Counterfeit Medical Products
Counterfeit medicines are drugs manufactured below established standards of safety, quality and efficacy and therefore create serious health risks, including death. Experts estimate that 10 per cent of medicines around the world may be counterfeit. The phenomenon has grown in recent years due to the growing sophistication of counterfeiting methods and the increasing amount of merchandise crossing borders.
According to the WHO, a counterfeit medicine is “a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source”. Counterfeiting can apply to both brand name and generic products and may include products with the wrong ingredients, without active ingredients or with insufficient active ingredients, or even poisoning ingredients. They may also include products with the correct ingredients but fraudulent packaging.
Counterfeit medicines are a serious threat to the health of individuals. The harm for individuals can be generated either by excessive activity of the principal active ingredient, by an insufficient dosage of active ingredient or by the toxicity of ingredients that should not be present in the medicine. Patients may also believe that they are protected against a disease or an undesired health event when in fact they are not, or that they are receiving healing treatment when they are not.
Counterfeit medicines, for instance, diluted or insufficiently-dosed medicines, are a threat to public health as they contribute to drug resistance in populations, leading to increased infection rates, increased need for research and development of new drugs, and increased health care spending. Counterfeits interfere with the analysis of adverse events related to a specific drug, as they give the impression that the genuine drug produced the adverse event, when, in fact, it was a counterfeit product that caused the problem. They deprive the developers and original producers of medicines or materials from their financial rewards, thus inhibiting further research and development. Even worse, they reduce patients’ trust in medication and also in physicians, and may, in consequence, diminish adherence to treatment schemes.
The World Medical Association, together with the partner organisations of WHPA, joined the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) lead by WHO in 2006 to combat the global problem of counterfeit pharmaceuticals. IMPACT brings together nearly two hundred countries, as well as organizations with expertise in enforcement, manufacturing, and patient advocacy, and has called attention to the public health and commercial impact of counterfeit medicines.
The World Medical Association together with WHPA is running the ‘Be Aware’ campaign against counterfeit medical products to assist dentists, nurses, pharmacists and physicians in recognizing and addressing the problem of counterfeit medical products in their daily practice. Education of health professionals is crucial for detection and prevention of counterfeit medical products and is required in order for them to educate patients and populations about the risks of buying counterfeit medical products from unknown and unreliable sources.
The core of the campaign is the ‘BE AWARE’ toolkit for health professionals to identify and report counterfeit medicines and to make treatments safer. The toolkit is translated into English, French, Spanish and Chinese. Furthermore international workshops for health professionals in several regional were organised which lead to a joint call for action.
WMA Current Policy & Action
- The WMA and World Health Professional Alliance WHPA ‚Be Aware Toolkit’ to fight counterfeit medical products, in English, French, Spanish and Chinese
- WHPA Statement on Counterfeit Medical Products
- Call for Action- Asia region
- Call for Action- Central America, the Caribbean, Colombia and Mexico region
- Call for Action- North Africa region
- WMA/ WHPA mission briefing April 2009, Geneva