- Medicine counterfeiting is first and foremost a crime against patients. By deliberately and deceitfully attempting to pass themselves off as something that they are not, namely, genuine approved medicines, counterfeit medicines pose a global public health risk, leading to resistance to treatment, illness, disability and even death.
- Counterfeit medicines threaten the full spectrum of legitimate medicines. They can be falsified versions of patented medicines, generic medicines or over-the-counter medicines and exist in all therapeutic areas (even traditional medicine). They range from medicines with no active ingredients to those with dangerous adulterations.
- Patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents. Purely commercial patent infringement disputes which may arise in the ordinary course of business should not be confused with disputes related to the fraudulent production of falsified versions of genuine approved medicines.
- All substandards are not counterfeits. A medicine which is approved and legally manufactured but does not meet all quality criteria is substandard, and may pose a significant health risk but should not be regarded as counterfeit. However, all counterfeits are, by their nature, at high risk of being substandard because they have not met recognized quality standards.
- The IFPMA calls on all stakeholders, including governments, health care providers, patients, the private sector and the World Health Organization (WHO), to take collaborative action and create a global policy environment that recognizes, prioritizes and effectively addresses the major threat to global health posed by counterfeit medicines.
In December 2004, a 22-year-old woman died in Argentina after being injected with a counterfeit iron supplement at a public hospital. Two other women also died after receiving the counterfeit product and another dozen women were less severely harmed. There is no doubt: counterfeit medicines pose a global public health risk, and there is a growing global epidemic that must be fought both locally and internationally. Information collected by the Pharmaceutical Security Institute confirms the increasing trend of counterfeiting of medicines. During 2009, 1,693 counterfeit medicine incidents were recorded by PSI, a 7% increase from the previous year.
Not only does the overall number of incidents reported every year continue to grow, but also the number of countries involved and number of incidents: 808 different pharmaceutical products were found in 118 countries during 2009, with as many as 43 different fake medicines involved in a single incident. PSI documented the arrest of 1,468 persons involved in counterfeiting, diversion or theft of pharmaceutical drugs worldwide during 2009, a 60% increase from the year before. This evidence clearly shows the criminal and global nature of this activity. Many authorities around the world are actively fighting counterfeiting, but there is still much to be done in terms of awareness and capacity building.
It is very difficult to tell the difference between real and counterfeit medicines. Patients, doctors and other medical staff often assume medicines are what the label says they are and do not even suspect that there may be anything wrong. Not only is it hard to detect counterfeit products in most cases, but there is also a lack of public awareness about counterfeit medicines and their potentially serious adverse effects. As a consequence, medicines that do not work or cause unusual side-effects are rarely reported, since symptoms (including deaths) are usually attributed to the disease.
The IFPMA is committed to safeguarding patients from the harmful effects of counterfeit medicines. Our member companies and associations work closely with the authorities to detect and test suspect products, pursue legal actions as appropriate, and are working with key health partners in education campaigns about the risks posed by counterfeits.
The IFPMA supports the definition of counterfeit medicines agreed at the WHO IMPACT meeting in Hammamet, Tunisia in December 2008 : The term counterfeit medical product describes a product with a false representation (a) of its identity (b) and/or source(c). This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components(d), with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches of, or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting. Notes: (a) Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behaviour shall be considered during the legal procedures for the purposes of sanctions imposed. (b) This includes any misleading statement with respect to name, composition, strength, or other elements (c) This includes any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder or steps of distribution (d) This refers to all components of a medical product
- Joint Position: EFPIA, IFPMA, PhRMA - Serialization and Product Verification – Helping to Secure the Legal Supply Chain for Greater Patient Safety
- IFPMA's 10 principles on counterfeit medicines (Infographic)
- Project Hope: China Safe Medicines Program
- IFPMA Statement under WHA 66 agenda item 17.1 on Substandard / spurious / falsely-labelled / falsified / counterfeit medical products
- IFPMA Statement: UNODC Commission on Crime Prevention and Criminal Justice, 22nd session
- News release: New report offers insights into the threats posed by falsified medicines
- UCL Matrix insight report: Falsified Medicines and the Global Public’s Health
- FIP-IFPMA Brochure: The threat of false friends
- 2012 Joint Industry Internet Statemet: Internet Sales and Access to Safe Medicines
- News Release: Global pharmaceutical industry calls for broad-based cooperation to fight online sales of counterfeit medicines around the world
- IFPMA Statement under WHA 65 agenda item 13.13 on Substandard / spurious / falsely-labelled / falsified / counterfeit medical products
- News Release: IFPMA launches Ten Principles on Counterfeit Medicines
- IFPMA Ten Principles on Counterfeit Medicines, 12 May 2010
- IFPMA Statement at 63rd World Health Assembly, 2010
- IFPMA Issue Brief Counterfeit Medicines, 9 October 2009
- IFPMA Statement at SEARO Regional Committee, 2009
- IFPMA Statement at 61st World Health Assembly, 2008
- La Convention Médicrime (Infographic)
- News Release: Fight the Fakes campaign
- Fight the Fakes (infographic)
- Joint News Release Fight the Fakes (internal link)
- Watch Out for Fake Medicines (youtube link)
- Geneva Pharma Forum: The Threat of False Friends - Fake Medicines (Dec. 2012)
- WHO Open Forum on IMPACT
- WHO’s Anti Counterfeiting Program
- Global Pharma Health Fund Minilab
- World Health Professional’s Alliance “Be Aware” campaign
- Counterfeit Medicines in Europe - EFPIA
- Chirac Foundation Initiative
- SANOFI: “BEWARE OF FAKE DRUGS!” campaign