Precision medicine: drowning in a regulatory soup?

The Hastings Center report, 2017

The United States' ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients' empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term "genomic citizenship"; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the de...

Annual review of genomics and human genetics, 2010

Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted p...

The New England journal of medicine, 2003

Legal and Political Theory in the Post-National Age, CEE-Forum for Legal, Political, and Social Theory Yearbook, Péter Cserne and Miklós Könczöl (eds.), Peter Lang Verlag, 2011

e paper addresses the issue of the necessary scope of legal protection of a person in the age of genomic medicine. More speci cally, the paper aims at analysing the problem of genetic discrimination and identifying justi ed restrictions on the use of genetic test results and genetic information, especially in the areas of employment and insurance. ere will be discussed the main controversies that arise when the legal restrictions on the use of genetic information are at stake.

European journal of human genetics : EJHG, 2008

Genetic research involving humans as well as the commercialisation of its results both raise intricate ethical questions. On the one hand this research is seen as the catalyst to facilitate scientific advancement possibly having enormous potential in treating hitherto incurable diseases, such as Parkinson’ s disease, diabetes or heart failure. On the other hand, moral dilemmas are posed as to justifiableness of research, such as that concerning human embryonic stem cells or manipulating with human biological material, all the more since the aforementioned potentials are rather uncertain at this point in time given the scarcity of expert’ s knowledge and technology in the field. This Report does not intend to discuss the issues of conflict between different values, opposite rights and obligations, or contrasting interests, because they are the prerogatives of every individual and every society, including each Croatian citizen and the Croatian society as a whole. However, a pluralist society has to increase public awareness of these issues, so that the citizens may engage in an informed debate and make a knowledgeable decision. While some of the practices dealt with in this Report have been commercialised, other still have not and are regulated insofar as the research is concerned. Furthermore, will inventions based on the latter become patentable in the future is the issue of balance the state has to maintain between costs and benefits thereof, in a view of investor’ s interests, society’ s commercial and social welfare, freedom of research, as well as ethically sensible aspects related to human rights, human dignity and religious and other convictions. In doing so, history of science and its mis(uses) in practice certainly may teach a good lesson and send the message of the need to increase awareness of the potential hazards an overcredulous acceptance of the “ promising” new practices may have over human kind.

American Journal of Bioethics, 2002

"fair use" exemption would not apply to the use of information in commercial product development; so by virtue of the murky boundary between commercial use and other research the legislation is likely unworkable. Still, it is a rst step toward acknowledging the other important player in the debate-the Everyman. Without evidence that genetics research would be severely hampered by diverging from classic patent law, current opportunity costs are too high and policy should err on the side of promoting all avenues for bringing genetic technologies into clinical care. There is considerable disease about the possibility that we are cramming a round peg representing personal well-being into a rigid, marketbased, square hole. We might gain some insight into this sensibility by considering Margaret Jane Radin's characterization of creeping property interests: "{C}ommodication worries seem to occur only in conjunction with other worries about social wrongs, in particular about subordination and maldistribution of wealth" (1996, 8). Given the considerable anxieties on all sides of the genepatenting issue, we would do well to acknowledge how problematic the current system is and how crucial reconguration is to promoting human health. n References Blumenthal, D., E. Campbell, M. Anderson, N. Causino, and K. Louis. 1997. Withholding research results in academic life sciences. JAMA 277(15):1224± 28. Brody, B. 1996. Public goods and fair prices: Balancing technological innovation with social well-being. Hastings Center Report 26(2):5± 11.

Science, 2011

European journal of cancer (Oxford, England : 1990), 2017

The increasing number of drugs targeting specific proteins implicated in tumourigenesis and the commercial promotion of relatively affordable genome-wide analyses has led to an increasing expectation among patients with cancer that they can now receive effective personalised treatment based on the often complex genomic signature of their tumour. For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required. It is becoming increasingly evident that a re-engineering of clinical research is necessary so that regulatory considerations and procedures facilitate the efficient translation of these required biomarker assays from the discovery setting through to clinical application. This article discusses the practical requirements and challenges of developing such new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovat...