Statement of Michael J. Werner, Esq.

Statement of Michael J. Werner, Esq.
Vice President, Bioethics
Biotechnology Industry Organization
Before the
President's Council on Bioethics
June 12, 2003

Good afternoon Mr. Chairman and members of this distinguished council. My name is Michael Werner. I am Vice President for Bioethics for the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 states and 33 other nations.

Thank you for the opportunity to speak today about the values underlying appropriate regulation of biotechnology and biomedical research.

BIO members conduct genetic, cellular and protein research, and develop health-care, agricultural, industrial and environmental biotechnology products that are used by billions of people world wide to identify and meet unmet medical needs, improve the quality of the food supply, and broaden scientific understanding.

The biotechnology industry has been a remarkable success story. There are currently 157 FDA-approved products on the market that have helped more than 325 million people worldwide. In 2002 alone, our members had 35 products approved by the FDA as safe and effective opportunities for treating a range of illnesses, including hepatitis B and C, arthritis, multiple sclerosis, and many forms of cancer.

Our industry has achieved these scientific accomplishments in part because the state and federal regulatory system that governs the development and use of our products works. Our nation's regulatory system assures patients and their physicians that they can rely on the safety and efficacy of our products. Biotechnology companies have always worked with and within this regulatory system to ethically bring safe and effective products to market. BIO is proud that scientists are able to sustain aggressive lines of inquiry while complying with a robust and diverse regulatory system including oversight from agencies such as the US Food and Drug Administration and National Institutes of Health.

We believe that knowledge and understanding progresses not only through scientific research, but also through dialogue and discussion. Throughout its history, BIO has been actively involved in bioethics education and discussion inside the industry, at all levels and branches of government, and with the public.

Many years ago, BIO formed a Bioethics Committee, chaired by a member of our Board of Directors to discuss bioethics issues and the Board adopted a Statement of Ethical Principles that details ethical uses of biotechnology. We are proud that the previous chair of our bioethics committee served on the National Bioethics Advisory Commission - the group that preceded you.

The existing regulatory and ethical framework within which biotechnology companies operate has successfully protected patients while allowing critical research to advance. Appropriately, current regulations embody values such as autonomy (for example, whether to participate in a clinical trial), beneficence, and social justice. These values should remain the basis of any regulatory system. In addition, personal autonomy and privacy as well as academic freedom should be a crucial part of the discourse for further understanding the use of what you call "new technologies and practices" in assisted reproduction, embryo research, and human genetics.

The American legal system is grounded in the fundamental right of individuals to define their own existence through personal and shared decision making. BIO members share the belief inherent in American civil rights laws that our lives are not preordained by our genetics, but are often the result of the choices that individuals make, the choices that parents make for their children and the opportunities available in our communities and our physical environment. Choices such as whom to marry, whether to have children, how to raise those children, and whether to accept or refuse medical care, have long been protected by the Constitution. The individual has a right to make these decisions, including health care decisions, whether or not biotechnology products or an understanding of genetic factors is involved.

The individual's freedom of self-determination extends to parental rights. American law and societal norms have historically respected the family's right to autonomy, and have long recognized parents' rights and responsibilities to make important decisions that affect their children's futures. These rights and duties should be read to include the responsible use of genetic information as well as other medical, social and personal information about the child.

BIO strongly supports education about biotechnology and genetics and the freedom to explore their potential uses for the benefit of humankind. State and federal regulatory systems must support and promote the "freedom of responsible inquiry" which is at the heart of First Amendment-protected academic freedom.

These values animate our members' research and their development of products that licensed practitioners use to provide services that may be elected by individuals for themselves and their children. Such products and services allow millions of people to pursue their own destinies as they choose to live productive and healthy lives.

In conclusion, members of the biotechnology industry respect the power of the technology they are developing, and accept the need for appropriate regulation. In our view, appropriate regulation of biotechnology is solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom.

BIO works with state, federal and international regulatory bodies to shape the development of regulatory policies that foster safe, effective and beneficial products. Moreover, BIO supports responsible and ethical testing of new technologies and believes that decisions regarding whether and how to use medical products and technologies always must be made with profound respect for the rights of patients.

But we cannot condone regulations that unjustifiably curtail the intellectual freedom of researchers to think and dream in the pursuit of greater understanding which could lead to a better life for all of us. Patients and their families are counting on our companies to develop products to meet unmet medical and health care needs. Thank you for the opportunity to express these views.