Foley & Lardner LLP partner Kyle Faget is quoted in the Clinical Trials Arena article, “Lack of consistency with data protection poses pain point for biotechs and sponsors,” commenting on the variances of data protection laws for clinical trials.
Faget, who is co-chair of Foley’s Health Care Practice Group and the firm’s Medical Devices team, said that for U.S. biotechnology startups, it can be difficult enough to understand legal frameworks in the United States, let alone being able to understand how this differs in the E.U.
“It becomes a question of whether these biotech companies want to conduct clinical trials in these jurisdictions as the risk is significant and the penalties are large,” Faget explained. “This is a huge undertaking for companies to take on all these additional laws, particularly when they’re more aggressive than in the U.S.”
According to Faget, it can sometimes be easier to consider the strictest legislation in the planning process, but it is not always the best plan. “You have to think of scalability so when you’re trying to build and scale a clinical trial, the easiest thing to do is to take the most conservative standard and adhere to it across the board, that operationally makes it easier but can also be much more expensive and can tie your hands in some jurisdictions where your hands wouldn’t normally be tied,” Faget said.
Faget added that as data laws will likely never be identical across the world, the easiest method for sponsors is to just ensure that patients in all jurisdictions know exactly where their data is going and allow patients to make an informed decision.
“There has to be some meaningful consent and that the patient has to consent to exactly where their information is going, whether it’s to CROs, sites, sponsors, a local lab, that has to be disclosed in the informed consent,” Faget concluded.