October 14, 2015 | Jonathan Patience, Managing Editor

Shedding light on the Sunshine Act

Those of you who work on medical publications may be aware of the Physician Payments Sunshine Act (the Act), which was passed in 2010 as part of the U.S. Patient Protection and Affordable Care Act, enacted to increase transparency of financial relationships between healthcare providers and pharmaceutical manufacturers.

What does the Sunshine Act involve?

The act requires manufacturers of healthcare products that are reimbursed by the U.S. Federal government (applicable manufacturers) to report certain financial transactions with licensed U.S. physicians (covered recipients). The transactions include not only direct payment for certain activities, but also the dollar value of in-kind services (known as transfer of value [TOV]). This information is made available annually in a publically available database called the U.S. Centers for Medicare and Medicaid Services (CMS) Open Payments database. This is in addition to the disclosure requirements of medical journals, where authors are responsible for disclosing financial relationships.

What are the issues?

Many authors, particularly of industry-funded articles, make use of medical writing services from independent Medical Communications agencies to help produce an article. Often such services are funded by Pharmaceutical companies. Because the rules for implementation of the act do not clearly delineate all types of TOV that must be reported, there has been a variance in interpretation as to whether medical writing support is a reportable TOV, causing some confusion among authors. This confusion and the lack of guidance is a major issue that has been highlighted in a recent article in our journal Postgraduate Medicine.

This article was written by professionals from academia, the pharmaceutical industry, medical communications agencies, and the International Society for Medical Publication Professionals, and it examines what guidelines have been issued by professional medical associations regarding whether industry-provided non-monetary assistance to authors of medical publications is a reportable TOV under the Sunshine Act. They found only sparse information was provided, and discussed the implications of this.

Another debated issue is whether, if the pharmaceutical company does report this support as a TOV, this is fair to the author. There is controversy over this, with some arguing that authors do not get much personal gain from this assistance.

Further, the general public may misconstrue this as authors being paid directly, which may cause authors to feel less inclined to get involved in publications that make use of this writing assistance. On the other hand, some argue this assistance does benefit the author by allowing them to publish high quality studies more regularly, thus improving their CV.

What do I need to know as a journal editor?

For editors, this issue highlights the importance of ensuring that all financial disclosures and writing assistance are fully and correctly disclosed in every published article. However, it is also important for editors to be aware of the issues and concerns that authors and all those involved in the publication of an article are faced with.

It is also worth noting that this issue does not only affect the U.S. Following on from the Sunshine Act in the U.S., several countries around world (e.g., France, Portugal, Slovakia) have either already passed similar laws or are preparing to do so.

Published: October 14, 2015 | Author: Jonathan Patience, Managing Editor | Category: Ethics and rights, Front page, News and ideas | Tagged with: