Five minutes at CPhI worldwide with …
CO/PH: How is the serialization project going at Recipharm?
Staffan Widengren: Formally the project started in 2013, but our company-wide serialization program began in 2016. We ordered almost 70% of the machines that we needed. The big challenge we have now is to take on board all the customers; we have around 200-250 customers to take on board. This has to happen before the end of 2018, since the European legislation will become binding in February 2019.
CO/PH: What about beyond Europe?
SW: Some countries such as South Korea, China and Saudi Arabia have already implemented serialization. The US legislation will come into force on the 27th November. However, this market has a grace period of one year. We do not know how it will be in Europe, everyone is working to reach compliance by 2019. Companies will have to report their serial numbers to the European Hub in Belgium that then connects to national systems. What I know however is that some countries are still behind on this work, and some national systems probably will not be ready by 2019.
CO/PH: So time is getting short and yet some countries are unprepared? Why?
SW: It is hard to say as there are so many factors at play. Some governments have perhaps not been aware of the complexity of the task of getting the National Medicines Verification Organisation (NMVO) system up and running, and in some instances, there may have been a lack of resources available. The main issue is that it is a huge investment that takes time and detailed preparation. The government/ authority in each European country needs to act in the event of NMVO delays to get the country system ready on time.
CO/PH: Is there a growing awareness about pharmaceutical counterfeiting? What developments do you see?
SW: In many developing countries serialization is not a requirement now or in the foreseeable future, and these are exactly the countries with more counterfeiting. But serialization can do little about, say, Internet black markets. It helps instead to strengthen the legal supply chain.
CO/PH: Is Recipharm doing something to increase awareness?
SW: We have put in a lot of effort to make sure we are ready for serialization regulations. In terms of raising awareness, we are working closely with our customers to ensure they understand the importance of preparing early. We also regularly present at industry events in order to share learnings and best practice from our serialization program.
CO/PH: What would you say to a customer about it?
SW: Oh, it’s easy. If you do not comply with this, you are out of the market!
CO/PH: Why should companies choose Recipharm?
SW: We will be ready for our customers and have invested significant time and resource to simplify their serialization challenges. As we were compliant in Saudi Arabia first, then the US, now our focus is on Europe – I would say 80% of the products we pack are for Europe now.
CO/PH: How is CPhI 2017 going?
SW: I am not at our booth so much; I am mainly visiting customers to answer the many questions they have on serialization, meeting with vendors and supporting our business managers in discussions relating to the serialization challenge.