[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4370 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 4370

                  To establish the AIDS Cure Project.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 10, 1994

Mr. Nadler (for himself, Mr. Dellums, Ms. Velazquez, Mr. Owens, and Mr. 
Miller of California) introduced the following bill; which was referred 
                to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
                  To establish the AIDS Cure Project.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``AIDS Cure Act''.

SEC. 2. ESTABLISHMENT OF PROJECT TO CURE AIDS.

    (a) In General.--The President shall in accordance with this Act 
direct the Secretary of Health and Human Services to establish a 
project for the purpose of developing a cure for acquired immune 
deficiency syndrome (in this Act referred to as ``AIDS''). The program 
may not be administered by any officer or employee of the National 
Institutes of Health. Subject to the preceding sentence, the Governing 
Council shall designate an individual to serve as a liaison between the 
Governing Council of the project (established under section 4(a)), the 
Secretary, and the President.
    (b) Definition.--For purposes of this Act, the term ``cure'', with 
respect to AIDS, means any and all approaches which will ensure a well-
functioning immune system and a normal life span with a reasonable 
quality of life.
    (c) Certain Requirements.--The Governing Council, in carrying out 
the project under subsection (a), shall ensure that the following 
requirements are met:
            (1) The project shall pursue comprehensive basic science 
        investigations, based on diverse theories and schools of 
        thought which elucidate the pathogenesis of AIDS.
            (2) The project shall identify, based on this work, all 
        promising curatives and oversee their timely and adequate 
        testing through the extraordinary powers detailed in section 5.

SEC. 3. OPEN AND PRODUCTIVE RESEARCH PATHS.

    The Governing Council, in carrying out the project under section 2, 
shall ensure that the following requirements are met:
            (1)(A) Thorough consideration shall be given to both 
        conventional and other medical approaches and scientific 
        theories, and researchers representing divergent approaches 
        shall be on the primary research staff as well as be 
        contributing researchers.
            (B) The project shall aggressively pursue research into all 
        areas of AIDS pathogenesis, including but not limited to--
                    (i) virological/immunological theories about how 
                immune system damage occurs, including understudied 
                approaches; and
                    (ii) theories about co-factors which may precede, 
                activate or even substitute for HIV in the process of 
                immune system damage leading to AIDS.
            (C) Examination shall be given to the full spectrum of 
        pathogenesis theories, from those maintaining that HIV is the 
        sole and sufficient cause to those considering HIV a primary 
        cause together with co-factors to those believing that HIV does 
        not necessarily play a causative role.
            (D) Further work shall be done on the potential role of 
        recreational drugs and environmental toxins in progression. The 
        role of nutrition, exercise, and adequate primary health care 
        must also be researched in the project. Psychoneuroimmunology 
        and the connections between psychological stress and immune 
        compromise shall also be studied.
            (E) A diversity of theories should be developed and tested 
        through both laboratory experiments and epidemiological 
        research, including careful examination of cases of people with 
        HIV and AIDS and interviews with people with HIV and AIDS and 
        their care providers including but not limited to primary care 
        clinicians, gynecologists, nutritionists, alternative or 
        holistic practitioners, and mental health workers.
            (F) All research funded in this Act shall be conducted in 
        conformity with the ethics and privacy of current medical 
        research.
            (G) Researchers shall study epidemiological and blood 
        studies of long-term survivors from diverse populations to 
        attempt to isolate the factors that have sustained them.
            (H) Consideration shall be given to the hypotheses and 
        results obtained in other countries. Researchers from other 
        countries shall be invited to participate in the project. This 
        may include agreements with another country to reassign 
        particular researchers to the project for an indefinite 
        commitment. The project's progress shall not await the 
        conclusion of such international agreements.
            (2) The project's study of AIDS pathogenesis and 
        manifestations must focus on all populations of people with 
        AIDS and HIV. Equal consideration shall be given to the 
        differences between these populations as to their similarities 
        or norms. This includes, but is not limited to people of all 
        age groups (including children and seniors), gender, sexual 
        orientation, women (regardless of reproductive health status), 
        gay men, lesbians, people of color (of various affected 
        national-cultural groups), injection drug users, prison 
        inmates, people with hemophilia and people with inadequate 
        medical care or nutrition (or both), and persons with 
        disabilities and chronic conditions related to AIDS.
            (3) Basic science investigations and therapeutic results 
        shall be geared to people at every point on the spectrum of 
        AIDS and HIV--from the sickest to the healthiest. Saving people 
        considered near death must be considered as important as early 
        intervention.
            (4) Information generated by the project shall be made 
        freely available worldwide to researchers, health care 
        providers, people with AIDS and HIV and their advocates as soon 
        as it is available, without being inhibited by professional 
        publication practices. Funds shall be available as needed for 
        the dissemination and translation of project materials.
            (5) Curatives and therapies ultimately released due 
        primarily to project research shall not result in financial 
        gain to any private organization, and shall be made available 
        to all affected people worldwide regardless of ability to pay. 
        The project shall be responsible for establishing a mechanism 
        for international funding and distribution of any such 
        curatives.

SEC. 4. EFFICIENT AND COOPERATIVE MANAGEMENT OF PROJECT.

    (a) Governing Council.--
            (1) In general.--The project under section 2 shall be 
        governed by, not merely advised by, a council composed of 
        scientists and clinicians representing divergent approaches, 
        and people with AIDS and HIV, and their advocates, from all 
        affected communities. This council shall set policy and oversee 
        research priorities, ethical standards, conflict of interest 
        rules and hiring of researchers, and administrators.
            (2) Certain authorities.--The Secretary shall ensure that 
        the following requirements are met with respect to the council 
        under paragraph (1):
                    (A) The council shall be composed of scientists 
                representing divergent approaches, clinicians with both 
                research and community-based experience and people with 
                AIDS and HIV and their advocates.
                    (B) The council shall have at least 21 members in 
                order to adequately represent diverse communities, 
                opinions and disciplines. People with AIDS and HIV from 
                diverse communities shall be in the majority to ensure 
                that the project staff are ultimately accountable to 
                people directly affected by the course and outcome of 
                the research. Council members shall step down and be 
                replaced by new members on a regular basis.
                    (C) The Council shall set policy for and oversee 
                research priorities. It shall develop guidelines for 
                and oversee the hiring of primary research staff, 
                ensuring both high quality (scientific credentials and 
                experience) and a diversity of disciplines and 
                perspectives (including alternative'' or holistic 
                approaches). Having pursued specific AIDS theories 
                shall not be a necessary prerequisite for hiring. The 
                Council shall have the power to create new research 
                positions when necessary and to remove scientists from 
                their positions after due process and appropriate 
                review of their work.
                    (D) The Council shall be charged with evaluating 
                the work of the project, as well as the pace of the 
                research, to ensure that it matches the urgency of the 
                epidemic. Initially, and throughout the life of the 
                project, the Council, in cooperation with the primary 
                research staff, shall solicit and evaluate theories 
                developed outside the project. It shall direct the 
                project scientists to evaluate and respond to deserving 
                proposals and to devise new research plans where 
                desirable.
                    (E) The Council shall adopt strict, detailed codes 
                governing medical ethics and conflicts of interest and 
                shall monitor compliance with these codes. Project 
                scientists shall report directly to the council about 
                the progress of their work in a manner to be determined 
                by the council. The Council shall report to the 
                President through the liaison about the progress of the 
                project.
                    (F) Council meetings, including those at which all 
                decisions are made, shall be public and shall be held 
                at least quarterly, with time allotted for public 
                comment. In addition, the Council shall hold an annual 
                public hearing on its priorities and progress. A 
                complete report of the project's goals and 
                accomplishments shall be updated by the Council, 
                submitted to the President and released to the public 
                at least once quarterly. The Council shall evaluate its 
                structure and process at least once per year and make 
                changes which allow it to function more effectively.
                    (G) Members of the Governing Council will not be 
                paid employees of the project. However, the Governing 
                Council will be provided with an operating budget, 
                including but not limited to, the following purposes: 
                Support staff; creation and dissemination of reports 
                and other materials; funds for transportation and other 
                per diem expenses; and funds for convening public 
                meetings.
    (b) Requirements.--The Governing Council, in carrying out the 
project under section 2, shall ensure that the following requirements 
are met:
            (1) The project shall establish a primary location for its 
        work, in an area with a high incidence of AIDS. All primary 
        research staff shall work at that location; contributing 
        researchers located around the world shall interact via video 
        teleconferencing, an international computer network, and 
        regularly scheduled face-to-face meetings.
            (2) The National Institutes of Health's existing AIDS 
        research programs shall be maintained. All National Institutes 
        of Health basic science research supplementary to that done by 
        the project shall be performed cooperatively with the project 
        in coordination with the Office of AIDS Research.
            (3)(A) All primary research staff and administrators shall 
        be financially compensated only by the project and may not have 
        conflicts of interests with private or public organizations 
        (including but not limited to universities, pharmaceutical 
        companies, and private research organizations).
            (B) All primary research staff and administrators shall be 
        required to suspend their relationship with any private or 
        public organizations for the duration of their association with 
        the project. These requirements shall include full-time, part-
        time, or consultant positions with a private or public 
        organization or other government agencies, and the suspension 
        would include employment, consulting or board membership fees, 
        and stock or business ownership.
            (C) The Governing Council members shall be required to 
        suspend their relationship with for-profit organizations which 
        represent a conflict of interest.
            (4) The project shall be funded by public, not private 
        monies. Appropriations for the project shall not be diverted 
        from other health research, health care, or human service 
        programs.
            (5) The project shall, in addition to basic research 
        investigations, operate an on-site clinic to conduct small 
        scale research trials with human participants if such trials 
        are crucial for testing hypotheses related to its basic 
        research.
    (c) Coordinating Committee.--The Governing Council shall ensure 
that a coordinating committee is established for the project under 
section 2, in accordance with the following:
            (1) The community of scientists selected for the project 
        shall elect three of their members to serve as the coordinating 
        committee for the project, and determine whether these 
        positions should be permanent or rotating.
            (2) The coordinating committee shall be responsible for 
        facilitating communication among the different scientists 
        working on the project, for evaluating the progress of its 
        work, and for convening the entire staff on a regular schedule 
        (or when necessary) to evaluate the progress of the project as 
        a whole, identify gaps in research, reevaluate the project's 
        direction, and to consider newly developed theories emanating 
        from both within and outside the project.
            (3) The coordinating committee shall also be responsible 
        for keeping the Governing Council informed of the progress of 
        the project's work, at times and in a manner to be determined 
        by the Governing Council. The coordinating committee shall also 
        make decisions regarding the hiring of research associates, 
        technical staff, purchases of equipment and other day-to-day 
        needs.
            (4) The first task of the coordinating committee shall be 
        to facilitate a preliminary review of all existing pathogenesis 
        hypotheses, as well as other relevant information about AIDS 
        pathogenesis. At the end of this review, which shall last no 
        longer than 3 months, the primary research staff shall 
        collectively develop plans for evaluating and testing each of 
        the viable hypotheses, including timelines for evaluating the 
        progress of this work, and submit these plans to the Governing 
        Council for review and comments.
    (d) Selection of Governing Council.--
            (1) In general.--The Secretary of Health and Human Services 
        (HHS) shall convene a national AIDS congress to make 
        recommendations to the President for selecting the Governing 
        Council. The AIDS congress will meet only once, and for the 
        sole purpose of nominating the initial Governing Council. The 
        Secretary of HHS shall solicit nominations from a wide variety 
        of sources, including, but not limited to, each of the 
        following: AIDS activist groups; health care providers; AIDS 
        advocacy organizations; AIDS service organizations; community-
        based AIDS research organization; biomedical researchers and 
        nonmainstream (including alternative or holistic) medical 
        organizations; and health care planning agencies, who shall 
        send their nominations for the Governing Council to the AIDS 
        congress. The AIDS congress will make recommendations to the 
        President for the Governing Council. The President shall select 
        the Governing Council based on the recommendations of the AIDS 
        congress. The AIDS congress will consist of 2 representatives 
        chosen by each of the HIV health services planning councils 
        under section 2602(b) of the Public Health Service Act, chosen 
        in a forum that is open to the public by each of the HIV 
        planning councils. The President shall widely publicize the 
        request for nominations.
            (2) Date certain for selection.--In keeping with the 
        emergency nature of this project, the nomination and selection 
        process must be completed within 3 months of the enactment of 
        this Act.

SEC. 5. EXTRAORDINARY POWERS.

    In carrying out the project under section 2, the Governing Council 
shall have extraordinary powers to carry out the following:
            (1)(A) Utilize, in cooperation with the agencies, any and 
        all existing United States Government funded research entities 
        nationwide (including but not limited to the AIDS Clinical 
        Trial Group (ACTG), the Community Program for Clinical Research 
        on AIDS (CPCRA)), and their facilities to clinically test 
        promising cures developed on the basis of its research and to 
        direct the manner in which such research shall proceed, 
        including staffing, participants, location, and timing. Such 
        research shall be funded by the project.
            (B) The project shall design its own protocols and work 
        with these existing clinical trial programs to develop research 
        designs and methods appropriate to the project's goals, 
        assuring that data gathered by the NIH would accurately reflect 
        the use of these compounds in all populations and stages of 
        illness.
            (C) The project shall provide funding for these clinical 
        trials of its own compounds. In areas of conflict, the project 
        shall have the power to implement its goals.
            (2) Exercise the right of eminent domain to carry out the 
        following:
                    (A)(i) Obtain from public and private 
                organizations, with just compensation, samples of all 
                potential curatives and all data (excluding medical 
                records) regarding their development (including safety 
                and efficacy data) as well as other information, 
                materials, or products deemed crucial to the project, 
                but protect the privacy of research subjects and the 
                researcher over which the project will be exercising 
                the right of eminent domain. The project shall use its 
                power of eminent domain only after reasonable attempts 
                at cooperation have failed.
                    (ii) To use eminent domain power, the project must 
                determine and identify whether this research is 
                essential information to the project's research and 
                that it is unavailable other than through eminent 
                domain.
                    (iii) Once obtaining through eminent domain the 
                research of an outside researcher, the project shall 
                make all efforts to preserve appropriate recognition of 
                the scientist's work. The project shall also afford any 
                researcher, whose work is acquired through eminent 
                domain, an opportunity to participate in the project 
                with just compensation.
                    (B) If a drug company is found to be impeding or 
                halting the development of a promising compound, the 
                project shall first attempt to work with the company to 
                develop the needed timetable for research and trials. A 
                company lacking the resources to develop a compound 
                shall have the option of selling the patent to the 
                project for just compensation, or allowing portions of 
                its development to be undertaken by the project.
                    (C) If, however, a company refuses to cooperate 
                with the project by not releasing needed data, or by 
                withholding samples of requested compounds, whether 
                under development or not, the project is authorized to 
                use powers of eminent domain to procure samples and 
                data. The project shall have the power to obtain the 
                patents of such compounds if, after reasonable attempts 
                at cooperation, it finds that a company will not 
                develop a promising compound according to an approved 
                timeframe by the coordinating committee. After 
                notification by the project that this power will be 
                used, a company shall have 30 days in which to develop, 
                for the project's approval, a plan for accelerated 
                development of the compound to avoid losing exclusive 
                rights to the patent. Unless said companies adhere to 
                an approved timeframe and are forthcoming with their 
                data as such work proceeds, then the project can 
                implement clinical testing for potential curatives by 
                private companies.
                    (D) Use existing pharmaceutical company facilities 
                (with just compensation) for the production of 
                promising curatives to be utilized in project research 
                and, if effective, to produce such curatives in 
                sufficient amounts to be disseminated to all people 
                needing them.

SEC. 6. PLANNING FUNDS.

    Funds shall be allocated immediately to be used for planning of the 
project under section 2 (including creating facilities, selection of 
staff, funding, structure, and schedules), so that the project can 
begin functioning as soon as is possible.

SEC. 7. REAUTHORIZATION OF PROJECT.

    After 5 years of operation, the Congress shall have the power to 
reauthorize the project under section 2.

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HR 4370 IH----2