17th September 2012: Domino held the first of a series of conferences on the impact of the EU Falsified Medicines Directive (FMD) on Wednesday where the need to take action now was emphasised by a range of expert speakers.
The event, which was held at Domino’s Cambridge headquarters, will be repeated across Europe in Paris, Barcelona and Frankfurt in the months leading up to the legislation’s implementation in 2013.
At the conference, Craig Stobie, Domino Global Life Sciences Sector Manager, warned that, while manufacturers have until 2016 to comply with the Directive’s requirements - which include applying sophisticated identification and authenticity features on the outer packaging of medicines - implementing the new systems effectively will require a complete business overhaul.
He said: “The legislation is impending and it is inevitable. While the EU has yet to confirm the detail of the legislation, many elements are already clear, such as the need to change the artwork on product packs and to introduce machine readable code, and the need to overhaul the business’s MIS and MRP systems. These elements will be standard, regardless of which framework is introduced.
“Manufacturers which are not ready for the new legislation will find that their business is fundamentally affected, while those that are compliant will have the competitive advantage and may gain market share.”
Other speakers at the conference, which also explored potential routes to compliance with the new legislation, included Grant Courtney, serialisation and security manager at GSK and representative for The European Federation of Pharmaceutical Industries and Associations (Efpia), Blue Sphere Health Chief Executive Mark Davison, Chief Executive and Founder of 3C Innovation Ian Haynes and GS1 Healthcare Sector Manager Roger Lamb.
Grant Courtney presented a potential route to FMD compliance developed by Efpia, an association made up of 31 national pharmaceutical associations and 38 companies, called the European Stakeholder Model (ESM). The ESM, which was piloted in Sweden from September 2009 to February 2010, uses a 2D barcode and four key data elements including a 14 digit manufacturer product code, a randomised unique serial number, an expiry date and batch number.
Ian Haynes, formerly associate engineering director at AstraZeneca, where he helped to implement a product serialisation pilot, also stressed the need to act now while telling of his own experiences.
He said: “Manufacturers have to get going because time is of the essence. Suppliers with the right kind of experience are thin on the ground and will be in huge demand as we move closer toward the date for mandatory compliance.”
The speakers also highlighted potential business benefits that could arise from introducing an effective product identification and authenticity system.
Ian Haynes said: “If done well, product authentication systems can help to improve operational effectiveness as people will quickly realise that having a linear production line makes life much easier. This is an opportunity for businesses to conduct a holistic review, to spring clean and tidy up what they are doing.”
Mark Davison added: “In the future perhaps we will see these product authentication systems adapt so that manufacturers are able to communicate directly with patients to offer prescription refill reminders, remote diagnostics, drug interactions warnings or even direct consultations with a doctor.”
Posted on Monday 18th November 2013