Pharmaceutical Serialization Is Doomed Unless We Implement A Big-Picture Approach

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

As I reviewed the articles for this month’s issue, one in particular got my attention to the point that I felt compelled to give my own opinion. Gail Dutton wrote an excellent article on page 34, “Planning For Serialization” — part two of a four-part serialization series. Dutton compares the issue of serialization in the pharmaceutical industry to Y2K back in 1999, with the difference being that the pharmaceutical industry has no defined parameters, whereas the computer industry did. In her article, she quotes an industry executive as saying that an industry consortium is appealing to both state and federal regulators for a single, national standard. When I read this statement, I was struck by the notion of this being what I can only describe as small-town thinking. The pharmaceutical industry is global, and as such, requires global standardization and interoperability. There are two models which could be used to demonstrate a solution — one comes from logistics and the other from banking.

Thanks to the International Civil Aviation Organization (ICAO), various airline functions have been standardized, such as Aeronautical Message Handling Systems (AMHS), machine readable passports, and three-letter airport codes. Imagine if these types of issues hadn’t been addressed? Pilots would be guessing if, how, and where to land a plane without the guidance of air traffic controllers. Your luggage would probably never get to its final destination, and getting through security screening would be even more unpleasant than it already is. In my opinion, if serialization is as big an issue as I have been hearing, then perhaps we should be looking to create an organization which would fall under the United Nations. We already have the WHO and the International Conference on Harmonization (ICH), but if we really want a global solution, we need a global authority for total industry buy in.

The banking industry has the other example I mentioned, and it pertains to the evolution of the credit card. Some people argue that the world needs an international currency. But, thanks to the credit card companies, we already have one. MasterCard is accepted by 28 million merchants in 210 countries, and Visa is accepted by about 30 million merchants in 170 countries. Global expansion of the credit industry has been fueled by the availability of global electronic networks which allow for distribution of funds and real-time management information systems with interoperability. Imagine if a retailer had to have a different machine to read every different type of possible credit card. The system would not function very efficiently.

These two examples represent standardization via two different models — push-down (airlines) and pull-through (banking). The banking model was successful because customers demanded the ability to have greater utilization of credit cards and industry accommodated, and everyone benefitted. Regulatory bodies, not customers, are clamoring for serialization. As such, I believe the only way we will see successful serialization on a global scale is for a unified, government-backed initiative. Think big picture.