International Disclosure Laws: ABPI Issues EFPIA-Modeled Disclosure Template, Increases Itemized Reporting Fields

Starting in 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies will make public the details of payments and transfers of value made to healthcare professionals and healthcare organizations. EFPIA sets out the requirements for tracking and reporting this information in its Disclosure Code. EFPIA member associations are required to transpose the language from this Code into their national codes. EFPIA states that the Code only sets out the “minimum standards,” for compliance. Polaris Insights Blog recently reported that the Association of the British Pharmaceutical Industry has already added some additional requirements for its member companies.

Background

EFPIA states that all member associations will be required to transpose the EFPIA Code “into their national codes in full, except where its provisions are in conflict with applicable national laws or regulations, in which case deviations are allowed, but only to the extent necessary to comply with such national law or regulation.” We covered one such conflict in our article on international privacy laws, which require doctors to grant consent before companies may publish individualized transfer of value information.

To facilitate the reporting process, EFPIA released a “disclosure template” in 2013, which breaks down the categories for member companies to file their information under. Companies must 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 (though EFPIA also recommends providing the document in English).

EFPIA notes that their “Code sets out the minimum standards which EFPIA considers must apply to all member associations in all member states” (emphasis added). Britain’s pharmaceutical association seems to have already expanded upon these standards.

ABPI Template

Polaris Insights Blog reported earlier this month that the Association of the British Pharmaceutical Industry (ABPI) has issued a draft reporting template. The ABPI template is very similar to the original EFPIA template, Polaris notes, but requires “more detailed collection and reporting of HCP/O demographic information than the EFPIA version, and requires itemized reporting for each HCO payment.”

View the ABPI template here.

New Demographic Fields

Polaris notes that under the EFPIA template “disclosure of demographic (i.e., non-transactional) information on HCP/O recipients is limited and general.”

Under the EFPIA template, the demographic 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

Polaris states: “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

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. Polaris states, that 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.”

The ABPI template also 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.” (Polaris)

Other Notes

Finally, Polaris states, the ABPI template differs from the EFPIA template in a number of smaller ways:

• 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 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 a link to the companies “Methodological Note.” Polaris speculatees this may "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."

The ABPI template treats itemized vs. aggregate disclosure in generally 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. View our article on managing physician consent under various countries' privacy laws here. 

Thanks to Polaris for the information.