In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Prescription Drugs Act''.

SEC. 2. COMPULSORY LICENSING OF CERTAIN PATENTED MEDICAL INVENTIONS.

    (a) In General.--Chapter 14 of title 35, United States Code, is 
amended by adding at the end the following:
``Sec. 158. Compulsory licensing
    ``(a) Compulsory Licensing of Certain Patented Medical 
Inventions.--In the case of any subject invention relating to health in 
which a patent holder, contractor, exclusive licensee, or assignee has 
acquired title under this title, the Secretary of Health and Human 
Services shall have the right to establish other use of the subject 
matter of the patent without authorization of the right holder if the 
Secretary makes the determination described in subsection (b).
    ``(b) Determination.--The determination of the Secretary of Health 
and Human Services referred to in subsection (a) is a determination 
that--
            ``(1) the patent holder, contractor, licensee, or assignee 
        referred to in subsection (a) has not taken, or is not expected 
        to take within a reasonable time, effective steps to achieve 
        practical application of the subject invention in a field of 
        use;
            ``(2) such compulsory license is necessary to alleviate 
        health or safety needs which are not adequately satisfied by 
        the patent holder, contractor, licensee, or assignee; or
            ``(3) the patented material is priced higher than may be 
        reasonably expected based on criteria developed by the 
        Secretary of Commerce.
    ``(c) Factors in Authorizing Other Use.--In exercising the right 
under subsection (a) to authorize other use of the subject matter of a 
patent, the following shall apply:
            ``(1) Authorization of such use shall be considered on its 
        individual merits.
            ``(2) Such use may only be permitted if, prior to such use, 
        the proposed user has made efforts to obtain authorization from 
        the right holder on reasonable commercial terms and conditions 
        and that such efforts have not been successful within a 
        reasonable period of time. This requirement may be waived in 
        the case of a national emergency or other circumstances of 
        extreme urgency or in cases of public noncommercial use. In 
        situations of national emergency or other circumstances of 
        extreme urgency, the right holder shall, nevertheless, be 
        notified as soon as reasonably practicable. In the case of 
        public noncommercial use, where the Government or (if 
        applicable) a contractor of the Government, without making a 
        patent search, knows or has demonstrable grounds to know that a 
        valid patent is or will be used by or for the Government, the 
        right holder shall be informed promptly.
            ``(3) Such use shall be nonexclusive.
            ``(4) Such use shall be nonassignable, except with that 
        part of the enterprise or goodwill which enjoys such use.
            ``(5) Authorization for such use shall be liable, subject 
        to adequate protection of the legitimate interests of the 
        persons so authorized, to be terminated if and when the 
        circumstances which led to it cease to exist and are unlikely 
        to recur. The competent authority shall have the authority to 
        review, upon appropriate request, the continued existence of 
        such circumstances.
            ``(6) The right holder shall be paid adequate remuneration 
        in the circumstances of each case, taking into account the 
        economic value of the authorization.
            ``(7) The legal validity of any decision relating to the 
        authorization of such use shall be subject to judicial review 
        or other independent review by a distinct Federal authority.
            ``(8) Any decision relating to the remuneration provided in 
        respect of such use shall be subject to judicial review or 
        other independent review by a distinct Federal authority.
            ``(9) The condition set forth in paragraph (2) is not 
        applicable where such use is permitted to remedy a practice 
        determined after judicial or administrative process to be 
        anticompetitive. The need to correct anticompetitive practices 
        may be taken into account in determining the amount of 
        remuneration in such cases. The competent authorities shall 
        have the authority to refuse termination of authorization if 
        and when the conditions which led to such authorization are 
        likely to recur.
            ``(10) Where such use is authorized to permit the 
        exploitation of a patent (`the 2nd patent') which cannot be 
        exploited without infringing another patent (`the 1st patent'), 
        the following additional conditions shall apply:
                    ``(A) The invention claimed in the 2nd patent shall 
                involve an important technical advance of considerable 
                economic significance in relation to the invention 
                claimed in the 1st patent.
                    ``(B) The owner of the 1st patent shall be entitled 
                to a cross-license on reasonable terms to use the 
                invention claimed in the 2nd patent.
                    ``(C) The use authorized in respect of the 1st 
                patent shall be nonassignable except with the 
                assignment of the 2nd patent.
    ``(d) Consistency With TRIPS.--Regulations adopted under subsection 
(a) shall be consistent with provisions of the Agreement on Trade-
Related Aspects of Intellectual Property Rights referred to in section 
101(d)(15) of the Uruguay Round Agreements Act.''.
    (b) Conforming Amendment.--the table of contents for chapter 14 of 
title 35, United States Code, is amended by adding at the end the 
following new item:

``158. Compulsory licensing.''.

SEC. 3. REPORT ON PHARMACEUTICAL COSTS AND SALES.

    (a) Report Requirement.--Any person engaged in the manufacture and 
sale of any drug approved under section 505 or 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360b) for which a patent is 
still in effect shall report to the Congress annually an audit of all 
financial information relevant to the pricing of that drug nationally 
and internationally, including the costs of research and development, 
sufficient to assess the reasonableness of that pricing, in accordance 
with specifications developed by the Secretary of Commerce in 
consultation with the Commissioner of Food and Drugs.
    (b) Disqualification From Participation in Federal Programs as 
Penalty for Noncompliance.--In the case of a person who the Secretary 
of Commerce determines has failed to submit a report required under 
subsection (a) on a timely basis, the person shall be ineligible to 
receive payment from the Federal Government or under any Federal 
program (including under the medicare and medicaid programs) for any 
prescription drug or biologic it manufactures or sells until the date 
the Secretary determines that such failure has ceased.

Output: Requires any person engaged in the manufacture and sale of any new drug or new animal drug approved under the Federal Food, Drug, and Cosmetic Act, for which a patent is still in effect, to report annually to Congress an audit of all financial information relevant to that drug's pricing nationally and internationally, including research and development costs, sufficient to assess the reasonableness of that pricing. Requires disqualification from participation in Federal programs as a penalty for noncompliance with this reporting requirement.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Silvio O. Conte Disabilities 
Prevention Act''.

SEC. 2. ESTABLISHMENT OF SILVIO O. CONTE DISABILITIES PREVENTION 
              PROGRAM.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 314 the following new 
section:

           ``silvio o. conte disabilities prevention program

    ``Sec. 315. (a) In General.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, may make 
grants to and enter into contracts with public and nonprofit private 
entities for the purpose of carrying out programs for the prevention of 
disabilities and the prevention of secondary conditions resulting from 
disabilities.
    ``(b) Certain Authorized Activities.--With respect to the 
prevention of disabilities and conditions described in subsection (a), 
activities for which the Secretary may provide financial assistance 
under such subsection include--
            ``(1) coordinating prevention activities;
            ``(2) conducting demonstrations and interventions;
            ``(3) conducting surveillances and studies;
            ``(4) educating the public; and
            ``(5) educating and training health professionals 
        (including allied health professionals) and conducting 
        activities to improve the clinical skills of such 
        professionals.
    ``(c) Priorities.--The Secretary, in consultation with the National 
Council on Disabilities, shall establish priorities among the 
activities that are to be carried out under subsection (a).
    ``(d) Reports to Secretary.--The Secretary may provide financial 
assistance under subsection (a) only if the applicant involved agrees 
to submit to the Secretary such reports as the Secretary may require 
with respect to such assistance.
    ``(e) Application for Assistance.--The Secretary may provide 
financial assistance under subsection (a) only if an application for 
such assistance is submitted to the Secretary and the application is in 
such form, is made in such manner, and contains such agreements, 
assurances, and information as the Secretary determines to be necessary 
to carry out this section.
    ``(f) Limitation Regarding Education of Health Professionals.--In 
providing financial assistance under subsection (a), the Secretary may 
not, for activities described in subsection (b)(5), obligated more than 
10 percent of the amounts appropriated under subsection (k) for any 
fiscal year.
    ``(g) Technical Assistance.--The Secretary may provide training, 
technical assistance, and consultations with respect to the planning, 
development, and operation of any program for the prevention of 
disabilities or the prevention of secondary conditions resulting from 
disabilities.
    ``(h) Provision of Supplies and Services in Lieu of Funds.--
            ``(1) In general.--Upon the request of a recipient of 
        financial assistance under subsection (a), the Secretary may, 
        subject to paragraph (2), provide supplies, equipment, and 
        services for the purpose of aiding the recipient in carrying 
        out such subsection and, for such purpose, may detail to the 
        recipient any officer or employee of the Department of Health 
        and Human Services.
            ``(2) Corresponding reduction in payments.--With respect to 
        a request by a recipient for purposes of paragraph (1), the 
        Secretary shall reduce the amount of payments under subsection 
        (a) to the recipient by an amount equal to the costs of 
        detailing personnel (including pay, allowances, and travel 
        expenses) and the fair market value of any supplies, equipment, 
        or services provided by the Secretary. The Secretary shall, for 
        the payment of expenses incurred in complying with such 
        request, expend the amounts withheld.
    ``(i) Evaluations and Reports.--
            ``(1) Evaluations.--The Secretary shall, directly or 
        through contracts with public or private entities, provide for 
        evaluations of programs carried out pursuant to subsection (a).
            ``(2) Reports.--Not later than January 31 of 1995 and of 
        every second year thereafter, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives, and to the Committee on Labor and Human 
        Resources of the Senate, a report summarizing evaluations 
        carried out pursuant to paragraph (1). The Secretary shall 
        provide a copy of each such report to the National Council on 
        Disability.
    ``(j) Definitions.--For purposes of this section:
            ``(1) The term `financial assistance' means a grant or 
        contract.
            ``(2) The term `prevention' means activities that address 
        the causes of disabilities and secondary conditions resulting 
        from disabilities, and activities that address the functional 
        limitations involved and the exacerbation of such limitations, 
        including activities that--
                    ``(A) eliminate or reduce the factors that cause or 
                predispose an individual to disabilities or that 
                increase the prevalence of disabilities;
                    ``(B) increase the early identification of existing 
                problems to eliminate circumstances that create or 
                increase functional limitations; and
                    ``(C) mitigate against the effects of disabilities 
                throughout the life of the individual.
    ``(k) Authorization of Appropriations.--For the purpose of 
providing financial assistance under this section, there are authorized 
to be appropriated $15,000,000 for fiscal year 1994, $20,000,000 for 
fiscal year 1995, $25,000,000 for fiscal year 1996, and such sums as 
may be necessary for each of the fiscal years 1997 and 1998.''.

            Passed the House of Representatives June 14, 1993.

            Attest:

                                           DONNALD K. ANDERSON,

                                                                 Clerk.

Output: Silvio O. Conte Disabilities Prevention Act - Amends the Public Health Service Act to authorize grants and contracts for the prevention of disabilities and the prevention of secondary conditions resulting from disabilities, including through demonstrations and interventions, surveillances and studies, public education, and training health professionals.  Authorizes appropriations.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Tuition Account Assistance Act of 
1995''.

SEC. 2. TREATMENT OF PARTICIPATION IN STATE PREPAID TUITION PROGRAM.

    (a) In General.--Part III of subchapter B of chapter 1 of the 
Internal Revenue Code of 1986 (relating to items specifically excluded 
from gross income) is amended by redesignating section 137 as section 
138 and by inserting after section 136 the following new section:

``SEC. 137. TREATMENT OF PARTICIPATION IN STATE PREPAID TUITION 
              PROGRAM.

    ``(a) General Rule.--No amount shall be includible in the gross 
income of any person by reason of--
            ``(1) education furnished to a designated beneficiary 
        pursuant to a qualified State prepaid tuition program, or
            ``(2) earnings on any amount paid to such a program for the 
        purchase of tuition credits for a designated beneficiary.
    ``(b) Qualified State Prepaid Tuition Program.--For purposes of 
this section--
            ``(1) In general.--The term `qualified State prepaid 
        tuition program' means a program established and maintained by 
        a State or any agency thereof under which--
                    ``(A) an individual may purchase tuition credits 
                for tuition for the undergraduate education of a 
                designated beneficiary,
                    ``(B) the value of the tuition credits is not 
                limited to the amounts paid for such credits and 
                earnings thereon,
                    ``(C) the individual has no authority to direct the 
                investment of amounts paid to the program, and
                    ``(D) the requirements of paragraph (3) are met 
                with respect to any refund of amounts paid to the 
                program.
        Subparagraph (B) shall not apply to tuition at an institution 
        of higher education which is not required by the laws of such 
        State to participate in such program.
            ``(2) Treatment of excess tuition credits.--A program shall 
        not fail to be treated as a qualified State prepaid tuition 
        program by reason of permitting tuition credits to be used 
        other than for tuition for an undergraduate education if--
                    ``(A) the only other purposes for which such 
                credits may be used are--
                            ``(i) for tuition for a graduate degree 
                        program of the designated beneficiary, or
                            ``(ii) for education expenses (other than 
                        tuition) of such beneficiary, and
                    ``(B) the program provides a significant reduction 
                in the value of such credits if used for such other 
                purposes.
            ``(3) Restrictions on refunds.--A refund meets the 
        requirements of this paragraph if the refund meets the 
        requirements of any of the following subparagraphs.
                    ``(A) Death or disability of designated 
                beneficiary.--A refund meets the requirements of this 
                subparagraph if the refund is made on account of the 
                death or disability of the designated beneficiary.
                    ``(B) Scholarships.--A refund meets the 
                requirements of this subparagraph if the refund is made 
                on account of a scholarship received by the designated 
                beneficiary and the amount of the refund does not 
                exceed the amount of the scholarship which is used for 
                tuition.
                    ``(C) Failure to gain admission.--A refund meets 
                the requirements of this subparagraph if the refund is 
                made on account of the failure of the designated 
                beneficiary to gain admission to an institution of 
                higher education (after making a good faith attempt, as 
                determined by the program, to gain admission) and the 
                amount of the refund does not exceed 90 percent of the 
                value of the designated beneficiary's account.
                    ``(D) Other withdrawals from participation.--A 
                refund meets the requirements of this subparagraph if 
                the refund is made on account of a termination of 
                participation in the qualified State prepaid tuition 
                program (other than for a reason described in any of 
                the preceding subparagraphs) and the amount of the 
                refund does not exceed the lesser of--
                            ``(i) 90 percent of the value of the 
                        designated beneficiary's account, or
                            ``(ii) the aggregate amount paid to such 
                        program for the benefit of the designated 
                        beneficiary.
    ``(c) Other Definitions.--For purposes of this section--
            ``(1) Tuition credit.--The term `tuition credit' means the 
        amount of tuition which is paid by the qualified State prepaid 
        tuition program reason of payments to such program.
            ``(2) Tuition.--The term `tuition' means tuition and 
        related expenses (as defined in section 117(b)(2)).
            ``(3) Designated beneficiary.--The term `designated 
        beneficiary' means the individual designated at the 
        commencement of participation in the qualified State prepaid 
        tuition program (or any substitute beneficiary to the extent 
        provided by the program) as the beneficiary of amounts paid (or 
        to be paid) to the program.
            ``(4) Value of designated beneficiary's account.--The value 
        of a designated beneficiary's account is an amount equal to the 
        sum of--
                    ``(A) the aggregate amount paid to the qualified 
                State prepaid tuition program for the benefit of such 
                designated beneficiary, plus
                    ``(B) such amount's pro rata share of the earnings 
                (if any) on the aggregate amount paid to such program 
                for all designated beneficiaries.
            ``(5) Person.--The term `person' includes a State and any 
        agency of a State.''
    (b) Clerical Amendment.--The table of sections for such part III is 
amended by striking the last item and inserting the following new 
items:

                              ``Sec. 137. Treatment of participation in 
                                        State prepaid tuition program.
                              ``Sec. 138. Cross references to other 
                                        Acts.''
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years ending after September 30, 1993.


Output: Tuition Account Assistance Act of 1995 - Amends the Internal Revenue Code to exclude from gross income amounts received by reason of education furnished pursuant to a qualified State prepaid tuition program (under which credits for tuition for the undergraduate education of a designated beneficiary may be purchased) or earnings on amounts paid to such a program.