LifeBee Q&A: What to Expect in Italy for Serialization, Bollino, and Potential EU FMD Delay
Before the EU Falsified Medicines Directive (EU FMD) and Delegated Act on safety features was published in 2016, a few EU member states already had serialization and coding schemes in place for the life sciences industry, creating a “grandfathering” provision—all were offered an additional six years of transition time to meet the February 2019 deadline. Italy is one of the countries, and is considering how to address the provision.
We recently spoke with managing consultants at LifeBee, an organization with decades of consulting experience working with life sciences companies in Italy. In a conversation with two founding partners, Operations Manager Elvis Graffeo, and CEO Teresa Minero, we discussed how Italy’s existing tracking system works, the impact of EU FMD, and what insights supply chain companies can gain from others’ implementation experiences.
What customers does LifeBee work with, and what expertise do you provide?
LifeBee customers are both international and Italian life sciences companies. The top 10 Italian pharmaceutical companies are customers of ours. For them, we provide management consulting and system integration services. For international companies, we deliver mainly management consulting and project management. We deeply know all the regulated processes within life sciences companies—both in their productions and logistic sites and in their R&D department—providing solutions and consulting for their specific needs.
In Italy, 73 percent of the drug production is exported outside the country. In Europe, that’s second behind Germany. We have a lot of small and medium enterprises and about 10 important Italian pharma companies that are also active at the international level.
What is LifeBee’s level of experience in life sciences?
Our employees have more than 20 years of average work experience in life sciences. We deliver management consulting and system integration services in the areas of logistics, production, laboratories, quality assurance, pharmacovigilance, regulatory, and R&D. Four of us are current partners of LifeBee and we have all been here together since the beginning in 2004. We were part of a team working together in a multinational consulting company in life sciences before founding LifeBee.
What are some of the challenges that companies face with serialization in Italy?
The big challenge for sure is to be required to manage the Italian Bollino together with many other serialization and track and trace regulations arising all over the world. As said, 73 percent of the Italian drug production is exported, and not only for Europe. Europe is the first target market, but there are also companies that currently produce for the U.S., Turkey, China, Brazil, and many other countries.
Another challenge is the typical size of Italian companies, and their expenditure capabilities. Aside from the 10 big companies, others are small and medium enterprise and they must spend very carefully. The planning stage can be very long to define exactly what is needed and what will be delivered, but with regulation changing, they need to do it.
And last but not least, the challenge here in Italy is the language. International regulations and worldwide vendors require consultants and system integrators to be your neighbors, understanding your language and having someone that can easily come and stay with the user to support the business. Remote connections are useful, but the presence of people being on site is very much appreciated.
What has your experience been in working with some of these companies so far?
We’ve done many different strategy studies, including market, production data, and packaging lines analysis, as well as process flow analysis, user requirements, vendor selection, and project setup. In working with different pharma companies, we have seen that serialization was underestimated in the beginning, mainly targeting the equipment level and minimizing IT involvement. In the past 6 to 8 months, they changed their mind, so now they are more aware of the risks and criticalities of the implementation of a serialization system. When companies started to think about serialization last year, it was already a bit late. Now we see the increased interest and we are having a peak in our activities.
The national tracking system in Italy is called the Bollino. How does it work?
We have had the Bollino system since 2000, and it is already assuring a very good control of the drug supply chain in Italy. Every company, to be able to sell drugs in Italy, needs to manage the Bollino process, buying and transmitting to the Italian Ministry of Health’s database. The Bollino is a single label that is applied on each single packet and is uniquely identified. You have to follow a procedure in order to register with the legal entity for all your products. The Ministry of Health supervises the whole system.
It's a kind of track and trace, but without the real tracking of the single drug package. Each Bollino contains a serial number, but you must buy it and assign it to a lot. It goes on the package and then you have to communicate to the Ministry of Health to say, for example, “Okay, I have shipped this list of Bollino for this lot, and this list has been destroyed.”
The Bollino system is used to control the expenditure of the government for public health and monitor the whole supply chain. Every actor in the production and distribution of drugs, including pharmacies, has been tracked and recorded. So in Italy, each actor has been identified and monitored.
The Bollino allows Italy to qualify for “grandfathering” under EU FMD, offering a six-year grace period. How will this impact serialization?
If the production is not for Italy, companies should serialize the items, where required. For Italian-only product, companies are not asked to do anything yet, apart from the Bollino. But multi-market companies have certain packaging lines that need to be upgraded for serialization, while their other lines maybe don’t.
Is there concern in the industry that Italy could become a destination for storing counterfeit medicines during the possible EU FMD extension?
When should companies start preparing to address the EU FMD requirements?
What risks do companies face when they decide to postpone their planning?
Do you recommend aggregation, even though EU FMD doesn’t require it?
Companies are very careful about requirements in Russia and Brazil, because it seems they are moving towards full aggregation requirements.
When should companies in Italy start connecting to the European hub?
What are the biggest technical challenges of serialization implementation?
How can serialization boost business or operational efficiencies?
How will LifeBee and TraceLink help customers achieve EU FMD compliance?
Elvis Graffeo is Operations Manager and founding partner of LifeBee. He oversees planning and execution of the company’s professional services and directly delivers strategic studies.
Teresa Minero is CEO and founding partner of LifeBee, Chair of ISPE Italy and Vice Chair of the ISPE European Affiliate Council. As a founding member of LifeBee, Minero has been at the forefront of supporting life sciences companies achieve innovation together with regulatory compliance and business process improvements.