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Are Tier One Countries Safe to Import Medicine From?
Just because medicine purports to come from a supposedly safe country doesn’t mean that the medicine itself was either manufactured or inspected for safety by the country’s regulatory officials. Medicines can be transshipped through countries without ever having been opened or evaluated, with an unknown or questionable provenance.
So-called Canadian web pharmacies assure customers that their drug imports are only from countries designated as Tier One by the Federal Food, Drug, and Cosmetic Act. Since 2010, these have included Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa and countries in the European Union.
“Tier One” countries regulate their pharmaceutical industry to ensure the safety and effectiveness of their drugs through the entire development, manufacturing and sales process and have a clear procedure for reporting adverse reactions and for withdrawing unsafe or ineffective drugs. But in the face of a worldwide surge in counterfeit drugs, Tier One status alone doesn’t guarantee the safety or effectiveness of prescription drugs.
The Food and Drug Adminstration warns that medicine bought over the Internet from foreign sources may not be safe or effective. These medicines may present health risks and the FDA cannot ensure the safety of medicine from these sources. FDA cannot help you if you have problems with medicine you get from outside U.S. regulation and oversight.
Since 2007, the Partnership for Safe Medicines has recorded 13 counterfeit incidents, involving Tier One countries where legal authorities have prosecuted counterfeit medicine manufacturers and sellers. Examples include:
- 2012 – Canada
Canadian citizen and online pharmacy entrepreneur Andrew Stempler was arrested in Florida after FDA investigators intercepted packages containing counterfeit medications. Stempler owned a company that filled medicine orders for 10 different online pharmacies. The counterfeit medication claimed to be made and tested in Canada, but was actually shipped in bulk from other countries.
- 2012- Canada, United Kingdom, Denmark, and Switzerland
CanadaDrugs.com, an online pharmacy not licensed in the United States, is implicated in the distribution of counterfeit cancer medications through US subsidiaries to American doctors. The counterfeit medication was passed between four Tier One countries before reaching US patients. The FDA is still investigating.
- 2012- Israel
Israeli citizens, Benny Carmi and Moshe Dahan, pled guilty to smuggling counterfeit and misbranded drugs in the US. The men used multiple websites to illegally sell approximately 9,029 large shipments of fake prescription drugs to U.S. purchasers.
- 2011 – New Zealand
Counterfeit drugs including heart medications and pain killers suspected of being manufactured in China were distributed internationally via the internet.
- 2010 – Germany
Prosecutors brought charges against a German pharmacist from the Braunschweig region who was accused of handling €1.68m-worth of counterfeit medicines, including impotency drugs, bodybuilding products, painkillers, antibiotics and cancer treatments.
- 2011 – United Kingdom
The United Kingdom’s Medicine & Healthcare Products Regulatory Agency (MHRA) seized £14.4 million in assets from convicted counterfeit medicine dealer, Simon Martin Hickman. Hickman was sentenced to two years imprisonment in June 2009 following his conviction for both selling and supplying fake and unlicensed drugs,and money laundering.
- 2009- Canada
Canadian officials seized 15,000 counterfeit pills and arrested nine people during raids in the Montreal region. The pills, which included counterfeit Viagra and cancer drugs, were being sold in stores, online and on the street.
- 2007 – European Union
A UK wholesaler imported counterfeit drugs which had been manufactured in China, but were being funneled through other EU member countries. 30,000 drug packs had made their way to pharmacies, doctors offices, hospitals and patients by the time the problem was discovered.