Product counterfeiting

An important aspect of our commitment to patient safety is ensuring the security of our medicines throughout their manufacturing and supply.

As part of this, we continuously work to combat the growing problem of counterfeit drugs that have the potential to affect the health and wellbeing of millions of people worldwide.

The World Health Organization (WHO) defines a counterfeit medicine as one that is deliberately and fraudulently mislabelled with respect to identity and/or source. Whilst the full extent of counterfeiting is difficult to quantify, the problem is worldwide and particularly prevalent in developing countries. WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that approximately 10 to 30% of medicines in emerging economies are counterfeit, with parts of Latin America, Asia and Africa even greater than that. By contrast, in countries with effective regulatory systems, counterfeits represent less than 1% of the market.

THE POTENTIAL DANGERS

Counterfeit medicines are unlikely to be as effective as genuine products and patients who take them may be at risk from a number of potentially dangerous health consequences, such as allergic reactions, unexpected side effects, or a worsening of their medical conditions. In extreme cases, counterfeit medicines could cause serious harm or even death.

OUR COMMITMENT

Whilst the counterfeiting of medicines is a complex problem with no single or absolute solution, we have a range of activities focused on protecting patients. These include:

• Using technologies that make our products easier to identify and more difficult for counterfeiters to copy.
• Monitoring market and supply chain activities to identify potential counterfeiting operations.
• Working with supply chain partners to address product security issues.
• Supporting increased awareness and education for patients and healthcare professionals.
• Alongside this, we continue to work with governments, regulatory authorities, law enforcement agencies and trade associations in collaborative efforts to ensure a secure drug supply chain.

We take immediate action when counterfeit AstraZeneca products are suspected. Suspected counterfeit samples are sent for analysis and authentication, and internally a global issues management team is convened. This team can comprise representatives from the local Marketing Company, Security, Legal, Quality Control, Medical, Regulatory, Supply, and Communications.

We are committed to the vigorous pursuit of anyone who makes, distributes or sells counterfeit versions of our products and we will seek prosecution of offenders to the fullest extent of the law.

We continue to explore other measures for combating counterfeit medicines and participate in a range of anti-counterfeiting public/private sector forums, including IMPACT and the Pharmaceutical Security Institute.

The content of this page was externally assured by Bureau Veritas, February 2009.

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At 20-Nov-2009 23:01  GMT