BIO's Commitment to the Socially Responsible Use of Biotechnology

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BIO is committed to the socially responsible use of biotechnology to save or improve lives, improve the quality and abundance of food, and protect our environment. Our board of directors has adopted a Statement of Ethical Principles, and we continue to refine a comprehensive vision of ways to ensure biotechnology is used for the betterment of humankind and not abused.

Ethics

Biotechnology was born under unique social and political circumstances, establishing a precedent that shaped the development of the industry and continues to influence its character even today.

In 1973, a few days after Drs. Herbert Boyer and Stanley Cohen described their successful attempt to recombine DNA from one organism with that of another, a group of scientists responsible for some of the seminal breakthroughs in molecular biology sent a letter to the National Academy of Sciences (NAS) and the widely read journal Science, calling for a self-imposed moratorium on certain scientific experiments using recombinant DNA technology. The scientists temporarily halted their research and publicly asked others to do the same. Even though they had a clear view of their work's extraordinary potential for good and no evidence of any harm, they were uncertain of the risks some types of experiments posed. They suggested that an international group of scientists from various disciplines meet, share up-to-date information and decide how the global scientific community should proceed. International scientists in this exceptionally competitive field complied with this request to halt certain research.

A few months after the request for a self-imposed moratorium, the scientists sent a second letter, endorsed by the NAS, to the National Institutes of Health (NIH), asking it to establish an advisory committee for evaluating the risks of recombinant DNA, develop procedures to minimize those risks and devise guidelines for research using recombinant DNA. In response to the request, the NIH formed the Recombinant DNA Advisory Committee (RAC), which received its official charter in October 1974.

In February 1975, 150 scientists from 13 countries, along with attorneys, government officials and 16 members of the press, met at the Asilomar Conference Center to discuss recombinant DNA work, consider whether to lift the voluntary moratorium and, if so, establish strict conditions under which the research could proceed safely. The conference attendees replaced the moratorium with a complicated set of rules for conducting certain kinds of laboratory work with recombinant DNA, but disallowed other experiments until more was known. The final report of the Asilomar Conference was submitted to the NAS in April 1975, and a conference summary was published in Science and the academy Proceedings on June 6, 1975.

At no other time has the international scientific community voluntarily ceased the pursuit of knowledge before any problems occurred, imposed regulations on itself and been so open with the public.

The NIH-RAC met for the first time hours after the Asilomar conference ended. The committee adopted the conference consensus as interim rules for federally supported laboratories in the United States. It spent the next year developing an initial set of guidelines for recombinant dna molecule research. After public review of the draft guidelines, the RAC published the final version in July 1976. Comparable organizations in other countries promulgated similar guidelines overseeing laboratory research with recombinant DNA. BIO member companies have voluntarily adhered to these guidelines since their inception.

Over the next few years, the RAC revised the guidelines in the face of accumulating data that supported the safety of recombinant DNA laboratory research. Oversight policies of laboratory research in many other countries relaxed as well. During the early 1980s, as the biotechnology industry moved from basic research into product development, the RAC assumed the responsibility of formulating safety standards for industrial manufacturing using recombinant organisms and reviewed proposals voluntarily submitted by companies such as Genentech and Eli Lilly.

As data supporting the safety of recombinant DNA research and product development grew, and biotechnology products moved toward commercialization under the regulatory oversight of the Food and Drug Administration, Environmental Protection Agency and U.S. Department of Agriculture, the RAC began to focus more on social and ethical issues, precipitated primarily by the use of recombinant DNA in humans for therapeutic purposes.

Thus, from its inception, the biotech industry has supported public discussion and appropriate regulation of its work.

BIO values the important role the academic scientific community and the RAC have played in the early stages of recombinant DNA research, biotechnology manufacturing and human gene transfer trials. Their approach, supported voluntarily by private and public researchers, ensured the thoughtful, responsible and very public introduction of and discussion about this new technology.

BIO Activities

BIO is committed to the socially responsible use of biotechnology to save or improve lives, improve the quality and abundance of food, and protect our environment. Our board of directors has adopted a Statement of Ethical Principles, and we continue to refine a comprehensive vision of ways to ensure biotechnology is used for the betterment of humankind and not abused.

As our companies develop technologies that promise to benefit humankind, these technologies also may bring ethical questions. To help us examine bioethics issues as they arise, BIO several years ago formed a committee on bioethics.

In June 2006, BIO's Board of Directors approved the establishment of a Board standing committee on bioethics to enable industry executives to participate in policy, strategy and planning discussions regarding bioethics issues that confront all sectors of the industry: human health, food and agriculture, and industrial and environmental biotechnology.

We actively encourage discussion of ethical and social implications of scientific developments in biotechnology. In response to a call from U.S. Supreme Court Justice Stephen Breyer and others for an ongoing conversation about the societal impacts of legal and judicial decisions, BIO and Ernst & Young initiated the Biojudiciary Project. The 501(c)(3) organization aims to develop informative, objective educational materials and programs to help judges, law clerks and attorneys learn more about biotechnology.

Biotechnology has extraordinary potential to improve the health and well-being of people in the developing world, but significant impediments exist to the development and dissemination of diagnostics, therapeutics and vaccines for the infectious diseases prevalent in developing countries. To explore the obstacles and devise mechanisms for circumventing them, BIO and the Bill and Melinda Gates Foundation joined forces in 2004 to establish BIO Ventures for Global Health, a new non-profit organization. BVGH works with companies, donors and investors to bring new vaccines, therapies, diagnostics and delivery tools to market in developing nations.

To further encourage public discussion of the ethical and social aspects of biotechnology, BIO initiated dialogue with leaders of major religious traditions and denominations. We also have met with members of the public who describe themselves as deeply religious.

These activities led to the signing of a memorandum of understanding between BIO and the National Council of Churches in 2003.

BIO and the biotechnology industry respect the power of the technology we are developing, and we accept the need for appropriate regulation. We work with state, federal and international regulatory bodies to shape the development of regulatory policies that foster safe, effective and beneficial products.

We must continue to address ethical questions that arise as science progresses. 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.

Ethical Issues

A wide variety of social and ethical issues are associated with biotechnology research, product development and commercialization. Below, we discuss some of these issues. For additional information on these and topics not discussed here, please visit our Web site at www.bio.org.

GENE THERAPY
Gene therapy is subject to greater oversight than virtually all other therapeutic technologies. The NIH guidelines require federally funded institutions and their collaborators to submit detailed information about proposed and ongoing clinical trials of gene therapy products. Much of this information must be disclosed to the public. The FDA, which has statutory authority to regulate gene therapy products including clinical trials, collects detailed information about investigational products and clinical trials, reviews adverse event reports, and requires annual reports of all ongoing trials. The combined activities and responsibilities of the FDA, through its statutory role as the regulator of drug development, and the NIH/Recombinant DNA Advisory Committee (RAC), as the forum for public discussion, have served to protect patients while ensuring that important research moves ahead.

The field of gene therapy continues to focus on patients with severe and life-threatening diseases who usually have few treatment options or who have failed all available therapies. Thousands of patients have now received somatic cell (nonreproductive cell) gene therapies targeted at life-threatening genetic diseases, cancer and AIDS.

Since the first clinical trial, started in 1990, more sponsors and academic researchers have moved into the area of gene therapy and are conducting human clinical trials, but the research pace has remained slow and deliberate. Even after a decade of research and clinical testing, many of the gene therapy clinical trials active today are in early-phase studies (Phase I/II) that evaluate the safety of the gene therapy vector (the agent used to carry new DNA into a cell). Gene therapies continue to be in early stages of development because researchers are methodically exploring options for routes of administration, dosing regimes, patient populations, indications, combination therapies and novel vectors.

BIO believes that both the FDA and the NIH/RAC play important roles in the oversight process. BIO recommends that any system of oversight for gene therapy provide the agencies with safety data while ensuring patient confidentiality and protection of trade secrets. BIO is always ready to work with the NIH/RAC and the FDA to develop a system that protects patients without hurting the integrity of the product development process.

GERM-LINE GENE THERAPY MORATORIUM
For more than a decade, the academic and industrial research communities have observed a voluntary moratorium on gene therapy procedures that would affect the germ-line cells-the egg and sperm-that pass on genetic composition.

MEDICAL PRIVACY AND GENETIC DISCRIMINATION
BIO recognizes the need for confidentiality of all individually identifiable medical information. We support national policy-legislation or regulations-to protect the confidentiality of all personal medical information, including data derived from genetic tests. The industry believes that an individual's medical information must be respected, treated confidentially and safeguarded from discriminatory misuse. This protection must be balanced, however, with the need to continue valuable medical research into new diagnostic tests, therapies and cures. BIO believes that protecting patient privacy and promoting medical research are mutually attainable goals.

In September 1996, BIO's board of directors called for strong controls on the use of all confidential medical information, including genetic information. At BIO's urging, 11 national biotechnology industry groups from around the world have also endorsed the call for strong protections against the misuse of personal medical information.

BIO supports legislation that prohibits insurers from denying individuals insurance based on their genetic information. People should have the option of using diagnostic or predictive tests that can help them recognize early warning signs of disease and seek proper treatment. This option could be jeopardized if genetic information were used to discriminate.

STEM CELLS
Researchers can now separate early, undifferentiated stem cells from blastocysts-the 5-day-old ball of cells that eventually develops into an embryo. Such embryonic stem cells can differentiate into any cell type found in the human body, and they also have the capacity to reproduce themselves. The ability to maintain stem cell lines in culture and direct their development into specific cell types holds the potential to save many lives by controlling cancer, re-establishing function in stroke victims, curing diabetes, regenerating damaged spinal cord or brain tissue and successfully treating many diseases associated with aging.

These undifferentiated cells lines are also powerful research tools. By studying these cells, we will begin to understand the mechanisms that guide cell differentiation and de-differentiation.

Scientists have also learned that undifferentiated cells from other tissue (for example, "adult" stem cells) have value. BIO supports research on these cells. However, according to the NIH and the NAS, only the embryonic stem cell can be turned into any cell type.

On August 9, 2001, President Bush announced federal funding would be allowed for research on embryonic stem cell lines that were derived from blastocysts prior to 9:00 p.m. that day. Fewer cell lines than anticipated are available for federal funding. A stem-cell bill calling for the relaxation of the restrictions passed the House in 2005 and the Senate in 2006. President Bush vetoed the legislation, however, and the House failed to override the veto, leaving the 2001 restrictions in place. In the meantime, privately funded research has advanced and use of stem cells in human clinical trials may start soon.

CLONING
Cloning is a generic term for the replication in a laboratory of genes, cells or organisms from a single original entity. As a result of this process, exact genetic copies of the original gene, cell or organism can be produced.

BIO is opposed to human reproductive cloning-using cloning technology to create a human being. BIO was one of the first national organizations to offer public support for voluntary moratorium on research into cloning a whole human being. Human reproductive cloning would involve taking the nucleus of a somatic cell (a body cell that is neither an egg nor a sperm) of a person and inserting it into an unfertilized egg from which the nucleus has been removed. The egg containing the somatic cell nucleus is then implanted into a woman's uterus. In theory, this would lead to the development of a human being after a gestation period. Reproductive cloning is too dangerous and raises far too many ethical and social questions to be undertaken. There are grave moral, ethical and safety concerns surrounding this issue.

Another type of cloning involves somatic cell nuclear transfer to an egg, as described above. However, as the egg divides, the undifferentiated cells are kept in culture and never implanted. A few days after cell division begins, stem cells are separated from the rest of the cells. The stem cells continue to divide, creating a cell line that is genetically identical to the somatic cell from which the nucleus was removed.

Undifferentiated cells that are genetically identical to the patient have remarkable therapeutic potential. Given the proper environments, these cells could develop into new tissues that could replace diseased tissues and cure diseases such as diabetes, Parkinson's, Alzheimer's and various types of cancer and heart disease. This avenue of study could produce replacement skin, cartilage and bone tissue for burn victims and nerve tissue for those with spinal cord or brain injuries. Research is also going on regarding the environmental cues, genes and structures that direct cell differentiation into whole organs composed of different tissue types. This application of cloning technology is often referred to as therapeutic cloning, or somatic cell nuclear transfer (SCNT).

One reason for doing SCNT is to understand the process of reprogramming-how the egg cell takes genetic material from a fully differentiated cell and turns it back into an undifferentiated cell. Once that process is understood, egg cells would not be needed and this process could be replicated in a lab.

Because of the remarkable potential of cellular cloning to cure diseases and restore function to diseased tissues, in 2002 the National Academy of Sciences released a report supporting the use of cloning for therapeutic purposes, but opposing its use for reproductive cloning. BIO agrees with academy's conclusions and positions.

FOOD AND AGRICULTURE Agriculture is fundamental to the economies and environments of the entire world. Agricultural biotechnology is used to modify plants and animals to meet consumer demand for more healthful, nutritious foods, and to produce foods in more environmentally sustainable ways. Crops and animals are also being modified to provide new, more plentiful and safer sources of medicine to treat human diseases. BIO is dedicated to open discussion with consumers, farmers, legislators and opinion leaders regarding ethical issues in the use of agricultural biotechnology.

BIO member companies affirm and uphold the science-based regulation and government oversight of agricultural biotechnology by the Food and Drug Administration, the U.S. Department of Agriculture and the Environmental Protection Agency. This oversight ensures the safety and quality of the food supply and has established effective performance standards for developing safe techniques to reduce agricultural losses to plant disease, insect pests and weeds.

We believe the public should fully participate in the introduction of these new products both through an open, accessible and accountable regulatory system and through exercise of free market choice via market mechanisms.

We encourage increased awareness and understanding of how agricultural biotechnology is being applied and its impact on farming practices, the environment and biological diversity.

USE OF ANIMALS IN RESEARCH
Research involving animals has been critical to understanding the fundamental processes of human biology that are so integral to modern medicine. Biotechnology companies have depended on this research to develop more than 200 drugs and vaccines approved by the U.S. Food and Drug Administration, helping 800 million people worldwide and preventing incalculable human suffering.

BIO members are compelled by ethical and legal concerns to evaluate the safety and efficacy of potential medicines and food products before they are given to humans and animals; the use of animals in research is a requirement for many such products. The appropriate and responsible use of animals is therefore an indispensable part of biomedical and agricultural research. BIO members are committed to act ethically and to apply high standards of care when using animals in scientific procedures.

BIO members are committed to reducing the number of animals used for research when it is possible to develop, validate and use alternative methodologies consistent with regulatory requirements for testing, while maintaining the scientific integrity of the research.

BIO affirms and upholds the science-based regulation and oversight of animal research by the U.S. government agencies. Furthermore, BIO members abide by the regulatory requirements of all other countries in which they conduct animal research. In addition, many BIO members welcome external unbiased agencies, such as the Association for Assessment and Accreditation of Laboratory Animal Care, to evaluate their facilities, provide feedback on programs, and accredit their work.

In addition to human therapeutics, animal research has also been critical to the development of biotechnology-derived veterinary biologics and vaccines approved by the USDA to improve the health of livestock, poultry and companion animals. Genomics, transgenics, and cloning technologies provide new approaches for advancing the quality and efficiency of the production of meat, milk, and eggs and reducing the environmental impact of agriculture. These technologies are also being used to help preserve endangered species.

The ability to conduct humane and responsible animal-based research must be preserved to help conquer disease, alleviate suffering, and improve quality of life. BIO believes that such use is a privilege, imposing a responsibility to provide proper care and humane treatment in accordance with the following principles:

Humane Treatment of Animals. BIO members are committed to improving the quality of human and animal life with biotechnology, while taking responsibility for respecting the animals that support their research and for treating those animals humanely.

Judicious Use of Animals. BIO is committed to the judicious use of animals in biotechnology research for experimental purposes. Alternative methodologies that reduce the number of animals used for research, replace animal experiments with non-animal methods when possible, and refine the use of animals in research (such as using cell and tissue cultures and computer modeling in early screening of the toxic potential of a substance) should be used whenever possible. Biotechnology offers great promise for further reducing use of animals in research.

High Standards of Care. High standards of care should be maintained for animals used in biotechnology research as published by the Institute for Laboratory Animal Research, Commission on Life Sciences, National Research Council (The Guide for the Care and Use of Laboratory Animals, 7th ed.,1996) and the Federation of Animal Science Societies (The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, 1999). Animals must be properly housed, fed and kept in surroundings appropriate to their species. BIO is committed to the minimization of discomfort, distress, and pain consistent with sound scientific practices. Investigators and personnel shall be appropriately qualified for and experienced in conducting procedures on animals and in the husbandry and handling of the species being studied.

Regulatory Oversight. Animal biotechnology research (including products from transgenic animals) is subject to science-based regulatory oversight by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Fish and Wildlife Service (FWS) and other local agencies. BIO will actively work with these agencies to ensure high standards of care and use for all animals involved in biotechnology research.

Increased Public Awareness. BIO encourages increased public awareness and understanding by raising awareness of how biotechnology research involving animals is being applied in human health, animal health, agricultural, industrial and environmental areas.

Open Discussion of Ethical Considerations. BIO seeks to actively and thoroughly study the ethical considerations involved in the use of animals in biotechnology, and to openly discuss these issues with ethicists, consumers, medical professionals, farmers, legislators, scientists, opinion leaders, and other interested groups.

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