Mettler Toledo asked: Still uncertainty about serialisation

Serialisation solutions on packaging will become mandatory for the pharmaceutical industry next year. However, „Track & Trace“ also offers advantages to manufacturers who are not legally obliged to make greater efforts to protect their products. What is the level of knowledge about and willingness to use serialisation solutions in companies? Mettler Toledo PCE has conducted an industry-independent survey on this topic.

The pharmaceutical industry in particular is looking forward to next year. From 9 February, all pharmaceutical packaging must include safety features such as a First-opening protection and bear a unique serial number. This is stipulated by the EUAnti-Counterfeiting Directive of 2011 and the delegated EU Regulation No. 161 of 2016.

Product protection and counterfeit protection are also important for manufacturers who are not subject to the strict guidelines for the pharmaceutical industry. After all, experts estimate that around five per cent of global trade is accounted for by counterfeit products, reports Wirtschaftswoche. In Germany alone, this corresponds to a trade volume of 65 billion euros.

Managing directors and decision-makers answered 24 questions

Are companies generally prepared to engage more with the topic of Serialisation to deal with? Pharmacontrol Electronic GmbH (PCE) in Heppenheim, the Mettler Toledo business unit specialising in serialisation and product traceability, was interested in finding out.

Mettler Toledo PCE therefore conducted an industry-independent survey of managing directors and decision-makers in Europe and North America. Representatives from companies in the agricultural, chemical and food industries, branded goods manufacturers in the consumer goods sector and several other sectors answered a total of 24 questions in the guided interviews.

The pharmaceutical industry has a signalling function

Romulo Leon, Head of Global Sales and Market Management at Mettler Toledo PCE, comments on the results of the Mettler Toledo study in an exclusive interview with „packaging journal“.

pj: Why is the topic of counterfeit protection using serialisation so relevant right now?

Romulo Leon: The role model and pioneer is the Pharmaceutical industry. This has a signalling function that also has an impact on other sectors. As many implementation deadlines in the pharmaceutical sector approach and expire, high-performance solutions are available on the market that are just as suitable for pharmaceuticals as they are for smartphone batteries, cosmetics, high-priced food and other branded goods.

pj: How do companies view the topic of serialisation?

Romulo Leon: Our study shows that many companies, regardless of their sector, are looking into the topic or have even already launched pilot projects. Many companies are expecting new Serialisation requirements. A third would even welcome legal requirements, although there are region-specific differences here. While European companies show a lot of initiative, US companies tend to see legal requirements as the driving force. In addition to legislators, however, there are also other market players such as large retail companies that play a key role and could become the central growth driver for serialisation.

Greater transparency in the logistics chain has advantages

pj: What advantages do respondents expect from serialisation solutions?

Romulo Leon: Primarily, of course, the Protection against brand and product piracy. Think of brands with high status or value, such as luxury watches or perfumes in the high-price segment. With a individual serial number on the packaging or the product itself and a Tamper protection originals can be clearly distinguished from sophisticated counterfeits. The greater transparency of the logistics chain also offers advantages. Recall campaigns, for example, can be carried out in a much more targeted manner. Or let's take the chemical industry as an example. Consumer protection and quality management play a particularly important role here. Serialisation solutions support the collection of specific data, which is then passed on to downstream partners in the value or supply chain.

pj: Do the companies also provide for interaction with the customer in this process?

Romulo Leon: It is conceivable to involve the consumer. For example, the consumer can QR code and thus check whether his product is an original. Loyalty programmes for users who have registered their product would be another use case. However, our study shows that one-to-one communication with the customer plays more of a downstream role for companies.

pj: To put it bluntly: are companies ready for serialisation?

Romulo Leon: Yes and no. As mentioned at the beginning, the necessary technology is available on the market, but there is still a lot of work to be done. Need for clarification in the area of data management. Companies are aware that software is an important component of a serialisation solution, but many underestimate the effort required to interlink IT, production and quality management. In the course of the supply chain, the serialised product passes through the hands of many partners and suppliers. For effective end-to-end verification, these must also be integrated into the infrastructure - for example in the form of a cloud solution. This is still the biggest obstacle at the moment.

Cloud solutions are favoured

pj: Let's stay with IT. Is there a trend in terms of where the data is stored?

Romulo Leon: Slightly less than half prefer to store and manage serialisation data via an internal ERP integration. Also popular is a Software-as-a-Service solution (SaaS). In this variant of cloud computing, the SaaS provider provides the IT infrastructure and application software that the company accesses. In the study, slightly more than half of respondents were in favour of a cloud solution. What was particularly striking was that the responses regarding the accessibility of data were sometimes very contradictory. This reflects the uncertainty, but also the lack of knowledge among companies. There is still a huge need for clarification here.

pj: What does this mean in practice?

Romulo Leon: For us as a provider of such technologies, this means that we have to provide even more intensive advice and educational work to companies that want to venture into „Track & Trace“. For many companies, a partner who already has implementation experience in the field of serialisation is the be-all and end-all. This is also confirmed by our study.