History of Voluntary Moratoria in Biotechnology Research

Given the potential harm to biomedical research which will be done by H.R. 922 and S. 1599/S. 1601, BIO urges the Congress to reconsider this entire effort. BIO has supported the President’s call for a moratorium on human cloning as an alternative to legislation and believes that such a moratorium, coupled with the FDA assertion of jurisdiction over any proposed experiment with it, provides an effective alternative to legislation.

The history of strong adherence to moratoria in biotechnology research shows that this moratorium can and should be continued with regard to the cloning of entire human beings and that it will be effective.

Early Biotechnology Research: In the mid 1970s, when the industry was very new, researchers wondered whether their work would pose hazards to human health, and they worried over the potential environmental impact of genetically engineered microorganisms.

There were no easy answers to those early concerns, although most researchers thought their work could be extraordinarily beneficial and would pose no safety risks. Because of these questions, however, a moratorium was declared by academicians and industry itself on all experimentation until there could be a full debate of the issues. In 1974, the NIH began a program to consider the state of knowledge and what risks might be posed by biotechnology. In 1975, at the Asilomar Conference Center in California, a group of scientists drew up principles to govern biotechnology research and established the NIH Recombinant DNA Advisory Committee. This subcommittee was given the responsibility to review experiments about which there was uncertainty or ethical concern.

These guidelines have been modified over the years as scientific and regulatory experience has shown that most biotechnology procedures pose little or no risk. In fact, high school students now conduct recombinant DNA experiments involving cloning cells in their biology labs.

BIO and its members support the research guidelines of the NIH advisory committee. Even though not specifically required to do so, BIO companies voluntarily adhere to these guidelines. Developing specific guidelines, rather than passing laws to try to determine the areas appropriate for scientific pursuit, allowed the biotechnology industry to grow and develop life-saving medications and vaccines. Hasty legislation could have halted the industry's growth in its infancy. The industry still maintains its promise of beneficial new medications that should not be swept aside.

Industry's Commitment to Moratorium on Germ Line Gene Therapy: During the past ten years, research and development efforts to perfect somatic cell gene therapy procedures in humans and germ line gene therapy procedures in animals have proceeded at a vigorous pace. At the same time, the academic and industrial research communities have observed a voluntary moratorium on the development and practice of germ line gene therapy procedures in humans; a voluntary moratorium which, to our knowledge, has not been violated. If and when this moratorium is lifted for a particular medical therapy, it will be because an informed public debate has produced a consensus that the benefits of this technology outweigh any potential harm.

BIO recognizes that some may argue that voluntary moratoria will inevitably fail as safeguards and thus would seek to prohibit all research procedures which if taken to their final possible conclusion would result in the cloning of entire human beings. We must however, respectfully disagree. Over the last decade the biomedical research community in the U.S. has provided a salutary example of the power of responsible, voluntary restraint, illustrated by honoring this moratorium on germ line gene therapy. The industry has worked closely with the NIH Recombinant DNA Advisory Committee in upholding this moratorium.

As a nation, we should take pride in this experience with a moratorium on germ line gene therapy in humans. We should follow this example in determining how to restrain the cloning of entire human beings, without undermining the use of nuclear transfer and cloning technologies to improve and save the lives of many Americans.

Recognizing the industry's experience with moratoria, BIO urged NBAC, and it urges the Congress, to rely on the continuation of the moratorium on the cloning of entire human beings, coupled with FDA regulatory jurisdiction, in lieu of legislation.

BIO has notified all of our member companies that the moratorium is in effect and request that they notify us if they are conducting any research which might be inconsistent with the moratorium. BIO has offered to work with NBAC and with the Congress to determine what procedures should be followed if and when a specific proposal is made to clone an entire human being. We believe that there is ample time to determine these procedures well before any such proposal is made. We have offered to develop recommendations and share them with the Subcommittee when they are available.

BIO believes any process to evaluate such a proposal must address all the pertinent scientific, medical, legal, cultural, and ethical issues. We believe such procedures should initiate a dialogue which should include all appropriate segments of society, the potential beneficiaries of the research as well as religious leaders and others, to evaluate the ethical implications and acceptability of such a proposal. Furthermore, any such proposal must meet scientific criteria for protecting human subjects in research.

BIO’s call for a moratorium has been echoed by the Federation of American Societies of Experimental Biology (FASEB), the Association of Societies of Reproductive Medicine, the Society for Developmental Biology and other prominent organizations representing scientists who might have the technical capacity to attempt human cloning. The moratorium statements of these groups are printed in the appendix to my statement.