When it comes to taking medicine, we usually have blind faith in what the pharmacist hands us and consume it without a second thought. The thought that a prescription drug may be fake or even harmful does not generally cross our minds. However, the issue of pharmaceutical counterfeiting is more serious than we can imagine.
Although the problem of counterfeiting persists across all major industries, including electronics, tobacco and cosmetics, it is all the more serious when it comes to pharmaceuticals. Fraud in healthcare does not only raise concerns related to monetary loss, but also because jeopardizes the peoples’ health. The pharmaceutical industry is an ideal target for counterfeiters primarily because of the high price of certain drugs and the involvement of complex supply chains. These make it easier for counterfeiters to introduce counterfeit products into the market. The level of severity of the problem can be understood from the fact that over 10% (on an average) of the medicines are counterfeits; this represents estimated sales worth USD 75 billion and the profits generated through the sale of such drugs can be as high as 25 times the cost incurred. This 10% figure is known to be higher in the case of developing countries, such as India, China and countries in the African continent, often going up to as high as 30% in certain regions. On the contrary, the percentage of counterfeit drugs is as low as 1% in developed countries. This can be attributed to the active efforts and vigilance of regulatory bodies and the implementation of stringent anti-counterfeiting laws and policies in developed markets.
Counterfeiters have also taken advantage of our dependence on e-commerce market. According to data by European Alliance of Access to Safe Medicines (EAASM), 62% of the medicines that are purchased online are fake or substandard, and over 8 in 10 online pharmacies do not actually exist. According to a screening done by the National Association of Boards of Pharmacy (NABP), 96% of the pharmacies running online were found to be out of compliance with state and federal laws and / or NABP patient safety standards. Apart from this, the following figures indicate the extent of medical counterfeiting across the globe and its impact on global health and the pharmaceutical industry:
- As per WHO estimates, at the global level, around 16% drugs contain improper ingredients, 17% contain incorrect amounts of the active ingredients and 60% contain no drug at all.
- The European Commission announced that in 2011, more than 27 million counterfeit or fake drugs were confiscated by the customs authorities in the EU alone.
- According to the WHO, up to 15% of all the medical products across the globe are counterfeit. In addition, nearly 50% of the total counterfeiting occurs in the developing countries of the Western Pacific region.
- It is estimated that counterfeit drugs are responsible for nearly 2,000 deaths worldwide on a daily basis, as per the estimates of Bosch Packaging Technology.
- In 2013, a substandard drug used to treat tuberculosis was implicated in the deaths of 100 patients at a hospital in Lahore, Pakistan.
- In 2013, 8,000 patients in India were reported to have died over a period of five years in a remote Himalayan hospital. The deaths were caused due to the use of an antibiotic to prevent infection after surgery that had no active ingredient at all.
- In May 2015, the WHO issued a warning on an expired meningitis vaccines that was being distributed in West Africa.
Some examples of popular products that have been counterfeited so far include Viagra® (Pfizer), Cialis® (Eli Lilly), Serostim® (Merck Serono), Ambien® (Sanofi Aventis), Neupogen® (Amgen), Diflucan® (Pfizer) and Zyprexa® (Eli Lilly). Although a number of initiatives have been taken up across the globe to address the issues related to fake drugs, the current scenario is such that a counterfeiter is more likely to be prosecuted for copying an Armani suit rather than a drug. The WHO actively organizes conferences and seminars to raise awareness related to medical counterfeiting and as of 2015. However, due to various reasons the organization has been prevented from introducing and enforcing strong anti-counterfeiting policies.