Fujifilm’s compliance team was used to reviewing policy and managing risk. But as the one-time camera company pushed further into drug development, it was fielding a growing number of ethical questions and falling into unfamiliar territory.
Consultants initially helped close the gap, but company leaders recognized they needed a better solution, said Patricia Colombo, vice president and chief compliance officer at Fujifilm Holdings America Corporation.
“We felt that it was necessary to have a formal and dedicated forum to discuss these topics more in depth with the most current data and reviews from subject matter experts,” she said.
As a result, the regional bioethics committee, a group of independent experts in bioethics, medicine, law, compliance, government affairs and patient advocacy, was born.
The advisory committee, which will meet for the first time in December, is tasked with weighing ethical questions and drafting policy in cell therapy, biomanufacturing, regenerative medicine and more, Colombo said. The goal is to help company leaders walk a responsible and ethical path as science evolves.
Fujifilm is not alone in grappling with moral challenges. In fact, the pharma industry is riddled with thorny questions. From high drug costs that create access disparities to biases introduced by AI, and issues around accelerated approval, companies today often tread potentially treacherous territory.
Fujifilm is also not the only firm to formalize its approach to ethics oversight. Large pharmas including Novartis, Roche, Bayer and Merck & Co. have also adopted similar ethics committees to tackle the questions that often emerge as scientists encounter new frontiers.
Emerging ethical flashpoints
The most challenging tasks ahead of the Fujifilm committee will be navigating unregulated or controversial areas such as embryonic stem cell research, Colombo said. Opponents of embryonic stem cell research argue that while the practice can fuel scientific progress, it’s immoral because it destroys a human embryo. The committee will discuss which stem cell lines the company will use and what types of research it will pursue.
It will also hash out proposed policies and ethical safeguards related to high-potency drugs, such as antibody-drug conjugates, primarily used in cancer therapy, and the use of AI in product development, with an eye toward protecting against bias and safe-guarding patient privacy.
“The bioethics committee's perspective on emerging issues and scientific trends can also help inform our life sciences R&D planning and policies in order to help ensure that the interest of the patients, researchers and the public remain core to our R&D activities,” she said.
Colombo hopes more companies will formalize ethical decision-making. Those without a concrete process and input from experts run the risk of making decisions that are not in the public interest while raising reputational risks for the company, she said.
Pharma leaders are often alert to business-related issues, but ethical complexities outside their expertise are easily overlooked.
“We understand that true integrity requires thoughtful governance and proactive engagement with complex moral questions, not just meeting minimum regulatory expectations,” Colombo said.
