EU efforts

PharmTech: On an industry wide basis, what would you identify as the significant initiatives or programs in place or under consideration to address supply-chain security in Europe?

Johnson: The European Union's Directive on Falsified Medicinal Products will drive a number of supply-chain security enhancements when implemented (2). Some key focus areas include: unit level authentication, tamper evidence , increased regulation of Internet pharmacies, enhanced controls around importation of APIs and excipients, and increased penalties for supply-chain security crimes. There are also a number of trade organizations, consortiums, and coalitions working on various aspects of the problem in Europe, including some of those previously mentioned. I think we are getting closer to a broad recognition that supply-chain security is a global issue for a global market requiring better collaboration and harmonization.

PharmTech: How do these initiatives in the US and EU connect with activities in Asia (such as in China and India) and other international programs?

Johnson: Both the FDA strategic plan and the EU directive recognize international cooperation among regulators as a key to success in our new global marketplace. The International Conference on Harmonization (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (WHO–IMPACT) are examples of where this is happening. Law enforcement also collaborates internationally on supply-chain security issues through organizations such as Interpol.

Many of the organizations that I previously mentioned (i.e., Rx–360, PSI, and PSM) also recognize the global nature of the supply-chain security problem and are working to pull international stakeholders together. As an example PSM just created an Indian chapter, and Rx–360, which is already an international consortium, is working hard to increase engagement in Asia.