Before Australia and EFPIA, however, the country of France instituted a law—the Bertrand Act—that requires companies to make public (1) any “benefits” given to health professionals, such as meals, lodging, donating equipment, etc., and (2) “conventions,” or agreements, between companies and providers, such as for speaking at conferences, research payments involving clinical trial work, training, etc.
A user-friendly, searchable database of the French disclosure information is available here.
They found the exemption from public reporting of remuneration to be groundless, as well as the partial exemption available to companies that manufacture or market contact lenses and tattoo products. Saint Louis Avocates, a French law firm, has also published a thorough interpretation of the requirements (the page requires translation).
Here are my top 10 regulatory issues to address when preparing or auditing physician contracts: 1. Stark and the AKS require signed, written agreements for independent contractor arrangements. Ensure the contract is current and accurately documents the parties’ performance. Do not continue performing after the contract has expired unless you fit within a different exception.
Employment contracts need not be written, but it is generally a good idea to reduce them to writing to avoid disputes. Avoid unnoticed or unintended lapses in the contract by including automatic renewals subject to appropriate termination clauses. Specify the services and compensation in the contract.
The Sunshine Act in the United States is but one physician payment disclosure obligation for manufacturers of drugs and devices to keep track of.
We recently wrote about Medicines Australia’s transparency code; additionally, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code sets out self-regulatory industry transparency standards for pharmaceutical companies operating in 33 European countries.
This approach is a cost-effective way to offer employee health benefits.