[Ip-health] Community biolabs and 'biohacked' insulin: A legal and policy conundrum

Kaplan, Warren wak at bu.edu
Thu Sep 13 16:53:08 PDT 2018

 Dear Colleagues:
The ever-increasing price for insulin is well known to readers of ip-health and the health consequences of rationing insulin because it is not affordable are dire. https://www.cbsnews.com/news/the-rising-cost-of-insulin-horror-stories-every-day/
As a result, people are taking matters into their own hands.  For instance, there are thousands of  crowdfunding campaigns related to insulin on the site GoFundMe and even insulin pump technology has been ‘hacked’.  https://www.bloomberg.com/news/features/2018-08-08/the-250-biohack-that-s-revolutionizing-life-with-diabetes.
One manifestation of this is that various “community biolabs” have sprung up around the country. Their defenders argue that "biohacking" is not a mere stunt and assert that much of their work is really about science outreach and education.  https://www.statnews.com/2018/06/04/biohacker-open-access-science/?utm_source=STAT+Newsletters&utm_campaign=b83a0a2e74-MR_COPY_08&utm_medium=email&utm_term=0_8cab1d7961-b83a0a2e74-149565953
I want to let the community know that today (September 13) our paper was published in Trends in Biotechnology and it takes a serious look at the scientific, legal and policy space surrounding the Open Insulin Project, which we use as a case study of this phenomenon. https://doi.org/10.1016/j.tibtech.2018.07.009
The horse is already out of the barn, as it were. We think that small-scale production of medicines by those outside the traditional biotechnology industry is already part of the healthcare ecosystem. The present regulatory and legal environment is out of alignment with this phenomenon. We trust this will not be yet another failure of imagination on the part of the present R&D system in this country.
For more information, please also see  https://theconversation.com/after-a-century-insulin-is-still-expensive-could-diyers-change-that-99822.
Warren Kaplan

Warren Kaplan, PhD, JD, MPH
WHO Collaborating Center for Pharmaceutical Policy
Boston University School of Public Health
801 Massachusetts Avenue
Boston, MA 02118
617 414 1152 (office)
617 414  1261 (fax)
Skype warren.kaplan

....( )/ ( )
" An imbalance between rich and poor is the oldest and most fatal ailment of all republics....“


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