Recent posts on popular social media outlets and websites have stated that research articles may be available directly from the authors for free (here, here, here and here). These posts are spreading the word that interested parties can access research articles directly from the authors without paying the subscription fees that most academic journals or other publishers charge. This idea has implications for pharmacists and other medical professionals articles are provided by life science companies are subject to reporting under the Physician Payment Sunshine Act. Could sharing by physicians be a “loophole” to consider?
What is the Sunshine Act?
The Sunshine Act came addressed concerns about pharmaceutical companies imposing undue influence on doctors offices and possibly affecting their prescribing decisions. While the exchange of information between pharmaceutical companies and medical professionals has positive benefits, the intention of the law was to add some transparency to that process. As a result, there is a publicly accessible website that lists exchanges of money and gifts between pharmaceutical companies and doctors.
How does the Sunshine Act become involved in the use of documents?
Individuals are often confused about how the Sunshine Act “jumps” from reporting on the exchange of money and gifts between pharmaceutical companies to the sharing of information. To understand this connection, it is important to first must understand the circumstances under which the law would even apply. If a doctor who does not work for, or on behalf of, a pharmaceutical company decides to share his or her own research article, the Sunshine Act is likely not implicated.
However, if the doctor does receive payments from the pharmaceutical company, the FDA may interpret that relationship to say that he or she does work for the pharmaceutical company. In the event such a Doctor shares articles, the Sunshine Act may be implicated. That is because the physician may be deemed to be an agent of the company even if s/he was sharing his or her own article/ original research. Such sharing may hence be deemed to be promotional by the FDA. It is important to note that such payment need not be of money, but may include the exchange of valuable goods (e.g., cars, trips, etc.). It is also important to recognize that the burden of reporting this exchange falls on the pharmaceutical company, not the doctor, though the physician may protest such assertions.
Intellectual Property, Licensing, and Contractual Considerations
If a physician who does not receive money from a pharmaceutical company shares his or her research article, it is likely irrelevant to the Sunshine Act. Nevertheless, it is important that individuals consider the impact on intellectual property laws in this circumstance.
When a researcher (or any author of an article) agrees to have his or her work published in a journal, an arrangement is made about who retains ownership of that article. If the journal has sole ownership of the article, then sharing the article without the journal’s permission could violate the contract between the author and the journal.
For example, an arrangement can be made with a publisher which guarantees the publisher the right of first publication. However, after that point, the author may be able to share sections or entire pieces of his or her work. The terms of the agreement would dictate how the author may (or may not) share the work, and contract agreement vary widely. We should note that this stipulation is independent of payment. That is, whether an author is paid for his or her writing does not decide if it can be shared.
From time to time, publishers do allow for sharing of articles if it is done for non-commercial purposes or for limited commercial purposes (such as part of a newsletter or the like). Unfortunately, unless the author is a key opinion leader, this can be difficult to negotiate with certain publishers.
Simply put, the Sunshine Act tells only a piece of the legal story that governs free information sharing. While there are circumstances under which the Sunshine Act would allow a researcher to share his or her work with an interested party, intellectual property and copyright considerations must also be reviewed.