Pharma Serialization: Going Totally Global Soon

World map.iStock.smallerOne of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”.  The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world.  The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market.  Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.

As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% of their global production will fall under some sort of serialization requirements in the coming years.  When you think about the countries that have announced serialization mandates, it includes most of the top markets in the world, but they only represent a small percentage of the total number of countries in the world.  Some surprising holdouts include Australia, New Zealand, South Africa, Mexico, Canada and Russia.  In all, there are well more than a hundred countries that currently do not have serialization requirements in the works.

Given the record of each country that does have a serialization mandate—each one different and some quite unique—manufacturers must be thankful that list has only a handful of countries on it.  However, all of this caused me to start thinking about the other 10% of global production volume for which serialization is NOT required.  The actual percentage will vary widely from company to company and will depend on the specific products and markets those products are sold into, but once the percentage requiring serialization exceeds maybe 60 to 70 percent, it seems to me that it would make more sense to just serialize ALL production, regardless of destination market and regardless of whether or not a country has a serialization mandate.  Beyond that percentage of production, it would just be too inefficient to serialize some and not serialize others.

But that’s just what I think, so I asked the question during the Q&A section of the session.  Sure enough, both company representatives indicated that they are planning to serialized all drugs regardless of market, as part of their programs over the next 3 years or so.

This means that the countries that currently do not have mandates are going to get serialized drugs from at least some (most?) companies anyway.  The most likely approach companies will use is to assign a GS1 GTIN to each drug package and encode it into a GS1 Datamatrix 2D barcode along with the lot number and expiration date, in alignment with the requirements in the U.S. and E.U., currently the two largest markets.  If a country has its own existing national drug identification code (like the Drug Identification Number, or “DIN” in Canada, for example), then a GS1 National Trade Identification Number (NTIN) can be added to the barcode to hold it.

In my view, this means that countries that do not currently have a serialization mandate will end up with better serialization of drugs than some countries that have specific mandates (like Brazil and China).  That’s because those counties have chosen largely to ignore global standards and have mandated their own proprietary schemes for applying a unique identifier to each pack.  That puts them off in left field by themselves.  Global standards will always be better than country-specific approaches when it comes to unique identification of products that are marketed globally because the more efficient global supply chains are, the more accuracy, more transparency, more security and lower costs you can expect within any one country.  And aren’t those the things serialization is all about?


3 thoughts on “Pharma Serialization: Going Totally Global Soon”

  1. Dirk,

    Excellent observation regarding the uniqueness of the serialization requirements for both China and Brazil. I loved how easy you described the shortcomings of their serialization approach. If only their governments representatives understood this…

    1. Pamela,
      Yeah, for a long time I wanted to write a much longer analysis of the serialization approaches of Brazil and China in an attempt to shame those governments into accepting a global standards-based approach, but I decided RxTrace is probably not the right forum for that. It’s probably too late for that anyway. The hope is that any country, like those I listed that do not (yet) have requirements, that might announce new requirements in the future will do their homework before producing home-grown requirements. We can only hope.


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