ROLE OF RESEARCHERS, PATIENTS AND UNIVERSITIES

Mr. Chairman and members of the subcommittee, thank you for inviting me to address the topic from the academic side, both from the perspective of the research scientist and the university. You have identified an issue which we have dealt with for a few years, in a manner designed to be fair to all concerned. I am pleased to have the opportunity of sharing our views with the committee in the hope that the Congress will be satisfied with our stewartship.

1. The Impact of Biotechnology on Universities

The "biotechology revolution" began in the 1970's with the development of techniques for manipulating microorganisms and mammalian cells so that they produce proteins and nucleic acids having practical and occasionally commercial value. Examples of such techniques are the preparation of hybridomas that produce monoclonal antibodies and the use of recombinant DNA to make proteins such as human insulin. These biotechnologic methods have provided countless opportunities to manufacture important new tools in biologic research and to make valuable new drugs, diagnostic products and agricultural products. The basic research leading to development of these techniques emanated primarily from university-based biomedical research laboratories both in the U.S. and abroad. The major source of support for this research in the U.S. was obtained from federal agencies,

especially the National Institutes of Health and The National Science Foundation.

The academic scientists whose laboratories were engaged in genetic engineering and hybridoma/monoclonal antibody procedures suddenly became the focus of attention of venture capitalists, entepreneurs and major pharmaceutical and chemical companies. With the Supreme Court decision to permit patenting of useful living cells and microorganisms, dozens of universities became engaged in biotechnology patent and licensing activities.

I do not believe that the commercialization of university research is a new phenomenon. Rather it seems to be an inevitable stage in the maturation of a scientific field when the field develops to the point that predicatable laws can be applied to practical situations. In Charles Darwin's time the field of biology was in its descriptive stage and remained so until the era of molecular biology began with Watson & Crick's work with DNA. The fields of organic chemistry and electronics entered their commercial stage generations ago and similar technology transfer activities were experienced in universities.

When

University scientists are engaged primarily in research aimed at fundamental discovery, ie., basic research. practical applications of that research emerge, the

scientist is faced with a decision; should he pursue these

practical applications in the university, transfer the technology to industry or transfer himself to industry. Actually there is a

fourth choice

in which

do not pursue the application at all case society fails to benefit. Many universities have established patent and licensing offices to encourage the

transfer of technology but retain the researcher. The primary motivation of both the university and the researcher is to obtain additional financial support of basic research and not for personal gain or enlarged endowments. I realize that such claims of altruism are suspect but I can assure you that there is little profit being realized within the academic sector from these ventures. My institution has never realized more than $200,000 annually from royalty income whereas our research budget exceeds $200,000,000 annually.

We do have a policy of retaining ownership of patentable inventions in order to insure that they are pursued diligently. However, we also have a royalty distribution policy which is based on the principle that all parties should share. Royalty income is allocated to the inventor, the inventor's department and a minor share is retained by the University. In this manner we encourage commercialization of inventions in a controlled fashion so that society can benefit while preserving the primary emphasis on basic research.

2. Procurement of Human Biological Materials

The most common research materials obtained from humans are blood and tissue specimens. These are commonly obtained from patients but may also be obtained from non-patient research subjects or blood donors. Informed consent is required if the

Special

material is being obtained solely for research purposes. consent is not required if the materials are "waste specimens" from the pathology laboratory although in most cases patients sign hospital consent forms which advise them that excess specimens may be used for research purposes. It should be appreciated that in the usual situation the researcher does not know at the time the material is obtained if it will ever become a component of a technique or product which might have commercial value. Furthermore, in many instances patient identifiers are not retained. These policies are routine and appear to be adequate. 3. Rights of Donors of Research Materials and Rights of

Researchers

In the case where the researcher requests donation of blood or tissue for use in research but is unaware that the material will eventually be used for a commercially valuable purpose, it seems to me that the donor has no rights to a financial claim. The donation was made for research. Under U.S.patent laws the researcher ("inventor") has all legal right to the invention for it is he whose creative talents transformed the human material into something useful. The donor supplied the raw material. This is no different than the owner of a farm who sells the property to a developer who in turn builds houses and retains the profit without returning a share to the original owner. I recognize that a donation is not a sale but I am also aware, as is this subcommittee, that the sale of organs and

tissues is a complex legal matter currently receiving much

attention.

In any event, no deception was involved at the

time of requesting the human materials.

Let us now turn to the situation where the patient or research subject is known to possess removable materials having unique characteristics thought to have commercial value. In this case the Federal regulations governing the protection of human research subjects (45 CFR 46) requires (in section 46.116) that the informed consent include "...an explanation of the purposes of the research...a description of any benefits to the subject or to others which may reasonably be expected from the research..." Clearly, the research subject would have a right to know of the commercial objective prior to deciding whether to donate. Knowlege of this purpose would logically prompt some individuals to request higher financial remuneration than is usually offered. While I see no objection to the attempt to obtain a larger fee or a share of royalty, I am concerned that such a transaction takes on the characteristics of a sale of tissue or blood and that the donor becomes a vendor who may be subject to product liability and warranty risks.

These objective considerations do not get to the essence of the problem trust. Clinical research can not proceed without volunteers. The altruism fundamental to a decision to participate in clinical research is fostered by trust in and respect for the researcher. The fact that we are here today discussing this

issue indicates that there are threats to this trust and respect.