		II
		110th CONGRESS
		2d Session
		S. 2976
		IN THE SENATE OF THE UNITED STATES

			May 6, 2008
			Mr. Lautenberg (for
			 himself, Mr. Dorgan,
			 Mr. Levin, Mr.
			 Casey, Mr. Sanders, and
			 Mrs. Clinton) introduced the following
			 bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To require the United States Trade Representative to
		  pursue a complaint of anticompetitive practices against certain oil exporting
		  countries.

		1.Short
			 titleThis Act may be cited as
			 the OPEC Accountability
			 Act.
		2.FindingsCongress makes the following
			 findings:
			(1)Gasoline prices
			 have more than quadrupled since January, 2002, with crude oil recently trading
			 at more than $119 per barrel for the first time ever.
			(2)Rising gasoline
			 prices have placed an inordinate burden on American families.
			(3)High gasoline
			 prices have hindered and will continue to hinder economic recovery.
			(4)The Organization
			 of Petroleum Exporting Countries (OPEC) has formed a cartel and engaged in
			 anticompetitive practices to manipulate the price of oil, keeping it
			 artificially high.
			(5)Eight member
			 nations of OPEC—Ecuador, Indonesia, Kuwait, Nigeria, Qatar, Saudi Arabia,
			 United Arab Emirates, and Venezuela—are also members of the World Trade
			 Organization. Algeria, Iran, Iraq, and Libya are also Observer Governments of
			 the World Trade Organization.
			(6)The agreement
			 among OPEC member nations to limit oil exports is an illegal prohibition or
			 restriction on the exportation or sale for export of a product under article XI
			 of the GATT 1994.
			(7)The export quotas
			 and resulting high prices harm American families, undermine the American
			 economy, impede American and foreign commerce, and are contrary to the national
			 interests of the United States.
			3.Actions to curb
			 certain cartel anticompetitive practices
			(a)DefinitionsIn
			 this Act:
				(1)Gatt
			 1994The term GATT 1994 has the meaning given such
			 term in section 2(1)(B) of the Uruguay Round Agreements Act (19 U.S.C.
			 3501(1)(B)).
				(2)Understanding
			 on rules and procedures governing the settlement of disputesThe
			 term Understanding on Rules and Procedures Governing the Settlement of
			 Disputes means the agreement described in section 101(d)(16) of the
			 Uruguay Round Agreements Act (19 U.S.C. 3511(d)(16)).
				(3)World Trade
			 Organization
					(A)In
			 generalThe term World Trade Organization means the
			 organization established pursuant to the WTO Agreement.
					(B)WTO
			 AgreementThe term WTO Agreement means the Agreement
			 Establishing The World Trade Organization entered into on April 15,
			 1994.
					(b)Action by
			 President
				(1)In
			 generalNotwithstanding any other provision of law, the President
			 shall, not later than 15 days after the date of enactment of this Act, initiate
			 consultations with the countries described in paragraph (2) to seek the
			 elimination by those countries of any action that—
					(A)limits the
			 production or distribution of oil, natural gas, or any other petroleum
			 product;
					(B)sets or maintains
			 the price of oil, natural gas, or any petroleum product; or
					(C)otherwise is an
			 action in restraint of trade with respect to oil, natural gas, or any petroleum
			 product, when such action constitutes an act, policy, or practice that is
			 unjustifiable and burdens and restricts United States commerce.
					(2)Countries
			 describedThe countries described in this paragraph are the
			 following:
					(A)Indonesia.
					(B)Kuwait.
					(C)Nigeria.
					(D)Qatar.
					(E)The United Arab
			 Emirates.
					(F)Venezuela.
					(G)Ecuador.
					(H)Saudi
			 Arabia.
					(c)Initiation of
			 WTO dispute proceedingsIf the consultations described in
			 subsection (b) are not successful with respect to any country described in
			 subsection (b)(2), the United States Trade Representative shall, not later than
			 60 days after the date of enactment of this Act, institute proceedings pursuant
			 to the Understanding on Rules and Procedures Governing the Settlement of
			 Disputes with respect to that country and shall take appropriate action with
			 respect to that country under the trade remedy laws of the United
			 States.


116 HR 2011 IH: Protecting Access to Biosimilars Act of 2019
U.S. House of Representatives
2019-04-01
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS1st SessionH. R. 2011IN THE HOUSE OF REPRESENTATIVESApril 1, 2019Ms. DeGette (for herself, Mr. Reed, Ms. Schrier, and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of
			 such Act (relating to exclusivity for reference products) of certain
			 products deemed to have a biologics license pursuant to section 7002 of
			 the Biologics Price Competition and Innovation Act of 2009.

 1.Short titleThis Act may be cited as the Protecting Access to Biosimilars Act of 2019. 2.Treatment of biological products deemed licensedSection 351(k)(7) of the Public Health Service Act (42 U.S.C. 262(k)(7)) is amended by adding at the end the following:

				(D)Deemed licenses
 (i)No additional exclusivity through deemingAn approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).
 (ii)Applicability of antievergreening provisionsSubparagraph (C) shall apply to any reference product, without regard to whether— (I)such product was first licensed under subsection (a); or
 (II)the approved application for such product was deemed to be a license for a biological product as described in clause (i)..