The coding technology specialist gauged the opinions of pharmaceutical manufacturers, industry bodies and thought leaders on the challenges of meeting the directive. The survey highlighted a broad range of opinion around subjects spanning data repository funding, impact on Overall Equipment Effectiveness (OEE), implementation and aggregation.
According to Domnino, 80% of respondents think counterfeiting is as much of a problem for generics as it is for branded pharmaceuticals.
Opinion was divided on the question of who should bear responsibility for funding the data repositories associated with FMD compliance: 50% of respondents believe responsibility should lie with the Manufacturing Authorisation Holder, 30% argued the Marketing Authorisation Holder while the remainder suggested variously that regulators, local supervising authorities and manufacturers, packagers and other 'e-pedigree' stakeholders should contribute.
"The survey highlights just how far the industry still has to go in agreeing the best way to address the challenge posed by compliance with the Falsified Medicines Directive," said Craig Stobie, global life sciences sector manager at Domino. "Manufacturers are facing a tight deadline, yet there is still a significant degree of uncertainty surrounding the overall cost, particularly regarding funding arrangements for the European repository.
"There is also considerable concern about the impact of serialisation on OEE, with most manufacturers believing they are facing a challenging time both operationally and financially, with the total impact on their bottom line significant but as yet unquantifiable."
He added: "That said, there's no doubt that manufacturers recognise that serialisation is the best means at their disposal in the battle against falsified medicines and most are doing their utmost to meet the deadline, using all available expertise, including their equipment suppliers."
