The World Health Organization estimates that 25 percent of medicines sold in poor countries are counterfeit. Monitoring by the World Bank and others suggests the overall global trade in fake and substandard drugs is now more than $30 billion per year. Experts are asking for stricter regulation and better international collaboration to check this public health menace.
Some 40 percent of the drugs available in many sub-Saharan African and South American countries are either fake or substandard, according to research by the World Bank and international public health groups. And experts say the widespread circulation of poor-quality or substandard medicines leads to frequent treatment failure and even loss of life.
Experts working to stop this counterfeit drug traffic met in Washington recently to discuss legal and enforcement solutions. Louise Shelley is a criminologist and director of the Terrorism, Transnational Crime and Corruption Center at George Mason University in Virginia.
“We are focusing much more on narcotics trafficking rather than on counterfeits that can do harm to many more individuals than consuming of illicit drugs,” said Ms. Shelley.
Ms. Shelley says sophisticated transnational criminal organizations are behind the manufacture and distribution of drugs that do not conform to proper standards. She says only a coordinated international effort can deal with organized crime on this scale.
“I think WHO, law enforcement community, consumer organizations, civil society everybody has a role in it,” she said.
“You have no guarantee of the safety, efficacy or quality of those products,” said Margaret Hamburg.
Dr. Hamburg heads the Food and Drug Administration, the federal agency which oversees the safety of drugs and food products in the United States. The FDA took strong action this week against thousands of internet pharmacies selling illegal medical products.
Patrick Lukulay of The United States Pharmacopeia, an organization that sets standards for medicines, says drug purity needs to be ensured through an international initiative, because the ingredients come from many parts of the world.
“In the U.S. 80 percent of active ingredients come from either India or China into the U.S. so U.S. companies are vulnerable,” said Lukulay.
“In India you have 10,000 manufacturing companies, and so although the regulators are making investments it’s difficult to catch up,” said Andreas Seiter.
Seiter is a global pharmaceutical expert. He says many countries need to increase their regulatory capabilities.
And Michael Bates of the World Health Organization says it is not only patients who are ignorant about fake medicines. He says many health professionals are also unaware.
“This is a complex international trade. And we need greater information on the scale and the scope, the harm and economic damage done by this issue to convince the policy makers to commit resources to tackle this,” said Bates.
Experts say a worldwide, coordinated effort is needed to deal with the problem, including better monitoring and regulation, upgrades in law enforcement capabilities, and the sharing of testing technology.