Governing Biotechnology

As noted last year by Lexvivo ("Recoordinated Framework", July 2, 2015), the United States federal government has been considering how to update its policy on biotechnology regulation.  On September 16, 2016, the White House released a draft revision of the "Coordinated Framework for the Regulation of Biotechnology" (commonly known as the "Coordinated Framework").  (Thank you to the brilliant Brian Mannix for alerting me about the draft's release.)  The original policy, in force since June 26, 1986, can be found here.  The draft new policy, entitled "Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology", can be found here.  The White House described its reformulated biotechnology regulatory policy as follows:

[It] sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the [draft new policy], the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.

Biotechnology has evolved rapidly and radically over the past three decades, so a comprehensive review of the policies that oversees its regulation would seem overdue, especially in light of signal innovations like de novo gene synthesis and in toto genome editing.  Let's hope that this proposed recoordination of policy on that most complex of technologies avoids tripping over its own feet.

Sometimes A Cigar Is Just A Trademark

On September 9th and 10th, 2016, I participated in "The Psychology and Sociology of Creativity and IP" at Stanford Law School.  Rebecca Tushnet, author of the superb 43(B)log, summarized each of the sessions:

Session 1: Why do people create? 

Session 2: Why do companies patent? 

Session 3: What can we learn from IP-free zones?

Session 4: The sociology and psychology of brands 

Session 5:  Fairness, efficiency, and distributive justice

Thank you very much to Mark Lemley for organizing and hosting this fascinating meeting.

2016 Freeman Prize

Sampsa Hyysalo, Torben Elgaard Jensen, and Nelly Oudshoorn just let us know that the book they edited, entitled New Production of Users - Changing Innovation Collectives and Involvement Strategies (Routledge), has received the 2016 Freeman Prize, which is awarded "for a publication which is a significant collective contribution to the interaction of science and technology studies with the study of innovation" by the European Association for the Study of Science and Technology ("EASST").  This award honors "Professor Chris Freeman, renowned expert on the social and economic consequences of developments in science and technology".  Eric von Hippel and I were invited to contribute a chapter, which we coauthored and named "Protecting the Right to Innovate:  Our Innovation "Wetlands"".

Thank you very much to Sampsa, Torben, and Nelly for their wonderful leadership in producing this book!  They deserve the lion's share of the congratulations for winning the Freeman Prize.