Under Secretary Robert D. Hormats for Economic, Energy and Agricultural Affairs today underscored that counterfeit medicines hurt eeople and endanger lives.
At the Sino-U.S. Pharmaceutical Industry Summit of 2011 in Beijing, Mr. Hormats said for most of the 19th century, drugs were neither safe nor effective.
“One of the leading physicians of the time and Dean of the Harvard Medical School, Oliver Wendell Holmes, Sr., famously commented that: “if all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes.” -Mr. Hormats
He said the world cannot afford to return to this era. The world must ensure that citizens – in their most desperate moments – have confidence that the medicines they are taking – or that their loved ones are taking – are safe and effective.
“I’m delighted that the Chinese government has been working with the U.S. Food and Drug Administration to raise its mandatory Good Manufacturing Practices requirements to meet international standards, to both protect public safety and aid domestic industries move up the value chain.” -Mr. Hormats
He said the Chinese are making progress, but there remains one area in which he believes there’s a need to re-double efforts, that is, the growing menace of counterfeit medicines. He said thsi is the issue that has sparked at lot of debate in a lot of different venues.
Mr. Hormats underlined that counterfeiters do not care about a patient’s health when selling fake, tainted, poisonous, or sub-standard forms of life-sustaining medicines. Moreover, they are not interested in whether the patient is taking other medications or if the combination of medications will result in an adverse reaction.
He noted that experts report that there has been a 700 percent increase in drug counterfeiting from 2002 to 2009. It’s not just life-style drugs that are being counterfeited. In 2009, the United States identified counterfeited versions of over 800 unique medicines, ranging from antibiotics to cardiovascular drugs to anti-cancer therapies.
“Let me be clear – counterfeit medicines hurt people and endanger lives. At best, counterfeit medicines have unpredictable therapeutic benefit; at worst, they can cause severe illness or death due to chemical toxicity.” -Mr. Hormats
He said the counterfeit, falsified, and substandard medicines are not a hypothetical problem. The results can be tragic. In the United States 81 patients died from contaminated Heparin in 2010. He reported that there have been reported deaths in China due to counterfeit and sub-standard medicines as well.
“Our citizens – in China and America – deserve better.” – Mr. Hormats
He said the United States has stringent statutory, regulatory, and enforcement regimes to protect consumers against dangerous counterfeit, unapproved, or illegally prescribed pharmaceuticals.
Mr. Hormats stressed that the United States will continue to fight against the spread of counterfeit and sub-standard medicines. He pointed out that there is an opportunity for Chinese companies to show leadership.
“It’s essential that we work toward a corporate culture in which problems are not swept under the rug but rather, are openly discussed.” -Mr. Hormats