AstraZeneca takes the problem of counterfeit medicines very seriously and understands this is a complex issue with no single or absolute solution.
The scale, complexity and covert nature of counterfeiting activity mean it is impossible to prevent all counterfeiting of our products. However, we aim to make it as difficult as possible for people to counterfeit our medicines.
Our Global Product Security strategy is to protect our patients from the dangers of counterfeit and illegally traded medicines by focusing on 3 key areas:
- Building strong, collaborative partnerships to strengthen enforcement, raise awareness and provide advocacy to increase the likelihood of regulation in this area being effective and efficient
- Working in enforcement to combat illegal activity through reporting and professional investigation of suspicions, and
- Securing our products through introduction of pack features and enhanced integrity of the end-to-end supply chain
Our Code of Conduct requires all our employees to report suspicions of possible illegal trade of medicines that come to their attention. The Code is supported by our Anti-counterfeiting and Illegal Trade Standard for Supply Chain Partners. This standard:
- Requires our partners (including suppliers and agents such as wholesalers or distributors, hospitals and retail pharmacies) to take the necessary steps to ensure the authenticity of the product through the end to end supply chain.
- Identifies the actions to be taken by AstraZeneca when a supply chain partner has been involved in counterfeiting or illegal trade, either knowingly or through lack of establishment of adequate controls. In the event that we find a supply chain agent or intermediary (ie suppliers, wholesalers, distributors) is suspected of involvement in counterfeiting or illegal trade, if specified criteria are satisfied, the relationship with the partner will usually be terminated.
We advocate through international trade associations (IFPMA, EFPIA, PhRMA), in-market trade associations, coalitions, alliances and patient groups aiming to strengthen regulations and raise awareness of the threat of counterfeit medicines amongst patients, healthcare professionals and regulators. AstraZeneca has been involved in the creation of the IFPMA “False Friends” video.
We work closely with other pharmaceutical companies through industry trade associations and through the Pharmaceutical Security Institute, a not-for-profit organisation, to identify cases of counterfeiting and coordinate investigations. We also collaborate with Interpol and local law enforcement agencies.
In addition, we conduct training and activities to raise awareness of counterfeiting and other types of illegal trade within our markets.
We include security features on our packs to enable us to distinguish legitimate products from counterfeits. We also work to improve security in our supply chains to inhibit the entry of counterfeit medicines. This includes:
- Strengthening our due diligence processes for new suppliers and distributors and adding product security clauses in our contracts with supply chain partners.
- Training our distributors to report any suspicions and to maintain secure distribution channels.
- Using seals and/or unique identification numbers on some packs to make it more difficult and expensive for counterfeiters to copy our packaging, and help identify packs which have been tampered with.
WHAT TO DO IF YOU HAVE A CONCERN
If you are concerned that the AstraZeneca medicine you have may not be genuine please contact your doctor(physician), pharmacist (or other healthcare professional) or your health authority. You can also contact AstraZeneca either through this website or in the country where you are based.
AstraZeneca urges patients and healthcare professionals to be alert to the possibility of counterfeiting. Patients can protect themselves from the risks associated with counterfeit medicines by obtaining all prescription and over-the-counter medicines from regulated licensed pharmacies. Patients should be vigilant when examining their medicines, paying attention to altered or unsealed packaging or changes in the product packaging.
Patients should be aware of the danger of purchasing prescription medicines on-line/via the Internet (the WHO note that the chances of receiving a counterfeit or substandard medicine are substantially increased by purchasing via unregulated sources on the internet.). Any patient wishing to purchase a prescription medicine via the internet should only use on-line pharmacies that are part of an accredited scheme (for example VIPPS, Verified Internet Pharmacy Practice Sites, in the US).
Frequently Asked Questions:
What is a counterfeit medicine?
The WHO (World Health Organisation) defines a counterfeit medicine as one that is deliberately and fradulently mislabelled with respect to identity and/or source.
Can counterfeit medicines be dangerous?
Counterfeit medicines pose a serious public health risk, three main concerns are:
- The counterfeit medicine may fail to provide effective treatment
- The counterfeit medicine may contain toxic substances which cause direct harm. There are reports of people dying as a result of taking counterfeit medicines
- The counterfeit medicine may contain some active ingredient but not enough to kill all disease agents, leading to the emergence of drug resisitant strains of disease.
How common is the counterfeiting of medicines?
There are various sources of statistics frequently referenced that speculate the extent of the problem globally, ranging from dollar values of the counterfeit medicines trade (in the region of tens of billions per year) to the number of deaths caused within various parameters relating to region and medicine type.
Some such sources are listed below:
- Centre for Medicine in the Public Interest
- Dr Paul Newton
- European Alliance for Access to Safe Medicines
- United Nations Office on Drugs and Crime
- World Health Organisation
It is impossible to estimate on a global scale how common counterfeiting is due to its nature; an illegal trade operating below the radar. It is not possible to know how many counterfeit medicines go undetected.
What types of medicines are counterfeited?
Counterfeits can be found for all types of medicines both branded and generic and in all regions throughout the globe. The sale and trade of counterfeit medicines is highly lucrative, and since counterfeiters typically face a variety of trademark, fraud, or money-laundering penalties as compared to more stringent penalties for other crimes, counterfeiting presents a low-risk, high reward opportunity for organized criminal groups. Counterfeiters have targeted AstraZeneca products as well as those of our peers. Our most counterfeited product globally is Meronem, an antibiotic used to treat acute life threatening infections.
What does AstraZeneca do when it finds a counterfeit medicine?
We have a small team of professionals recruited from various law enforcement agencies and they focus on identifying the main manufacturers and distributors of counterfeit medicines. They gather the evidence needed for a prosecution and pass this to relevant local law enforcement agencies, for example. All their work is recorded, fully auditable, and complies with globally acceptable standards of ethics and human rights. Our investigators have also been asked to act as witnesses during court cases, helping to secure convictions.
We work with our local markets and report counterfeit medicine cases to the relevant health authority. We will agree with our local market/health authority any in-market action, for example, we may alert doctors, pharmacists or wholesalers via letters or other channels. We rely on their cooperation and the local health authority to stop counterfeit medicines from reaching patients.
How does AstraZeneca identify counterfeit medicines?
We find counterfeits through the work of our investigators, by monitoring internet pharmacies, via reports from sales representatives, customs, other law enforcement agencies, healthcare professionals, patients and others.
We analyse suspect counterfeit samples and if the samples are found to be counterfeit our global team works with our local markets to report counterfeit medicine cases to the relevant health authority. We will agree with our local market/health authority any in-market action, for example, we may alert doctors, pharmacists or wholesalers via letters or other channels. We rely on their cooperation and the local health authority to stop counterfeit medicines from reaching patients.
We will vigorously pursue anyone who makes, distributes or sells counterfeit versions of our products and seek prosecution of offenders to the fullest extent of the law.
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