The Wake Forest Journal of Business and Intellectual Property Law will be hosting its spring symposium, “Intellectual Property and Medical Technology: From Creation to Commercialization,” beginning at 8:30 a.m. this Friday, February 2, 2018, in the Wake Forest Biotech Place Atrium at Wake Forest Innovation Quarter. Medical patents, the intersection of bioethics and the law, and the venture capitalist-side of regenerative medicine are among some of the topics to be discussed at this year’s symposium. This blog post is meant to provide a brief overview of bioethics and venture capitalists of medical devices.
Similar to law, medicine is an ancient profession with roots going back for thousands of years. Because the medical profession’s main focus is saving lives and helping those in need, issues of ethics and morality inevitably arise. The Hippocratic Oath has been around for over two-thousand years and is deemed the oldest expression of medical ethics in the Western world. The oath consists of a set of ethics for medical practitioners to follow. However, the idea of ethics in medicine has greatly evolved since the time of the Hippocratic Oath’s conception by ancient Greek philosophers, and thus some of its elements have begun to fall out of favor with modern medical professionals. Although it is still used by many, the Hippocratic Oath has adapted to modern medicine, and sections like those refusing to commit abortion or using knives in practice, have been removed, and other sections have been added, like the one stating that prevention is preferable to curing.
Nevertheless, updating the Hippocratic Oath is not sufficient to meet all of the modern ethical quandaries in medicine. In the 1960s, new ethical questions arose in the medical field with increasing knowledge of genetics, organ transplants, the ability to keep a brain-dead patient alive, growing healthcare costs, etc. The Hippocratic Oath didn’t cover that. So, in 1970, the term bioethics was coined by University of Wisconsin oncologist, Van Rensselaer Potter, and the idea of ethics in the medical field rose to prominence. In the 1970s, ethics became a subject taught in medical schools, and hospital ethics committees were established for the purpose of deciding ethical issues.
Thus, bioethics appeared at the forefront of the medical profession, but the term is vague and does not come prepackaged with a set of rules to follow, mostly due to its constantly evolving nature. According to dictionary.com, bioethics is defined as “a field of study concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments, as organ transplants, genetic engineering, and care of the terminally ill.” Bioethics covers more than just doctors treating patients. Bioethics is involved in both the human testing and animal testing of new treatments, devices, and drugs. In addition, bioethics is also considered in the idea of assisted suicide and organ transplantation. Bioethics is not even just limited to treatment and research, it also encompasses the ideas of race, gender, and sexual orientation. Over time, the list continues to grow with stem cell research, human cloning, and even combining humans and computers. This list is far from all-inclusive. As medical science continues to advance, new ethical questions will always present themselves.
Since the 1970s, bioethics has a profound connection with the law. Medical scholars discuss their hopes for bioethics, but this doesn’t provide any manner of actual enforcement. Instead, this is where the law and bioethics must intersect. The courts considered bioethical issues like informed consent in Canterbury v. Spence, and whether a mental health professional should warn someone if a patient has made a credible threat of violence during treatment in Tarasoff v. Regents of the University of California. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) was created by Congress. The National Commission went on to create the Belmont Report in 1976 which described three basic ethical principles of respect for persons, beneficence, and justice, which has ultimately served to guide the law of bioethics. The of bioethics is always shifting and always advancing. In the future, there may be countless medical advancements that we can never comprehend. But, we can count on bioethics remaining on medicine’s side, serving as a guide and a legal restraint to protect humanity.
In addition to bioethics, the topic of venture capitalists of medical devices will be discussed at the upcoming symposium. Since 1992 medical technology’s (“medtech”) share of venture capital has been on the decline. More alarmingly, this trend has continued even amidst our recent financial boom. According to a study done by Silicon Valley Bank, medical device financing as a percentage of total venture investments has fallen by nearly 50% since 2010. This shortage of capital has an immediate impact on those involved in the medtech industry as fewer new companies have been emerging. Additionally, it will also eventually affect our entire society due to our dependence on medical devices that enhance our quality of life.
The lack of funding has been driven by various factors, such as difficult liquidity paths and consolidation among the large medical device original equipment manufacturers. However, the biggest deterrent has been that U.S. Food and Drug Administration approvals have become much less predictable and more time-consuming. This has made medical device investments less attractive on the risk versus return scale when compared to other possible investments.
Despite the tough funding environment, there remains a cause for optimism among promising medtech start-ups. According to a report done by the National Venture Capital Association, healthcare-focused venture capital funds raised over $12 billion of new capital in 2016. Additionally, with venture capitalist such as New Enterprise Associates, Versant Ventures, and Domain Associates leading the way, many who have lived through a number of business cycles feel the investment pendulum will eventually swing back to medical devices.
Hopefully, this general overview of topics has sparked your interest and provided you with some understanding of what will be discussed at this Friday’s symposium! The Journal of Business and Intellectual Property Law sincerely hopes to see you there. If you have any questions regarding the symposium please visit our website.