Pharmaceutical Serialization and Brand Management
A few days ago, as I was checking through my medicine locker, I found the first serialized package I have seen in public. The package was from an European brand, purchased May 2014 as I could read from the pharmacist’s note. As a technical person working on the field, I was, of course, interested to see how the code worked.
The code had an expiry date, a 8-digit lot number, a GTIN and a 15-digit serial number. I did a GTIN search on the code and ran right into a surprise: the code was assigned to an Indian pharmaceutical manufacturer.
To protect Indian pharmaceutical manufacturers reputation, India has set up the requirement to apply serialization to each pharmaceutical package exported since beginning of 2013. If the target market has a comparable serialization requirement of its own, Indian authorities permit the exporter to use that serialization instead of the Indian one.
This should, in fact, not be a surprise. The reality of today’s pharmaceutical manufacturing is that brands do not produce themselves all the products they sell. One brand has a modern, efficient factory to manufacture drug A, and it thus produces and in many cases also packages drug A for several other brands. In a similar way, the same brand sells drugs B and C, which are produced, and maybe packaged too, by other manufacturers. Each brand has a longer list of products on the market than it actually manufactures itself. Then there exist specialized contract manufacturers which do not sell drugs on their own brand at all.
Naming the Location of Production
In the European market, as the actual location of production is not public, consumers most often take for granted that the pharmaceutical brand manufactures its product itself, and close to home. Thus people have the regard that medicine from this brand ”N” comes from the UK, and those of this other brand ”P” from e.g. Germany. This is not the reality, as publicly shown in the case of ibuprofen early this week: another European pharmaceutical brand is recalling its premium ibuprofen product due to a failure of production integrity at a factory of a contract manufacturer in France.
Unlike the US system where the country of manufacturing the active substance needs to be printed on the package (”Made in …”), in Europe only the marketing authorization holder’s name and address (brand) is printed. That is usually the local branch office of the brand, responsible for adapting to the local language and other rules. No information is printed about the actual location of manufacture.
There is, however, some pressure for disclosing the country of actual origin as well. To support European (and its own) pharmaceutical manufacturing, France is pushing for regulation to show if inactive (excipients) or active ingredients of the medicine, production, or packaging happens inside or outside the European Economic Area.
The label proposed by France as an optional display of location where each stage of pharmaceutical production happens.
he Issue of Brand Integrity
What is clear, however, that for brand integrity, the package should give the consumer the same understanding of the brand what the consumer is expecting. Finding information about production in India, when one expects the product to be from a Western European country is detrimental to the brand. As people do not – in general – expect this, the damage to the brand can be substantial and spread fast in social media.
”Now, many of our fellow citizens do not have the same trust in the competent authorities of non-Member States as they do in the competent authorities of the European Union.” Notification 215/561/F (France)
One must remember that the location of the production also affects the consumer view on the corporate social responsibility. The working conditions of the manufacturer, environmental and tax issues are some of the aspects that do not necessarily influence the effectiveness and safety of the medicine, but do influence the corporate brand.
The case highlights the importance of the pharmaceutical brand owner’s understanding what is going on in global serialization and other regulation concerning pharmaceutical manufacturing and packaging. It is not only your local market’s serialization and country of origin regulation that you need to be keenly aware of, but also the regulation in the country of manufacture.
In the current case of the medicine package made in India for the European brand, the brand owner did not have any beforehand expectation of Indian serialization appearing on their subcontracted products. Otherwise, they should have arranged for a GTIN code of their own, not let the subcontractor use its code. Another question is if the local governmental medicines agency has approved the medicine package with the Indian serialization codes.
Now that the pharmaceutical brand knows about the situation, it is a question of cost/benefit analysis if the package should be modified. As the European pharmaceutical serialization and track & trace system becomes operational, the product can be marked with the European serialization codes, thus with a GTIN of the brand owner.
If you do not carefully oversee your contract manufacturing and your whole supply chain, you may run into situation where your brand is compromised – even if the product itself is of good quality.
Iiro Jantunen, D.Sc.
Chief Technology Officer
Servicepoint Ltd in Finland provides serialization and other types of automation to pharmaceutical industry as well as other industries in North-Eastern Europe
+358 44 7868 215