What a Pharma Rep Can Still Leave Behind in a Doctor’s Office

Europe is dropping its tolerance for low-value gifts to physicians. What a rep can still leave behind in a doctor's office, and why a detail aid is not a gift.

By David Harenz

Sometimes a pharmaceutical rep walks back into a doctor’s office a year after the last visit and finds the leave-behind from that visit still there. It unfolds, a tab pulls out, it has to be handled: a paper piece with a mechanism built in, built to catch the eye and be remembered. And it lands exactly where the rules get difficult — the point at which material that informs a physician starts to look like a gift. U.S. industry rules drew that line more than 15 years ago. European law is about to move it.

In the U.S., that line runs through three sets of rules. The first is the PhRMA Code on Interactions with Health Care Professionals, the industry’s voluntary code. Since January 2009, it has told companies to stop providing items that do not advance disease or treatment education, “even if they are practice-related items of minimal value (such as pens, note pads, mugs, and similar ‘reminder’ items with company or product logos).” The current version, in effect since January 1, 2022, still allows items “designed primarily for the education of patients or health care professionals,” as long as they are worth $100 or less and have no value to physicians outside their professional responsibilities. Promotional materials handed over by reps must be accurate, substantiated, balanced between risks and benefits, and consistent with FDA requirements.

The second is the FDA. A company must file each piece of promotional labeling for a prescription drug with the agency, on Form FDA 2253, at the time of its initial dissemination. The third is Open Payments, the federal transparency program created by the Physician Payments Sunshine Act. In 2026, transfers of value under $13.82 do not have to be reported unless a physician’s total for the year exceeds $138.13. Educational materials and items “that directly benefit patients or are intended to be used by or with patients” are excluded from reporting.

Europe tightens its own rule

Europe is now moving its line, in law this time. The EU’s Pharma Package, a revision of the bloc’s pharmaceutical legislation that includes Directive 2001/83/EC, reached political agreement on December 11, 2025. The Committee of Permanent Representatives of the member states endorsed it on March 6, 2026, and the European Parliament’s public health committee approved it on March 18. Lawyers following the file expected formal adoption between summer and late fall 2026, with full application in 2028.

In the advertising chapter, the compromise text drops the “minimal intrinsic value” exception. According to law firm Crowell & Moring, which analyzed the text, any gift able to influence a health care professional is now treated as advertising, however small. The current directive bans gifts to prescribers unless they are “inexpensive and relevant to the practice of medicine or pharmacy.” That tolerance is going away.

Europe’s industry code already draws the distinction that matters for a leave-behind. The EFPIA Code of Practice, in its 2019 consolidated version, bans gifts for the personal benefit of health care professionals. It also bans “promotional aids,” defined as non-monetary items given for a promotional purpose, and specifies that the category “does not include promotional materials.” A pen with a product logo is a promotional aid. The brochure that explains the product is not.

The rep comes around less often

What stays behind matters more as access shrinks. According to Veeva Pulse data published in May 2024, 45% of health care professionals were accessible to biopharma companies, down from 60% in 2022. Half of those still accessible met with three or fewer companies, and nearly 30% of physicians in internal medicine, oncology, psychiatry and urology limited access to a single company.

Morddy Mouyal, CEO of B.MOSS USA Inc., which creates and produces tactile print marketing tools, sees the same shift among clients. “A pharma company used to send out dozens of reps. Today it sends fewer,” he says. “The budget per piece hasn’t dropped. What has changed is how often reps visit, so the quantities used are smaller. Companies were very drawn to the low cost of digital, but now they’re coming back to physical contact, which nothing can replace.”

The Veeva data partly back him up: among accessible physicians, the share open to in-person and video meetings with field teams was growing compared with prior years. Mouyal adds that clients sometimes find the leave-behind from an earlier visit still in the doctor’s office, when it made an impression on the physician.

Servier: a patient’s journey, built in paper

One recent project was for Servier in Switzerland. The company had a very clear message for physicians, and that message depended on a visual showing the entire path a patient goes through. Servier’s agency, Studio New, came up with the visual. Turning it into a physical piece required B.MOSS’s paper engineer to develop a mechanism that, according to Mouyal, no one had built before, B.MOSS included: a pull tab unfolds the piece panel by panel, following the patient’s path. It was produced in a very small run, with maximum sophistication and quality. “The client is ready to invest to get what it needs, something that becomes an effective tool in the hands of its reps,” Mouyal says.

Then there’s the price question. Asked how a flat leave-behind compares with a piece like this, Mouyal says: “It’s obviously more expensive, but less than people imagine. And there’s no comparison, just as you don’t compare a bicycle and a car. Our tools don’t stop at information. They’re also there to grab attention and to make the message easier to understand and remember, through effects created by paper engineering.”

The line is drawn case by case

Mouyal says B.MOSS pieces have never been treated as gifts. “They’re not gifts. They’re simply brochures or sophisticated boxes,” he says. By his account, the pieces have gone before France’s medicines agency, ANSM, and equivalent agencies elsewhere “hundreds of times” without ever being blocked. Even when a paper pad comes with the leave-behind, or a box has a special mechanism built in, the piece serves, in his view, to educate physicians or patients.

On principle, the codes back him up. EFPIA excludes promotional materials from promotional aids, and PhRMA allows educational items. None of these provisions makes the form of a piece a criterion. Function decides, and each piece is judged on its own.

For U.S. brands launching in Europe, one difference comes up before any of this. U.S. rules require a company to file promotional labeling with the FDA at the time of initial dissemination. In France, every promotional document for a medicine aimed at health care professionals must be cleared by ANSM before it is distributed. The same leave-behind can reach a U.S. sales force the day it is filed. In France, it waits for the regulator.

David Harenz is the pen name of the BMOSS blog’s editorial team.

Sources: PhRMA Code on Interactions with Health Care Professionals, effective January 1, 2022; PharmaTimes, July 10, 2008; McGuireWoods, July 2008; 21 CFR 314.81(b)(3)(i); CMS, Open Payments data collection; 42 CFR 403.904(h); Council of the EU, December 11, 2025; Setterwalls, May 2026; Crowell & Moring, EU Pharma Package: Advertising Compromise Proposal; Directive 2001/83/EC, Article 94; EFPIA Code of Practice, 2019; Veeva Pulse, May 2024; ANSM.