Latest update on the reporting process for disclosing MR payments to known healthcare professionals:
A Europe-wide EFPIA Disclosure Code has been published to encourage increased transparency of the relationships between HCPs, HCOs and pharmaceutical companies.
In January 2015 the ABPI Code of Practice’s new disclosure requirements came into force. The ABPI Code is mandatory for all ABPI member companies (and non-members that have agreed to adhere to it). Consequently disclosure requirements apply to BHBIA member companies who are also ABPI members. Disclosure requires pharmaceutical companies to make publicly available the details of MR-related payments (incentives and/or expenses), on a named basis, IF the identities of HCPs or HCOs who take part in the MR are intentionally known or disclosed to the pharmaceutical company.
The BHBIA has incorporated these requirements into its Legal and Ethical Guidelines, which give details of the requirements and include a pro forma for a disclosure consent statement.
Within the Legal and Ethical Guidelines section of the website you will also find our Frequently Asked Questions resource, which includes a section on queries that our ethics advisor has been asked about the disclosure requirements.
PMCPA advice on when disclosure is not likely to be required
The PMCPA have informally advised us that if there was never an intention to identify HCPs to the pharmaceutical company but an HCP respondent becomes known to the pharmaceutical company as a result of another process e.g. AE reporting, then disclosure is not likely to be required. The ‘other process’ being an indirect consequence of the MR rather than a direct outcome.
This means that disclosure is not likely to be required if:
- an adverse event is forwarded and it contains HCP reporter details – EFPIA have confirmed this within their FAQs, or
- when viewing fieldwork a pharmaceutical company observer happens to recognise and can identify what should have been an unknown HCP respondent
For full details, please see the notes on Interpretation of ‘known’ healthcare professionals below.
Additional resources available on this page (click on the download links on the right hand side):
- A short ready-reference guide on disclosure requirements, produced by the BHBIA
- A copy of the ABPI template for disclosure (This is also available on the PMCPA website as are the other documents referred to below).
- A short slide deck on their plans for the development of a central platform.
- Contact names for any questions – see slide 14 within the slide deck referred to above
- ABPI Model Clause - a template for use when designing wording around consent in agreements with HCPs for use in 2015, ready for disclosure in 2016. (the BHBIA provides a simpler pro forma within the Guidelines)
- Supplementary guidance for the Model Clause.
PMCPA Informal advice on interpretation of ‘known’ healthcare professionals
What if the identity of an HCP is shared as a result of an AE report or revealed when research is viewed?
The BHBIA has raised the following questions:
• If an adverse event is forwarded from a MR survey and the AE report form (which goes directly to the drug safety/pharmacovigilance department and not through the MR department) has the name and address of the reporter on it and that reporter is a HCP, does this mean that the HCP has to be named under the disclosure clause requirements?
• If during viewing of fieldwork a commissioning client company employee recognises and knows the identity of a HCP MR respondent, is disclosure required?
The PMCPA response (quoted below) addresses the adverse event reporting question but the principles laid out apply to recognising a respondent whilst viewing too.
The focus on the
requirements concerning transparency is on areas where there are direct
relationships between the parties and in that regard companies must
publicly disclose details of payments made in relation to the market
research only where the company knows the identity of those
participating. In our view, in otherwise anonymous market research, once
a health professional reports an adverse event seen in the course of
that research and the company thus becomes aware of his/her identity, a
direct relationship between the parties has been formed – albeit
inadvertently. It could be argued, however, that the relationship is a
result of or consequence of the market research and not a direct
outcome. There is no disclosure exemption in the Code for health
professionals reporting adverse events. The general view from
discussions at EFPIA is that if the health professional’s details become
known to the company as a result of an adverse event then it does not
fall in that section of market research which needs to be disclosed. It
is, however, worth thinking about the spirit of the Code and the
importance that companies have placed on reputation and disclosure.
Companies will not be censored for disclosing more than they strictly
need to. The health professional can of course refuse to give consent to
be publicly named, in which case the company would have to disclose the
payment as part of its aggregate figures (Clause 21.9 refers).
The supplementary information to Clause 21.1, Consent to Disclosure, gives guidance on the wording of contracts such as to encourage disclosure and perhaps public disclosure in the event of adverse event reporting should be a point to consider in market research contracts so that, if needed, the company already has in place the appropriate arrangements to lawfully publicly disclose payment details. Any arrangements for disclosure should not compromise the pharmacovigilance process in any way.
The Authority [i.e. the PMCPA] cannot approve any materials or activities, it can only give informal advice based upon its interpretation of the Code. If a complaint were to be received about a matter which had been the subject of such advice, it would have to proceed in the normal way. The Code of Practice Appeal Board would make the final decision if a case went to appeal.
In view of the PMCPA’s informal advice, pharmaceutical company members may want to review their approach to disclosure of market research payments in conjunction with their legal and/or compliance departments to determine their policy and procedures.
The BHBIA’s Ethics & Compliance Committee is providing this guidance as general information for its members. It is not legal advice and should not be relied upon as such. Specific legal advice should be taken in relation to any specific legal problems or matters. Whilst every reasonable effort is made to make sure the information is accurate, no responsibility for its accuracy or for any consequences of relying on it is assumed by the BHBIA.