IMPLEMENTATION LEVEL

National

AFFECTED FLOW

Inflow

ANNOUNCED AS TEMPORARY

No

NON-TRADE-RELATED RATIONALE

No

ELIGIBLE FIRMS

all

JUMBO

No

TARIFF PEAK

No
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Inception date: No inception date

Import ban

The 'Pharmaceutical Market Access and Drug Safety Act of 2009' would amend Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) to waive the limitation on the reimportation of prescription drugs that have been exported from the United States. Reimportation would be allowed only under certain conditions and from certain countries, especially Canada.
 
The stated aim of the sponsors is to introduce more competition into the U.S. prescription drug market, and thereby reduce costs to consumers. In his introductory remarks on March 4, 2009, Senator Byron Dorgan (Democrat of North Dakota) declared that
  
We have a law in this country that says the drug companies can import drugs into our country, made in other regions of the world, but consumers cannot, registered or licensed pharmacists cannot, and wholesalers cannot. Our piece of legislation is very simple. It says, let's provide some competition here. If the prescription drug industry is selling their drugs in virtually every other country in the world for a fraction of the price they sell those drugs here, let's let licensed pharmacists in our country purchase them from Canada or another country and pass the savings along to the consumer.
 
The description that follows is based on the most recent version of this bill as introduced in the Senate, where it is designated as S.1232. That version of the bill was introduced on June 10, 2009 by Senator Dorgan and 29 other co-sponsors. The list of sponsors includes members of both parties. Other versions of the bill include an earlier Senate version (S.525) and companion legislation in the House of Representatives (H.R.1298).
The existing U.S. law generally provides, with certain exceptions, that no drug that 'is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.' The bill would allow the reimportation of qualifying drugs by a registered importer or an individual for personal use. It would also establish registration conditions for importers and exporters, and require the Department of Health and Human Services (DHS) to inspect places of business, verify chains of custody, etc. The bill would prohibit manufacturers from discriminating against registered exporters or importers; causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or engaging in any action that the Federal Trade Commission determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. Resale in the United States of prescription drugs that were properly sold abroad would not constitute patent infringement. DHS would be required to educate consumers regarding prescription drug importation, and the terms of the bill would govern the sale of prescription drugs through an Internet site.
Reimportation would be allowed only from certain countries. Canada would be immediately designated for such treatment, while other 'permitted countries' could be designated if DHS finds that 'the country has statutory or regulatory standards that are equivalent to the standards in the United States and Canada.' These potentially eligible countries include Australia, members of the European Union (except any country whose 'Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired'), Japan, New Zealand, Switzerland, and any other country that meets certain criteria laid out in the bill.
An attempt was made in June, 2009 on the Senate floor to attach this bill as an amendment to an unrelated bill that was also sponsored by Senator Dorgan. That effort failed due to the parliamentary maneuvers of one senator from a state where major pharmaceutical companies are headquartered. Senate Majority Leader Harry Reid (Democrat of Nevada) nevertheless assured Senator Dorgan that he would allow the bill to be considered on the Senate floor, possibly as a stand-alone measure, later in 2009.
The consideration of this measure is tied to the larger debate over major reforms in the U.S. health-care system. President Obama had been one of the sponsors of a similar bill that was introduced while he still served in the Senate, and his proposal for the Food and Drug Administration's Fiscal Year 2010 budget supports reimportation. According to a story in the Wall Street Journal (July 8, 2009), "White House officials have told the industry if the larger health care bill passes, the cost savings will be so great that reimportation will be unnecessary." The story attributes that observation to President Billy Tauzin of the Pharmaceutical Research and Manufacturers of America. That group is the principal opponent of reimportation, which is supported by (among others) the American Association of Retired Persons and the Canadian International Pharmacy Association.
 
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On December 15, 2009 the Senate defeated an amendment to the healthcare bill (H.R.3590) that would have permitted pharmacies and wholesalers to import lower-priced, Federally approved pharmaceuticals from Australia, Canada, European Union, Japan, and New Zealand. The amendment was sponsored by Senator Byron Dorgan (Democrat of North Dakota) but was opposed by the Obama administrtion. It was failed on a vote of 51-48.

AFFECTED COUNTRIES

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TABLE
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AFFECTED SECTORS AND PRODUCTS

341 Basic organic chemicals
2914 Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulphonated, nitrated or nitrosated derivatives.
291411 Acetone
291412 Butanone (methyl ethyl ketone)
291413 4Methylpentan2one (methyl isobutyl ketone)
291419 Other
291422 Cyclohexanone and methylcyclohexanones
291423 Ionones and methylionones
291429 Other
291431 Phenylacetone (phenylpropan2one)
291439 Other
291440 Ketonealcohols and ketonealdehydes
291450 Ketonephenols and ketones with other oxygen function
291461 Anthraquinone
291469 Other
291470 Halogenated, sulphonated, nitrated or nitrosated derivatives
2918 Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives.
291811 Lactic acid, its salts and esters
291812 Tartaric acid
291813 Salts and esters of tartaric acid
291814 Citric acid
291815 Salts and esters of citric acid
291816 Gluconic acid, its salts and esters
291819 Other
291829 Other
291830 Carboxylic acids with aldehyde or ketone function but without other oxygen function, their anhydrides, halides, peroxides, peroxyacids and their derivatives
291899 Other
2921 Aminefunction compounds.
292111 Methylamine, di or trimethylamine and their salts
292119 Other
292121 Ethylenediamine and its salts
292122 Hexamethylenediamine and its salts
292129 Other
292130 Cyclanic, cyclenic or cycloterpenic mono or polyamines, and their derivatives; salts thereof
292142 Aniline derivatives and their salts
292143 Toluidines and their derivatives; salts thereof
292144 Diphenylamine and its derivatives; salts thereof
292145 1Naphthylamine (alphanaphthylamine), 2naphthylamine (beta naphthylamine) and their derivatives; salts thereof
292149 Other
292151 o, m, pPhenylenediamine, diaminotoluenes, and their derivatives; salts thereof
292159 Other
2922 Oxygenfunction aminocompounds.
292211 Monoethanolamine and its salts
292212 Diethanolamine and its salts
292219 Other
292221 Aminohydroxynaphthalenesulphonic acids and their salts
292229 Other
292239 Other
292249 Other
292250 Aminoalcoholphenols, aminoacidphenols and other amino compounds with oxygen function
2924 Carboxyamidefunction compounds; amidefunction compounds of carbonic acid.
292421 Ureines and their derivatives; salts thereof
2925 Carboxyimidefunction compounds (including saccharin and its salts) and iminefunction compounds.
292511 Saccharin and its salts
292519 Other
292529 Other
2928 Organic derivatives of hydrazine or of hydroxylamine.
292800 Organic derivatives of hydrazine or of hydroxylamine.
2930 Organosulphur compounds.
293020 Thiocarbamates and dithiocarbamates
293030 Thiuram mono, di or tetrasulphides
293040 Methionine
293090 Other
2931 Other organoinorganic compounds.
293110 Tetramethyl lead and tetraethyl lead
293120 Tributyltin compounds
293190 Other
2932 Heterocyclic compounds with oxygen heteroatom(s) only.
293211 Tetrahydrofuran
293212 2Furaldehyde (furfuraldehyde)
293213 Furfuryl alcohol and tetrahydrofurfuryl alcohol
293219 Other
293293 Piperonal
293299 Other
2933 Heterocyclic compounds with nitrogen heteroatom(s) only.
293329 Other
293331 Pyridine and its salts
293339 Other
293349 Other
293361 Melamine
293371 6Hexanelactam (epsiloncaprolactam)
293379 Other lactams
293391 Alprazolam (INN), camazepam (INN), chlordiazepoxide (INN), clonazepam (INN), clorazepate, delorazepam (INN), diazepam (INN), estazolam (INN), ethyl loflazepate (INN), fludiazepam (INN), flunitrazepam (INN), flurazepam (INN), halazepam (INN), lorazepam
293399 Other
2934 Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds.
293410 Compounds containing an unfused thiazole ring (whether or not hydrogenated) in the structure
293420 Compounds containing in the structure a benzothiazole ring system (whether or not hydrogenated), not further fused
293491 Aminorex (INN), brotizolam (INN), clotiazepam (INN), cloxazolam (INN), dextromoramide (INN), haloxazolam (INN), ketazolam (INN), mesocarb (INN), oxazolam (INN), pemoline (INN), phendimetrazine (INN), phenmetrazine (INN) and sufentanil (INN); salts ther
293499 Other
2942 Other organic compounds.
294200 Other organic compounds.
352 Pharmaceutical products
2918 Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulphonated, nitrated or nitrosated derivatives.
291821 Salicylic acid and its salts
291822 OAcetylsalicylic acid, its salts and esters
291823 Other esters of salicylic acid and their salts
2922 Oxygenfunction aminocompounds.
292241 Lysine and its esters; salts thereof
292242 Glutamic acid and its salts
2923 Quaternary ammonium salts and hydroxides; lecithins and other phosphoaminolipids, whether or not chemically defined.
292310 Choline and its salts
292320 Lecithins and other phosphoaminolipids
292390 Other
2924 Carboxyamidefunction compounds; amidefunction compounds of carbonic acid.
292411 Meprobamate (INN)
292419 Other
292429 Other
2932 Heterocyclic compounds with oxygen heteroatom(s) only.
293220 Lactones
2933 Heterocyclic compounds with nitrogen heteroatom(s) only.
293319 Other
293321 Hydantoin and its derivatives
293352 Malonylurea (barbituric acid) and its salts
293353 Allobarbital (INN), amobarbital (INN), barbital (INN), butalbital (INN), butobarbital, cyclobarbital (INN), methylphenobarbital (INN), pentobarbital (INN), phenobarbital (INN), secbutabarbital (INN), secobarbital (INN) and vinylbital (INN); salts there
293359 Other
293369 Other
2934 Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds.
293430 Compounds containing in the structure a phenothiazine ring system (whether or not hydrogenated), not further fused
2935 Sulphonamides.
293500 Sulphonamides.

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