Firms Must Draw Hard Line Between Royalty, Training Deals, Experts Say
Full article reprinted from "The Gray Sheet" - June 15, 2009
Companies need to be wary of blurring distinctions between payments made to physicians for product royalties and as compensation for training colleagues, compliance experts warn. Read more...
Firms Must Draw Hard Line Between Royalty, Training Deals, Experts Say
Full article reprinted from "The Gray Sheet" - June 15, 2009
Companies need to be wary of blurring distinctions between payments made to physicians for product royalties and as compensation for training colleagues, compliance experts warn.
"It's very important to distinguish between a payment made for the transfer of intellectual property - know-how, if you will - versus the other activities that that particular designer may be doing for the company," says Austin Byrd, senior vice president of ethics and compliance at orthopedics firm Smith & Nephew.
"We should never pay a royalty for speaking, or training, or teaching," he said at an international device meeting in May.
However, a physician is not barred from training colleagues to use a product that he or she helped create, Byrd was quick to add.
"You would find that most of the time, the designer is going to be very involved in training and creating market acceptance for the product," in some cases, without any financial compensation, he said.
If physician inventors do receive paid training arrangements, these must be carefully distinguished from royalty deals, Tamara Tubin, a European compliance exec at Zimmer, said at the international meeting, co-sponsored by AdvaMed.
"We have to make sure ... there is absolutely no link to the royalties. The selection of the trainers should be done through the medical affairs people, based on the company's needs," Tubin said.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives. Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
