BIO Statement of Ethical Principles

BIO is committed to the socially responsible use of biotechnology to save or improve lives, improve the quality and abundance of food, and clean up hazardous wastes. We encourage discussion of the ethical and social implications of scientific developments in biotechnology research. As our companies develop promising new technology to benefit humankind, this technology also may bring new ethical questions. To help us examine bioethical issues as they arise, we have formed a standing, Board of Directors'-level committee on bioethics.

The bioethics committee was established to define, articulate and communicate effectively BIO's positions and standards of conduct with respect to major bioethical issues. We have put some of our key positions in this web site to give you a perspective on some of our ethical issues.

Preamble

The Biotechnology Industry Organization (BIO) represents biotechnology companies, academic institutions, state biotechnology centers and related organizations throughout the United States and in many other countries. The members of BIO apply biological knowledge and techniques to develop products and services for use in health care, agriculture, environmental remediation and other fields. The benefits of these products and services include saving lives threatened by disease, protecting the blood supply from some infectious agents, improving the abundance and quality of food, and cleaning up hazardous wastes.

While biotechnology can greatly improve the quality of life, we recognize that this new technology should be approached with an appropriate mixture of enthusiasm, caution and humility. Biotechnology can provide useful tools for combating disease, hunger and environmental contamination, but it should not be viewed as a panacea or as miraculous. For example, life-saving medicines may have serious side effects, and, while our expanding knowledge of genetics can help create the next generation of medicines, it can also raise important ethical issues.

With these considerations in mind, we have adopted the following statement of principles. While some of these principles are codified in government statutes and regulations, this statement is intended to provide guidance to our industry that goes beyond legal requirements.

Because biotechnology is changing and growing rapidly, this statement may be expanded from time to time to address new issues that arise.

We respect the power of biotechnology and apply it for the benefit of humankind.

We will pursue applications of biotechnology that promise to save lives or improve the quality of life. We will avoid applications of our technology that do not respect human rights or carry risks that outweigh the potential benefits.

We listen carefully to those who are concerned about the implications of biotechnology and respond to their concerns.

The resolution of bioethical issues requires broad public discourse. We acknowledge our responsibility to consider the interests and ideas of all segments of society and to be sensitive to cultural and religious differences. We will seek dialogue with patients, ethicists, religious leaders, health-care providers, environmentalists, consumers, legislators and other groups who share an interest in bioethical issues.

We help educate the public about biotechnology, its benefits and implications.

For informed debate to occur, the public and our elected representatives need greater knowledge and a better understanding about biotechnology and its applications. BIO and its members pledge to advance public awareness and understanding.

We place our highest priority on health, safety and environmental protection in the use of our products.

In the United States, biotech products are extensively regulated by federal agencies such as the Food and Drug Administration, the Environmental Protection Agency and the Department of Agriculture. Our industry supports science-based regulation by government agencies to safeguard health, ensure safety and protect the environment.

We support strong protection of the confidentiality of medical information, including genetic information.

Individually identifiable medical information must be treated confidentially and safeguarded from misuse. We oppose the use of medical information to promote intolerance, to discriminate against or to stigmatize people.

We respect the animals involved in our research and treat them humanely.

Laboratory animals are essential to research on new therapies and cures. We test new treatments on laboratory animals to assess product safety before administering them to humans. We develop transgenic animals-those with genes from another species, usually humans-to test treatments for life-threatening diseases. We also develop transgenic sheep, goats and cattle by inserting a gene that allows them to produce human pharmaceuticals in their milk. We breed animals that may provide tissues and organs for transplantation to humans. We will follow rigorously all government regulations and professional standards in the United States, such as the Animal Welfare Act and the federal guidelines for animal care and use promulgated by the National Institutes of Health.

We are sensitive to and considerate of the ethical and social issues regarding genetic research.

We will not, for example, treat genetic disorders by altering the genes of human sperm or eggs until the medical, ethical and social issues that will arise from this kind of therapy have been more broadly discussed and clarified. Also, we support continuation of the voluntary moratorium on the potential cloning of entire human beings, with the understanding that research should continue on the cloning of genes and cells to benefit humankind.

We adhere to strict informed-consent procedures.

For clinical research conducted in the United States, the National Institutes of Health and the Food and Drug Administration require informed consent from all participants and approval by a national or local review board. We adhere to these requirements in our medical research, except in situations in which obtaining consent is not necessary (e.g., research on anonymous information) or not possible (e.g., emergency care of unconscious patients).

We will abide by the ethical standards of the American Medical Association and, where appropriate, other health-care professional societies to ensure that our products are appropriately prescribed, dispensed and used.

These ethical standards are designed to ensure that health-care professionals do not receive monetary or other compensation that might adversely affect how they care for their patients.

We develop our agricultural products to enhance the world's food supply and to promote sustainable agriculture with attendant environmental benefits.

There are significant advantages to increasing the yield of crops. Farmers must produce increasing amounts of food per acre to feed a growing global population. We will strive to make this possible while reducing the amount of external supplements (fertilizers, pesticides, etc.) necessary. We will develop our products with an eye toward good stewardship of our agricultural and environmental resources and the sustainability of such development. With regard to the development of new agriculture crops, we pledge to abide by established standards of environmental safety at home and abroad.

We develop environmental biotechnology to clean up hazardous waste more efficiently with less disruption to the environment and to prevent pollution by treating waste before it is released.

Many environmental engineering firms, industry and governments are using biotechnology to harness the power of naturally occurring organisms to degrade contaminants at hazardous waste sites. We will strive to optimize the cost-efficiencies and environmental advantages associated with using biotechnology while protecting human health and the environment. We also will continue to develop and implement more environmentally safe and cost-effective means of treating hazardous waste streams in industrial processes.

We oppose the use of biotechnology to develop weapons.

We support the Biological Weapons Convention, a treaty signed by the United States and many other nations banning development and use of biological weapons. We will not undertake any research intended for use in developing, testing or producing such weapons.

We continue to support the conservation of biological diversity.

The genetic variation of animals, plants and other organisms is a valuable natural resource. The environment is constantly changing, and without an adequate store of genetic diversity, organisms will not be able to adapt. Genetic diversity decreases every time a species, breed or crop variety becomes extinct. Working with governments and other organizations, we will help to catalog and conserve these precious resources.