According to the Pharmaceutical Security Institute (PSI), pharmaceutical crime incidents are up 38% from 2020. Brand-name, generic, prescription, or over the counter medicines can all be falsified. Although counterfeiters often target lifestyle drugs, life-saving medicines are the fastest growing category of falsified medicines.

IFPMA acts against falsified medicines with vigor, and we campaign to persuade governments and the public to join us in action. Our members work closely with regulatory and enforcement officials, local authorities, and international bodies.

Falsified medicines put patients at great risk of being harmed or failing to receive the treatment they need. They can trigger additional illness, disability, resistance to authentic medicines, and even death.

Analysis of falsified medicines found samples that contained no active pharmaceutical ingredient (API), or even worse, contained the wrong API, the wrong dosage, or other dangerous substances.

On top of this, falsified medicines undermine patients’ trust in health systems, government agencies, health care providers, and manufacturers of genuine medicines.

Falsified medicines can be manufactured everywhere. But they travel and are sold more easily in countries where they can move across borders with less risk of detection and a country’s regulatory system is weak or non-existent.

While this is an issue worldwide, Africa is particularly at risk, with the greatest prevalence of falsified medicines.

A study published in The American Journal of Tropical Medicine and Hygiene found that 52.8% of all counterfeit medicines detected in the legitimate supply chain are life-saving-related treatments.

Africa accounts for 42% of all substandard and falsified medicines. Estimates suggest that, in some parts of Africa, up to 70% of medicines may be falsified or substandard.

Once falsified medicines enter the supply chain, they endanger lives across the globe. This international threat is magnified by the growing online market for falsified medicines.

The WHO defines falsified medicines as “medical products that deliberately/fraudulently misrepresent their identity/composition or source.

Intention to deceive is the key distinction between substandard and falsified medicines.

A substandard medicine is approved and legally manufactured but does not meet all quality criteria. Even though it may pose a significant health risk, it shouldn’t be regarded as falsified.

But falsified medicines are also, by definition, likely to be substandard.

As defined by the WHO Member States Mechanism, the term falsified can be used “when the authorized manufacturer deliberately fails to meet these quality standards or specifications due to misrepresentation of identity, composition, or source…”

IFPMA agrees with the WHO definition which is in line with our position, as stated in our Ten Principles.

IFPMA is at the forefront of a collective, integrated, multi-stakeholder fight against the complex health challenge of falsified medicines.

An effective response to the threat of falsified medicines demands collaboration by all stakeholders including patients, public health professionals, public and private organizations, pharmaceutical distributors, wholesalers, retailers, national regulatory and enforcement agencies, and the WHO.

It calls for strong national regulatory frameworks, effective legislation, robust awareness, and the prevention, control, detection, and monitoring of falsified medicines.

Dealing in falsified medicines is currently easy, cheap, and lucrative, with a low risk of being caught or punished.

If criminals are caught, the punishment for falsifying medicines doesn’t come close to reflecting the severity of the crime.

Fortunately, some authorities are taking measures to deal with falsified medicines that are, for the first time, appropriately tough. The Medicrime Convention is chief among them.

IFPMA is an observer to the Medicrime Convention drawn up by the Council of Europe, the first international treaty against counterfeit medical products and similar crimes involving threats to public health.

It helps enable effective prosecution, seizes proceeds from falsification, and ensures national and international cooperation to fight this crime.

The convention establishes as criminal offenses:

• Manufacturing counterfeit medical products
• Supplying, offering to supply, and trafficking in counterfeit medical products
• Falsifying documents
• Unauthorized manufacturing or supplying of medicinal products and placing medical devices on the market that do not comply with conformity requirements.

Public awareness and education are vital to addressing the impact of falsified medicines.

Effective awareness campaigns equip patients with the knowledge to help avoid this threat and safeguard their own health. But many patients around the globe have not received information about the threat of falsified medicines and the resulting health risk.

IFPMA helps inform patients and the global population about the risk posed by falsified medicines. We have developed impactful educational materials in partnership with like-minded organizations, which are designed to build productive awareness and avoid sensational claims.