A New Year! A New You!: Update Your Look on Regenerative Healing Law

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF)  where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

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