Mr. Chairman, Members of the Committee, I am pleased to appear before you today to discuss the Administration’s views on the Human Genome Project and the use of human genomic discoveries.

I will begin by briefly describing the Human Genome Project and the extraordinary progress that is being made right now in the field of genomics. The Human Genome Project is an international collaborative research effort to characterize the genomes of human beings and selected model organisms. Among the project’s goals are:

· to identify the approximately 100 thousand genes within the human genome;

· to determine the complete sequence of the human genome, the three billion biochemical letters or base pairs of DNA that are the blueprint of life itself;

· to assemble a catalog of common genetic variations within the human genome;

· to analyze the functions of genes and how they interact;

· to develop new technologies to analyze the genomes of humans and other organisms;

· to examine the ethical, legal, and social implications of human genomic research; and

· to train a generation of scientists in this important and expanding field.

Formally launched in October 1990, the Human Genome Project is the largest coordinated biological research effort ever undertaken. The U. S. component of this project is supported by the National Institutes of Health’s National Human Genome Research Institute and the Department of Energy’s Human Genome Program.  The U. K.’s Wellcome Trust, a private philanthropy, also contributes to the global initiative and supports one of the five principal large-scale human genome sequencing centers. Due to advances in technology and increased efficiency in the sequencing process, the project has been proceeding on an accelerated schedule, and expects to completely sequence the human genome two years earlier than was originally anticipated.

This accomplishment – the complete sequencing of the three-billion-letter genetic code – will stand as one of the major achievements of modern biology, one that is significant not as an endpoint so much as a turning point. The Human Genome Project is ushering in a new paradigm of biological and biomedical research, which uses large-scale genomic data to enable us to understand how biological phenomena at a microscopic level are connected to the health and functioning of the whole organism. Fundamental genomics research will offer a new level of understanding of how genes interact, how they vary and where they come from, how they are regulated in development and influenced by the environment, and many other questions at the frontiers of biology.

This fundamental research, enabled in large part by Federal support, will be of tremendous long-term medical and economic value. For example, genes have been identified that are linked to certain forms of cancer, yet much remains to be discovered about what turns them on and off, and what process turns a healthy cell into a cancerous one. In the short term, these genes will be valuable for predictive and diagnostic purposes, and could lead the way to precisely targeted forms of chemotherapy. In the long term, understanding the regulation of genes and their role in the larger disease process will be the key to effective cures or preventative measures. Both public and private support and cooperation will be needed to enable these avenues of research, all of which we must pursue to improve human health.

The Human Genome Project will have a lasting impact on how we detect, treat, and prevent disease. Genome research will help us to design drugs that specifically target the root causes of an illness, to intervene at the earliest possible stages of disease, and to custom-tailor treatments according to a patient’s specific needs. Genomics is also the basis of a burgeoning new industry which, in another decade, is expected to produce more than $45 billion worth of DNA-based products and biotechnologies each year. Federally supported genomics research, in tandem with this vibrant science-based industry, will enable long-term advances in genomic science along with treatments and diagnostics that are of immediate value today.

Right now, the field of genomics is in a period of extraordinary progress. In just the past two weeks we have reached the following milestones:

· The Human Genome Project announced that it had sequenced two billion out of the three billion base pairs of the human genome. Researchers are progressing at a rate of twelve thousand base pairs per minute, 20 times faster than was possible just three years ago. They expect to a complete a working draft of the entire human genome by June. By 2003, we expect to have the human genome sequenced to an accuracy of 99.99%.

· Celera Genomics Corporation, together with the Berkeley and European Drosophila Genome Projects, completed the genome of the fruit fly, an organism that geneticists have studied as a model system for nearly a century. (Celera and the Berkeley group are both represented by witnesses on this panel: Dr. Venter and Dr. Rubin, respectively.) The fruit fly is the most complex organism yet to be understood at this level. Its genome is being made freely available to anyone who requests it.

·  Earlier this week, Monsanto announced its completion of a working draft of the rice genome. Sometimes referred to as the world’s most important crop, rice is the principal food of half of the people on this planet. Monsanto’s data are being shared with an international consortium led by Japan that is sequencing the rice genome, and are also being made accessible to all scientists for basic agricultural research.

These impressive accomplishments in the accumulation of genomic knowledge are due to intensive efforts involving both the public and private sectors. Our knowledge of life at the level of the genome will have a profound impact on fundamental discoveries in biology, on improvements in all areas of medicine, and on our understanding of ourselves as human beings.

President Clinton and British Prime Minister Blair agreed that it is important to take notice, at the highest levels of our governments, of the progress our countries have made in human genomics and of the era of new opportunities before us. Last month, they issued a joint statement of position to help ensure that human genomic discoveries are used as effectively as possible for the advancement of human health throughout the world.

The statement consists of two equally important, complementary principles, designed to maximize scientific opportunities to understand the human genome, as well as medical and economic opportunities for the development of health care products.

· First, the statement reiterates the principle that raw fundamental sequence data from the human genome – the ordering of the A’s, T’s, G’s, and C’s that make up DNA – should be distributed as broadly as possible, in an unencumbered manner, for use by scientists around the world. Since 1996, this principle has been a condition of funding by the Human Genome Project, which makes genomic sequence data freely available over the Internet in a public database called GenBank. Some private-sector genomics companies have also made their raw genomic data broadly available, and we strongly encourage all companies to adopt such policies.

· Second, our statement makes clear that intellectual property protection for gene-based inventions will play an important role in stimulating the development of health care products, which will in turn allow the public to realize the full medical benefits of the fundamental scientific discoveries. As a new generation of medicine begins to rely on gene-based technologies, it is essential that we afford these technologies the kind of intellectual property protection that has enabled the development of every other wave of medical innovations.

Taken together, these principles will speed the translation of the sequence information that we are discovering into products that improve the health of humankind. The human genome is a unique, finite, precious biological resource. These principles will ensure that it is utilized to its fullest.

I want to emphasize that the joint statement does not represent a new position or a change in policy on what can or should be patented. What was patentable before the statement is still patentable today. There was some misunderstanding of this point in the press. The statement does not conflict with or supersede any aspect of existing patent law. Nor does the statement change any aspect of the patent protection that is available for useful genes. The statement reiterates the policy of protecting gene-based inventions.

The complementary principles described in the statement are beneficial to both the private sector and the public. They reinforce the public-private partnership that has fueled the genomics and biotechnology enterprises, by enabling fundamental biological discoveries as well as the entrepreneurship that can capitalize on those discoveries and bring innovations to market. Key companies involved in genomics were quick to issue statements last month endorsing the joint statement.

I would like to close by underscoring the importance of public-private partnerships, which have enabled government funds, investment capital, and research organizations of all shapes and sizes to work together and take risks together on what history will record as one of the most significant scientific and medical endeavors of our time. The Drosophila project led by Dr. Venter and Dr. Rubin is a superb example of the fruits of this kind of collaboration.

A project known as The SNP (pronounced “snip”) Consortium is another exciting collaboration. The SNP Consortium is systematically identifying localized variations in the genetic code, known as single nucleotide polymorphisms or SNPs (“snips”). This consortium of 12 pharmaceutical and technology companies, the Wellcome Trust, and leading academic centers of the Human Genome Project, has discovered more than 40,000 SNPs and has made those data publicly available.

As I said earlier, the sequencing of the genome – the best-known aspect of the Human Genome Project – is only the beginning of genomics. It is the first step into a future of discoveries and innovations that genomics will enable, that the public and private sectors must pursue together. Scientists will learn how genes interact to cause disease; which genes turn on when we learn something new; how genes are affected by hormones, stress, and the environment; and how we can manipulate them for our betterment. There is no phenomenon on earth that is more complex than human health. Genomics will help us to truly understand it.

Genomic discoveries will clearly raise social and ethical issues as well, which will require our attention as a public, as companies, as researchers, citizens, medical practitioners, policy makers, and entrepreneurs. It has been the policy of this Administration to encourage all of these communities to work together as we move along, so that as we increase our understanding of the science, we also advance our understanding of the important social issues that are involved. From the outset, three to five percent of the Human Genome Project budget has been devoted to the ethical, legal, and social issues raised by genetics and genomics.

In his first Executive Order of the new millenium, the President prohibited discrimination in the Federal workplace on the basis of genetic tests. Genetic discrimination is a key concern of patients that has stopped some people from taking advantage of potentially life-saving genetic tests. The Executive Order was developed through consultation with the legal, medical, and scientific communities, and I raise it as an example of how the different communities involved in genomics can and must continue to interact.

An expanding, evolving partnership has made human genomics discoveries possible, and is now poised to make those discoveries beneficial for everyone. It is our desire to see greater collaboration between the public and private sectors in all aspects of human genomics. I believe that the policies that we have pursued will help to strengthen this partnership, allowing genomic discoveries and innovations to move steadily forward for the benefit of our Nation and for all humankind.

Thank you.

Testimony by Neal Lane before the Subcommittee on Energy & Environment, Committee on Science, United States House of Representatives - April 6, 2000

Subcommittee on Energy and Environment

Subcommittee on Energy and Environment

J. Craig Venter, Ph.D. Subcommittee On Energy And Environment

Written Testimony Of Gerald M. Rubin

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