While action is heating up at the international level to tackle counterfeit drugs, Europe is making its own efforts to stop fake medicines from entering the legal supply chain.
An improbable cross-sector partnership is struggling to secure support for a pan-European system to keep counterfeits out. It’s improbable because it brings together not only manufacturers, wholesalers, and pharmacists, but also parallel traders — long treated by drug manufacturers as pariahs and even downright enemies.
It’s a struggle also because time is running out. This is not a spontaneous gesture by the private sector. It is a response to European Union rules adopted three years ago, that are due to come into full effect less than three years from now. There are no options: heavy new obligations will fall on each of these components of the medicines supply chain. If they fail, they face legal action for non-compliance, and still tougher obligations under additional legislation and systems that will be imposed on them by the authorities.
In June, the partnership issued a progress report, with an impressive plan of action and an even more impressive appeal for urgent action by the thousands of drug makers, wholesalers, pharmacists and traders across the continent.
The report listed the many tasks that must be accomplished for the system to work. Specifically, manufacturers will have to modify production lines to affix a 2D data matrix code on each pack that will bear the product code, batch or lot number, expiry date, and a unique randomised serial number. They will also have to apply tamper-evidence features to each pack. And they will have to report the data securely to a national data repository that they will also have to create, along with a Europe-level “hub” that can allow national systems to talk to each other.
Parallel traders will have to work with the system too, affixing new 2D codes and new tamper-evidence features to every medicine they re-label or repackage, and reporting the new data to the system.
There are costs as well as long lead-times attached to all these elements. Current estimates range from $100 million a year to double that sum, just for running the system. Above all, the cost question has caused a split among manufacturers, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) firmly inside the partnership, and the generics industry still hesitant on the outside.
The European Generic medicines Association (EGA) feels its members are being unfairly treated, since the products they produce are — it claims — so rarely counterfeited that the complex new EU requirements are disproportionate and excessive.
There are countless other questions to be resolved to get this system up and running in time for the 2017 deadline that the EU has set — and on which the Commission is refusing to make any concessions. By a profound irony, the one thing that all these efforts will have no impact at all on is the one thing that Operation Pangea VII was exclusively devoted to: illegal online drug sales.
The full version of this article will appear in the July issue of Pharmaceutical Executive.