How can I be sure the medicine I take is genuine? In some countries, there is an almost even chance that it is counterfeit; not just a cheap substitute, but a real fake, ineffective, probably harmful, and maybe fatal. Some counterfeit medicines were found in Hamilton, Ontario, earlier this year and the pharmacist has now been charged by the RCMP.
Counterfeit medicines are a global problem, with trade estimated to exceed US $36 billion a year. The World Health Organization estimates 8-10% of all drugs supplied globally are counterfeit. The European Union estimates counterfeit drugs cost their health systems €1.5 billion annually.
Counterfeits are a clear and present danger to human health. Africa is threatened by counterfeit AIDS drugs, while in Haiti, Nigeria, and Bangladesh almost 500 mainly children were killed from fake paracetamol syrup. Perhaps 192,000 people were killed in 2001 in China from counterfeit medicines. Counterfeits circulate in the European Union, with two recent cases in the UK alone. And Canada.
Fake medicines are hazardous, with documented toxicity, instability and ineffectiveness but few people are experts in pill authentication (even pharmacists get fooled). Counterfeit drugs are easier to make — in portable cement mixers – and fake than money. But there is little patients can do but rely on assurances by others that drugs are genuine. That may not be good enough.
Our health and medicines regulators believe there isn’t a problem because there are few cases. But recent research in Europe counters this regulatory denial with evidence that regulators have little hard evidence on the scale of counterfeiting. Problems with medicines are rarely associated with the drug being fake.
Counterfeit medicines don’t just show up in the local pharmacy, they are infiltrated into the supply and distribution of legitimate medicines by rogue, criminal organizations and individuals, who specifically target the weaknesses in this system. But counterfeiting is seen as a patent issue not the criminal act it is.
Once a medicine has been factory sealed by the pharmaceutical manufacturer, there is no assurance that it will reach the patient unopened; a pharmacist and doctor can open it. However, there are companies with the licensed authority to repackage factory-sealed medicines with new labels in new languages. Unscrupulous distributors can conceal the illegal substitution of counterfeits within our apparently highly regulated system. Canada, a net importer of medicines, is vulnerable from this as it imports medicines from countries that are known sources of counterfeit medicines.
While US/Canada medicines trade has focused on internet pharmacies, the real problem the internet is also a counterfeit drug delivery system and a real problem by the US, which views Canada’s system as easily compromised by counterfeiters.
Therefore, we need to ensure that any tampering with a product’s factory packaging is clearly evident to others. Using ‘drug provenance’ would show who has handled, opened or repackaged a product; another way is to use advanced ‘track-and-trace’ technologies such as radio-frequency tags (RFIDs) to track shipments of medicines and determine if they have been tampered with. However, there are stricter controls in place to deal with the movement of cattle than medicines.
Nevertheless, things are slowly improving, with the US FDA promoting the use of RFIDs by 2007, and efforts to improve data collection on counterfeiting. But there is little public awareness of this global threat, as regulators focus on the operation of pharmacies rather than the origin and safety of the medicines themselves. Legal sanctions are often weak, or inappropriate, considering the grave health risk counterfeit medicines represent.
The way forward will require ‘counterfeit proofing’ the supply and distribution of medicines. The criminal law needs rethinking to link human health and counterfeit medicines. Good data is needed to inform our actions and understanding to ensure appropriate regulation. Finally, the problem must be viewed as a global one and Canada could show international leadership in proposing solutions in an area were there is common cause amongst regulators, health professionals, pharmaceutical companies, and healthcare organizations.
The health system works on the basis of trust, and patients must trust that the pills in that little bottle are what they are supposed to be. But while the vast majority of drugs are perfectly legitimate, a more comprehensive solution to the problem of counterfeits is needed.