FAQs - Anti-Counterfeiting

The World Health Organization defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.” Counterfeits may include products with the correct ingredients, but at a dosage that is either too high or too low, without active ingredients, with a manipulated expiry date or with fake packaging.

Some counterfeits look so similar to the genuine products that they deceive both health professionals and patients.

Counterfeit products don´t provide the expected therapeutic benefit. Thus, they pose a significant danger to patients everywhere. In the most severe cases, using counterfeit products can be life-threatening. A patient may be harmed by counterfeit products containing too much/too little of the active ingredient or by dangerous and toxic ingredients. Furthermore, counterfeit products may be contaminated, as they are often made in substandard and unregulated environments.

Counterfeit medical devices and diagnostic equipment also present a danger to human health.

Counterfeit medicines of all kinds can be found anywhere in the world. The Internet has accelerated the globalisation of counterfeiting. The growing number of medicines and medical devices purchased through online pharmacies makes it very difficult to trace the source of these products.

Some Internet pharmacies operate legally, of course. These pharmacies require prescriptions for drugs and operate in government-licensed facilities.

The best way to avoid counterfeits is to purchase prescription medicines or diagnostic devices from a reputable pharmacy, or physician. Only buy medical products from online pharmacies that are licensed in your country and that require prescriptions for such products.

Ask for the medical product in the manufacturer's original package, if it is available, and closely scrutinise the appearance of the product and its packaging. Patients should take steps to protect themselves from the threats posed by counterfeits. Be aware of unexpected adverse side effects or changes in packaging, labelling, colour, shape and taste, such as:

• packaging that appears to have been altered or compromised

• labels that aren’t straight or different from previous prescriptions

• pills or vials that are cracked, chipped or a different colour from earlier prescriptions

• taste that is different from earlier prescriptions, if the drug is taken orally

We cannot prevent counterfeiting, however, we have taken steps to increase the likelihood that counterfeit products can be identified.

Increasingly sophisticated technology makes it very difficult for patients to know if a medicine or diagnostic product is counterfeit or authentic.

In some cases, patients have noticed a different taste, consistency or appearance of products that are later identified as counterfeit. Sometimes a patient may have an unusual reaction to the counterfeit product. Typical abnormalities associated with the use of counterfeit diagnostic or medical devices could be performance related, such as suspicious results or application issues.

If you have any doubts about the authenticity of a medical product that you have purchased, save the product and contact your physician or pharmacist immediately. Further, if you suspect a medical product to be a counterfeit of a Roche product, please contact a local Roche office.

Several factors, such as globalisation and the Internet, provide ready access to attractive distribution channels for counterfeiters. Insufficient regulations governing the distribution of medicines also make it difficult to discover counterfeiters and, thus, to apply penalties.

Additionally, technological advances have made it easier to manufacture counterfeit medical products. This makes counterfeiting increasingly profitable for organised crime.

Beyond the significant negative impact counterfeits can have on the health and lives of patients who receive them, counterfeiting has significant social and economic ramifications.

Counterfeit medical products may not meet the strict quality standards imposed by authorities and legitimate manufacturers. So, the counterfeits may be either ineffective or contain harmful ingredients or both, placing consumers at serious risk. For counterfeit diagnostics and medical devices, possible consequences include inaccurate test results or compromised sterility.

In addition counterfeiting reduces the effectiveness of healthcare systems, health professionals, legitimate medicines and burdens governments with enforcement and other unnecessary medical costs.

In the end, everybody loses – patients, governments and the healthcare industry.

Counterfeit products can enter the market at many points in the distribution channel. So, there is no easy solution. Our goal is to ensure patient safety by maintaining the integrity of the supply chain.

National and international governments, authorities and organisations take primary responsibility for preventing and controlling counterfeiting. Roche, meanwhile, aims to guarantee product safety within its distribution system by working cooperatively with all stakeholders.

Collectively, these measures focus on strengthening accountability within global distribution systems. The aim is to increase enforcement, impose stricter sanctions and employ the latest technology against counterfeiting.