By James Love
The United States, like other countries, uses the grant of legal monopolies as the incentive to reward successful R&D investments. The legal mechanisms are varied, and include most importantly patents on medical inventions, but also a variety of regulatory exclusivities in a patchwork of programs that address (for example) delays in regulatory approval, testing for pediatric patients, development of treatments for rare diseases, rights in test data used to provide new drugs and vaccines, and the development of new antibiotic drugs.
Each of these legal mechanisms that are used to block competition can be evaluated separately, but it is also useful to look at the big picture, and ask – what is the cost of the drug monopolies in the United States?
By James Toomey
After his wife died, Tom, 83, lived with a caretaker. His daughter was worried. Tom wasn’t his old self. He was getting slower, repeated himself, didn’t seem to remember things that mattered. But when Adult Protective Services interviewed him, they thought he seemed fine. Later, when his daughter finally managed to get him into court to appoint a guardian, they discovered that the caretaker had made off with most of his savings.
Meanwhile, Patricia, 85, lived alone. She had some mild cognitive impairment, that was obvious. She didn’t get jokes the way she used to, seemed withdrawn, and her memory wasn’t as sharp. But she could get around on her own. She managed her finances and made her own decisions. A nephew disagreed. He referred her case to a doctor who found that her impairment had progressed to mild dementia, and a court declared the nephew her temporary guardian. If she hadn’t by chance run into an old friend who was an elder law attorney, the nephew would have stolen the tens of thousands of dollars he planned to.
These anecdotes were recently related to me by Professor Peter Lichtenberg of Wayne State University, a clinical psychologist and national expert on the financial exploitation of seniors. We met at last April’s conference “Our Aging Brains” at Harvard Law School, where panelists demonstrated the challenges—and profound stakes measured in human suffering—involved in a legal ruling that an individual with dementia either has or lacks legal capacity.
In March 2018, Cambridge University Press will publish Big Data, Health Law, and Bioethics. This volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, Urs Gasser, and Effy Vayena, stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and examine potential solutions (industry best practices, common law, legislative, executive, domestic, and international) for better use of big data in health care and health research in the U.S.