Serialization In Life Science: A Business Perspective
By Liam O’Riordan, Serialization Director and Senior Consultant with Enterprise System Partners
If you haven’t begun making provisions for your serialization strategy, there are important points to consider. In 2010, The Centre for Medicines in the Public Interest in the United States predicted that counterfeit drug sales would reach $75 billion globally in 2010, an increase of more than 90 percent from 2005 based on estimates from WHO. Based on findings from the IMS Institute for Healthcare Informatics, the world pharmaceutical market was worth over $856 billion in 2010, meaning counterfeit medicines accounted for 8.76% of the global market.
The World Health Organization (WHO) classifies spurious/falsely-labeled/falsified/counterfeit medicines (SFFC) as “one which is deliberately and fraudulently mislabeled with respect to identity and/or source,” can “apply to both branded and generic products,” and “may include products with the correct ingredients or with the wrong ingredients, without active ingredient, with insufficient active ingredients or with fake packaging.” While estimations have been made, no global study has been carried out and so figures are speculative. However, it has been estimated that in over 50% of cases, medicines purchased over the internet from illegal sites that conceal their physical address[i] have been found to be counterfeit. In developing countries it is thought that between 30% and 40% of drugs in supply are counterfeit.[ii]
While the nature of the problem varies from country to country, pharmaceutical companies, governments and health agencies believe that the threat from organized crime can be curtailed by the implementation of serialization.
This White Paper has been prepared to inform the reader of the impact of executing serialization in life science packaging facilities and will cover the following areas:
- The Threats and Impact of Counterfeit Medicines
- Market Response
- Key Business Drivers to Serialization
- Serialization Strategy
- Best Practice