At a time when genetic sequencing technologies are becoming more common within clinical care and research, it is crucial to outline appropriate policies and regulations for the next generation medical and research technologies used. This is according to experts from the Center for Medical Ethics and Health Policy at Baylor College of Medicine, who recently published a special policy issue of the Journal of Law, Medicine & Ethics, addressing the potential legal and ethical challenges, an analysis aimed to help policy makers conduct the transition to a new medical era.
The special issue was developed by the experts as an invitation, and funded with a $1.6 million grant from the National Human Genome Research Institute provided to Dr. Amy McGuire, director of the Center and specialist in legal and ethical issues regarding genetics. The publication addresses a series of subjects, including the U.S. Food and Drug Administration regulation, reimbursement, intellectual property issues, and proprietary databases. The researchers focused on studying the evolution of the genetic sequencing industry, as well as its impacts on politics.
Genetic sequencing technologies are next generation instruments and practices that enable physicians to have more precise data on nucleotides, or building blocks, in a DNA sequence. However, ethically and legally, sequencing is not an easy question to address, and McGuire believes that “this special issue of the journal represents the most comprehensive analysis to date of legal and policy issues associated with the clinical integration of next generation sequencing,”
“Next generation sequencing is potentially transformative for genetic testing applications because it allows clinicians to look broadly across the genome to identify a wide range of genetic changes that are, or may in the future be, clinically significant, as well as to more precisely diagnose and treat disease,” stated the authors McGuire, Dr. David Kaufman, director of research at the Genetics and Public Policy Center at Johns Hopkins University in Washington, D.C., and Dr. Margaret Curnutte, a post-doctoral fellow in the Center for Medical Ethics and Health Policy at Baylor, in an introductory commentary.
“The potential expansion of clinical utility and the decreasing costs have brought next generation sequencing methods to the cusp of mainstream clinical diagnostic testing,” the authors noted, as they highlighted the areas they consider priority of polity uncertainty.
However, while there are already some companies and laboratories working in clinical sequencing and engaged in addressing policy challenges, there is still variability in the analysis, and the authors believe that those challenges must be faced before genomic sequencing integrates clinical care, a reason why they coordinated the publication. “We believe that a more coordinated approach to policy development is needed since this technology presents several challenges that lie outside existing regulatory frameworks,” they said.
The special issue on policy was designed to support policy makers’ decisions, and is divided into several reports, addressing different themes, including the “Regulation of clinical genetic testing by the Center for Medicare and Medicaid Services through its Clinical Laboratory Improvement Amendments, state law, and the FDA,” an article by the legal experts Gail Javitt, of the Johns Hopkins Berman Institute of Bioethics and counsel at Sidley Austin LLP, and Katherine Carner, associate with Allen Boone Humphries Robinson LLP.
The adjunct associate professor at the University of North Carolina at Chapel Hill School of Pharmacy, Dr. Patricia Deverka, and the principal of Dreyfus Consulting, LLC, Jennifer Dreyfus, are the authors of a “Comprehensive review of the coverage and reimbursement environment confronting clinical next generation sequencing.”
The issue also includes the “Examination of current case law related to the patenting of human genes” by Dr. Robert Cook-Deegan of the Sanford School of Public Policy at Duke University; Dr. Subhashini Chandrasekharan of the Global Health Institute also at Duke University; and the “Discussion of the legality of proprietary databases held as trade secrets,” authored by Dr. Barbara Evans, director of the Center for Biotechnology & Law at the University of Houston Law Center.
“There is an immediate need for critical thought about what the highest policy priorities surrounding clinical next generation sequencing are and how we may begin to address them,” the authors added. “To develop policy priorities for clinical NGS in the absence of robust clinical data, we suggest input and deliberation from a broad array of stakeholders including NGS technology and informatics companies, clinical laboratories, health care professionals, insurers, regulatory and public health agencies, health economists and patient groups.”