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Part 1.6. Health Research Fairness of California Health And Safety Code >> Division 1. >> Part 1.6.
This act shall be known and may be cited as the Health
Research Fairness Act.
The Legislature finds and declares all of the following:
(a) The National Institutes of Health (NIH), the nation's major source of funding for medical research conducted in the United States, spends approximately 13 percent of its budget for research on conditions and diseases that are primarily women's health issues. Although it is true that the great majority of the NIH research funds are expended for studies of diseases that affect both men and women, or for fundamental research that has significance for diseases affecting all segments of our population, women have not been adequately represented in research populations in major NIH-funded studies of diseases which affect both men and women.
(b) Today many medical treatments currently used on women are based on studies conducted entirely on men. For example, although cardiovascular illness is the number one cause of death and disability in American women, women have consistently been excluded from major research studies in this area.
(c) It is estimated that 175,000 American women will develop breast cancer, and 44,000 women will die from the disease this year. Currently, one in nine women born in the United States will develop breast cancer in her lifetime.
(d) Women constitute 11 percent of all reported AIDS cases. Eighty percent of all HIV-infected women are women of color.
(e) Osteoporosis, a condition characterized by excessive loss of bone tissue, affects an estimated 24 million Americans and results annually in an estimated $10 billion in direct medical costs. The cost of this disease will continue to escalate as the population ages and the incidence of osteoporosis increases. If current trends continue, the cost of osteoporosis treatment could be as much as $62 billion by the year 2020.
(f) Eighty percent of individuals affected by osteoporosis are women. One-half of all women over age 45 years, and 90 percent of all women over age 75 years, suffer from osteoporosis.
(g) Nearly one million couples seek medical advice or treatment for infertility. In the last 20 years, the number of infertility-related visits to doctors has nearly quadrupled. The risk of infertility is one and one-half times greater for blacks than for whites.
(h) Despite these facts, women's health issues--which are defined as diseases or conditions that are unique to women, are more prevalent or more serious in women, or for which specific risk factors or interventions differ for women--have received insufficient attention both in terms of funding and research.
(i) The best way to treat women's health problems is to prevent them from occurring, or to catch them in their earliest stages when they are most treatable. Without research into the causes and cures of diseases affecting women, these diseases cannot be effectively treated.
(j) On August 24, 1990, the NIH published a revised, strengthened "NIH/ADHMA Policy Concerning Inclusion of Women in Study Populations." That policy clearly stated that adequate numbers of women must be included in NIH-funded clinical studies, in proportion to the prevalence of the condition under study, unless an appropriate justification is provided. The revised policy also states that NIH will not fund grants that do not comply with its provisions.
(k) The majority of biomedical research funded by, or based at, the University of California is fundamental research that investigates basic life processes and disease mechanisms, often at the cellular or molecular level, and that yields benefits for all segments of our population.
(a) The National Institutes of Health (NIH), the nation's major source of funding for medical research conducted in the United States, spends approximately 13 percent of its budget for research on conditions and diseases that are primarily women's health issues. Although it is true that the great majority of the NIH research funds are expended for studies of diseases that affect both men and women, or for fundamental research that has significance for diseases affecting all segments of our population, women have not been adequately represented in research populations in major NIH-funded studies of diseases which affect both men and women.
(b) Today many medical treatments currently used on women are based on studies conducted entirely on men. For example, although cardiovascular illness is the number one cause of death and disability in American women, women have consistently been excluded from major research studies in this area.
(c) It is estimated that 175,000 American women will develop breast cancer, and 44,000 women will die from the disease this year. Currently, one in nine women born in the United States will develop breast cancer in her lifetime.
(d) Women constitute 11 percent of all reported AIDS cases. Eighty percent of all HIV-infected women are women of color.
(e) Osteoporosis, a condition characterized by excessive loss of bone tissue, affects an estimated 24 million Americans and results annually in an estimated $10 billion in direct medical costs. The cost of this disease will continue to escalate as the population ages and the incidence of osteoporosis increases. If current trends continue, the cost of osteoporosis treatment could be as much as $62 billion by the year 2020.
(f) Eighty percent of individuals affected by osteoporosis are women. One-half of all women over age 45 years, and 90 percent of all women over age 75 years, suffer from osteoporosis.
(g) Nearly one million couples seek medical advice or treatment for infertility. In the last 20 years, the number of infertility-related visits to doctors has nearly quadrupled. The risk of infertility is one and one-half times greater for blacks than for whites.
(h) Despite these facts, women's health issues--which are defined as diseases or conditions that are unique to women, are more prevalent or more serious in women, or for which specific risk factors or interventions differ for women--have received insufficient attention both in terms of funding and research.
(i) The best way to treat women's health problems is to prevent them from occurring, or to catch them in their earliest stages when they are most treatable. Without research into the causes and cures of diseases affecting women, these diseases cannot be effectively treated.
(j) On August 24, 1990, the NIH published a revised, strengthened "NIH/ADHMA Policy Concerning Inclusion of Women in Study Populations." That policy clearly stated that adequate numbers of women must be included in NIH-funded clinical studies, in proportion to the prevalence of the condition under study, unless an appropriate justification is provided. The revised policy also states that NIH will not fund grants that do not comply with its provisions.
(k) The majority of biomedical research funded by, or based at, the University of California is fundamental research that investigates basic life processes and disease mechanisms, often at the cellular or molecular level, and that yields benefits for all segments of our population.
(a) On or before June 30, 1992, state agencies shall
adopt, and it is the intent of the Legislature that the Regents of
the University of California adopt, policies based on the publication
"NIH/ADHMA Policy Concerning Inclusion of Women in Study
Populations," so that women and members of minority groups are
appropriately included as subjects of health research projects
carried out by state agencies or University of California
researchers. The review of research proposals funded by state
agencies or the University of California should include consideration
of the appropriateness of the composition of research populations.
(b) On or before September 30, 1992, state agencies and the University of California shall transmit to the Legislature copies of the policies adopted pursuant to this section, along with copies of the specific procedures put in place to carry out those policies.
(b) On or before September 30, 1992, state agencies and the University of California shall transmit to the Legislature copies of the policies adopted pursuant to this section, along with copies of the specific procedures put in place to carry out those policies.
State agencies shall, and it is the intent of the
Legislature that the University of California:
(a) Provide special opportunities for funding research projects devoted to diseases, disorders, or other health conditions of particular concern to women and minorities, or in health research areas in which women and minorities have been traditionally underrepresented.
(b) At the same time, ensure that funding will enable researchers to adapt to changing population distribution of diseases.
(a) Provide special opportunities for funding research projects devoted to diseases, disorders, or other health conditions of particular concern to women and minorities, or in health research areas in which women and minorities have been traditionally underrepresented.
(b) At the same time, ensure that funding will enable researchers to adapt to changing population distribution of diseases.
(a) State agencies and the University of California shall
report, consistent with available data, on the extent to which state
funds administered by those agencies and the University of California
are used to support research on diseases, disorders, or other health
conditions that meet one or more of the following criteria, as
determined by the state agency or the University of California:
(1) Are unique to women or minorities, more prevalent in women or minorities, or more serious for women or minorities.
(2) For which the risk factors or interventions are different for women or minorities.
(b) On or before June 30, 1992, state agencies and the University of California shall adopt procedures for collecting and classifying data on the extent to which state-funded research projects address medical issues of particular concern to women and minorities. On and after June 30, 1993, information concerning the extent to which research supported by particular programs of state agencies and the University of California addresses medical issues of particular concern to women and minorities shall be incorporated into the appropriate periodic program reports required under existing law.
(1) Are unique to women or minorities, more prevalent in women or minorities, or more serious for women or minorities.
(2) For which the risk factors or interventions are different for women or minorities.
(b) On or before June 30, 1992, state agencies and the University of California shall adopt procedures for collecting and classifying data on the extent to which state-funded research projects address medical issues of particular concern to women and minorities. On and after June 30, 1993, information concerning the extent to which research supported by particular programs of state agencies and the University of California addresses medical issues of particular concern to women and minorities shall be incorporated into the appropriate periodic program reports required under existing law.
It is the intent of the Legislature to encourage research
on the effectiveness of RU-486 (mifepristone) in treating breast and
ovarian cancer, meningioma, endometriosis, Cushing's syndrome,
osteoporosis, diabetes, and AIDS.
For purposes of this part, "state agency" has the same
meaning as defined in Section 11000 of the Government Code.
