Editors: Michio Okamoto, M.D., Norio Fujiki, M.D. & Darryl R.J. Macer, Ph.D.
Scientific Attache, French Embassy-Japan
In 1992, three Ministers, Mr Curien (Research), Mr Bianco (Health) and Mr Sapin (Justice), lodged three projects of law:
- Project related to the Respect of Human Body (Justice).
- Project related to the Use of Products of the Human Body, Medical Care, Procreation and Prenatal Diagnosis (Health).
- Project related to the treatment of registered data for research purposes in the field of Health (Research).
This active work of experts, scientists, parliamentarians, and industrial people was realized while the scandal of blood contamination with HIV occurred in France.
Finally two laws were adopted in 1994, commonly called the "Bioethics Laws". These "Bioethics Laws" (Laws 94-653 and 94-654, July 29th, 1994) define the civil status of the Human Body, the gift and use of elements and products of the Human Body for medical care for procreation and prenatal diagnosis. These laws were introduced to make a framework for the trade of body or elements in order to preserve the dignity of human beings. It completes the Law on the Protection of Persons in the Biomedical Research known as Huriet 's law.
With these laws, some organizations have been settled to avoid scandals like the HIV blood contamination mentioned above, including: the Drug Agency, the French Blood Agency. the National Establishment of Transplantation. All this helps the better collection and use of human biological materials. The demonstration of the efficacy in human is also strictly regulated and nobody, now, disagrees with the notion of free consent. Some fields are not covered by the legislation.
Since 1990 when the project of Genethon to sequence all the human genome started, many debates occurred in the problems of patenting. The NIH was the first to deposit demands of patenting for cDNA sequences and opened the controversial debate on the problem of patenting the human genome, which can be regarded, by some, as a non-bioethical practice or giving commercial rights on the use of human body or its elements. Many national assemblies or international bodies agreed on the non-patentibility of the human Genome or partial sequences if no function are described. But the necessity to do so should not prevent the promotion of the scientific knowledge, the necessity to finance the research lead to improve some guidelines to allow the possibility of patenting.
For many reasons, years of efforts to find that way were destroyed in the European Parliament which rejected the guideline for patenting in the field of Biotechnology. The text was rejected, therefore so was the possibility of patenting an invention obtained on or from living organisms or human body. The text distinguished the human body and its elements "as such" and the substances obtained by a technical process from the human body. For substances like these there is no guideline and many opponents took refuge in bioethics.
For the bioindustry this refusal means its death in Europe and for the others, a stop of the use and trade of their own property. This is confusing? Is bioethics a superlaw, a system above the different legislations including the European patent laws? Are the definition of the term employed in the different texts of the laws or guidelines clear enough?
The civil code declares the existence of an extra-patrimonial right to the respect of human body for the benefit of every person. It consider the inviolable status of the human Body (articles 16-1 and 16-3 of civil code).
The non-patentability "de facto" of the human Body, of its elements and products "as such", and the knowledge of total or partial structure of a human gene are declared in article L 611-17 of the Intellectual Property Code. In fact the legislator considers that non-patrimoniality means non patentable. The legislator uses very specific words to design the body, its elements, its products and the operative (daily) wastes but "as such" still remains confusing for neophytes which voted in March at the European Parliament.
The definition of the human body is not yet clear. Some articles of the Public Health code examine different aspects: Dead Body, Operative Wastes. The child still-born is defined as a human person because a civil act is demanded by the Civil Code but this status doesn't exist before. With the new laws an embryo can be regarded as a human body every time the human dignity is affected. Some product of the human body are already defined: blood (law of 4/01/1994 and articles L 666-1 to L 666-13 csp), milk (L 184 csp). But several products are not concerned by the code (L 665-16).
Also the definition of "as such" is not clear for the professional of patenting. Does it mean that when there is no activities on it, the product is non-patentable? Moreover, the comprehension of what is a patent is not well understood as well as the advancement of the sciences especially biotechnology. Many people believe that having a patent means to have the right to exploit the patented invention. This is not the case for instance a drug that is patented still needs approval to enter in the market. Having a sequence of cDNA will not conduct every time to an invention.
Although the European guidelines are rejected, experts on the field of genome analysis and patents agree that a lot of discussion and explanations must be done before the public acceptance of biotechnology will peak. We hope that France and Japan will continue to be more involved in this international debate.