Beyond the United States’ Physician Payments Sunshine Act reporting requirements, international pharmaceutical and device companies must account for a growing number of transparency requirements related to their interactions with healthcare professionals.
For example, in France, the Bertrand Act requires transparency related to: (1) the agreements between companies and healthcare professionals (HCPs) and (2) any benefits, such as small gifts, travel and accommodations, received by the HCPs from companies except, at least as it has been understood until very recently, for the remuneration earned for their services.
Specifically, the Bertrand Act requires companies to disclose on a single public website: (1) the identities of the parties to the agreement, (2) the date that the agreement was signed, (3) the general purpose of the agreement (worded to protect any trade and industry secrets), and (4) the program of an event, if applicable. This website is searchable by HCP’s name.
With respect to the benefits that the HCPs receive, the Bertrand Act requires companies that manufacture, market, or provide services in connection with health and cosmetic products to publicly disclose: (1) the value of the benefit provided (including taxes and rounded to the nearest euro if greater than €10), (2) the recipient of the benefit, (3) the nature and date of the benefit, and (4) the half-year period during which the benefit was granted.
Initially, the law was not read to require the disclosure of remuneration to HCPs for actual services rendered, either with regard to agreements with HCPs or the benefits HCPs receive.
However, on February 24, 2015, the French Administrative Supreme Court (Conseil d’Etat) ruled that:
- The exemption from public reporting of any remuneration paid to French healthcare professionals (HCPs) was groundless.
- The partial exemption available to companies that manufacture or market non-corrective contact lenses and cosmetic and tattoo products did not apply, providing for the same reporting obligations as drug and device manufacturers.
As a result, the French Ministry has taken the opportunity to pursue an amendment of the Bertrand Act that would formally require disclosure of the remuneration paid to HCPs for their services. Until the amendment is passed, it is unclear whether the expanded requirements will be retroactive as of January 1, 2012 (when the Bertrand Act was passed), or whether they will be implemented from the enforcement of the Bertrand Act.
The U.S. Sunshine Act similarly requires drug and medical device manufacturers participating in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. The U.S. law, however, does not cast as wide of a net as the French law. For example:
- The U.S. Sunshine Act covers medical supplies, drugs, medical devices and biologics; the French Sunshine Act is broader because it covers the same products as the U.S. Sunshine Act but also cosmetics, contraceptives, biomaterials, biology test products, contact lenses, health software and additional therapeutic products.
- The U.S. Sunshine Act covers physicians and teaching hospitals; the French Sunshine Act covers physicians, non-physician HCPs, both teaching and non-teaching hospitals, professional and patient organizations, and other healthcare institutions.
- The U.S. Sunshine Act covers payments and “transfers of value;” the French Sunshine Act covers agreements and benefits.
- The U.S. Sunshine Act excludes discounts and rebates, items that directly benefit patients, buffet meals, snacks, or drinks made available to all participants of a large-scale conference, loans of covered medical device for less than 90 days; the French Sunshine Act excludes only agreements involving the purchase of goods or services.