes, are mentioned in the EFPIA Code, but not made mandatory. The ABPI template seems to make them mandatory, though that needs to be confirmed.

Finally, and notably, the ABPI template treats itemized vs. aggregate disclosure in the same way as the EFPIA template (with the exception of the difference regarding HCO payments, discussed above). This suggests that ABPI will not be providing any more guidance on how to navigate British data privacy rules with dealing with EFPIA disclosure, but further guidance may be forthcoming.