Balancing Act: Sanofi GC Karen Linehan Discusses Managing the Risks of Vaccine Development | Corporate Counsel - Law.com

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As the quest for a COVID-19 vaccine intensifies, companies at the forefront of research need to grapple with complex legal issues at all stages of the work, from the science of creating a safe and effective vaccine to the logistics of distribution and the management of risk. Karen Linehan, executive vice president of legal affairs and general counsel of Sanofi, the France-based pharmaceutical giant, took time out recently to discuss how her team gets involved in her company’s efforts to bring a COVID-19 vaccine to market.

Sanofi has a large presence and long track record in vaccines. What are the key issues in vaccine development and production that come immediately to your attention as general counsel?

Product liability. No vaccine is ever 100% effective, which is one reason why serious efforts to develop them take place on many levels, involving many players. In the context of COVID-19, much of this work is taking place on an expedited basis—“pandemic speed”—but that does not mean any relaxation of standards.

I also pay attention to force majeure. When you have a contract to produce hundreds of millions of doses of vaccine before you know when it will be ready, that is a risk. As a company, we know what it is like to go at-risk, and we are ready to do that.

Karen Linehan, Sanofi general counsel.

What are some of the ways Sanofi, and other vaccine developers, mitigate risk?

Balancing risk and benefit is always a human judgment, and nobody goes it alone. There are well-developed partnerships on the national, regional and global levels to manage production and ensure equitable distribution. A crucial part of our work is drawing up the terms of our partnerships and looking for new ones.

Liability funds, such as the one in the United States [the National Vaccine Injury Compensation Program], also help mitigate the risks of product liability litigation.

Communication has emerged as a critical issue in managing public expectations of when a COVID-19 vaccine could be available. How does the general counsel’s office get involved?

As a company, we communicate on the importance of vaccination generally. One of the challenges in public health is people not getting routine vaccinations. We work closely with external affairs and our medical colleagues to get that message out, and that supports the effort to communicate about COVID.

When it comes to specific products, regulatory rules determine what we can say and when. That goes for communications with the public, by our public affairs and marketing teams, and with investors, which is handled by investor relations. We work closely with those teams to review statements and publications in advance.

The most important thing, legally and in general, is to be transparent. Vaccine development is a long journey, and it’s in everyone’s interest to have a good outcome, not necessarily the quickest one.