ORIGINAL FRENCH ARTICLE: ’ADN business « Les biobanques stockent cellules et tissus humains »
by Ulysse Mathieu
Translated Wednesday 18 August 2010, by Bill Scobleand reviewed by
In recent years the development of genetics has given rise to the creation of bio-banks. These structures amass large quantities of genetic information. The legal framework for their activities is fluid. This raises serious issues, and whets diverse appetites.
Sheltering gigantic collections, they are special types of libraries, called bio-banks, which shelve rather peculiar works. Fragments of DNA, extracted from umbilical cords, samples of cancerous tissue by thousands, even hundreds of thousands. This is the case in the United Kingdom, where the DNA of more than 500,000 persons is recorded. While the conservation of human fragments for therapeutic ends and for research is a practice that has long existed, in recent years, with the development of bio-technologies, their number has increased exponentially. "To begin with, they are a tool of the utmost importance for scientists," explains Christine Noiville, legal expert and researcher in the CNRS, director of the Research Center on Law for Science and Technology . "The development of bio-technologies, allied with computer-assisted calculation, permits us to compare thousands of fragments of DNA, and thus to identify the genes that predispose people to certain diseases." The analysis of samples, principally of DNA, also permits us to retrace the path of human population groups. Genetic material is also a source of information about individuals, and the collection of such quantities of information raises some real questions.
"In Europe, and particularly in France, legislation protecting donors has developed notably along two axes: consent, and confidentiality," recalls Christine Noiville. "One of the main concerns is that of extent of consent. Certain donors will be ready to furnish their DNA to aid in research against cancer, but not necessarily for research on cosmetics." While most bio-banks inform their donors about the future use of their samples, this is not the case for certain private companies such as deCODEme, which offers services of detection of predisposition toward certain diseases. The contract states that the donors’ genetic information can be used for research. What types of research? For what period of time? Is this lack of information carefully maintained by the company? By the same measure, it is difficult to know how these private companies will maintain confidentiality of their data. Christine Noiville points also to a gap in the legislation "For the DNA bio-banks, public or private, nothing is set forth for those situations where an organization administering a collection undergoes financial failure." A lack of judicial clarity on this question can be dangerous. Thus, in Japan, we have seen bio-banks sell their collections at auction, along with the furniture.
Bio-banks don’t all have the same statutory existence. In Europe most collections are in the public sector, within institutions overseen by government agencies, research centers, and hospitals. Private bio-banks also exist, mainly with a non-profit profile, controlled by associations. These two types of organisms are mostly financed by public funds allocated for research, and to a lesser degree as partnerships between the public and private sectors. But in certain countries, the bio-banks, in order to make financial gain on their investment, count on patents arising from research on their samples.
Thus, in Iceland, the company deCODE Genetics, which has collected DNA from more than half of the adult population since 1996, is financed by the Roche and Merck laboratories, two entities not known for their altruism.
It’s this DNA business that promises to be lucrative. By registering a patent on a gene responsible for a disease, the company can commercialize a test to detect it, and prevent any other research organization or laboratory from working on counter-expertise or on a less invasive test. For Christine Noiville, it’s not so much the principle of patents that creates the problem, but the manner in which the patents have been accorded and employed these past 15 years in the domain of bio-technology.
A New York judge has just invalidated seven patents covering genes linked to cancer of the breast and ovaries, registered by the laboratory Myriad Genetics. A "Don Quixote" action, according to the jurist. Twenty percent of human genes now identified have already been patented , and their market value already runs to billions of dollars. Enough to indicate that if a legislator wants to deal with this question, he had better get busy with it!