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.
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 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.