Disclosure - Methodological Note for Annual Disclosure of Transfers of Value to Health Professionals, Other Relevant Decision Makers and Healthcare Organisations.
Introduction
The pharmaceutical industry’s relationships with health professionals (HCPs), other relevant decision makers (ORDMs) and healthcare organisations (HCOs) are a key area of public interest. Members of the public want to be confident that such relationships are appropriate and that they can trust their health professional to provide high quality care based on clinical evidence and experience. There are detailed requirements in the ABPI Code of Practice for the Pharmaceutical Industry setting out the basis of these relationships which include disclosure obligations. Since 2012, certain transfers of value have been required to be collected and disclosed. Current ABPI Code requirements mean that data identifying HCPs, ORDMs and HCOs, who have received certain transfers of value, are now published on a publicly available central platform, Disclosure UK. The platform was launched in June 2016 when 2015 data was published and lists data for three calendar years.
By creating greater transparency around the pharmaceutical industry’s collaborations and partnerships with HCPs, ORDMs and HCOs, the ABPI Code requirements for disclosure of certain transfers of value aim to improve understanding and increase the public’s confidence in these relationships.
The ABPI Code disclosure requirements are predominantly set out in Clauses 28 to 31.
Methodological Note for Annual Disclosure of Transfers of Value to Health Professionals, Other Relevant Decision Makers and Healthcare Organisations.
As part of the requirements of the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations, which has been transposed in the ABPI Code, each company is required, at the same time as it discloses the data, to publish a methodological note. This document is also submitted to and published via Disclosure UK and gives important additional information about, and context to, the disclosed data. Clause 28.6 of the ABPI Code states:
‘Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.’
Companies are likely to take different approaches in developing their methodological note; some might develop a document to cover the whole of Europe whilst others might decide on a separate methodological note for each country. The length and content of a methodological note will differ from company to company; much will depend on the size of the company and the range and complexity of its relationships with HCPs, ORDMs and HCOs. It is important that it is written in such a way as to help a member of the public easily understand the data disclosed.
The form of the methodological note is for each company to determine. However, the following points may be helpful when preparing methodological notes alongside the requirements of the ABPI Code.
Form of disclosure
- Data year/date of publication
- Disclosure platform
Financial data
How has the company treated:
- Tax considerations?
- VAT (included or not)?
- Currency aspects (including conversion rates)?
- Calculation rules (e.g. in-kind ToVs, other non-monetary values)
- Cross border payments?
- Multi-year contracts?
Recipients
- Include types of recipients and define if required e.g. health professional
- How are ToVs to retired health professionals disclosed?
- How is data relating to deceased health professionals published/managed?
Data protection
- Which lawful basis has been used to publish individual HCP/ORDM information?
- Are the appropriate arrangements in place to lawfully disclose the information and are recipients aware of the process?
- Partial disclosures - how many individuals agreed to some payments being disclosed individually, and some in aggregate? The supplementary information to Clause 28.5 should be consulted.
Specific considerations
- Do the disclosures go beyond what is required by the ABPI Code? If so, is this made clear?
- ToVs in case of partial attendances or cancellation and refund – how are these disclosed?
- Self-incorporated health professionals – what approach is taken to disclose ToVs to health professionals with their own Limited company? Clauses 1.8 and 1.25 should be consulted.
- How has the company defined ‘Donation’, ‘Grant’, ‘Sponsorship’ and has this been made clear?
- R&D transfers of value – consider a summary of the types of activities included in the disclosure under the R&D definition in the ABPI Code; have other R&D activities been included in the disclosure where appropriate?
- Is it clear whether the disclosures cover company subsidiaries, affiliates, etc.? Or, have these been disclosed separately?
- If the company has changed name or merged etc., how is this explained? Can relevant disclosures be easily tracked? Consider adding information to any previous year’s methodological note to ensure a member of the public can identify related disclosures.
- When working with other pharmaceutical companies, how are disclosures handled? How are transfers of value divided amongst the parties (e.g., collaborative working projects, etc.)?
- Are the necessary links included and active e.g. for collaborative working executive summaries?
- Over-the-counter transfers of value - are they/some included?
- Medical device transfers of value - are they/some included?
- Summary of internal company pre-disclosure quality checks undertaken prior to data submission – were these completed, and how?
Additional Information
- Include as necessary
September 2024