Géraldine Drevon, PhD, GSK; John Gonzalez, PhD, Solanum Medical Communications; Siobhan Southam, MSc, Delonix Medical Affairs; Veronica Porkess, PhD, CMPP, UCB; Stephanie Daniels, PhD, CMPP, Independent Medical Publications Professional; Beryl Gonzalez, ACIM, Bioscript Group
The information presented here reflects the opinions of the authors and does not necessarily represent the position of their current or past employers. In addition, the information does not represent official guidance from ISMPP. Compensation for activities should be made in consultation with a company’s Legal, Compliance, and/or other applicable representatives.
Email your questions and comments on this article to TheMAP@ismpp.org.
Compensation for publications activities is highly regulated to protect patients, healthcare professionals (HCPs) and the reputation of the pharmaceutical, biotech and device industries, and to limit perceptions of bias and conflict.
This article aims to address the practical application of current regulations and guidelines that apply to industry-sponsored research, and to give the reader insights into our own experience as publications professionals. It is based on a parallel session presentation by the authors at the 2024 European Meeting of ISMPP.[i]
Key considerations
- It is important to separate out the provision of expert advice by HCPs, which may be legitimately compensated for, from discussions on authorship and publication content, which generally are not compensated for
- Determining patient compensation in publications can be guided by considering the capacity in which a patient is engaged (e.g. advisor, reviewer, author) and whether the activity would usually be a paid service
- Authors who are developing the manuscript as part of their salaried employment (which also applies to industry authors) would not be considered to have been paid for authorship
Setting expectations
Several of the GPP 2022 authors recently laid out the historical context of publications compensation in an article in The MAP.[ii] The authors highlighted how previous issues with ghost writing, guest authorship and other practices addressed by various Corporate Integrity Agreements underlined the need for rigorous processes around compensation for publication activities.
Guaranteeing quality, robustness and value for peer-reviewed publications starts with authorship. Setting authorship expectations in advance of drafting is an important ethical safeguard. These expectations are based on several key principles:
- Authorship is voluntary, optional and conventionally unpaid, whether the authors are HCPs, patients, researchers or industry employees.
- All authors must be treated equally.
- All authors should, as a minimum, fulfil the ICMJE authorship criteria. Guest authorship goes against this defining principle and compromises the integrity of scientific publications.
The crux of the matter on whether to compensate for publication activities is the difference between being an author or service provider.
The crux of the matter on whether to compensate for publication activities is the difference between being an author or service provider.
At first sight, the boundary between authorship and publication services seems self-evident; a stakeholder participating in an advisory board or an agency assisting with medical writing would naturally be considered as providing a service that comes with fair compensation.
But is it really that obvious?
For example, how do you set the threshold for when a service provider like a medical writer becomes an author? How does payment influence participation as a publication author, and when does lack of payment become a barrier to participation? In the following sections, we briefly cover relevant guidance for compensation related to publication activities and then explore three scenarios.
Sources of guidance for compensation relevant to publications
Various industry codes of practice provide advice on the compensation that can be paid to HCPs and patients for services provided. Some of these codes are shown below, alongside legislation that governs financial transactions, which otherwise could amount to bribery or corruption.
| Sources of guidance for compensation relevant to publications |
|---|
| Association of the British Pharmaceutical Industry (ABPI) European Federation of Pharmaceutical Industries and Associations (EPPIA) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Pharmaceutical Research and Manufacturers of America (PhRMA) The Prescription Medicines Code of Practice Authority (PMCPA) Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) International Committee of Medical Journal Editors (ICMJE) The Bribery Act 2010 US Office of the Inspector General (Corporate Integrity Agreements) US Department of Justice (Foreign Corrupt Practices Act, False Claims Act) The Sunshine Act (Physician Payments) |
Publication steering committees
Perceptions persist that payments are made to doctors to “mould their minds” [iii], and therefore, we need to be aware of the continued scrutiny surrounding the industry as a whole, and publications specifically. Participation in a publication steering committee (PSC) would typically not be compensated. A PSC is, in essence, a type of advisory board as per GPP guidelines, and the PMCPA code of practice states that “advisory boards should only be held to enable companies to answer legitimate business questions to which they do not know or have the expertise in-house to answer”.
If a company is legitimately seeking advice on outstanding clinical questions, data gaps/post hoc analyses and subsequent publication needs in an advisory board setting, then compensation could be provided. The PSC will provide more granular advice on the publication planning specifics for each study or post hoc analysis, such as topline content for each publication, target audience, etc. However, the problem is that many PSC members will likely be involved in the studies as investigators or advisors and have potential authorship eligibility. It can be difficult to separate out the provision of expert advice, which may be legitimately compensated for, from discussions on authorship and content, which generally are not compensated.
It can be difficult to separate out the provision of expert advice, which may be legitimately compensated for, from discussions on authorship and content, which generally are not compensated.
The following is typical practice:
Collaborations with patients
The principles of treating all authors the same and not paying for authorship are important as they protect all parties from potential concerns about conflict of interest. Where payment is involved between industry and patients or patient groups, there is the potential for this to be perceived as commercially motivated.[iv] The evolving publication and compliance landscape can make navigating compensation, particularly when involving patients, quite a challenge. The goal of collaboration must be to ensure that practices are ethical, transparent and fair. We offer some practical guidance that may provide a useful demarcation between authorship activities and compensated publication services.
Asking in what capacity a patient is being involved with publications and whether the activity is something that an HCP would be paid for may be a useful starting point for determining whether an activity is a paid for service or not. One area of difference would be asking a (non-author) patient to review a plain language summary (PLS), which would be a paid for service. However, if the authors of the publication, including a patient author, review a PLS, this is part of the usual authorship activities that are not paid for.
Asking in what capacity a patient is being involved with publications and whether the activity is something that an HCP would be paid for may be a useful starting point for determining whether an activity is a paid for service or not.
Helpful resources to support working with patients and considerations for remuneration are listed below.
Working with full-service contract research organizations (CROs)
Another area of uncertainty around appropriate payment arises when working with CROs. Frequently, the industry will engage a CRO to run research, such as a real-world evidence study, and the researchers from the CRO would usually qualify for authorship. If that CRO is also contracted to provide medical writing services on the manuscript reporting the study, the CRO research lead may also be the most logical person to lead the medical writing. Could this be construed as ‘payment for authorship’?
Some companies take the conservative approach that, indeed, it is payment for authorship and, therefore, would pay the CRO to write a study report and then engage a separate medical writing agency to develop the publication. GPP 2022 provides us with some clear guidance that “Paid employment in any role that contributes to study conduct, analysis, or publication development (including professional medical writing) is not a disqualification from authorship”.[v] This means authors who are developing the manuscript as part of their job (which also applies to industry authors) would not be considered to have been paid for authorship, as illustrated in the case study below. However, if the company has engaged an independent medical writer, it would not be appropriate to also pay the CRO authors for the time they are spending reviewing the drafts provided. Be sure to check individual company SOPs, and ensure the CRO is qualified to provide quality publications medical writing services before deciding who will lead the manuscript writing activities. In all cases, it is important to ensure disclosure in the publication of any payment for writing support, and of potential sources of bias or conflicts of interest for all authors, including employment status if relevant.[v][vi]
Authors who are developing the manuscript as part of their job (which also applies to industry authors) would not be considered to have been paid for authorship.
Conclusion
Authorship of industry-supported publications continues to evolve with wider stakeholder groups involved. Alongside the benefits of including these broader perspectives, it will be important to maintain ethical practices to protect the reputation of authors and industry.
A key skill for medical publication professionals is interpreting and applying compliance guidelines. Often, we are faced with so-called ‘gray areas’. Distinguishing between compensated and uncompensated publication activities is one such area of ongoing debate. Here, we have contributed to this discussion, providing practical examples of our approaches to this issue. Pulling all of these examples together, the following provides a summary of considerations for stakeholder payments across the publication planning and development process:
Acknowledgement: Graphics support provided by Bioscript Group.
References
[i] Parallel session presentation at the European Meeting of ISMPP January 2024 – Stakeholder compensation for services in the evolving publications landscape. Faculty: Géraldine Drevon, GSK; John Gonzalez, Solanum Medical Communications; Siobhan Southam, MundiPharma; Veronica Porkess, UCB.
[ii] DeTora L, DiBiasi F, Dormer L, Hanekamp E, Toroser D, Citrome L. Author payments: same policies, different scope. The MAP Newsletter. 2024 Apr 24. Author Payments: Same Policies, Different Scope | the Map (ismpp-newsletter.com)
[iii] Sismondo S, Bernisson M. How an opioid giant deployed a playbook for moulding doctors’ minds BMJ 2024; 385 doi: https://doi.org/10.1136/bmj.q1208.
[v] DeTora LM, Toroser D, Sykes A, et al. Good publication practice (GPP) guidelines for company-sponsored biomedical research: 2022 Update. Ann Intern Med.2022;175:1298-1304. [Epub 30 August 2022]. doi:10.7326/M22-1460.
[vi] International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2024. https://www.icmje.org/icmje-recommendations.pdf.