New regulation around serialisation and aggregation is forcing pharmaceutical companies worldwide to look for trustworthy vendors with a proven solution. World Pharmaceutical Frontiers talks to Frank Madden, CEO of Crest Solutions, Stéphane Van Hoof, CEO of VistaLink and Adriano Fusco, marketing director at Antares Vision, about their roles in the largest serialisation implementation team in Europe and what they bring to the market.
When the World Health Organisation released a study stating that up to 10% of all drug sales involved counterfeit medicines, it was evident that action needed to be taken. Criminal interference with the pharmaceutical supply chain compromises the integrity of the entire industry, not to mention the safety and confidence of end-users.
However, while there is widespread agreement on the necessity for visibility and traceability in pharmaceutical manufacturing, the serialisation of products and regulated storage of data is now one of the key challenges facing organisations worldwide. Companies are striving to create supply chains that are as visible and compliant as they are efficient, and are seeking the right partners to help them do so.
Turkey was the first country to implement legislation on the serialisation of drug packages. Its track and trace regulation required pharmaceutical companies to print unique barcodes on each of their individual cartons and cases. This was no simple feat. Existing packaging lines needed to be retrofitted with hardware and software that could print and inspect barcodes and create unique serial numbers on each and every product. Luckily, Italy-based Antares Vision was on hand to successfully install 100 aggregated lines in Turkey during 2011 alone. Such satisfactory customer experience has propelled the firm to the global stage and the Antares Tracking System (ATS) is the most widely employed solution for serialisation, aggregation and track and trace worldwide, with top pharma companies employing the solution across multiple sites for a number of years now.
Given the importance of fast, reliable and local support for customers, Antares has looked outwards to find partners that can support their systems in territories outside of their own. This is a vital factor for pharma manufacturers given that requirements for compliance will soon extend to a global standard as regulatory bodies worldwide, including the FDA, EFPIA and GS1, are united on the significant role played by track and trace in patient safety. Antares Vision has formed exclusive partnerships with sister companies Crest Solutions and VistaLink, experts in machine vision engineering who are tasking their highly skilled team of engineers with integrating and supporting the Antares Vision solution in Ireland, the UK and the Benelux. This partnership is of particular relevance given that 2013 is seen by most as the year for pharmaceutical companies to take definitive action to comply with impending regulations. Countries such as France and Turkey have already implemented regulations and now others are following suit, with requirements soon to be imposed in China, South Korea, Brazil, Argentina, the US and Europe, where a roadmap is currently being prepared. In California, the implementation of an e-Pedigree law from 1 January 2015 will be the first of its kind in the US and is likely to set the ball rolling, with other states expected to follow suit. "A number of countries are already working to ensure that all pharmaceutical products will be tracked using a unique number," says Frank Madden, CEO of Crest Solutions. "There's still a lot of work to be done; in Europe alone, 7,000 packaging lines will need to have new capacities."
So what does it take to achieve compliance? With so many countries set to introduce legislation, the possibility of regulatory arbitrage looms large.
Adriano Fusco, marketing director at Antares Vision says: "Having the right partners in place with the right expertise is vital. Pharma customers are looking for reliable and high-performance solutions, coupled with outstanding turnkey services to be provided locally. Moreover, multinational customers are seeking suppliers who are able to support their solutions on a worldwide basis, as they have plants scattered all over the world, and a unique solution can enhance their overall efficiency, from procurement to operations, providing great savings. For this reason, Antares' strategy is to gain a worldwide footprint, leveraging expert, reliable and loyal partners, able to deliver our solutions and offer support to customers in their markets.
"The first example of this strategy was in Turkey, where track and trace has been in force for some time," he continues. "Here, Antares gained nearly 50% of the market thanks to the reliability of the solution and the expertise of our local partner, which helped us to deploy over 100 full aggregation lines in less than a year. To successfully deploy systems in territories like this requires more than proven technology from the vendor, it requires great partners. After a strategic agreement to cover the US market in anticipation of impending regulation in California, Crest and Vistalink are the most recent additions to our network that now counts nearly 200 engineers worldwide.
"The areas covered by Crest and Vistalink represent 25% of the European production, therefore it was vital for us to team up with actual integrators who have the resources and expertise to cover such a large potential. Crest Solutions and VistaLink offer a unique proposition in that they are sister companies, and both market leaders in their territories. They have achieved a synergy of their key competencies that allows their customers to benefit from the expertise of their combined team of 50 engineers and their on-site support on a day-to-day basis."
As the leading company in the world for serialisation and aggregation solutions for track and trace, Antares Vision's ATS system has proven its functionality in a range of production environments as a solution that can cover every aspect of serialisation.
"Reliable solutions mean proven solutions," says Stephane Van Hoof, CEO of VistaLink. "Clients in the pharmaceutical industry don't like to be the guinea pig, so to speak, trying out something for the first time. That is what the markets in the UK, Ireland and the Benelux really gain by this partnership. The fact that Antares has had such deserved success in Turkey speaks multitudes, as this market has tried and tested solutions from many providers and Antares' ATS has come out on top time and time again. Antares has a proven solution and Crest and VistaLink have the knowledge, the experience and the resources to adapt and support the existing structure and reality of our customers to reflect the impending regulations.'
With new regulations being rolled out globally, the requirements for serialisation, aggregation, and track and trace mean that these changes are no longer a matter of if or even when. Companies have now turned their attention to how they will achieve compliance. This group confidently offers a proposition that combines the requirements of legislation, the need to distribute an established product worldwide, and the local knowledge and expertise to upgrade existing packaging lines and support new installations.
"That's the core of the partnership," says Madden. "We have the advantage of using a proven solution for serialisation and offering expertise and local support to our customers."
Collaborations like the one between Crest Solutions, VistaLink and Antares Vision will prove increasingly important for pharmaceutical companies who wish to achieve compliance across multiple sites while working with one proven solution and one team of experienced integrators.