With regard to packaging, the legislation stipulates that packaging should enable verification of authenticity, identification
of individual packs, and capacity to show tampering evidence. These features would be backed by a pan-European information-technology
network that is linked to a central database.
The exact nature of the safety features and the verification system, including any data-matrix characteristics and the size
of the centralized databank, still needs to be finalized. The details are likely to be a controversial because they could
trigger costly changes in packaging processes and equipment.
Already, the generic-drug sector is demanding exemptions from the scheme on the grounds that generic drugs are the least likely
to be counterfeited and that producers of high-priced drugs should bear most of the costs of the changes.
"Manufacturers that have medicines considered at high risk of being falsified should pay (for the costs of the system) by
the value of the medicine and not by the volume in the market," says Hugo Carradinha, EGA's senior manager for health economics
Tighter supply-chain controls for finished medicines as well as for raw materials will offer new openings to chemical distributors,
particularly those adhering to good distribution practice, which is also a requirement of the new legislation.
"This legislation is a positive development for us," says Michael Cooke, who is responsible for the pharmaceutical sector
at Univar, a leading chemicals distributor in Europe. "Traceability will become of even greater importance with pharma customers
needing to be assured that suitable GMP standards are applied to all materials. We've invested in creating robust traceability
Drug manufacturers will be seeking help from suppliers and distributors to reduce the extra costs of the legislation. "Funding
of the FMD is a key concern," says Marechal-Jamil. Already, the enforcement of the new regulations faces delays because of
a limited budget. Scarcity of funds could be major factor holding up the implementation of FMD as well.
Sean Milmo is a freelance writer based in Essex, UK