Legitimate interests globally are facing a battle with pharmaceutical counterfeiters.
Legitimate interests around the world are facing a battle with pharmaceutical counterfeiters, Jeffrey Gren, director of the Office of Health and Consumer Goods, Department of Commerce, said at a conference in Washington.
Drug counterfeiters, he said, "are very sophisticated, well organized, and right now they are winning the battle because every year there are more counterfeit medicines in the world than there were the year before."
Gren said about 40% of active pharmaceutical ingredients (API) manufacturing is done in India and China, and most industry experts expect that to rise to 80% over the next 15 years. By contrast, 20 years ago "most APIs in the world were manufactured in the United States and Europe. Many of the APIs were 'captive APIs,' were made in-house or under contract by innovative companies. And economics has driven much of the production overseas," he said.
Gren spoke at the Global Forum on Pharmaceutical AntiCounterfeiting, held in June and attended by about 100 people. It was sponsored by Reconnaissance International, a company in the United Kingdom that does publishing and consulting on product security.
Gren said that China's State Food and Drug Administration has authority to implement good manufacturing inspections on chemical producers only if they state their products are for medical use. If they do not claim medicinal use, that regulatory authority doesn't exist. "We have been trying to get the Chinese to close that loophole," he said. "The Chinese are taking this issue much more seriously."
Among signs of progress, Gren noted a recent investigation in which the Chinese government shut down some Web sites advertising APIs for medicinal use from companies not complying with manufacturing regulations. There are also plans for a U.S.-China joint counterfeit medicine seminar later this year, he said, and the United States has had or is planning seminars with a number of other nations.
The United States also has raised the API issue with India. Currently India is awaiting completion of a survey on the extent of counterfeiting; it may take six months: "Hopefully, once that study is complete, we can get back to some activities," Gren said. Overall, however, "we clearly see a lack of cooperation," he said, both within countries, among regulators, customs, and law enforcement, and among the nations of the world.
Gren praised the efforts of the World Health Organization (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which has been meeting for about one and a half years to strengthen global cooperation. IMPACT is comprised of several international organizations and will, according to WHO, look at laws around the world, present models that countries can replicate and adapt. It also plans to adopt a legal definition of counterfeit medicines, as well as other activities.
"It is really fostering global cooperation. But it is a slow process. And it's probably going to take quite a number of years until we see significant results out of IMPACT," Gren said. "Clearly a risk of doing nothing is that this problem will continue to grow. We need to protect the integrity of the supply chain."
In another conference presentation, Peter Pitts, former Food and Drug Administraion (FDA) associate commissioner for external relations from 2002 to 2004, asserted that, while the U.S. presidential candidates have endorsed the idea of importing Canadian drugs, it's not likely to become reality once FDA educates the new administration on the hazards and lack of staff to oversee the process. Pitts is now head of the Center for Medicine in the Public Interest.
Also at the meeting, a European group on safe medications released a report on 18 orders placed on Internet pharmacies. The European Alliance for Access to Safe Medicines (EAASM) said the majority of the medications were counterfeit, substandard, or generics that were made without permission. The EAASM was formed last year to act on counterfeit and substandard medications.
THE AUTHOR is a writer based in the Washington, D.C., area.