[Congressional Record Volume 145, Number 165 (Friday, November 19, 1999)]
[Senate]
[Pages S15094-S15096]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY:
  S. 1981. A bill to amend title XI of the Public Health Service Act to 
provide for the use of new genetic technologies to meet the health care 
needs of the public; to the Committee on Health, Education, Labor, and 
Pensions.


                genetics and public health services act

  Mr. KENNEDY. Mr. President, advances in biomedical science and 
technology in this century have given us many tools to improve our 
understanding of the causes of disease, and to develop better 
strategies to prevent and treat human illness. The recent explosion of 
knowledge in genetics offers us the newest and most powerful weapons in 
the war against disease and suffering.
  The legislation I am introducing, the Genetics and Public Health 
Services Act, will increase the federal, state and local public health 
resources needed to translate genetic information and technology into 
strategies to improve public health.
  Our national investment in science, and in particular in the National 
Institutes of Health, is reaping important dividends for the entire 
country. As a result of the Human Genome Project and other public and 
private sector research, we soon may have access to the entire human 
genetic code. From work accomplished so far, scientists have begun to 
develop a greater understanding of how genes contribute to the 
development of common diseases, such as cancer, diabetes, hypertension, 
depression, heart disease and many other illnesses. Genetic information 
and technology have enormous potential for improving our efforts to 
promote health and combat disease.
  Based on current understanding of genes and human disease, we know 
that at least 65 percent of Americans have or will have a health 
problem for which there is a clear genetic contribution. Some have 
rare, but serious, conditions--such as cystic fibrosis, sickle cell 
disease or phenylketonuria. Many more have common disorders--asthma, 
diabetes, cancer, heart disease, stroke and depression--in which 
genetic predisposition plays an important role.
  Genetic information can help us to understand and identify those at 
risk for serious diseases and conditions, and help doctors monitor 
their health in order to diagnose and treat the diseases before they 
cause irreversible injury or death.
  Advancing our understand of genetics will revolutionize the treatment 
of disease. For example, understanding the genetic factors that 
contribute to Alzheimer's disease will help us to understand why some 
patients seem to respond to a new treatment, while others do not. 
Genetic information may soon be able to predict the types of 
individuals who have intolerable side effects from certain therapies. 
Doctors will be able to use genetic information to choose safer and 
more effective treatments that are tailored to each individual.
  Medical scientists are now beginning to think about genetic-based 
strategies to prevent illness, too. Understanding how genes contribute 
to the development of disease will give us new ways to intervene before 
disease develops. We will be able to use new therapies to prevent 
stroke, heart disease and many other conditions that cause disability 
and premature death.
  We have an unprecedented opportunity to use the expanding knowledge 
in genetics to improve health care. Scientific discoveries based on 
genetic information will change the face of health care in the future. 
But we lack the resources and systems needed today to translate that 
information into effective steps to diagnose, treat, and ultimately 
prevented disease.
  In order to realize the potential benefits of genetic information and 
technology, we must invest the resources needed to translate this 
knowledge into practical approaches to health care. We must do this 
quickly, to keep pace with the explosion of knowledge coming from 
public and private sector scientists.
  This legislation accomplishes these goals by creating two new grant 
programs in the Department of Health and Human Services. The first 
provides grants to states to develop and maintain ways to safely and 
effectively use genetic information in their state and local public 
health programs. The second grant program focuses on the translation of 
new genetic information and technologies to practical public health 
strategies that can be used in public and private health care.
  The grant program for states will support methods to incorporate 
genetics at every level of state and local public health systems. Each 
state and territory has a unique population and a unique public health 
program. This proposal provides states with the support and flexibility 
to design approaches tailored to their specific needs and existing 
resources. States may use funds to establish and maintain essential 
resources, such as information systems, service programs, and other 
fundamental elements. States

[[Page S15095]]

will be required to monitor, evaluate and report on the impact of 
programs and systems funded by the Act.
  Responsible use of genetic information must be based on scientific 
data. The second grant program created by this legislation addresses 
the need for ongoing development and evaluation of public health 
strategies that use genetic information and technology. The bill 
creates a demonstration program for public and private non-profit 
organizations to test innovative approaches for using genetic 
information to improve people's health, and to evaluate the suitability 
of such approaches for incorporation into state and local public health 
programs.
  Broad input from all parties is a key ingredient for successful and 
safe use of genetic information to improve public health. Individuals 
must not be coerced to participate in genetic testing. It is important 
to involve the public in local, state and federal decisions about how 
to use genetic information in developing public health policy.
  Evidence suggests that many people are afraid to take advantage of 
available genetic tests because they fear discrimination in the 
workplace or in the health insurance market. Until we pass legislation 
to stop such discrimination, those fears are grounded in reality. We 
know that steps can be taken to protect the confidentiality of genetic 
information and to better educate the public about the issues 
surrounding genetic testing. This legislation requires each state to 
show how it plans to involve the public in the design and 
implementation of its proposal. The legislation also establishes a 
federal advisory committee to assist the Secretary of Health and Human 
Services in the implementation and oversight of programs under this 
Act.

  Public participation is essential. Our system has failed if we offer 
population-wide testing for predisposition to stroke, but fail to 
educate individuals who must decide whether to be tested. Our system 
has failed if we implement population-wide testing for predisposition 
to breast cancer, but fail to provide access to the care that is needed 
to reduce the risk of developing disease.
  Effective integration of genetics into public health systems must 
build on current efforts of the private and the public sector, 
including the work of many federal agencies. These include the 
achievements of the Human Genome Project at the National Institutes of 
Health, the Food and Drug Administration's oversight of certain aspects 
of genetic testing, the ongoing work of the Secretary's Advisory 
Committee on Genetic Testing, and the contributions of the project on 
the Ethical Legal and Social Implications of the Human Genome Project 
at the Department of Energy. Our new Federal commitment to safe and 
effective use of new genetic information and technology in the public 
health system will also draw significantly upon the expertise of the 
Health Resources and Services Administration. Translating genetic 
information and technology into practice will benefit as well from the 
expertise of the Centers for Disease Control and Prevention in disease 
surveillance and in developing and testing new public health 
strategies.
  This legislation emphasizes the need to educate both health care 
providers and the general public. It also provides the structure and 
resources to include genetics in all aspects of public health--from the 
development of policy to the delivery of services. We must ensure that 
our entire public health system is ready and able to respond to the 
challenge of using genetic information for improving health.
  The Genetics and Public Health Services Act is supported by leading 
public health and genetics organizations, including the American Public 
Health Association, the American College of Medical Genetics, the 
National, Society of Genetic Counselors, and the American Society of 
Human Genetics. The Alliance of Genetic Support Groups--representing 
those who live with genetic diseases--has written eloquently about the 
need to improve the resources dedicated to integrating genetics into 
public health. I am confident this support will grow in the coming 
months.
  Genetics research has brought us to an era of limitless possibility. 
The 21st century will be the century of life sciences. I hope my 
colleagues will join me in this effort to take advantage of this 
unprecedented opportunity to improve America's health. I ask unanimous 
consent that a summary of the bill and letters of support be printed in 
the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

              The Genetics and Public Health Services Act

       Amends the Public Health Service Act to (1) establish, 
     expand and maintain resources and expertise needed for safe 
     and effective use of genetic information and technology in 
     state and local public health programs and (2) support 
     essential applied research and systems development to 
     translate new and emerging genetic information into practical 
     public health strategies.


       block grants, applied research and demonstration projects

       Creates a new federal-state matching block grant program to 
     (1) develop systems that promote access to quality genetic 
     services regardless of race, ethnicity, and ability to pay; 
     (2) establish, maintain, or supervise programs to reduce the 
     mortality and morbidity for heritable disorders in the 
     population of the state; (3) identify and develop a network 
     of experts within state and county health agencies to assess 
     the need for and assure the referral to or provision of 
     quality genetic services; (4) promote understanding among the 
     public and health care professionals of genetic disorders; 
     and (5) provide a mechanism for public input on state-
     designed genetic policies and programs.
       Establishes new authority to develop and evaluate 
     strategies to use emerging genetic information and technology 
     to improve the public health.
     Application requirements and procedures
       Block grants: In general, individual states will apply for 
     and receive the block grants; however, two or more states may 
     submit a joint multi-state application.
       Applied research/demonstration projects: Eligible entities 
     are states and public or private non-profit organizations, 
     which may partner with other entities in the private sector.


                   establishes an advisory committee

       Members include representatives from other appropriate 
     federal agencies, the clinical genetics community, research 
     community, private sector, the public, and state health 
     agencies. The Committee shall (1) assist the Secretary in the 
     implementation of the Act, (2) assist with coordination among 
     participating agencies and (3) maintain involvement of the 
     broader health community in the development and oversight of 
     related Public Health and Genetics programs.


                     authorization and allocations

       Authorizes $100,000,000 for each of fiscal years 2000 
     through 2009. Seventy percent is dedicated to state block 
     grant programs, evaluation activities and the Advisory 
     Committee. Thirty percent of the total allocation is set-
     aside for funding demonstration projects. States are eligible 
     for a minimum of up to $400,000 annually from the block 
     grant; allocations in excess of $400,000 are determined by a 
     formula based upon population. Funds may be expended for two 
     fiscal years after initial award; unspent funds may be 
     reallocated. States must provide $2 for every $3 federal 
     dollars.


                                reports

       States report annually to HHS on the activities supported 
     by the block grant. HRSA and CDC submit an annual report to 
     the Advisory Committee on activities supported by the Act; 
     this report is transmitted by the Advisory Committee with 
     comments to the Secretary and to Congress.
                                  ____



                           American Public Health Association,

                                 Washington, DC, November 9, 1999.
     Hon. Edward M. Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: The American Public Health 
     Association (APHA), representing over 50,000 public health 
     professionals dedicated to advancing the nation's health is 
     pleased with your introduction of the Genetics and Public 
     Health Services Act.
       This legislation would amend the Public Health Service Act 
     to expand public health resources needed to translate genetic 
     information and technology into practical strategies to 
     improve the public health. APHA strongly supports the safe 
     and effective integration of genetic information and 
     technology into public health practice.
       Specifically, the legislation would provide funding to 
     states to develop and maintain resources needed to use 
     genetic information and technology at all levels of public 
     health systems. The bill would support the development of 
     expertise within state and county health agencies to evaluate 
     the potential impact of public health strategies based on 
     genetic information, to assess the need for genetic services, 
     to provide expert input for policy development, and to assure 
     appropriate referral to or provision of quality genetic 
     services regardless of race, ethnicity or ability to pay.
       APHA looks forward to working with you in moving this 
     important legislation forward. Thank you again for your 
     leadership on this important public health matter.
           Sincerely,
                                                Mohammad N. Akher,
                                               Executive Director.

[[Page S15096]]

     
                                  ____
                           Alliance of Genetic Support Groups,

                                Washington, DC, November 10, 1999.
     Senator Edward Kennedy,
     U.S. Senate, Washington DC.
       Dear Senator Kennedy: On behalf of the members of the 
     Alliance of Genetic Support Groups, I am writing to express 
     our strong interest in increasing resources for the necessary 
     expansion of genetic services within state, federal and local 
     public health systems.
       The Alliance of Genetic Support Groups is a national 
     coalition of individuals, families and professionals working 
     together to enhance the lives of everyone with genetic 
     conditions. The Alliance mission is to bring the ``people 
     perspective'' to the forefront of discussions about access to 
     quality healthcare, privacy, discrimination and research. 
     Representing 280 support groups of individuals and families 
     with genetic conditions and professional organizations, the 
     Alliance acts on behalf of over three million individuals and 
     families.
       We know, through our membership network and callers to our 
     Genetics Helpline, that resources are desperately needed to 
     address the disparities across the state and federal public 
     health systems.
       We want to emphasize that genetics, from a public health 
     perspective, is much more than simply genetic testing. Vastly 
     increased resources are needed to prepare public health 
     systems to deliver comprehensive and quality genetic 
     services. We need to train public health professionals, 
     educate the public, create family-centered public policies 
     and develop a comprehensive care system that links people to 
     all the services they need--before, after and as a result of 
     genetic testing.
       We applaud your commitment to address these concerns, as 
     well as others close to our members' hearts, about genetic 
     discrimination, privacy and access to quality health care. 
     The Alliance of Genetic Support Groups deeply appreciates all 
     that you have done and are continuing to do to ensure the 
     translation of genetic knowledge into improved public health.
           Sincerely,
                                                 Mary E. Davidson,
     Executive Director.
                                  ____

                                                  American College


                                           of Medical Genetics

                                  Bethesda, MD, November 10, 1999.
     Hon. Edward M. Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: As President of the American College 
     of Medical Genetics (ACMG), I am writing to express our deep 
     appreciation and support for your efforts to address the need 
     for more extensive resources and services for public health 
     genetics at the state and federal levels.
       The ACMG is a professional organization representing board-
     certified clinical and laboratory geneticists. We are the 
     newest specialty to be recognized by the American Board of 
     Medical Specialties, and we have full representation in the 
     House of Delegates of the American Medical Association.
       As I recently testified before the Secretary's Advisory 
     Committee on Genetic Testing, knowledge of genetics has 
     expanded rapidly thanks to the enormous international 
     investment in the Human Genome Project. However, little 
     attention has been paid to the crucial issue of integrating 
     it into health care delivery. Medical geneticists are 
     uniquely aware of the need for a thoughtful and organized 
     approach to the translation of achievements in research so 
     that all physicians can more effectively address the problems 
     of individuals who suffer from or have a predisposition 
     toward diseases caused by genetic defects. It is increasingly 
     clear that virtually every common (or rare) disease has a 
     genetic component, thereby making every American citizen a 
     potential beneficiary of medical genetic services. Thus the 
     tools to prevent and to effectively treat diabetes, cancer, 
     hypertension, heart disease, Alzheimer's, asthma, and so many 
     others, will depend not only on knowledge and technology, but 
     also on a systematic integration of these into our health 
     care system at all levels.
       The bill you have introduced (Genetic and Public Health 
     Services Act) provides the resources and organization that 
     can unite the expertise of geneticists and public health 
     officials and help us enter the next century with tools to 
     dramatically improve the public health.
           Sincerely,
                                                 R. Rodney Howell,
     President.
                                  ____

                                               National Society of


                                     Genetic Counselors, Inc.,

                               Wallingford, PA, November 16, 1999.
     Senator Edward M. Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: The National Society of Genetic 
     Counselors (NSGC) is pleased to write this letter of support 
     for a bill you are introducing to establish ``The Genetics 
     and Public Health Services Act.''
       The National Society of Genetic Counselors is the leading 
     voice, authority and advocate for the genetic counseling 
     profession and represents over 1700 genetic counselors. 
     Genetic counselors are master's degree level trained 
     healthcare professionals. We work with patients to help them 
     understand the genetics of their condition and implications 
     for other family members, coordinate evaluations, testing and 
     care and link patients with supportive resources. In our work 
     with patients, we translate complex genetic information into 
     understandable terms and promote autonomous decision-making 
     about their healthcare. Additional information about the NSGC 
     can be found on our website (http://www.nsgc.org).
       Advances are rapidly being made on the identification of 
     gene mutations that cause diseases and genetic conditions. 
     The Human Genome Project, which was initiated in 1990, is 
     mapping the location of all genes. The wealth of genetic 
     information generated by the Human Genome Project will 
     require wide dissemination. Strategies must be developed to 
     translate this genetic information into quality healthcare. 
     Clearly, there is a great need for the development of 
     programs that will ensure that patients are appropriately 
     referred and have access to quality genetic services 
     regardless of race, ethnicity and ability to pay. It will 
     also be important to develop programs that will ease the 
     physical burden associated with genetic conditions and 
     improve treatment.
       We would like to express our appreciation for your past 
     efforts on healthcare issues, particularly your efforts with 
     the Kennedy-Kassebaum bill to address the risk of genetic 
     discrimination. With the introduction of ``The Genetics and 
     Public Health Services Act,'' you demonstrate foresight in 
     anticipating the greater need for genetic services, once 
     again showing your commitment to quality healthcare for all 
     of us.
           Sincerely,
                                                 Wendy R. Uhlmann,
     President.
                                  ____

                                              The American Society


                                            of Human Genetics,

                                  Bethesda, MD, November 10, 1999.
     Hon. Edward M. Kennedy,
     U.S. Senate, Washington, DC.
       Dear Senator Kennedy: As President of the American Society 
     of Human Genetics (ASHG), I am writing to express our deep 
     appreciation and support for your efforts to address the need 
     for more extensive resources and services for public health 
     genetics at the state and local levels.
       The ASHG is a professional organization representing a wide 
     spectrum of human genetics professionals including clinical 
     and laboratory geneticists, genetic counselors, nurses and 
     others interested in the many phases of human genetics 
     studies.
       As was recently stated before the Secretary's Advisory 
     Committee on Genetic Testing, knowledge of genetics has 
     expanded rapidly thanks to the enormous international 
     investment in the Human Genome Project. However, little 
     attention has been paid to the crucial issue of integrating 
     this knowledge into health care delivery. Medical geneticists 
     are uniquely aware of the need for a thoughtful and organized 
     approach to the translation of achievements in research, so 
     that all physicians can more effectively address the problems 
     of individuals who suffer from or have a predisposition to 
     diseases caused by genetic defects. It is increasingly clear 
     that genetic factors are important for virtually every common 
     condition that affects large segments of the population. 
     Thus, the capability to prevent and effectively treat 
     diabetes, cancer, hypertension, heart disease, Alzheimer's, 
     asthma, and many others, will depend not only on expanding 
     knowledge and technology, but also on a systematic 
     integration of these advances into our health care system at 
     all levels.
       The bill you have introduced (Genetic and Public Health 
     Services Act) provides the resources and organization that 
     can unite the expertise of geneticists and public health 
     officials and provide the means to dramatically improve the 
     health of the people by the provision of quality genetic 
     services.
           Sincerely,
                                                      Uta Francke,
                                                        President.
                                 ______