Property of Marv Shepherd, University of Texas Industry Issue: Importation/Reimportation of Drugs By Marv Shepherd, Ph.D. Director Center for Pharmacoeconomic

Property of Marv Shepherd, University of Texas

Industry Issue: Industry Issue: Importation/Reimportation of Importation/Reimportation of

DrugsDrugsByBy

Marv Shepherd, Ph.D.Marv Shepherd, Ph.D.

DirectorDirector

Center for Pharmacoeconomic StudiesCenter for Pharmacoeconomic Studies

College of PharmacyCollege of Pharmacy

University of TexasUniversity of Texas

Austin, TX 78712Austin, TX 78712

Email: Email: [email protected]@mail.utexas.edu



IntroductionIntroduction First an overview of the extent of drug First an overview of the extent of drug

importation.importation. Threats of product integrity from imported Threats of product integrity from imported

drugs.drugs. Overview of counterfeit drugs.Overview of counterfeit drugs. Why people procure imported drugs.Why people procure imported drugs. Vulnerability points of the US drug distribution Vulnerability points of the US drug distribution

system.system. Canadian Drug MarketCanadian Drug Market Political realitiesPolitical realities


Bringing prescription drug products into the Bringing prescription drug products into the U.S. from Mexico and Canada has been going on U.S. from Mexico and Canada has been going on for decades, if not centuries. for decades, if not centuries.

With the easy access to Internet pharmacies, With the easy access to Internet pharmacies, the problem of drug importation continues to the problem of drug importation continues to grow at enormous proportions. grow at enormous proportions.

Introduction


Myth # 1Myth # 1

“It is legal to personally import drugs into the U.S.”


Drug importation is illegal!Drug importation is illegal! The only groups which can import The only groups which can import

drug products are pharmaceutical drug products are pharmaceutical manufacturers. Personal drug manufacturers. Personal drug importation is illegal.importation is illegal.

However, FDA has allowed some However, FDA has allowed some variances. variances.


Myth # 2Myth # 2

“Drug importation is a one dimensional issue. It purely an economic issue!”


Drug importation is not just a one Drug importation is not just a one dimensional issue! It is a very dimensional issue! It is a very complicated issue.complicated issue.

The problem has many fronts. There The problem has many fronts. There are political issues, financial issues, are political issues, financial issues, economic/competition issues, economic/competition issues, international trade concerns, legal and international trade concerns, legal and liability concerns, health care issues, liability concerns, health care issues, plus many social issues. plus many social issues.


For legal importation to take place it For legal importation to take place it will take the understanding and will take the understanding and cooperation from many governmental cooperation from many governmental agencies, law enforcement agencies, agencies, law enforcement agencies, private and public organizations, private and public organizations, consumer groups and associations. consumer groups and associations. This cooperation cannot only occur in This cooperation cannot only occur in the U.S. It requires cooperation from the U.S. It requires cooperation from exporting countries.exporting countries.

Plus, it will require additional funding Plus, it will require additional funding for FDA and U.S. Customs.for FDA and U.S. Customs.


Myth # 3Myth # 3

Drug importation is safe. No one has ever been hurt from imported drugs.


People have been harmed and people People have been harmed and people have died from imported drugs.have died from imported drugs. Some imported products contain the Some imported products contain the

correct amount of active ingredients correct amount of active ingredients others contain no active ingredient, too others contain no active ingredient, too little or too much.little or too much.

Counterfeit drugs w/o active ingredients Counterfeit drugs w/o active ingredients usually do not kill. It may take weeks, usually do not kill. It may take weeks, months or years to see the effects.months or years to see the effects.


Myth # 4Myth # 4

All foreign pharmacies doing business with Americans are licensed and follow U.S. laws and regulations.


There are over a thousand internet There are over a thousand internet pharmacy sites worldwide offering a pharmacy sites worldwide offering a variety of drug products.variety of drug products.

Many do follow regulations within their Many do follow regulations within their country but some of these regulations country but some of these regulations are weak compared to U.S. standards.are weak compared to U.S. standards.

Many DO NOT abide by U.S. or state Many DO NOT abide by U.S. or state standards to do business with U.S. standards to do business with U.S. residents.residents.


Many of these foreign pharmacy internet Many of these foreign pharmacy internet sites selling drugs to Americans are rogue, sites selling drugs to Americans are rogue, fraudulent sites. They pop-up one day and fraudulent sites. They pop-up one day and disappear the next. They are difficult to track disappear the next. They are difficult to track and difficult to find their location.and difficult to find their location.

Some sites are operated by felons, criminals Some sites are operated by felons, criminals with links to organized crime, and drug with links to organized crime, and drug cartels.cartels. Many are not operated by Many are not operated by pharmacists.pharmacists.

Some site dispense counterfeit, non-FDA Some site dispense counterfeit, non-FDA approved drugs.approved drugs.


In an examination of 45 Canadian In an examination of 45 Canadian Internet pharmacy sites, 15 appeared to Internet pharmacy sites, 15 appeared to falsely advertise that their country of falsely advertise that their country of origin was Canada.origin was Canada.

Investigations found the sites were Investigations found the sites were from U.S., Barbados, and Mexico.from U.S., Barbados, and Mexico. For example, the site CanadaRxfree.com For example, the site CanadaRxfree.com

is from Mexico City. is from Mexico City. (Source: Global Options)(Source: Global Options)


Some sites are very deceptive. For Some sites are very deceptive. For example many sites have been found to example many sites have been found to use Canada in their domain name but use Canada in their domain name but the pharmacy is located in another the pharmacy is located in another country. CanadaRx.com was country. CanadaRx.com was dispensing drugs out of a pharmacy in dispensing drugs out of a pharmacy in the Bahamas, when patients thought the Bahamas, when patients thought they were located in Canada.they were located in Canada.


To assure that the To assure that the internet site is a internet site is a legitimate, licensed legitimate, licensed pharmacy, look for the pharmacy, look for the VIPPS seal on the VIPPS seal on the opening screen.opening screen.

The VIPPS (Verified The VIPPS (Verified Internet Pharmacy Internet Pharmacy Provider Site) seal is Provider Site) seal is given by the National given by the National Association of Boards Association of Boards of Pharmacy. of Pharmacy.


Myth # 5Myth # 5

Americans are required to have a prescription to get prescription drugs from a foreign pharmacy.


For many pharmacy sites you don’t For many pharmacy sites you don’t even need a prescription!!! All you even need a prescription!!! All you need is a credit card number and need is a credit card number and address.address.

In fact, for many countries, such as In fact, for many countries, such as Mexico, prescriptions are not Mexico, prescriptions are not necessary for many therapeutic necessary for many therapeutic categories of drugs.categories of drugs.


In Canada, it is illegal to fill a prescription In Canada, it is illegal to fill a prescription written by U.S. physician unless they are written by U.S. physician unless they are licensed in Canada. licensed in Canada. Canadian physicians are Canadian physicians are required to rewrite the prescription or co-required to rewrite the prescription or co-signed the prescription.signed the prescription. Many Canadian health care practitioners, Many Canadian health care practitioners,

associations and regulators want to ban this co-associations and regulators want to ban this co-signing of prescriptions. It is an unethical signing of prescriptions. It is an unethical practice: no patient contact, no examination.practice: no patient contact, no examination.

It has been reported that Canadian internet firms It has been reported that Canadian internet firms pay physicians $10.00 per Rx rewritten.pay physicians $10.00 per Rx rewritten.


Myth # 6Myth # 6

Although drug importation is a hot political issue, few drugs are coming from other countries.


Extent of Drug ImportationExtent of Drug Importation At a U.S. House At a U.S. House

Congressional open hearing Congressional open hearing (June 24, 2003), Rep. (June 24, 2003), Rep. Greenwood reported that Greenwood reported that 30,000 drug packages30,000 drug packages arrive each day at the Miami arrive each day at the Miami international mail facility. international mail facility.

Over Over 10,000 parcels10,000 parcels arrive arrive daily at the Carson City mail daily at the Carson City mail facility here in California.facility here in California.

40,000 parcels arrive daily 40,000 parcels arrive daily at the JFK airport.at the JFK airport. Each package contained chewable

sildenafil (Viagra).

Many parcels contain more than one drug.


All these shipments in brown and white envelops were from Honduras, UK or Belize. All were labeled Valium. This bin is 3x4x3 feet. This is one days shipment. Miami International Mail Branch.

Fake Valium shipments


Counterfeit Valium shipments for one day—Miami International Mail Branch, March 2004.


Drugs are from all over the world. The true manufacturing site is unknown on many. Container size suggest more than 90 day personal use.


Teddy bears stuffed with counterfeit Viagra being shipped to a carpet cleaning business in Ohio.


It is estimated that It is estimated that 20 million packages20 million packages containing drugs arrive annually via containing drugs arrive annually via international U.S. mail. This is an increase of international U.S. mail. This is an increase of 1000% in just two years and it continues to 1000% in just two years and it continues to grow. These estimates do not include Fed grow. These estimates do not include Fed Express, UPS or other delivery mechanisms.Express, UPS or other delivery mechanisms.

The HHS Drug Importation study released in The HHS Drug Importation study released in December 2004 estimates that 12 million December 2004 estimates that 12 million prescriptions were sold by Canada to U.S. prescriptions were sold by Canada to U.S. residents. This was approximately a $700 residents. This was approximately a $700 million transaction.million transaction.


More current estimates indicate that More current estimates indicate that Canadians export an estimated Canadians export an estimated $1.1 $1.1 billionbillion (U.S. dollars) of drugs to U.S (U.S. dollars) of drugs to U.S residents. Considering that the total residents. Considering that the total Canadian drug market is just $8 to $10 Canadian drug market is just $8 to $10 billion, this constitutes a major billion, this constitutes a major business for Canada.business for Canada.

Mexico sells $800 million just from Mexico sells $800 million just from border farmacias.border farmacias.


Myth # 7Myth # 7

Imported drug products are safe and effective products.


Partially true! Some drugs are of good quality some are not.

Few are FDA approved.

Problem: it is difficult to determine what is good what is bad.

Source: www.fda.gov/news/2003/new00948.html


What is troubling is that the vast majority of the pharmaceutical products coming into the U.S. are NOT approved by the FDA. Many are substandard products or fake products.

Source: www.fda.gov/news/2003/new00948.html


FDA has determined thatFDA has determined that imported drug products may imported drug products may

Contain no active ingredient, too little Contain no active ingredient, too little or too much active ingredient.or too much active ingredient.

Be expired or have a false expiration Be expired or have a false expiration date.date.

Be contaminated.Be contaminated. Be stored at the wrong temperature or Be stored at the wrong temperature or

under unsafe conditions.under unsafe conditions.


Be a counterfeit or fake medicine.Be a counterfeit or fake medicine. Be fraudulently or inadequately labeled.Be fraudulently or inadequately labeled. Be a product which has been Be a product which has been

withdrawn from the market.withdrawn from the market. Be animal drugs not for approved Be animal drugs not for approved

human use.human use. Be inappropriately packaged.Be inappropriately packaged.



Continuation of Myth # 7Continuation of Myth # 7

Imported drugs are safe and effective.


CAUTION: MEDICINE MAY BE FAKE

WARNING: MAY BE EXPIRED,WATERED DOWNED OR MISLABELED

DIRECTIONS: TAKE WITH HEALTHY DOSE OF SKEPTISMDIRECTIONS: TAKE WITH HEALTHY DOSE OF SKEPTISM

Threat of Counterfeit Pharmaceuticals


Definition of Counterfeit Definition of Counterfeit Prescription DrugsPrescription Drugs

Counterfeit medication is one which is Counterfeit medication is one which is deliberately and fraudulently mislabeled deliberately and fraudulently mislabeled with respect to identity and/or source.with respect to identity and/or source.

Counterfeiting can apply to both brand Counterfeiting can apply to both brand and generic products.and generic products.

Counterfeit products may include Counterfeit products may include products with correct ingredients, wrong products with correct ingredients, wrong ingredients, without active ingredients, ingredients, without active ingredients, with insufficient quantities of active with insufficient quantities of active ingredient or with fake packaging.ingredient or with fake packaging.


Trend in Number of FDATrend in Number of FDA Counterfeit Drug Cases Counterfeit Drug Cases

5 4 6 6

20 22 22

58

0

10

20

30

40

50

60

Number of Cases

1997 1998 1999 2000 2001 2002 2003 2004

Year

Source: FDA Counterfeit Drug Report, February 2004, the 2004 figure came from Business Week, February 7, 2005.


Counterfeit drugs Counterfeit drugs continue to be a continue to be a growing concern. It growing concern. It is anticipated that is anticipated that the number of the number of counterfeit drugs counterfeit drugs will continue to will continue to increase. Since increase. Since 1996, 73 fake 1996, 73 fake pharmaceutical pharmaceutical cases have been cases have been opened in the U.S. opened in the U.S. Legal results show Legal results show 44 arrests and 27 44 arrests and 27 convictions. In 2003 convictions. In 2003 there were 22 fake there were 22 fake drug cases opened drug cases opened by the FDA.by the FDA.

Most recent Most recent counterfeit drugs counterfeit drugs found in the U.S.found in the U.S.

ProcritProcrit®® LipitorLipitor®® SerostimSerostim®® NeupogenNeupogen®® EpogenEpogen®® CombivirCombivir®® ZyprexaZyprexa®® ViagraViagra®® Diflucan®Diflucan® Ortho Evra ®Ortho Evra ® Ambien®Ambien® BotoxBotox

Caution: Fake


Extent of Counterfeit Drugs and Major SourcesExtent of Counterfeit Drugs and Major Sources

It has been estimated It has been estimated by the WHO that by the WHO that counterfeit drugs counterfeit drugs comprise 8 percent of comprise 8 percent of the world market.the world market.

For some countries For some countries (African, Latin) (African, Latin) counterfeits comprise counterfeits comprise 40 to 50 percent of the 40 to 50 percent of the market.market.

Estimated to be $20 to Estimated to be $20 to over a $40 billion over a $40 billion market. (WHO)market. (WHO)

Sources of Counterfeit Sources of Counterfeit DrugsDrugs India—it is estimated at India—it is estimated at

15 to 20% drugs are 15 to 20% drugs are fake. fake. ((ScriptScript, April 16, 2003), April 16, 2003)

ChinaChina Brazil (40% to 50% fake)Brazil (40% to 50% fake) Mexico (25% fake)Mexico (25% fake) PakistanPakistan BelizeBelize ChileChile Southeast Asia Countries Southeast Asia Countries

(30 to 50%)(30 to 50%)


The extent of counterfeit drugs in the U.S. has not been determined. Some commonly heard estimates are that it is less than 1%. However, with the proliferation of internet drug sites and the number of drug entering the U.S. from other countries, this estimate may be low.


Often times the counterfeit product Often times the counterfeit product is mixed with legitimate products is mixed with legitimate products to confuse investigators. The to confuse investigators. The counterfeit Lipitor found in the U.S. counterfeit Lipitor found in the U.S. last summer was mixed with last summer was mixed with authentic product.authentic product. Makes it difficult to determine the Makes it difficult to determine the

extent of counterfeitingextent of counterfeiting..


Lipitor® (atorvastatin calcium)

Which one is the counterfeit Lipitor®?

Source: Pfizer Inc.


Lipitor® (atorvastatin calcium)

Which one is the counterfeit Lipitor®?

FAKE AUTHENTIC

Source: Pfizer Inc.


Celebrex® (celecoxib)

Which one is the fake Celebrex®?

Source: Pfizer Inc.


Celebrex® (celecoxib)

Which one is the fake?

COUNTERFEIT AUTHENTIC

Source: Pfizer Inc.


Drugs purchased over the Internet by an American patient who was told that the products were manufactured in the United States and were being sold from Canada. The drugs he actually received are fake “knockoffs” from India.

Counterfeit Gabantin


Counterfeit Zantac

Manufactured in Taiwan, discovered in United Kingdom.

Excellent packaging of counterfeit, even includes counterfeit package insert.

Source: Pharmaceutical Research Manufacturers Association


Ponstan is an anti-inflammatory product. This counterfeit was found in Columbia. First is the yellow powder; it consist of boric acid, floor wax, yellow highway paint. Pressed into tablets and placed in foil packs with labeling.

Source: Pharmaceutical Manufacturer Research Association

Counterfeit Ponstan


Authentic Ortho Evra Contraceptive Patch and packaging

Counterfeit Patch—no active ingredient


Counterfeit Viagra is a worldwide problem. The University of London reported in September, 2004 that half the men buying Viagra online are getting a counterfeit drug. Many having no active ingredient, wrong active ingredient, or wrong quantity. (BBC, September 28, 2004)

Countries exporting fake Viagra are India, China, Israel, Thailand, Costa Rica, Belize, Mexico.


Viagra® (sildenafil)

Which one is the fake drug?


Viagra® (sildenafil)

Which one is the fake drug?

FAKEAUTHENTIC


Manufacturing Facility for Counterfeit Panadol

Source: Pharmaceutical Research Manufacturers Association

This facility depicts the conditions in which many counterfeits are manufactured. This counterfeit lab was found in South East Asia.


Recent Fake Drugs From Alleged Recent Fake Drugs From Alleged Canadian Web SiteCanadian Web Site

Counterfeit Ambien®, Viagra® and Lipitor® were found coming into the U.S.

All three products were so-called “generic” versions. However, none of these products have approved generic versions.

Tests showed that the drugs were the wrong strength, didn’t dissolve properly and contained contaminants.


Ambien® was found to be double the labeled strength listed.

The “generic” Lipitor® was found to be sub-potent. On average, only 57% of the active ingredient was found.

Some tablets of Viagra® had both too little and too much active ingredient. Viagra® failed the dissolution tests and tablets had unacceptable levels of impurities.

Source: FDA.gov/bbs/topics/news/2004 accessed July 20, 2004


In April, it was reported that a Vancouver In April, it was reported that a Vancouver Internet Pharmacy operator (Internet Pharmacy operator (www.canadapharmacytrust.comwww.canadapharmacytrust.com )is openly )is openly selling Viagraselling Viagra® (Sildenafil), Cilalis (Sildenafil), Cilalis® (tadalafil) and Levitra(tadalafil) and Levitra® (vardenafil) which are (vardenafil) which are not approved by the Health Canada nor the not approved by the Health Canada nor the U.S. FDA.U.S. FDA.

These counterfeit drugs were coming from These counterfeit drugs were coming from Mexico.Mexico.

Source: Scrip, (PJB Publications) April 9, 2004.


Best Pharmacist’s StrategyBest Pharmacist’s Strategy Know your suppliers!!!! Deal only with Know your suppliers!!!! Deal only with

trustworthy reputable wholesalers. Just trustworthy reputable wholesalers. Just because a wholesaler has a license doesn’t because a wholesaler has a license doesn’t necessarily mean they can be trusted!necessarily mean they can be trusted!

Be careful of theBe careful of the “Good“Good Deal”.Deal”. If it If it appears to be too good to be true, you may appears to be too good to be true, you may have a problem. Be very careful, especially have a problem. Be very careful, especially if it from a new source. Due diligence is if it from a new source. Due diligence is needed to check on suppliersneeded to check on suppliers

Be careful of fax and email deals.Be careful of fax and email deals.


What if you suspect something is What if you suspect something is wrong?wrong?

Contact FDA at Contact FDA at http://www.fda.gov/medwatchhttp://www.fda.gov/medwatch

Or call FDA at 1-800-FDA-1088Or call FDA at 1-800-FDA-1088 Also contact the manufacturer.Also contact the manufacturer.


Myth # 8Myth # 8

The only reason people obtain their pharmaceuticals from a foreign pharmacy is to save money.


Saving money is partially correct. There are other reasons why people import medicines.


Reasoning for Going Outside the U.S.Reasoning for Going Outside the U.S. The primary reason why Americans go to The primary reason why Americans go to

Canada to obtain drugs is because of the Canada to obtain drugs is because of the cheaper price.cheaper price.

The primary reason why Americans go to The primary reason why Americans go to Mexico to obtain drugs is because of the Mexico to obtain drugs is because of the cheaper price and easy access.cheaper price and easy access.

The primary reason why Americans use a The primary reason why Americans use a foreign internet site is because of the foreign internet site is because of the cheaper price, easy access and convenience.cheaper price, easy access and convenience.

Other reasons areOther reasons are to avoid the law, obtain to avoid the law, obtain controlled substances without a prescription, controlled substances without a prescription, and don’t have to see a physician to get a and don’t have to see a physician to get a prescription.prescription.


One frightening thing about the open door to One frightening thing about the open door to drug importation is the purchasing of drug importation is the purchasing of controlled substances. Narcotics are flowing controlled substances. Narcotics are flowing freely into this country via foreign internet freely into this country via foreign internet sites.sites.

As pointed out in a recent As pointed out in a recent Washington PostWashington Post series of articles on importation, when series of articles on importation, when children can order controlled substances children can order controlled substances from their homes with a credit card number, from their homes with a credit card number, without a prescription, and have drugs without a prescription, and have drugs delivered to their home--delivered to their home--we have a problem.we have a problem.


Terrorist Group InvolvementTerrorist Group Involvement

Terrorist groups such as IRA, Homas, Terrorist groups such as IRA, Homas, Hezbollah and Al Queda have been linked to Hezbollah and Al Queda have been linked to counterfeit drug production and distribution.counterfeit drug production and distribution. IRA manufactured counterfeit Ivomec and other IRA manufactured counterfeit Ivomec and other

fake hormone products in Florida.fake hormone products in Florida. Hezbollah smuggled large quantities of Hezbollah smuggled large quantities of

pseudoephredrine from Canada to make pseudoephredrine from Canada to make methamphetamine. methamphetamine.

The link between terrorists groups, organized The link between terrorists groups, organized crime, narcotic cartels and counterfeit drugs is crime, narcotic cartels and counterfeit drugs is extremely strong.extremely strong.


Myth # 9Myth # 9

Canada can meet the prescription drug needs of U.S. residents.


Source: AARP Bulletin, February 3, 2005, 3.


Canadians Cannot Meet U.S. Drug Canadians Cannot Meet U.S. Drug DemandsDemands

Canada’s population is 32 million compared Canada’s population is 32 million compared the 290 million in the U.S.the 290 million in the U.S.

The number of U.S. elderly are greater than The number of U.S. elderly are greater than the total Canadian population.the total Canadian population.

The Canadian drug supply would last the 38 The Canadian drug supply would last the 38 days in the U.S.days in the U.S.

To supply just half of the U.S. elderly, Canada would have increase their total annual drug supply 2.5 times.


U.S. Demands are a Threat to U.S. Demands are a Threat to Canadian Drug SupplyCanadian Drug Supply

New York Times (Oct. 16, 2004) reported that New York Times (Oct. 16, 2004) reported that many in Canada are concerned about the many in Canada are concerned about the lack of drug supplies in Canada.lack of drug supplies in Canada.

““It is completely untenable to think that It is completely untenable to think that Canada could supply their (U.S.) needs and Canada could supply their (U.S.) needs and our own for even one month let alone on an our own for even one month let alone on an on going basis.” Canadian Treatment on going basis.” Canadian Treatment Action Council and Best Medicine Coalition Action Council and Best Medicine Coalition (Globe Technology, Associated Press, Oct. (Globe Technology, Associated Press, Oct. 19, 2004)19, 2004)


In December, the Health Minister of Canada, Mr. Ujjal Dosanjh spoke out against Americans getting drugs from Canada. He stated: “We cannot be the drugstore for the United States.” Furthermore he stated, “I want to make sure that we don’t have…250 million Americans buying drugs in Canada.”Source: Television interview, CTV Television, December 12, 2004.


Script recently reported that Canadameds.com is now filling about half of their prescriptions with products from outside of Canada. Canadameds.com has pharmacies in more than 30 countries, approximately 10,000 prescriptions a week are coming into the US from these foreign pharmacies. Source: Script, World Pharmaceutical News, February 11, 2005.


Myth # 10Myth # 10

All drugs for export by Canada are approved by Health Canada and manufactured in Canada.


Approximately 60% of the drugs used Approximately 60% of the drugs used in Canada are imported, the remaining in Canada are imported, the remaining are manufactured in Canada. Canada are manufactured in Canada. Canada imports drugs from more than 80 imports drugs from more than 80 foreign countries. ($4.5 billion are foreign countries. ($4.5 billion are imported, $4.4 billion manufactured, imported, $4.4 billion manufactured, but Canadian manufacturers export but Canadian manufacturers export $1.5 billion).$1.5 billion).


Concerns About Canadian DrugsConcerns About Canadian Drugs

Canada is on record of saying that they will Canada is on record of saying that they will NOTNOT assure the quality of the products assure the quality of the products coming into the U.S.coming into the U.S.

Canadian Internet operators are on record of Canadian Internet operators are on record of saying that they will obtain drugs from other saying that they will obtain drugs from other sources (countries) if supplies become sources (countries) if supplies become limited. Our research shows that Canada is limited. Our research shows that Canada is importing drugs from 80 countries.importing drugs from 80 countries.


It is important to realize that under Canadian Drug Law, drugs which are intended for export may not be regulated by Health Canada. In other words, drugs which are for export by Canada do NOT have to have approval from Health Canada.


Canadian Food and Drug Act, 37.(1)Canadian Food and Drug Act, 37.(1)“This act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word “Export” or “Exportation” and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or about to be consigned has been issued in respect of the packaging and its contents in prescribed form and manner.”


This also explains why many American politicians proclaim that Canadian drugs are just as safe as U.S. drugs. They say “show me the Canadian bodies.” There will not be Canadian bodies because drugs sold in Canadian “brick and mortar” pharmacies have a different standard than some drugs sold by internet exporting companies.


To emphasize this point, papers filed in Canadian federal court late last month by CanadaRX.com has asked the judge to prevent Health Canada inspectors from visiting their facilities, calling the proposed inspection ‘invalid and unlawful” and a violation of the company’s charter rights.

Their basis is that since they do not dispense drugs to Canadians they legally cannot inspect their facilities.


Increase in Canadian Pharmaceutical Imports Increase in Canadian Pharmaceutical Imports from Selected Countries for Drugs Packaged from Selected Countries for Drugs Packaged

forfor Retail Use Retail Use 2002 vs. 2003 2002 vs. 2003

U.S.: U.S.: $1.7 billion to $2.1 billion + 23.5% $1.7 billion to $2.1 billion + 23.5% IndiaIndia $25.2m to 26.1m $25.2m to 26.1m + 3.5% + 3.5% China: $2.3m to $2.9m China: $2.3m to $2.9m + 26.1%+ 26.1% Ecuador: $1.5m to $2.7m Ecuador: $1.5m to $2.7m + 80.0%+ 80.0% Mexico: $15.8m to $25.3mMexico: $15.8m to $25.3m + 60.1%+ 60.1% Singapore: $1.4m to $4.9m + 250 .0%Singapore: $1.4m to $4.9m + 250 .0%

All countries: $3.7 billion to $4.7 billion All countries: $3.7 billion to $4.7 billion + 27.0%+ 27.0%

Source:http://strategis.gc.ca/sc_mrkti/ 03/3/04Source:http://strategis.gc.ca/sc_mrkti/ 03/3/04


Myth # 11Myth # 11

Drug importation is free trade.


Many argue, including legislators, that drug importation is a “free trade” issue.

The flaw with this argument is that countries where they want to import drugs have price controls.

This is NOT free trade.

We are importing price controls not pharmaceuticals.

We are imposing foreign price controls on American goods in a U.S. market.


Myth # 12

All drugs outside the U.S. are cheaper than U.S. drugs.


Wrong!!Wrong!! Generic drug products which constitute Generic drug products which constitute

50% of all drugs dispensed in the U.S. 50% of all drugs dispensed in the U.S. are cheaper in the U.S. are cheaper in the U.S.

Sources exist in the U.S. to obtain Sources exist in the U.S. to obtain lower cost pharmaceuticals, including lower cost pharmaceuticals, including brand name drugs without the added brand name drugs without the added risk foreign drugs have. risk foreign drugs have.


Safe Saving SourcesSafe Saving Sources www.Helpingpatients.orgwww.Helpingpatients.org

Access to 275 public and private patient assistance Access to 275 public and private patient assistance programs.programs.

1-800-762-46361-800-762-4636 www.RxOutreach.comwww.RxOutreach.com

Prescription assistance program run by Express scriptsPrescription assistance program run by Express scripts 1-800-769-38801-800-769-3880

www.TogetherRx.comwww.TogetherRx.com 10 PRMA Companies offering over 150 FDA-approved drugs10 PRMA Companies offering over 150 FDA-approved drugs Savings from 20 to 40%Savings from 20 to 40%

www.Safemedines.orgwww.Safemedines.org Provides links to various drug savings programsProvides links to various drug savings programs


When a patient is not progressing well on When a patient is not progressing well on their drug regimen, possible questions their drug regimen, possible questions you may want to ask are:you may want to ask are:

Where are you obtaining your prescription drugs or a specific drug?

Are you using a pharmacy internet provider site for your medications? What is the site?

Is the pharmacy site a foreign site? (Remember: sometimes it is difficult to determine.)

Is the patient using medications you are not aware?


If patients are using an “out-of-country” If patients are using an “out-of-country” pharmacy other questions are:pharmacy other questions are: Who is monitoring the patient’s drug therapy Who is monitoring the patient’s drug therapy

for:for: Drug interactions?Drug interactions? Proper drug use?Proper drug use? Inappropriate therapies?Inappropriate therapies? Drug adherence monitoring?Drug adherence monitoring?

Who does the patient call if they have drug Who does the patient call if they have drug therapy questions?therapy questions?

Who is counseling the patients on their Who is counseling the patients on their therapies?therapies?


Concerns---continuedConcerns---continued

When patients use an out-of-country When patients use an out-of-country Internet provider for chronic care needs Internet provider for chronic care needs and use a local community pharmacy and use a local community pharmacy for acute care needs, the result is an for acute care needs, the result is an incomplete patient drug profile.incomplete patient drug profile.

The community pharmacist may not be The community pharmacist may not be aware of the chronic medications the aware of the chronic medications the patient is taking. This raises the risks patient is taking. This raises the risks of drug interactions or drug of drug interactions or drug misadventures. misadventures.


This raises the question of liability. What can This raises the question of liability. What can an American do if they get hurt?an American do if they get hurt? Is the foreign internet pharmacy provider Is the foreign internet pharmacy provider

liable? liable? Remember: patients who use Canadian sites Remember: patients who use Canadian sites

are required to sign a waiver of their rights.are required to sign a waiver of their rights. What are the patient’s chances in suing a What are the patient’s chances in suing a

pharmacy located in Pakistan, China, etc? pharmacy located in Pakistan, China, etc? For Canada is the U.S. doctor or the For Canada is the U.S. doctor or the

Canadian doctor responsible?Canadian doctor responsible? Is the manufacturer liable?Is the manufacturer liable?

Remember: the U.S. drugs sold to Canada are Remember: the U.S. drugs sold to Canada are for Canadian use ONLY and Canada will not for Canadian use ONLY and Canada will not assure quality of the products shipped to U.S.assure quality of the products shipped to U.S.


Demand for Foreign Drugs ContinuesDemand for Foreign Drugs Continues

Demand for cheaper pharmaceuticals Demand for cheaper pharmaceuticals continues; people appear to be blind continues; people appear to be blind to the hazards-just give them cheap to the hazards-just give them cheap drugs. drugs.

The pressure continues to mount to The pressure continues to mount to legalize drug importation despite the legalize drug importation despite the fact that FDA and the White House fact that FDA and the White House say they cannot assure safety and say they cannot assure safety and effectiveness of foreign drug effectiveness of foreign drug products.products.


Conclusions from the HHS Drug Conclusions from the HHS Drug Importation Task ForceImportation Task Force

“It would be extraordinarily difficult and costly for ‘personal’ importation to be implemented in a way that ensures the safety and effectiveness of imported drugs.”

“…national savings from legalized commercial importation will likely be a small percentage (1% to 2%) of the total drug spending and developing and implementing such a program would incur significant costs and require significant additional authorities.”


Thanks So Much!Thanks So Much!Hope you gained from the Hope you gained from the presentation.presentation.

Marv Shepherd, Marv Shepherd, Ph.D.Ph.D.

Documents

Property of Marv Shepherd, University of Texas Industry Issue: Importation/Reimportation of Drugs By Marv Shepherd, Ph.D. Director Center for Pharmacoeconomic