Fake and substandard medicines harm and kill patients in developed and developing countries, say Canadian and international researchers calling for an international treaty to tackle the problem.
The deadly meningitis outbreak in the U.S. from contaminated steroid injections highlights the consequences of fake medicines that contain little or no active ingredients and substandard drugs that don't meet regulatory quality control standards, experts said in this week's issue of the British Medical Journal.
U.S. authorities are investigating connections between the Canadian owner of an internet pharmacy firm and the sale of counterfeit versions of bevacizumab, an injectable cancer medication that goes by the brand names Avastin and Altuzan.
"Why is it that global law on money counterfeiting a fake 10 dollar bill is tougher than global law on a fake cancer treatment that can kill you?" asked Amir Attaran, Canada Research Chair in law, population health, and global development policy at the University of Ottawa, an author of the report.
In developing countries, a heart medicine containing a toxic overdose of a malaria drug led to 125 deaths in Pakistan, the researchers said.
The World Health Organizations estimates more than one in every 10 drug products in poorer nations are fake and in richer countries, substandard drugs cause thousands of adverse reactions and some deaths.
"Currently, the biggest problem with the governance of falsified medicines is that they are legal in global trade," and his co-authors wrote.
Stopping trade of fake medications
Governments, drug companies and non-governmental organizations want reliable access to safe and effective medications but the authors said it's difficult to act because the discussions often trespass into thorny issues like pharmaceutical pricing and intellectual property rights.
To overcome those problems, the researchers pointed to the model of global treaties like the Framework Convention on Tobacco Control that track and criminalize illicit trade in tobacco products.
The researchers from the World Federation of Public Health Associations, International Pharmaceutical Federation and the International Council of Nurses endorsed a five-point global treaty:
- Define illegitimate medicines in legal terms to avoid confusion.
- Define new public health crimes in international law, such as to manufacture, traffic or sell falsified medicines.
- Mandate intergovernmental cooperation on transborder crimes.
- Create an international forum to protect the legitimate trade of medicine such as setting global standards for authenticating medicines with tracking and tracing technology.
- Offer financial and technical assistance to strengthen regulatory authority in poorer countries.
Attaran said an international treaty would oblige countries to stop safe havens for criminals trading in fake medicines. He expects Canada would sign on to the treaty.
The authors received funding from Canada's Social Sciences and Humanities Research Council and the Wellcome Trust. The World Health Organization paid consulting and travel expenses for one of the authors.