BIO Statement of BIO Ethical Principles
The Biotechnology Innovation Organization (BIO) is committed to the socially responsible development and use of biotechnology to help save or improve lives, improve the abundance of food and reduce agriculture’s environmental impact, develop renewable sources of energy, and reduce the production of pollution in manufacturing. We encourage discussion of the ethical and social implications of scientific developments in biotechnology. As our companies work to develop promising new technologies to benefit humankind, applications of these technologies also may raise ethical questions. To help us examine bioethics issues as they arise, we have an established BIO Board Standing Committee on Bioethics.
Our Bioethics Committee was established to define, articulate, and communicate effectively BIO's positions with respect to major bioethics issues. As part of this commitment, we have developed these principles and post them publicly.
BIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations throughout the United States and in more than 30 other countries. The members of BIO apply biological knowledge and techniques to develop products and services for use in health care, agriculture, energy, 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, increasing food production on less land and with fewer chemical, water, and energy inputs, diversifying energy sources, and aiding the clean-up of hazardous wastes.
While biotechnology can greatly improve the quality of life, we recognize that this technology should be approached with an appropriate mixture of enthusiasm, oversight and humility. Biotechnology can provide useful tools for combating disease, hunger, climate change, 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, its potential for misuse requires ethical assessment.
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 not intended to establish any legally-binding standards; rather, it is intended to reach beyond legal requirements to provide a framework for members of our industry to consider and address ethical issues.
Because biotechnology is changing and growing rapidly, this statement may be expanded or amended periodically to address new issues that arise.
We respect the power of biotechnology and apply it for the benefit of humankind.
We place our highest priority on health, safety, and environmental protection in the development and use of our products. We will pursue applications of biotechnology that hold the promise of saving lives or improving the quality of life. We will avoid applications of our technology that do not respect human rights or carry risks that outweigh their potential benefits. We support science-based regulation by government agencies of the development and use of our products to safeguard health, ensure safety, and protect the environment.
We support universal access to affordable, sustainable, high-quality health care for all.
We are committed to expanding the boundaries of science by discovering, developing, and delivering innovative and needed medications to patients. We believe that all patients who can benefit from our medications and therapies should have access to them. We support effective and sustainable solutions to enable more people to secure health coverage and access to the latest innovations in medical treatment, while maintaining incentives for innovation to occur. We also recognize the significant unmet health needs that are prevalent in the developing world and believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are mutually supportive.
We listen carefully to those who are concerned about the implications of biotechnology and respond to their concerns. We help educate the public about biotechnology to enable an informed public discourse about its benefits and implications.
BIO and its members pledge to advance public awareness and understanding. The resolution of bioethics issues requires an informed, broad public discourse. We appreciate the responsibility to consider the interests and ideas of all segments of society, including sensitivity to cultural and religious differences. We will seek and engage in dialogue with patients, ethicists, religious leaders, health-care providers, researchers, environmentalists, consumers, legislators, and others who share an interest in bioethical issues. BIO believes that patient and consumer viewpoints and concerns should be represented and respected throughout the product development process.
We support strong protection of the confidentiality of medical and genetic information.
We respect the confidentiality and privacy of medical and genetic information. We also recognize the potential clinical benefit and improvements in the quality of care associated with the adoption of electronic health records and support the adoption of health information technology aimed at improving the efficiency and effectiveness of the health care system. Individually identifiable medical and genetic information needs to be treated confidentially and safeguarded from misuse. We oppose the use of medical or genetic information to promote intolerance, to discriminate against, or to stigmatize people.
We adhere to strict informed-consent procedures.
We support adherence to the requirement of informed consent in our medical research. For example, for clinical research involving human participants conducted in the United States, the Office of Human Research Protections, the National Institutes of Health, and the Food and Drug Administration require informed consent from all participants and approval by a national, regional, or local review board.
We are sensitive to and considerate of the ethical and social issues raised by the research, development, and application of gene therapy.
We will pursue applications of biotechnology that hold the promise of saving lives or improving the quality of life. We recognize and agree that the medical, ethical, and social issues surrounding treatment of some genetic disorders by certain gene therapies require continued clarification and discussion. We will support and participate in such discussions and work toward advancing gene therapies in a medically and socially responsible manner.
We support the current voluntary moratorium on the cloning of entire human beings.
We support the continuation of the voluntary moratorium on research and practices designed solely to clone entire human beings, with the understanding that research should continue on the cloning of genes and cells to benefit humankind due to its potential to save lives or improve the quality of life.
We must balance access to novel therapies with appropriate regard for patient safety and efficacy.
We have an ethical obligation to develop drugs and biological products for patients and make them available as fast as possible to those who may benefit. A patient's interest in obtaining treatment from an unapproved product does not supersede this ethical obligation. In certain situations, companies may work with regulatory authorities to make unapproved products available to seriously ill patients outside of the clinical trial process if they (and their physicians) believe an experimental product could save or prolong their lives. Recognizing that early access programs could hurt the integrity of the clinical trial process and thus may jeopardize availability of the drug for a larger patient population, we encourage companies to weigh carefully the attendant benefit and risks when considering development of an early access program.
We will support policies that protect patient care and research integrity, as well as promote productive relationships among industry, academic, and government researchers. We will not provide financial or other compensation to researchers or clinicians to influence their research results or clinical decision-making.
When addressing financial conflicts of interest, institutional and government policymakers should develop policies that promote important and beneficial collaborations, while maintaining research integrity and ensuring that patients receive high-quality care.
Financial conflicts and potential conflicts of interest should be identified, disclosed, and addressed. However, close relationships among industry, academia, and government researchers have benefitted research and patient care. Financial relationships between academia and industry help bring new drugs to the market for patients and fuel economic development in states or regions. They also increase research budgets, supplementing funds obtained elsewhere. Nevertheless, financial relationships should never be used to influence research results or clinical care.
We respect the animals involved in our research and treat them humanely.
Laboratory animals are essential to research on new therapies and cures, as well as environmental and industrial products that support sustainable development. We test new treatments on laboratory animals to assess product safety before administering them to humans. We test new environmental and industrial products and applications on laboratory animals to assess human health and environmental safety. We will follow rigorously all government laws and regulations for animal care and use. For example, in the United States we will adhere to the Animal Welfare Act and guidelines promulgated by the National Institutes of Health. We also search for ways to reduce the use of animals in research.
We develop our agricultural products to enhance the world's food supply and to promote sustainable agriculture with attendant environmental benefits.
Agricultural products improved through biotechnology have provided significant benefits to farmers and consumers by substantially increasing the productivity of food, feed, and fiber, while simultaneously helping to decrease the environmental impact of agriculture. Crops improved through biotechnology are a key tool for enhancing the sustainability of agriculture, strengthening rural economies, and providing a safe and abundant food supply, especially as farmers must produce increasing amounts of food per acre to feed a growing global population. As we develop new products, we will practice good stewardship of our agricultural and environmental resources and promote sustainability. We pledge to advance science-based approaches to regulation and stewardship.
We develop environmental biotechnology to help reduce pollution and increase environmental sustainability by developing cleaner bio-based manufacturing processes.
We will strive to optimize the cost-efficiencies and environmental advantages and benefits associated with using biotechnology in traditional manufacturing, while protecting human health and the environment.
We use biotechnology to develop new sources of energy.
We use biotechnology in our efforts to develop biofuels that provide energy in a manner that promotes environmental stewardship and reduces our nation's dependency on and use of fossil fuels. We also promote the development of technologies to improve the production of biomass and dedicated energy crops for use as feedstocks for bioenergy production.
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. BIO supports research and development activities, including public-private partnerships, that identify, treat, or prevent harm from any biological, chemical, radiological, or nuclear agent.
We 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 conserve these precious resources.