As the country holds its breath regarding Brexit negotiations and an uncertain future, the pharmaceutical industry is understandably starting to ask questions
Denny Bros provides a range of FMD-compliant pharmaceutical labelling solutions
One of the current concerns relates to the future of the EU’s Falsified Medicines Directive. The directive has been on the table for a number of years now as a crucial way of preventing fake drugs getting through the system. In early 2016, the European Commission published a delegated regulation that enforces the placement of two safety features on the packaging of most human medicines by no later than 9 February 2019.
These two features were a unique identifier — namely a two-dimensional barcode — and an anti-tampering device, and both would guarantee the authenticity of medicine for the benefit of patients and businesses alike. This was all progressing smoothly until the Brexit vote. My hope is that this will not change!
We were recently hit with the news that the European Medicines Agency (EMA), the watchdog for approving and monitoring the safety of drugs across the continent, was preparing to leave London in the wake of Britain triggering the process to exit the EU. Uncertain times to be sure, but our message is a far more certain one.
During the last few months, I have heard a few whispers about whether the Falsified Medicines Directive would still comply when negotiations are complete. From our point of view, we shouldn’t be worrying about politicians and sabre rattling. The directive is still clear and makes perfect sense in the fight against counterfeiters. It is still relevant and should still be adhered to — regardless of the political landscape.
My hope is that most companies will continue with the directive’s guidelines. Against that, our worry is that some won’t prioritise this as much as they should, that they will hide behind the Brexit negotiations and save taking action until much nearer February 2019. This would be wrong on so many levels.
The directive provides a perfect platform against fraudsters with the unique identification code logged onto a central database by the manufacturer and medicines verified at the point of dispensing across Europe. It is obviously going to help companies, both in terms of profits — through a better inventory and the ability to streamline a product — but also, most importantly, it will prevent fakes from getting onto the market.
We shouldn’t be adopting a wait-and-see approach and I remain confident that the majority of companies will act now rather than wait for the future. At Denny Bros, we provide a range of pharmaceutical labelling solutions that support compliance with the Falsified Medicines Directive regarding packaging for prescription drugs and high risk over-the-counter medicines. These include tamper-evident labels and the ability to incorporate a unique serial number to identify and authenticate individual products.
As with so many walks of life, Brexit will continue to pose challenges and concerns in the coming years. For one, Health Secretary Jeremy Hunt has indicated that he expects that the UK will leave the EMA organisation — a move that has led some to believe it will have a detrimental effect on British pharma. But that is for another day with so many unanswered questions remaining about the UK’s future relationship with the EU.
Regardless of the future, the standards set by EMA should be adhered to for safety reasons and common sense business practice. The same very much applies to the Falsified Medicines Directive.