Regulatory Systems

Counterfeit medicines

Counterfeit Medicines

Counterfeit medicines increasingly put patients and the general public at risk across the world. IFPMA is working closely with its members and with other key stakeholders to respond to this crime threatening global public health.

  • Medicine counterfeiting is first and foremost a crime against patients;
  • Counterfeit medicines can be falsified versions of patented, generic or over-the-counter medicines and exist in all therapeutic areas;
  • Counterfeit medicines undermine the health system by creating mistrust in healthcare providers;
  • Counterfeit medicines are everybody’s business!

Medicines and vaccines are meant to save and improve lives, while fake medicines put people’s lives and wellbeing at risk. Counterfeit medicines are the indirect and direct cause of death for thousands of people each year – whether they succumb to the illness they were attempting to heal or suffer adverse reactions to the often random ingredients that have made their way into the fake syrups, pills and vaccines. For example, it is estimated that 700,000 deaths per year occur due to counterfeit anti-malaria and anti-tuberculosis medicines.

Tackling counterfeit medicines requires a multi-disciplinary approach:

  • Regulatory system and legislative framework strengthening, data collection and policy research, and awareness raising.
  • Cooperation amongst all stakeholders across the pharmaceutical supply chain (public and private organizations, national regulatory and enforcement agencies, health professionals, patients, research-based and generic pharmaceutical manufacturers, drug distributors, wholesalers and retailers).


The lack of a globally approved definition of counterfeit medicines is one key reason impeding strong coordinated actions. The notion of counterfeit encompasses various meanings depending on the countries and the international organizations using it. To date, IFPMA has supported the definition of counterfeit medicines agreed at the WHO IMPACT meeting in 2008 (IMPACT Handbook, p.51) and anchored its activities to its “Ten principles on counterfeit medicines”, which can be found here.


Due to its criminal nature, determining the nature and scale of counterfeiting is difficult. This information is however paramount to ensure the development and implementation of appropriate policies and mitigation measures.

119 countries

have been impacted by pharmaceutical crime in 2014

450,000 preventable deaths

may occur from fake antimalarial medicines every year

Every 5 minutes a child dies

of malaria because of taking fake medicines

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